Dermatology News

TOPLINE:

The use of low-dose methotrexate among older adults with chronic kidney disease (CKD) was associated with a significantly increased risk at 90 days for serious adverse events requiring a hospital visit, compared with starting treatment with hydroxychloroquine.

METHODOLOGY:

• In a retrospective, population-based cohort study conducted in Ontario, researchers used linked administrative healthcare data to identify adults aged 66 years and older with CKD who were not undergoing dialysis and were new to medication; CKD was defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m².
• The study population included 2,309 individuals who began treatment with low-dose methotrexate (5-35 mg/week); they were matched with 2,309 individuals who began treatment with hydroxychloroquine (200-400 mg/day). The median age was 76 years, 69% were women, and rheumatoid arthritis was the most common diagnosis (56%).
• The primary outcome was the risk of a hospital visit at 90 days for a composite of serious adverse events that included myelosuppression, sepsis, pneumotoxic effects, or hepatoxic effects.

TAKEAWAY:

• Overall, 3.55% of methotrexate patients and 1.73% of hydroxychloroquine patients met the primary outcome (risk ratio, 2.05); these events occurred at a median of 49 days and 43 days after starting the medications for the two groups, respectively.
• In an analysis by eGFR category, the risk of serious adverse events at 90 days increased among patients with eGFR levels less than 45 mL/min per 1.73 m² (RR, 2.79).
• In a secondary comparison, the 90-day risk of serious adverse events was higher among methotrexate patients who began treatment with doses of 15-35 mg/week in comparison with those whose initial doses were 5 to less than 15 mg/week.

IN PRACTICE:

“Patients with CKD starting low-dose methotrexate should have active surveillance, including blood tests and chest radiographs performed regularly to monitor for signs of myelosuppression, infection, hepatotoxic effects, and pneumotoxic effects,” the researchers wrote.

SOURCE:

The lead author on the study was Flory T. Muanda, MD, of Western University, London, Ont. The study was published online in JAMA Network Open.

LIMITATIONS:

The observational design and lack of data on patients’ adherence to medications were among the limiting factors, as were the focus on older adults with CKD and the lack of assessment of the risk-benefit ratio of low-dose methotrexate.

DISCLOSURES:

The study was supported by the Institute for Clinical Evaluative Sciences. Dr. Muanda had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

The use of low-dose methotrexate among older adults with chronic kidney disease (CKD) was associated with a significantly increased risk at 90 days for serious adverse events requiring a hospital visit, compared with starting treatment with hydroxychloroquine.

METHODOLOGY:

• In a retrospective, population-based cohort study conducted in Ontario, researchers used linked administrative healthcare data to identify adults aged 66 years and older with CKD who were not undergoing dialysis and were new to medication; CKD was defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m².
• The study population included 2,309 individuals who began treatment with low-dose methotrexate (5-35 mg/week); they were matched with 2,309 individuals who began treatment with hydroxychloroquine (200-400 mg/day). The median age was 76 years, 69% were women, and rheumatoid arthritis was the most common diagnosis (56%).
• The primary outcome was the risk of a hospital visit at 90 days for a composite of serious adverse events that included myelosuppression, sepsis, pneumotoxic effects, or hepatoxic effects.

TAKEAWAY:

• Overall, 3.55% of methotrexate patients and 1.73% of hydroxychloroquine patients met the primary outcome (risk ratio, 2.05); these events occurred at a median of 49 days and 43 days after starting the medications for the two groups, respectively.
• In an analysis by eGFR category, the risk of serious adverse events at 90 days increased among patients with eGFR levels less than 45 mL/min per 1.73 m² (RR, 2.79).
• In a secondary comparison, the 90-day risk of serious adverse events was higher among methotrexate patients who began treatment with doses of 15-35 mg/week in comparison with those whose initial doses were 5 to less than 15 mg/week.

IN PRACTICE:

“Patients with CKD starting low-dose methotrexate should have active surveillance, including blood tests and chest radiographs performed regularly to monitor for signs of myelosuppression, infection, hepatotoxic effects, and pneumotoxic effects,” the researchers wrote.

SOURCE:

The lead author on the study was Flory T. Muanda, MD, of Western University, London, Ont. The study was published online in JAMA Network Open.

LIMITATIONS:

The observational design and lack of data on patients’ adherence to medications were among the limiting factors, as were the focus on older adults with CKD and the lack of assessment of the risk-benefit ratio of low-dose methotrexate.

DISCLOSURES:

The study was supported by the Institute for Clinical Evaluative Sciences. Dr. Muanda had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

The use of low-dose methotrexate among older adults with chronic kidney disease (CKD) was associated with a significantly increased risk at 90 days for serious adverse events requiring a hospital visit, compared with starting treatment with hydroxychloroquine.

METHODOLOGY:

• In a retrospective, population-based cohort study conducted in Ontario, researchers used linked administrative healthcare data to identify adults aged 66 years and older with CKD who were not undergoing dialysis and were new to medication; CKD was defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m².
• The study population included 2,309 individuals who began treatment with low-dose methotrexate (5-35 mg/week); they were matched with 2,309 individuals who began treatment with hydroxychloroquine (200-400 mg/day). The median age was 76 years, 69% were women, and rheumatoid arthritis was the most common diagnosis (56%).
• The primary outcome was the risk of a hospital visit at 90 days for a composite of serious adverse events that included myelosuppression, sepsis, pneumotoxic effects, or hepatoxic effects.

TAKEAWAY:

• Overall, 3.55% of methotrexate patients and 1.73% of hydroxychloroquine patients met the primary outcome (risk ratio, 2.05); these events occurred at a median of 49 days and 43 days after starting the medications for the two groups, respectively.
• In an analysis by eGFR category, the risk of serious adverse events at 90 days increased among patients with eGFR levels less than 45 mL/min per 1.73 m² (RR, 2.79).
• In a secondary comparison, the 90-day risk of serious adverse events was higher among methotrexate patients who began treatment with doses of 15-35 mg/week in comparison with those whose initial doses were 5 to less than 15 mg/week.

IN PRACTICE:

“Patients with CKD starting low-dose methotrexate should have active surveillance, including blood tests and chest radiographs performed regularly to monitor for signs of myelosuppression, infection, hepatotoxic effects, and pneumotoxic effects,” the researchers wrote.

SOURCE:

The lead author on the study was Flory T. Muanda, MD, of Western University, London, Ont. The study was published online in JAMA Network Open.

LIMITATIONS:

The observational design and lack of data on patients’ adherence to medications were among the limiting factors, as were the focus on older adults with CKD and the lack of assessment of the risk-benefit ratio of low-dose methotrexate.

DISCLOSURES:

The study was supported by the Institute for Clinical Evaluative Sciences. Dr. Muanda had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

NEW YORK – From clinical trials to textbooks, patients with darker skin types who have psoriasis overall – and Black patients in particular – are underrepresented, which might at least partially explain why clinicians are slow to recognize nail involvement, even when the skin disease has already been diagnosed, according to Shari R. Lipner, MD.

In a recently published review of 45 randomized controlled trials of therapies for nail psoriasis, almost all included information about the gender of the patients enrolled, but only about 35% reported race and/or ethnicity, Dr. Lipner, associate professor of dermatology, Weill Cornell Medical College, New York, said at the Skin of Color Update 2023. The proportion climbed to 59% in trials that included at least one study site in the United States, although representation of non-White patients in studies conducted in the United States was not proportional to the population (13.4% vs. 39.9%), said Dr. Lipner, senior author of the review .
 

Black patients largely unrepresented in photos

When an Internet search was conducted for images of nail psoriasis, the proportion of images fell as the number of the Fitzpatrick scale increased. Fitzpatrick skin types 1 or 2 represented 70% of the images, skin types 3 to 4 represented about 27%, leaving just 3% represented by darker skin types, Dr. Lipner said.

Ted Bosworth/MDedge News

“Unfortunately, things are not much better if you look at the dermatology and nail-specific textbooks. In fact, the percentages we see are almost identical,” said Dr. Lipner, noting that her review of images suggested that only about 3% of images in textbooks are of Fitzpatrick skin types 5 or 6, an obstacle for clinicians learning to recognize nail involvement in skin of color patients with psoriasis.

“We have written a couple of papers on this topic, including a call to action” in a letter to the editor in the Journal of the American Academy of Dermatology, Dr. Lipner noted. “To ensure access to safe and effective treatments for all patient populations,” she and her coauthor wrote, “we advocate the prioritized enrollment of racial and ethnic minority groups in psoriasis, PsA [psoriatic arthritis], and NP [nail psoriasis] clinical trials.”

Data from the 2009-2010 U.S. National Health and Nutrition Examination Survey (NHANES) confirms that psoriasis is less common in Blacks (1.9%) and Hispanics (1.6%) than Whites (3.6%). But these lower numbers still translate into substantial numbers nationally. Of those with psoriasis, the lifetime incidence of nail involvement has been variously estimated between 80% and 90%, Dr. Lipner said.

In about 10% of patients with psoriasis, nail involvement is isolated, occurring in the absence of skin lesions, a proportion that appears to be similar in Blacks and Whites according to Dr. Lipner.
 

Patient characteristics similar by race

In a study conducted at her own center, many of the characteristics of psoriasis were similar when those with a Fitzpatrick skin type 4 or higher were compared to those of 3 or lower. This included male-female distribution, smoking history, and presence of accompanying psoriatic arthritis. There was one discrepancy between lighter and darker skin.

“The big difference was that it took almost 3 years longer [on average] for darker skin to be diagnosed, and there was worse severity of disease,” Dr. Lipner said.

Like cutaneous manifestations of psoriasis, there are differences in appearance in the nail, many of which are simply produced by how skin color alters the appearance, such as the brownish hue of erythema in darker versus lighter skin. Dr. Lipner also noted that many of the features, such as keratosis, can be more severe in patients with darker skin types, but this is likely because of the delay in diagnosis.

The problem with overlooking nail psoriasis in patients of any skin color is the significant and independent adverse impact imposed by nail disease on quality of life, she added. She recounted the case of a 22-year-old Black patient whose nail psoriasis was overlooked even as she was being treated for her skin lesions.

“The diagnosis of nail psoriasis was missed for 3 years,” said Dr. Lipner, noting that the nail involvement was not trivial. “She had trouble doing her daily activities of life, but also, she was very embarrassed by her nails, not surprisingly.”

The problem of underrepresentation of Blacks in photos depicting nail diseases is not going unnoticed.

“Recently, there has been a concerted effort on the part of authors and editors to include more images of skin of color patients in published articles and textbooks,” said Jane S. Bellet, MD, professor of dermatology, Duke University, Durham, N.C.

An expert in nail disorders, particularly in children, Dr. Bellet said in an interview that this trend “must continue and increase in volume.” She said that the need for more images of nail disease in skin of color is not restricted to textbooks but includes “other learning materials, such as online atlases.”

Dr. Lipner and Dr. Bellet reported no potential conflicts of interest relative to this topic.

NEW YORK – From clinical trials to textbooks, patients with darker skin types who have psoriasis overall – and Black patients in particular – are underrepresented, which might at least partially explain why clinicians are slow to recognize nail involvement, even when the skin disease has already been diagnosed, according to Shari R. Lipner, MD.

In a recently published review of 45 randomized controlled trials of therapies for nail psoriasis, almost all included information about the gender of the patients enrolled, but only about 35% reported race and/or ethnicity, Dr. Lipner, associate professor of dermatology, Weill Cornell Medical College, New York, said at the Skin of Color Update 2023. The proportion climbed to 59% in trials that included at least one study site in the United States, although representation of non-White patients in studies conducted in the United States was not proportional to the population (13.4% vs. 39.9%), said Dr. Lipner, senior author of the review .
 

Black patients largely unrepresented in photos

When an Internet search was conducted for images of nail psoriasis, the proportion of images fell as the number of the Fitzpatrick scale increased. Fitzpatrick skin types 1 or 2 represented 70% of the images, skin types 3 to 4 represented about 27%, leaving just 3% represented by darker skin types, Dr. Lipner said.

Ted Bosworth/MDedge News

“Unfortunately, things are not much better if you look at the dermatology and nail-specific textbooks. In fact, the percentages we see are almost identical,” said Dr. Lipner, noting that her review of images suggested that only about 3% of images in textbooks are of Fitzpatrick skin types 5 or 6, an obstacle for clinicians learning to recognize nail involvement in skin of color patients with psoriasis.

“We have written a couple of papers on this topic, including a call to action” in a letter to the editor in the Journal of the American Academy of Dermatology, Dr. Lipner noted. “To ensure access to safe and effective treatments for all patient populations,” she and her coauthor wrote, “we advocate the prioritized enrollment of racial and ethnic minority groups in psoriasis, PsA [psoriatic arthritis], and NP [nail psoriasis] clinical trials.”

Data from the 2009-2010 U.S. National Health and Nutrition Examination Survey (NHANES) confirms that psoriasis is less common in Blacks (1.9%) and Hispanics (1.6%) than Whites (3.6%). But these lower numbers still translate into substantial numbers nationally. Of those with psoriasis, the lifetime incidence of nail involvement has been variously estimated between 80% and 90%, Dr. Lipner said.

In about 10% of patients with psoriasis, nail involvement is isolated, occurring in the absence of skin lesions, a proportion that appears to be similar in Blacks and Whites according to Dr. Lipner.
 

Patient characteristics similar by race

In a study conducted at her own center, many of the characteristics of psoriasis were similar when those with a Fitzpatrick skin type 4 or higher were compared to those of 3 or lower. This included male-female distribution, smoking history, and presence of accompanying psoriatic arthritis. There was one discrepancy between lighter and darker skin.

“The big difference was that it took almost 3 years longer [on average] for darker skin to be diagnosed, and there was worse severity of disease,” Dr. Lipner said.

Like cutaneous manifestations of psoriasis, there are differences in appearance in the nail, many of which are simply produced by how skin color alters the appearance, such as the brownish hue of erythema in darker versus lighter skin. Dr. Lipner also noted that many of the features, such as keratosis, can be more severe in patients with darker skin types, but this is likely because of the delay in diagnosis.

The problem with overlooking nail psoriasis in patients of any skin color is the significant and independent adverse impact imposed by nail disease on quality of life, she added. She recounted the case of a 22-year-old Black patient whose nail psoriasis was overlooked even as she was being treated for her skin lesions.

“The diagnosis of nail psoriasis was missed for 3 years,” said Dr. Lipner, noting that the nail involvement was not trivial. “She had trouble doing her daily activities of life, but also, she was very embarrassed by her nails, not surprisingly.”

The problem of underrepresentation of Blacks in photos depicting nail diseases is not going unnoticed.

“Recently, there has been a concerted effort on the part of authors and editors to include more images of skin of color patients in published articles and textbooks,” said Jane S. Bellet, MD, professor of dermatology, Duke University, Durham, N.C.

An expert in nail disorders, particularly in children, Dr. Bellet said in an interview that this trend “must continue and increase in volume.” She said that the need for more images of nail disease in skin of color is not restricted to textbooks but includes “other learning materials, such as online atlases.”

Dr. Lipner and Dr. Bellet reported no potential conflicts of interest relative to this topic.

NEW YORK – From clinical trials to textbooks, patients with darker skin types who have psoriasis overall – and Black patients in particular – are underrepresented, which might at least partially explain why clinicians are slow to recognize nail involvement, even when the skin disease has already been diagnosed, according to Shari R. Lipner, MD.

In a recently published review of 45 randomized controlled trials of therapies for nail psoriasis, almost all included information about the gender of the patients enrolled, but only about 35% reported race and/or ethnicity, Dr. Lipner, associate professor of dermatology, Weill Cornell Medical College, New York, said at the Skin of Color Update 2023. The proportion climbed to 59% in trials that included at least one study site in the United States, although representation of non-White patients in studies conducted in the United States was not proportional to the population (13.4% vs. 39.9%), said Dr. Lipner, senior author of the review .
 

Black patients largely unrepresented in photos

When an Internet search was conducted for images of nail psoriasis, the proportion of images fell as the number of the Fitzpatrick scale increased. Fitzpatrick skin types 1 or 2 represented 70% of the images, skin types 3 to 4 represented about 27%, leaving just 3% represented by darker skin types, Dr. Lipner said.

Ted Bosworth/MDedge News

“Unfortunately, things are not much better if you look at the dermatology and nail-specific textbooks. In fact, the percentages we see are almost identical,” said Dr. Lipner, noting that her review of images suggested that only about 3% of images in textbooks are of Fitzpatrick skin types 5 or 6, an obstacle for clinicians learning to recognize nail involvement in skin of color patients with psoriasis.

“We have written a couple of papers on this topic, including a call to action” in a letter to the editor in the Journal of the American Academy of Dermatology, Dr. Lipner noted. “To ensure access to safe and effective treatments for all patient populations,” she and her coauthor wrote, “we advocate the prioritized enrollment of racial and ethnic minority groups in psoriasis, PsA [psoriatic arthritis], and NP [nail psoriasis] clinical trials.”

Data from the 2009-2010 U.S. National Health and Nutrition Examination Survey (NHANES) confirms that psoriasis is less common in Blacks (1.9%) and Hispanics (1.6%) than Whites (3.6%). But these lower numbers still translate into substantial numbers nationally. Of those with psoriasis, the lifetime incidence of nail involvement has been variously estimated between 80% and 90%, Dr. Lipner said.

In about 10% of patients with psoriasis, nail involvement is isolated, occurring in the absence of skin lesions, a proportion that appears to be similar in Blacks and Whites according to Dr. Lipner.
 

Patient characteristics similar by race

In a study conducted at her own center, many of the characteristics of psoriasis were similar when those with a Fitzpatrick skin type 4 or higher were compared to those of 3 or lower. This included male-female distribution, smoking history, and presence of accompanying psoriatic arthritis. There was one discrepancy between lighter and darker skin.

“The big difference was that it took almost 3 years longer [on average] for darker skin to be diagnosed, and there was worse severity of disease,” Dr. Lipner said.

Like cutaneous manifestations of psoriasis, there are differences in appearance in the nail, many of which are simply produced by how skin color alters the appearance, such as the brownish hue of erythema in darker versus lighter skin. Dr. Lipner also noted that many of the features, such as keratosis, can be more severe in patients with darker skin types, but this is likely because of the delay in diagnosis.

The problem with overlooking nail psoriasis in patients of any skin color is the significant and independent adverse impact imposed by nail disease on quality of life, she added. She recounted the case of a 22-year-old Black patient whose nail psoriasis was overlooked even as she was being treated for her skin lesions.

“The diagnosis of nail psoriasis was missed for 3 years,” said Dr. Lipner, noting that the nail involvement was not trivial. “She had trouble doing her daily activities of life, but also, she was very embarrassed by her nails, not surprisingly.”

The problem of underrepresentation of Blacks in photos depicting nail diseases is not going unnoticed.

“Recently, there has been a concerted effort on the part of authors and editors to include more images of skin of color patients in published articles and textbooks,” said Jane S. Bellet, MD, professor of dermatology, Duke University, Durham, N.C.

An expert in nail disorders, particularly in children, Dr. Bellet said in an interview that this trend “must continue and increase in volume.” She said that the need for more images of nail disease in skin of color is not restricted to textbooks but includes “other learning materials, such as online atlases.”

Dr. Lipner and Dr. Bellet reported no potential conflicts of interest relative to this topic.

BERLIN – The open-label extension trials of deuruxolitinib for alopecia areata in adults show a persistent climb in response with the majority of patients achieving complete or near complete hair regrowth by 52 weeks, according to data presented at the annual congress of the European Academy of Dermatology and Venereology.

With response curves still climbing at follow-up to date, the results are “truly, truly remarkable,” said Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn.

Deuruxolitinib is a JAK inhibitor that has specificity for the 1 and 2 subtypes. At 24 weeks in the phase 3 THRIVE-AA1 and THRIVE-AA2 trials, presented at the American Academy of Dermatology annual meeting earlier this year, about 40% of those on the 12-mg twice-daily dose and 32% of those on the 8-mg twice-daily dose achieved a Severity of Alopecia Tool (SALT) score of ≤ 20%, signifying 80% or greater hair regrowth at 24 weeks. The placebo response was 0%.

Ted Bosworth/MDedge News

There were 741 patients available at 52 weeks for this on-going analysis. The mean SALT scores at entry exceeded 80%, meaning complete or near complete hair loss. The substantial proportion of patients who met the primary endpoint of SALT ≤ 20 at the end of the blinded period was encouraging, but Dr. King said that the 52-week results are important, not only showing the response was sustained, but that greater regrowth occurs over time.

“Alopecia takes time to treat,” said Dr. King, summarizing the lesson from these data. Moreover, he added that the long-term data are likely to under represent the absolute benefit even if no further growth is achieved with even longer follow-up. One reason is that missing long-term data were accounted for with a last-observation-carried-forward approach.

In other words, “this is the floor when considering response at 52 weeks,” Dr. King said. “In the real world, where adjunctive measures such as intralesional Kenalog [triamcinolone acetonide] or topical treatments are added, we are likely to do even better,” he added.
 

Adverse events remained low

Treatment-emergent adverse events remained low with “nothing particularly surprising,” Dr. King said. The rate of serious adverse events over 52 weeks was less than 2% on either dose of deuruxolitinib. The proportion of patients who discontinued treatment because of an adverse event was 0.7% in the 8-mg twice-daily arm and 1.1% in the 12-mg twice-daily arm.

Most approved oral JAK inhibitors carry a boxed warning based on a trial conducted with the relatively nonspecific tofacitinib. The trial enrolled older patients with rheumatoid arthritis at risk for thrombotic events, raising questions about its relevance to selective JAK inhibitors employed for other indications. There was only one thrombosis observed in the 52-week alopecia areata follow-up in a patient on deuruxolitinib. Dr. King noted that this patient, who was obese and was on the higher of the two doses, had multiple comorbidities, including systemic lupus erythematosus.

There were no major adverse cardiac events reported in long-term follow-up or cases of tuberculosis. The rate of opportunistic infections was 0.1% in the 8-mg twice-daily arm and 0.2% in the 12-mg twice-daily arm. Serious infections were observed in 0.6% and 0.4% of these two arms, respectively. There were four malignancies (0.5%) in each of the two study arms.

Of the side effects likely to be related to deuruxolitinib, acne was observed in about 10% of patients on either dose. The mechanism is unclear, but Dr. King reported this has been commonly observed with other JAK inhibitors.

Asked his opinion about the optimal starting dose of deuruxolitinib, Dr. King said, “in my mind, the efficacy of 8 mg is so impressive that I would not struggle at all in starting there,” noting that the higher dose could be considered with a slow or inadequate response.
 

Two JAK inhibitors are already approved

If approved for alopecia areata, deuruxolitinib will be the third JAK inhibitor available for this indication, following the recent approvals of baricitinib and ritlecitinib.

Calling JAK inhibitors “a major advance in the treatment of alopecia areata, particularly for those patients with severe, refractory disease,” Lynne Goldberg, MD, professor of dermatology at Boston University, and director of the hair clinic, Boston Medical Center, said that the proportion of patients with SALT scores ≤ 20 at 52-weeks is “huge.”

She is generally comfortable with the safety of the JAK inhibitors for alopecia areata.

“I believe that, in general, these medications are well tolerated in the alopecia areata population, particularly in otherwise healthy, young patients,” she said, indicating the benefit-to-risk ratio is particularly acceptable when disease is severe.

“This disease has tremendous emotional and functional implications, and many patients with severe or recurrent disease are willing to chance the side effects to live with a full head of hair,” she said. She added that well-informed patients can “make their own, individual assessment.”

Dr. King has financial relationships with approximately 20 pharmaceutical companies, including Concert Pharmaceuticals, which makes deuruxolitinib and provided funding for this study. Dr. Goldberg reports no financial conflicts relevant to this topic.

BERLIN – The open-label extension trials of deuruxolitinib for alopecia areata in adults show a persistent climb in response with the majority of patients achieving complete or near complete hair regrowth by 52 weeks, according to data presented at the annual congress of the European Academy of Dermatology and Venereology.

With response curves still climbing at follow-up to date, the results are “truly, truly remarkable,” said Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn.

Deuruxolitinib is a JAK inhibitor that has specificity for the 1 and 2 subtypes. At 24 weeks in the phase 3 THRIVE-AA1 and THRIVE-AA2 trials, presented at the American Academy of Dermatology annual meeting earlier this year, about 40% of those on the 12-mg twice-daily dose and 32% of those on the 8-mg twice-daily dose achieved a Severity of Alopecia Tool (SALT) score of ≤ 20%, signifying 80% or greater hair regrowth at 24 weeks. The placebo response was 0%.

Ted Bosworth/MDedge News

There were 741 patients available at 52 weeks for this on-going analysis. The mean SALT scores at entry exceeded 80%, meaning complete or near complete hair loss. The substantial proportion of patients who met the primary endpoint of SALT ≤ 20 at the end of the blinded period was encouraging, but Dr. King said that the 52-week results are important, not only showing the response was sustained, but that greater regrowth occurs over time.

“Alopecia takes time to treat,” said Dr. King, summarizing the lesson from these data. Moreover, he added that the long-term data are likely to under represent the absolute benefit even if no further growth is achieved with even longer follow-up. One reason is that missing long-term data were accounted for with a last-observation-carried-forward approach.

In other words, “this is the floor when considering response at 52 weeks,” Dr. King said. “In the real world, where adjunctive measures such as intralesional Kenalog [triamcinolone acetonide] or topical treatments are added, we are likely to do even better,” he added.
 

Adverse events remained low

Treatment-emergent adverse events remained low with “nothing particularly surprising,” Dr. King said. The rate of serious adverse events over 52 weeks was less than 2% on either dose of deuruxolitinib. The proportion of patients who discontinued treatment because of an adverse event was 0.7% in the 8-mg twice-daily arm and 1.1% in the 12-mg twice-daily arm.

Most approved oral JAK inhibitors carry a boxed warning based on a trial conducted with the relatively nonspecific tofacitinib. The trial enrolled older patients with rheumatoid arthritis at risk for thrombotic events, raising questions about its relevance to selective JAK inhibitors employed for other indications. There was only one thrombosis observed in the 52-week alopecia areata follow-up in a patient on deuruxolitinib. Dr. King noted that this patient, who was obese and was on the higher of the two doses, had multiple comorbidities, including systemic lupus erythematosus.

There were no major adverse cardiac events reported in long-term follow-up or cases of tuberculosis. The rate of opportunistic infections was 0.1% in the 8-mg twice-daily arm and 0.2% in the 12-mg twice-daily arm. Serious infections were observed in 0.6% and 0.4% of these two arms, respectively. There were four malignancies (0.5%) in each of the two study arms.

Of the side effects likely to be related to deuruxolitinib, acne was observed in about 10% of patients on either dose. The mechanism is unclear, but Dr. King reported this has been commonly observed with other JAK inhibitors.

Asked his opinion about the optimal starting dose of deuruxolitinib, Dr. King said, “in my mind, the efficacy of 8 mg is so impressive that I would not struggle at all in starting there,” noting that the higher dose could be considered with a slow or inadequate response.
 

Two JAK inhibitors are already approved

If approved for alopecia areata, deuruxolitinib will be the third JAK inhibitor available for this indication, following the recent approvals of baricitinib and ritlecitinib.

Calling JAK inhibitors “a major advance in the treatment of alopecia areata, particularly for those patients with severe, refractory disease,” Lynne Goldberg, MD, professor of dermatology at Boston University, and director of the hair clinic, Boston Medical Center, said that the proportion of patients with SALT scores ≤ 20 at 52-weeks is “huge.”

She is generally comfortable with the safety of the JAK inhibitors for alopecia areata.

“I believe that, in general, these medications are well tolerated in the alopecia areata population, particularly in otherwise healthy, young patients,” she said, indicating the benefit-to-risk ratio is particularly acceptable when disease is severe.

“This disease has tremendous emotional and functional implications, and many patients with severe or recurrent disease are willing to chance the side effects to live with a full head of hair,” she said. She added that well-informed patients can “make their own, individual assessment.”

Dr. King has financial relationships with approximately 20 pharmaceutical companies, including Concert Pharmaceuticals, which makes deuruxolitinib and provided funding for this study. Dr. Goldberg reports no financial conflicts relevant to this topic.

BERLIN – The open-label extension trials of deuruxolitinib for alopecia areata in adults show a persistent climb in response with the majority of patients achieving complete or near complete hair regrowth by 52 weeks, according to data presented at the annual congress of the European Academy of Dermatology and Venereology.

With response curves still climbing at follow-up to date, the results are “truly, truly remarkable,” said Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn.

Deuruxolitinib is a JAK inhibitor that has specificity for the 1 and 2 subtypes. At 24 weeks in the phase 3 THRIVE-AA1 and THRIVE-AA2 trials, presented at the American Academy of Dermatology annual meeting earlier this year, about 40% of those on the 12-mg twice-daily dose and 32% of those on the 8-mg twice-daily dose achieved a Severity of Alopecia Tool (SALT) score of ≤ 20%, signifying 80% or greater hair regrowth at 24 weeks. The placebo response was 0%.

Ted Bosworth/MDedge News

There were 741 patients available at 52 weeks for this on-going analysis. The mean SALT scores at entry exceeded 80%, meaning complete or near complete hair loss. The substantial proportion of patients who met the primary endpoint of SALT ≤ 20 at the end of the blinded period was encouraging, but Dr. King said that the 52-week results are important, not only showing the response was sustained, but that greater regrowth occurs over time.

“Alopecia takes time to treat,” said Dr. King, summarizing the lesson from these data. Moreover, he added that the long-term data are likely to under represent the absolute benefit even if no further growth is achieved with even longer follow-up. One reason is that missing long-term data were accounted for with a last-observation-carried-forward approach.

In other words, “this is the floor when considering response at 52 weeks,” Dr. King said. “In the real world, where adjunctive measures such as intralesional Kenalog [triamcinolone acetonide] or topical treatments are added, we are likely to do even better,” he added.
 

Adverse events remained low

Treatment-emergent adverse events remained low with “nothing particularly surprising,” Dr. King said. The rate of serious adverse events over 52 weeks was less than 2% on either dose of deuruxolitinib. The proportion of patients who discontinued treatment because of an adverse event was 0.7% in the 8-mg twice-daily arm and 1.1% in the 12-mg twice-daily arm.

Most approved oral JAK inhibitors carry a boxed warning based on a trial conducted with the relatively nonspecific tofacitinib. The trial enrolled older patients with rheumatoid arthritis at risk for thrombotic events, raising questions about its relevance to selective JAK inhibitors employed for other indications. There was only one thrombosis observed in the 52-week alopecia areata follow-up in a patient on deuruxolitinib. Dr. King noted that this patient, who was obese and was on the higher of the two doses, had multiple comorbidities, including systemic lupus erythematosus.

There were no major adverse cardiac events reported in long-term follow-up or cases of tuberculosis. The rate of opportunistic infections was 0.1% in the 8-mg twice-daily arm and 0.2% in the 12-mg twice-daily arm. Serious infections were observed in 0.6% and 0.4% of these two arms, respectively. There were four malignancies (0.5%) in each of the two study arms.

Of the side effects likely to be related to deuruxolitinib, acne was observed in about 10% of patients on either dose. The mechanism is unclear, but Dr. King reported this has been commonly observed with other JAK inhibitors.

Asked his opinion about the optimal starting dose of deuruxolitinib, Dr. King said, “in my mind, the efficacy of 8 mg is so impressive that I would not struggle at all in starting there,” noting that the higher dose could be considered with a slow or inadequate response.
 

Two JAK inhibitors are already approved

If approved for alopecia areata, deuruxolitinib will be the third JAK inhibitor available for this indication, following the recent approvals of baricitinib and ritlecitinib.

Calling JAK inhibitors “a major advance in the treatment of alopecia areata, particularly for those patients with severe, refractory disease,” Lynne Goldberg, MD, professor of dermatology at Boston University, and director of the hair clinic, Boston Medical Center, said that the proportion of patients with SALT scores ≤ 20 at 52-weeks is “huge.”

She is generally comfortable with the safety of the JAK inhibitors for alopecia areata.

“I believe that, in general, these medications are well tolerated in the alopecia areata population, particularly in otherwise healthy, young patients,” she said, indicating the benefit-to-risk ratio is particularly acceptable when disease is severe.

“This disease has tremendous emotional and functional implications, and many patients with severe or recurrent disease are willing to chance the side effects to live with a full head of hair,” she said. She added that well-informed patients can “make their own, individual assessment.”

Dr. King has financial relationships with approximately 20 pharmaceutical companies, including Concert Pharmaceuticals, which makes deuruxolitinib and provided funding for this study. Dr. Goldberg reports no financial conflicts relevant to this topic.

BERLIN – Tapinarof cream is highly effective, safe, and well tolerated for the treatment of atopic dermatitis (AD) in adults as well as children as young as 2 years of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.

If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.

Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.

In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.

For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).

For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).

The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.

The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.

“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
 

Itch control evaluated

In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).

Ted Bosworth/MDedge News

“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.

Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.

“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.

By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
 

Forty-eight–week follow-up planned

More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.

The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.

In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.

Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.

Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.

If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”

The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”

Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.

Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.

Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.

BERLIN – Tapinarof cream is highly effective, safe, and well tolerated for the treatment of atopic dermatitis (AD) in adults as well as children as young as 2 years of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.

If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.

Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.

In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.

For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).

For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).

The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.

The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.

“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
 

Itch control evaluated

In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).

Ted Bosworth/MDedge News

“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.

Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.

“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.

By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
 

Forty-eight–week follow-up planned

More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.

The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.

In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.

Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.

Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.

If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”

The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”

Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.

Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.

Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.

BERLIN – Tapinarof cream is highly effective, safe, and well tolerated for the treatment of atopic dermatitis (AD) in adults as well as children as young as 2 years of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.

If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.

Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.

In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.

For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).

For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).

The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.

The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.

“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
 

Itch control evaluated

In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).

Ted Bosworth/MDedge News

“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.

Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.

“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.

By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
 

Forty-eight–week follow-up planned

More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.

The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.

In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.

Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.

Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.

If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”

The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”

Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.

Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.

Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.

BERLIN – In separate trials conducted in patients with hidradenitis suppurativa (HS), two biologics that inhibit the activity of interleukin-17A (IL-17A) and IL-17F were associated with highly encouraging rates of control.

One of the trials evaluated a nanobody inhibitor, sonelokimab, a molecule with a substantially smaller size than traditional monoclonal antibodies (40 kilodaltons vs. 150 kilodaltons). After 24 weeks of treatment, the most effective of the two study doses almost doubled the proportion of patients with complete resolution of draining tunnels (41.1% vs. 23.8%; P < .05) relative to placebo.

“I think the size of sonelokimab is important,” Brian Kirby, MD, a consultant dermatologist at St. Vincent’s Hospital, Dublin, said at the annual congress of the European Academy of Dermatology and Venereology. “We think the smaller size results in better penetration of inflamed tissue,” he added, noting that penetration of abscesses, fistulae, and tunnels has been recognized in the past as a potential weakness of the larger monoclonal antibodies.

Ted Bosworth/MDedge News

The other set of anti-17-A/F set of data were generated by a pooled 48-week maintenance from the BE HEARD I and II trials with bimekizumab. The 16-week data from these two trials were presented at the annual meeting of the American Academy of Dermatology earlier this year.
 

IL-17A/F trials

Both the 16-week phase 2 data with sonelokimab and the 48-week pooled phase 3 maintenance data with bimekizumab were presented as late-breakers at the EADV Congress.

In the sonelokimab trial, called MIRA, 234 adults with HS were randomized in a 2:2:2:1 ratio to one of the two experimental arms, placebo, or a reference arm with the tumor necrosis factor (TNF) inhibitor adalimumab. Nearly 64% had Hurley stage II HS.

The primary endpoint was a 75% or greater reduction in total abscesses and nodules with no increase in draining tunnel count (HiSCR75) from baseline. Dr. Kirby said that this is more rigorous than the HiSCR50 endpoint more commonly used in HS clinical trials. Treatments were administered every 2 weeks for the first 8 weeks of a planned follow-up of 24 weeks and then every 4 weeks thereafter.

At 16 weeks, according to the data Dr. Kirby presented, both doses of sonelokimab were more active than placebo, but Dr. Kirby reported that the lower dose performed better for most objective endpoints.

For example, the HiSCR75 was reached by 43.3% of those randomized to the 120-mg dose (P < .001 vs. placebo), 34.8% of those randomized to the 240-mg dose (P <.01), and 14.7% of those randomized to placebo.

For HiSCR50, response rates were 65.7%, 53.0%, and 27.9%, for the 120-mg, 240-mg, and placebo arms, respectively. Again, both the lower dose (P < .001) and the higher dose (P < .01) were significantly superior to placebo.

On the International Hidradenitis Suppurativa Severity Score System (IHS4), which counts nodules and abscesses, score reductions were 19.3, 14.5, and 7.9 for the lower dose, higher dose, and placebo, respectively, with a greater statistical advantage for the lower relative to the higher dose over placebo (P <.001 vs. P <.01).

However, patient-focused outcomes were not necessarily greater for the lower dose. For the patient-completed measure, the Numerical Rating Scale 50% reduction in skin pain (NRS50), the proportion of patients responding at 12 weeks was numerically greater for the 240-mg dose (41.3%) than with the 120-mg dose (32.0%), although both reached the same statistical advantage (P < .001) over the 4.3% who reached this level of response on placebo.

For the Dermatology Life Quality Index (DLQI) and the Patient Global Impression of Severity (PGI-S), improvements from baseline were similar for the lower and higher dose, although there was a modest numerical and statistical advantage for the higher dose over placebo (P < .001 vs. P <.01).

The HiSCR50 (57.6%) and HiSCR75 (36.4%) responses were both lower for those randomized to the TNF inhibitor adalimumab relative to sonelokimab, but the smaller number of patients in this arm prohibited a statistical comparison.

Although oral candidiasis was more common among patients receiving either dose of sonelokimab than placebo, these were of mild to moderate severity. Dr. Kirby said that there were no unexpected safety issues, and sonelokimab was generally well tolerated.

The results are encouraging, but Dr. Kirby acknowledged that data are now needed to confirm that resolution of tunnels and fistulae is greater with a nanobody inhibitor of IL-17A/F than other targeted therapies. Even if this is validated, he said studies are needed to prove that the small relative molecule size is the reason behind the benefits.
 

Forty-eight–week bimekizumab data

From the pooled BE HEARD I and BE HEARD II maintenance data, the major message is that the robust responses observed at 16 weeks versus placebo were maintained at 48 weeks. More than 75% of patients retained a HiSCR50 response and more than 55% achieved a HiSCR75 response at the 48-week follow-up. The durable response was also reflected in other measures, according to Christos C. Zouboulis, MD, PhD, director of the department of dermatology, Brandenburg Medical School, Neuruppin, Germany.

“Improvements in disease severity were seen over time,” Dr. Zouboulis reported. “The majority of patients with severe HS at baseline shifted to mild to moderate disease according to the IHS4 classification.”

To the degree that both sonelokimab and bimekizumab target IL-17A/F, these data are mutually reinforcing. Dr. Kirby said that there is a sizable body of data implicating IL-17A/F in driving HS, and the activity of inhibitors in support the clinical value of IL-17A/F suppression.

On Oct. 18, shortly after the EADV meeting concluded, the Food and Drug Administration approved bimekizumab for treating moderate to severe plaque psoriasis, the first approved indication in the United States. In the European Union, it was approved for psoriasis in 2021, and for psoriatic arthritis and ankylosing spondylitis in June 2023.

Dr. Kirby has financial relationships with more than 10 pharmaceutical companies, including MoonLake, which is developing sonelokimab and sponsored the MIRA trial. Dr. Christos, president of the European HS Foundation, has financial relationships with multiple pharmaceutical companies, including UCB, which makes bimekizumab and provided funding for the BE HEARD I and II trials.

BERLIN – In separate trials conducted in patients with hidradenitis suppurativa (HS), two biologics that inhibit the activity of interleukin-17A (IL-17A) and IL-17F were associated with highly encouraging rates of control.

One of the trials evaluated a nanobody inhibitor, sonelokimab, a molecule with a substantially smaller size than traditional monoclonal antibodies (40 kilodaltons vs. 150 kilodaltons). After 24 weeks of treatment, the most effective of the two study doses almost doubled the proportion of patients with complete resolution of draining tunnels (41.1% vs. 23.8%; P < .05) relative to placebo.

“I think the size of sonelokimab is important,” Brian Kirby, MD, a consultant dermatologist at St. Vincent’s Hospital, Dublin, said at the annual congress of the European Academy of Dermatology and Venereology. “We think the smaller size results in better penetration of inflamed tissue,” he added, noting that penetration of abscesses, fistulae, and tunnels has been recognized in the past as a potential weakness of the larger monoclonal antibodies.

Ted Bosworth/MDedge News

The other set of anti-17-A/F set of data were generated by a pooled 48-week maintenance from the BE HEARD I and II trials with bimekizumab. The 16-week data from these two trials were presented at the annual meeting of the American Academy of Dermatology earlier this year.
 

IL-17A/F trials

Both the 16-week phase 2 data with sonelokimab and the 48-week pooled phase 3 maintenance data with bimekizumab were presented as late-breakers at the EADV Congress.

In the sonelokimab trial, called MIRA, 234 adults with HS were randomized in a 2:2:2:1 ratio to one of the two experimental arms, placebo, or a reference arm with the tumor necrosis factor (TNF) inhibitor adalimumab. Nearly 64% had Hurley stage II HS.

The primary endpoint was a 75% or greater reduction in total abscesses and nodules with no increase in draining tunnel count (HiSCR75) from baseline. Dr. Kirby said that this is more rigorous than the HiSCR50 endpoint more commonly used in HS clinical trials. Treatments were administered every 2 weeks for the first 8 weeks of a planned follow-up of 24 weeks and then every 4 weeks thereafter.

At 16 weeks, according to the data Dr. Kirby presented, both doses of sonelokimab were more active than placebo, but Dr. Kirby reported that the lower dose performed better for most objective endpoints.

For example, the HiSCR75 was reached by 43.3% of those randomized to the 120-mg dose (P < .001 vs. placebo), 34.8% of those randomized to the 240-mg dose (P <.01), and 14.7% of those randomized to placebo.

For HiSCR50, response rates were 65.7%, 53.0%, and 27.9%, for the 120-mg, 240-mg, and placebo arms, respectively. Again, both the lower dose (P < .001) and the higher dose (P < .01) were significantly superior to placebo.

On the International Hidradenitis Suppurativa Severity Score System (IHS4), which counts nodules and abscesses, score reductions were 19.3, 14.5, and 7.9 for the lower dose, higher dose, and placebo, respectively, with a greater statistical advantage for the lower relative to the higher dose over placebo (P <.001 vs. P <.01).

However, patient-focused outcomes were not necessarily greater for the lower dose. For the patient-completed measure, the Numerical Rating Scale 50% reduction in skin pain (NRS50), the proportion of patients responding at 12 weeks was numerically greater for the 240-mg dose (41.3%) than with the 120-mg dose (32.0%), although both reached the same statistical advantage (P < .001) over the 4.3% who reached this level of response on placebo.

For the Dermatology Life Quality Index (DLQI) and the Patient Global Impression of Severity (PGI-S), improvements from baseline were similar for the lower and higher dose, although there was a modest numerical and statistical advantage for the higher dose over placebo (P < .001 vs. P <.01).

The HiSCR50 (57.6%) and HiSCR75 (36.4%) responses were both lower for those randomized to the TNF inhibitor adalimumab relative to sonelokimab, but the smaller number of patients in this arm prohibited a statistical comparison.

Although oral candidiasis was more common among patients receiving either dose of sonelokimab than placebo, these were of mild to moderate severity. Dr. Kirby said that there were no unexpected safety issues, and sonelokimab was generally well tolerated.

The results are encouraging, but Dr. Kirby acknowledged that data are now needed to confirm that resolution of tunnels and fistulae is greater with a nanobody inhibitor of IL-17A/F than other targeted therapies. Even if this is validated, he said studies are needed to prove that the small relative molecule size is the reason behind the benefits.
 

Forty-eight–week bimekizumab data

From the pooled BE HEARD I and BE HEARD II maintenance data, the major message is that the robust responses observed at 16 weeks versus placebo were maintained at 48 weeks. More than 75% of patients retained a HiSCR50 response and more than 55% achieved a HiSCR75 response at the 48-week follow-up. The durable response was also reflected in other measures, according to Christos C. Zouboulis, MD, PhD, director of the department of dermatology, Brandenburg Medical School, Neuruppin, Germany.

“Improvements in disease severity were seen over time,” Dr. Zouboulis reported. “The majority of patients with severe HS at baseline shifted to mild to moderate disease according to the IHS4 classification.”

To the degree that both sonelokimab and bimekizumab target IL-17A/F, these data are mutually reinforcing. Dr. Kirby said that there is a sizable body of data implicating IL-17A/F in driving HS, and the activity of inhibitors in support the clinical value of IL-17A/F suppression.

On Oct. 18, shortly after the EADV meeting concluded, the Food and Drug Administration approved bimekizumab for treating moderate to severe plaque psoriasis, the first approved indication in the United States. In the European Union, it was approved for psoriasis in 2021, and for psoriatic arthritis and ankylosing spondylitis in June 2023.

Dr. Kirby has financial relationships with more than 10 pharmaceutical companies, including MoonLake, which is developing sonelokimab and sponsored the MIRA trial. Dr. Christos, president of the European HS Foundation, has financial relationships with multiple pharmaceutical companies, including UCB, which makes bimekizumab and provided funding for the BE HEARD I and II trials.

BERLIN – In separate trials conducted in patients with hidradenitis suppurativa (HS), two biologics that inhibit the activity of interleukin-17A (IL-17A) and IL-17F were associated with highly encouraging rates of control.

One of the trials evaluated a nanobody inhibitor, sonelokimab, a molecule with a substantially smaller size than traditional monoclonal antibodies (40 kilodaltons vs. 150 kilodaltons). After 24 weeks of treatment, the most effective of the two study doses almost doubled the proportion of patients with complete resolution of draining tunnels (41.1% vs. 23.8%; P < .05) relative to placebo.

“I think the size of sonelokimab is important,” Brian Kirby, MD, a consultant dermatologist at St. Vincent’s Hospital, Dublin, said at the annual congress of the European Academy of Dermatology and Venereology. “We think the smaller size results in better penetration of inflamed tissue,” he added, noting that penetration of abscesses, fistulae, and tunnels has been recognized in the past as a potential weakness of the larger monoclonal antibodies.

Ted Bosworth/MDedge News

The other set of anti-17-A/F set of data were generated by a pooled 48-week maintenance from the BE HEARD I and II trials with bimekizumab. The 16-week data from these two trials were presented at the annual meeting of the American Academy of Dermatology earlier this year.
 

IL-17A/F trials

Both the 16-week phase 2 data with sonelokimab and the 48-week pooled phase 3 maintenance data with bimekizumab were presented as late-breakers at the EADV Congress.

In the sonelokimab trial, called MIRA, 234 adults with HS were randomized in a 2:2:2:1 ratio to one of the two experimental arms, placebo, or a reference arm with the tumor necrosis factor (TNF) inhibitor adalimumab. Nearly 64% had Hurley stage II HS.

The primary endpoint was a 75% or greater reduction in total abscesses and nodules with no increase in draining tunnel count (HiSCR75) from baseline. Dr. Kirby said that this is more rigorous than the HiSCR50 endpoint more commonly used in HS clinical trials. Treatments were administered every 2 weeks for the first 8 weeks of a planned follow-up of 24 weeks and then every 4 weeks thereafter.

At 16 weeks, according to the data Dr. Kirby presented, both doses of sonelokimab were more active than placebo, but Dr. Kirby reported that the lower dose performed better for most objective endpoints.

For example, the HiSCR75 was reached by 43.3% of those randomized to the 120-mg dose (P < .001 vs. placebo), 34.8% of those randomized to the 240-mg dose (P <.01), and 14.7% of those randomized to placebo.

For HiSCR50, response rates were 65.7%, 53.0%, and 27.9%, for the 120-mg, 240-mg, and placebo arms, respectively. Again, both the lower dose (P < .001) and the higher dose (P < .01) were significantly superior to placebo.

On the International Hidradenitis Suppurativa Severity Score System (IHS4), which counts nodules and abscesses, score reductions were 19.3, 14.5, and 7.9 for the lower dose, higher dose, and placebo, respectively, with a greater statistical advantage for the lower relative to the higher dose over placebo (P <.001 vs. P <.01).

However, patient-focused outcomes were not necessarily greater for the lower dose. For the patient-completed measure, the Numerical Rating Scale 50% reduction in skin pain (NRS50), the proportion of patients responding at 12 weeks was numerically greater for the 240-mg dose (41.3%) than with the 120-mg dose (32.0%), although both reached the same statistical advantage (P < .001) over the 4.3% who reached this level of response on placebo.

For the Dermatology Life Quality Index (DLQI) and the Patient Global Impression of Severity (PGI-S), improvements from baseline were similar for the lower and higher dose, although there was a modest numerical and statistical advantage for the higher dose over placebo (P < .001 vs. P <.01).

The HiSCR50 (57.6%) and HiSCR75 (36.4%) responses were both lower for those randomized to the TNF inhibitor adalimumab relative to sonelokimab, but the smaller number of patients in this arm prohibited a statistical comparison.

Although oral candidiasis was more common among patients receiving either dose of sonelokimab than placebo, these were of mild to moderate severity. Dr. Kirby said that there were no unexpected safety issues, and sonelokimab was generally well tolerated.

The results are encouraging, but Dr. Kirby acknowledged that data are now needed to confirm that resolution of tunnels and fistulae is greater with a nanobody inhibitor of IL-17A/F than other targeted therapies. Even if this is validated, he said studies are needed to prove that the small relative molecule size is the reason behind the benefits.
 

Forty-eight–week bimekizumab data

From the pooled BE HEARD I and BE HEARD II maintenance data, the major message is that the robust responses observed at 16 weeks versus placebo were maintained at 48 weeks. More than 75% of patients retained a HiSCR50 response and more than 55% achieved a HiSCR75 response at the 48-week follow-up. The durable response was also reflected in other measures, according to Christos C. Zouboulis, MD, PhD, director of the department of dermatology, Brandenburg Medical School, Neuruppin, Germany.

“Improvements in disease severity were seen over time,” Dr. Zouboulis reported. “The majority of patients with severe HS at baseline shifted to mild to moderate disease according to the IHS4 classification.”

To the degree that both sonelokimab and bimekizumab target IL-17A/F, these data are mutually reinforcing. Dr. Kirby said that there is a sizable body of data implicating IL-17A/F in driving HS, and the activity of inhibitors in support the clinical value of IL-17A/F suppression.

On Oct. 18, shortly after the EADV meeting concluded, the Food and Drug Administration approved bimekizumab for treating moderate to severe plaque psoriasis, the first approved indication in the United States. In the European Union, it was approved for psoriasis in 2021, and for psoriatic arthritis and ankylosing spondylitis in June 2023.

Dr. Kirby has financial relationships with more than 10 pharmaceutical companies, including MoonLake, which is developing sonelokimab and sponsored the MIRA trial. Dr. Christos, president of the European HS Foundation, has financial relationships with multiple pharmaceutical companies, including UCB, which makes bimekizumab and provided funding for the BE HEARD I and II trials.

NEW YORK – Many inflammatory diseases, such as psoriasis and atopic dermatitis (AD), can present differently in patients with darker skin types, but it is the pigmentary changes themselves that are often a dominant concern for parents, according to pediatric dermatologist Candrice R. Heath, MD.

Skin diseases pose a greater risk of both hyper- and hypopigmentation in patients with darker skin types, but the fear and concern that this raises for permanent disfigurement is not limited to Blacks, Dr. Heath, assistant professor of pediatric dermatology at Temple University, Philadelphia, said at the Skin of Color Update 2023.

“Culturally, pigmentation changes can be huge. For people of Indian descent, for example, pigmentary changes like light spots on the skin might be an obstacle to marriage, so it can really be life changing,” she added.

In patients with darker skin tones presenting with an inflammatory skin disease, such as AD or psoriasis, Dr. Heath advised asking specifically about change in skin tone even if it is not readily apparent. In pediatric patients, it is also appropriate to include parents in this conversation.
 

Consider the parent’s perspective

“When you are taking care of a child or adolescent, the patient is likely to be concerned about changes in pigmentation, but it is important to remember that the adult in the room might have had their own journey with brown skin and has dealt with the burden of pigment changes,” Dr. Heath said.

For the parent, the pigmentation changes, rather than the inflammation, might be the governing issue and the reason that he or she brought the child to the clinician. Dr. Heath suggested that it is important for caregivers to explicitly recognize their concern, explain that addressing the pigmentary changes is part of the treatment plan, and to create realistic expectations about how long pigmentary changes will take to resolve.

As an example, Dr. Heath recounted a difficult case of a Black infant with disseminated hyperpigmentation and features that did not preclude pathology other than AD. Dr. Heath created a multifaceted treatment plan to address the inflammation in distinct areas of the body that included low-strength topical steroids for the face, stronger steroids for the body, and advice on scalp and skin care.

“I thought this was a great treatment plan out of the gate – I was covering all of the things on my differential list – I thought that the mom would be thinking, this doctor is amazing,” Dr. Heath said.
 

Pigmentary changes are a priority

However, that was not what the patient’s mother was thinking. Having failed to explicitly recognize her concern about the pigmentation changes and how the treatment would address this issue, the mother was disappointed.

“She had one question: Will my baby ever be one color? That was her main concern,” said Dr. Heath, indicating that other clinicians seeing inflammatory diseases in children with darker skin types can learn from her experience.

“Really, you have to acknowledge that the condition you are treating is causing the pigmentation change, and we do see that and that we have a treatment plan in place,” she said.

Because of differences in how inflammatory skin diseases present in darker skin types, there is plenty of room for a delayed diagnosis for clinicians who do not see many of these patients, according to Dr. Heath. Follicular eczema, which is common in skin of color, often presents with pruritus but differences in the appearance of the underlying disease can threaten a delay in diagnosis.

In cases of follicular eczema with itch in darker skin, the bumps look and feel like goose bumps, which “means that the eczema is really active and inflamed,” Dr. Heath said. When the skin becomes smooth and the itch dissipates, “you know that they are under great control.”

Psoriasis is often missed in children with darker skin types based on the misperception that it is rare. Although it is true that it is less common in Blacks than Whites, it is not rare, according to Dr. Heath. In inspecting the telltale erythematous plaque–like lesions, clinicians might start to consider alternative diagnoses when they do not detect the same erythematous appearance, but the reddish tone is often concealed in darker skin.

She said that predominant involvement in the head and neck and diaper area is often more common in children of color and that nail or scalp involvement, when present, is often a clue that psoriasis is the diagnosis.

Again, because many clinicians do not think immediately of psoriasis in darker skin children with lesions in the scalp, Dr. Heath advised this is another reason to include psoriasis in the differential diagnosis.

“If you have a child that has failed multiple courses of treatment for tinea capitis and they have well-demarcated plaques, it’s time to really start to think about pediatric psoriasis,” she said.
 

Restoring skin tone can be the priority

Asked to comment on Dr. Heath’s advice about the importance of acknowledging pigmentary changes associated with inflammatory skin diseases in patients of color, Jenna Lester, MD, the founding director of the Skin of Color Clinic at the University of California, San Francisco, called it an “often unspoken concern of patients.”

“Pigmentary changes that occur secondary to an inflammatory condition should be addressed and treated alongside the inciting condition,” she agreed.

Even if changes in skin color or skin tone are not a specific complaint of the patients, Dr. Lester also urged clinicians to raise the topic. If change in skin pigmentation is part of the clinical picture, this should be targeted in the treatment plan.

“In acne, for example, often times I find that patients are as worried about postinflammatory hyperpigmentation as they are about their acne,” she said, reiterating the advice provided by Dr. Heath.

Dr. Heath has financial relationships with Arcutis, Janssen, Johnson & Johnson, Lilly, and Regeneron. Dr. Lester reported no potential conflicts of interest.

NEW YORK – Many inflammatory diseases, such as psoriasis and atopic dermatitis (AD), can present differently in patients with darker skin types, but it is the pigmentary changes themselves that are often a dominant concern for parents, according to pediatric dermatologist Candrice R. Heath, MD.

Skin diseases pose a greater risk of both hyper- and hypopigmentation in patients with darker skin types, but the fear and concern that this raises for permanent disfigurement is not limited to Blacks, Dr. Heath, assistant professor of pediatric dermatology at Temple University, Philadelphia, said at the Skin of Color Update 2023.

“Culturally, pigmentation changes can be huge. For people of Indian descent, for example, pigmentary changes like light spots on the skin might be an obstacle to marriage, so it can really be life changing,” she added.

In patients with darker skin tones presenting with an inflammatory skin disease, such as AD or psoriasis, Dr. Heath advised asking specifically about change in skin tone even if it is not readily apparent. In pediatric patients, it is also appropriate to include parents in this conversation.
 

Consider the parent’s perspective

“When you are taking care of a child or adolescent, the patient is likely to be concerned about changes in pigmentation, but it is important to remember that the adult in the room might have had their own journey with brown skin and has dealt with the burden of pigment changes,” Dr. Heath said.

For the parent, the pigmentation changes, rather than the inflammation, might be the governing issue and the reason that he or she brought the child to the clinician. Dr. Heath suggested that it is important for caregivers to explicitly recognize their concern, explain that addressing the pigmentary changes is part of the treatment plan, and to create realistic expectations about how long pigmentary changes will take to resolve.

As an example, Dr. Heath recounted a difficult case of a Black infant with disseminated hyperpigmentation and features that did not preclude pathology other than AD. Dr. Heath created a multifaceted treatment plan to address the inflammation in distinct areas of the body that included low-strength topical steroids for the face, stronger steroids for the body, and advice on scalp and skin care.

“I thought this was a great treatment plan out of the gate – I was covering all of the things on my differential list – I thought that the mom would be thinking, this doctor is amazing,” Dr. Heath said.
 

Pigmentary changes are a priority

However, that was not what the patient’s mother was thinking. Having failed to explicitly recognize her concern about the pigmentation changes and how the treatment would address this issue, the mother was disappointed.

“She had one question: Will my baby ever be one color? That was her main concern,” said Dr. Heath, indicating that other clinicians seeing inflammatory diseases in children with darker skin types can learn from her experience.

“Really, you have to acknowledge that the condition you are treating is causing the pigmentation change, and we do see that and that we have a treatment plan in place,” she said.

Because of differences in how inflammatory skin diseases present in darker skin types, there is plenty of room for a delayed diagnosis for clinicians who do not see many of these patients, according to Dr. Heath. Follicular eczema, which is common in skin of color, often presents with pruritus but differences in the appearance of the underlying disease can threaten a delay in diagnosis.

In cases of follicular eczema with itch in darker skin, the bumps look and feel like goose bumps, which “means that the eczema is really active and inflamed,” Dr. Heath said. When the skin becomes smooth and the itch dissipates, “you know that they are under great control.”

Psoriasis is often missed in children with darker skin types based on the misperception that it is rare. Although it is true that it is less common in Blacks than Whites, it is not rare, according to Dr. Heath. In inspecting the telltale erythematous plaque–like lesions, clinicians might start to consider alternative diagnoses when they do not detect the same erythematous appearance, but the reddish tone is often concealed in darker skin.

She said that predominant involvement in the head and neck and diaper area is often more common in children of color and that nail or scalp involvement, when present, is often a clue that psoriasis is the diagnosis.

Again, because many clinicians do not think immediately of psoriasis in darker skin children with lesions in the scalp, Dr. Heath advised this is another reason to include psoriasis in the differential diagnosis.

“If you have a child that has failed multiple courses of treatment for tinea capitis and they have well-demarcated plaques, it’s time to really start to think about pediatric psoriasis,” she said.
 

Restoring skin tone can be the priority

Asked to comment on Dr. Heath’s advice about the importance of acknowledging pigmentary changes associated with inflammatory skin diseases in patients of color, Jenna Lester, MD, the founding director of the Skin of Color Clinic at the University of California, San Francisco, called it an “often unspoken concern of patients.”

“Pigmentary changes that occur secondary to an inflammatory condition should be addressed and treated alongside the inciting condition,” she agreed.

Even if changes in skin color or skin tone are not a specific complaint of the patients, Dr. Lester also urged clinicians to raise the topic. If change in skin pigmentation is part of the clinical picture, this should be targeted in the treatment plan.

“In acne, for example, often times I find that patients are as worried about postinflammatory hyperpigmentation as they are about their acne,” she said, reiterating the advice provided by Dr. Heath.

Dr. Heath has financial relationships with Arcutis, Janssen, Johnson & Johnson, Lilly, and Regeneron. Dr. Lester reported no potential conflicts of interest.

NEW YORK – Many inflammatory diseases, such as psoriasis and atopic dermatitis (AD), can present differently in patients with darker skin types, but it is the pigmentary changes themselves that are often a dominant concern for parents, according to pediatric dermatologist Candrice R. Heath, MD.

Skin diseases pose a greater risk of both hyper- and hypopigmentation in patients with darker skin types, but the fear and concern that this raises for permanent disfigurement is not limited to Blacks, Dr. Heath, assistant professor of pediatric dermatology at Temple University, Philadelphia, said at the Skin of Color Update 2023.

“Culturally, pigmentation changes can be huge. For people of Indian descent, for example, pigmentary changes like light spots on the skin might be an obstacle to marriage, so it can really be life changing,” she added.

In patients with darker skin tones presenting with an inflammatory skin disease, such as AD or psoriasis, Dr. Heath advised asking specifically about change in skin tone even if it is not readily apparent. In pediatric patients, it is also appropriate to include parents in this conversation.
 

Consider the parent’s perspective

“When you are taking care of a child or adolescent, the patient is likely to be concerned about changes in pigmentation, but it is important to remember that the adult in the room might have had their own journey with brown skin and has dealt with the burden of pigment changes,” Dr. Heath said.

For the parent, the pigmentation changes, rather than the inflammation, might be the governing issue and the reason that he or she brought the child to the clinician. Dr. Heath suggested that it is important for caregivers to explicitly recognize their concern, explain that addressing the pigmentary changes is part of the treatment plan, and to create realistic expectations about how long pigmentary changes will take to resolve.

As an example, Dr. Heath recounted a difficult case of a Black infant with disseminated hyperpigmentation and features that did not preclude pathology other than AD. Dr. Heath created a multifaceted treatment plan to address the inflammation in distinct areas of the body that included low-strength topical steroids for the face, stronger steroids for the body, and advice on scalp and skin care.

“I thought this was a great treatment plan out of the gate – I was covering all of the things on my differential list – I thought that the mom would be thinking, this doctor is amazing,” Dr. Heath said.
 

Pigmentary changes are a priority

However, that was not what the patient’s mother was thinking. Having failed to explicitly recognize her concern about the pigmentation changes and how the treatment would address this issue, the mother was disappointed.

“She had one question: Will my baby ever be one color? That was her main concern,” said Dr. Heath, indicating that other clinicians seeing inflammatory diseases in children with darker skin types can learn from her experience.

“Really, you have to acknowledge that the condition you are treating is causing the pigmentation change, and we do see that and that we have a treatment plan in place,” she said.

Because of differences in how inflammatory skin diseases present in darker skin types, there is plenty of room for a delayed diagnosis for clinicians who do not see many of these patients, according to Dr. Heath. Follicular eczema, which is common in skin of color, often presents with pruritus but differences in the appearance of the underlying disease can threaten a delay in diagnosis.

In cases of follicular eczema with itch in darker skin, the bumps look and feel like goose bumps, which “means that the eczema is really active and inflamed,” Dr. Heath said. When the skin becomes smooth and the itch dissipates, “you know that they are under great control.”

Psoriasis is often missed in children with darker skin types based on the misperception that it is rare. Although it is true that it is less common in Blacks than Whites, it is not rare, according to Dr. Heath. In inspecting the telltale erythematous plaque–like lesions, clinicians might start to consider alternative diagnoses when they do not detect the same erythematous appearance, but the reddish tone is often concealed in darker skin.

She said that predominant involvement in the head and neck and diaper area is often more common in children of color and that nail or scalp involvement, when present, is often a clue that psoriasis is the diagnosis.

Again, because many clinicians do not think immediately of psoriasis in darker skin children with lesions in the scalp, Dr. Heath advised this is another reason to include psoriasis in the differential diagnosis.

“If you have a child that has failed multiple courses of treatment for tinea capitis and they have well-demarcated plaques, it’s time to really start to think about pediatric psoriasis,” she said.
 

Restoring skin tone can be the priority

Asked to comment on Dr. Heath’s advice about the importance of acknowledging pigmentary changes associated with inflammatory skin diseases in patients of color, Jenna Lester, MD, the founding director of the Skin of Color Clinic at the University of California, San Francisco, called it an “often unspoken concern of patients.”

“Pigmentary changes that occur secondary to an inflammatory condition should be addressed and treated alongside the inciting condition,” she agreed.

Even if changes in skin color or skin tone are not a specific complaint of the patients, Dr. Lester also urged clinicians to raise the topic. If change in skin pigmentation is part of the clinical picture, this should be targeted in the treatment plan.

“In acne, for example, often times I find that patients are as worried about postinflammatory hyperpigmentation as they are about their acne,” she said, reiterating the advice provided by Dr. Heath.

Dr. Heath has financial relationships with Arcutis, Janssen, Johnson & Johnson, Lilly, and Regeneron. Dr. Lester reported no potential conflicts of interest.

Telehealth has been a boon for modern-day patients, allowing people who might have difficulty accessing in-person appointments to continue seeing their physicians. But how many patients actually follow through on their physician’s recommendations afterward?

A new study suggests that many patients don’t complete recommended diagnostic tests or specialist referrals after appointments with their primary care physicians, especially when those appointments take place via telehealth.

Investigators retrospectively examined test and referral orders for more than 4,000 patients to see how many complied with recommendations to have a colonoscopy, consult a dermatologist for a suspicious skin lesion, or undergo a cardiac stress test.

Completion of a recommended test or specialty referral was termed “diagnostic loop closure.” In particular, the researchers wanted to compare loop closure after telehealth versus in-person visits.

Rates of loop closure were low across all visit modalities but were lower for tests and referrals ordered during telehealth visits, compared with in-person visits – especially for colonoscopies.

“The take-home message for practicing clinicians is that they should be especially aware of follow-up for tests or referrals ordered during telehealth visits,” said corresponding author Maëlys Amat, MD, MBA, a primary care physician at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston.

The study was published online on in JAMA Network Open.
 

‘Unintended side effects’

“Diagnostic errors present a huge safety concern, impacting many patient lives and costing the health care system billions of dollars, said Dr. Amat, who is also an instructor at Harvard Medical School.

“Telehealth utilization increased rapidly during the COVID pandemic, and although there are clear benefits to utilizing telehealth, our team sought to investigate unintended side effects of this technology and highlight opportunities for improvement,” she said.

To investigate the question, the researchers reviewed medical records of 4,113 patients, with a mean age of 59 years, at two Boston-based primary care sites: an urban hospital–based primary care practice and an affiliated community health center.

Orders for tests or referrals in both centers were placed electronically through the medical record. During an in-person visit, the patient was handed a form with a phone number to call to schedule the test or referral. Patients with limited English proficiency or complex needs may have received help with the scheduling the referral during check-out.

For telehealth visits, the clinician gave the patient the phone number to call to schedule the test or referral during the visit itself. In all scenarios, patients did not receive communication after the visit reminding them about the referral or test.

A loop was considered “closed” if the orders were completed within 365 days, 90 days, or 45 days for colonoscopy, dermatology visits, or cardiac stress testing, respectively.

Of the tests, 52.4% were ordered during an in-person visit, 27.8% were ordered during a telehealth visit, and 19.7% were ordered without a visit.

Tracking systems, virtual checkout

Fewer than half of the orders (42.6%) placed during a telehealth visit were completed within the designated time frame, compared with 58.4% of the orders placed during an in-person visit and 57.4% placed without a visit.

Patients who had telehealth visits were roughly half as likely as those who had in-person visits to close the loop on high-risk tests and referrals, even in an analysis that adjusted for test type, patient demographic characteristics, comorbidities, clinical site, clinician type, and patient engagement (odds ratio, 0.55; 95% confidence interval, 0.47-0.64).

Only 39.8% of colonoscopy referrals ordered during a telehealth visit were completed during the 365-day time period, compared with 56.9% ordered during an in-person visit and 56.7% ordered without a visit.

Follow-through with dermatology referrals within 90 days was roughly the same across all types of visits (63.1% for telehealth, 61.5% for in-person, and 62.9% for no visit). No significant differences were found between telehealth and in-person visits or orders placed without a visit.

Although patients seen via telehealth were less likely than those seen in person to follow through on cardiac stress tests within the 45-day window (59.1% vs. 63.2%), this difference didn’t reach statistical significance.

“Ideally, clinicians would implement automatic tracking systems to help ensure that an ordered test or referral is completed,” Dr. Amat commented. “However, if these systems aren’t yet in place, we strongly encourage clinicians to create their own work flows for tracking tests to completion.”

Additionally, “clinicians should consider implementing a virtual checkout system, similar to what is done during in-person visits, to help patients better understand recommended next steps,” she continued.

Other potentially helpful ways to improve loop closure include automatic tracking for outstanding tests, interventions such as telephone outreach to patients, automated text and email reminders, and the use of referral managers – especially in remote, rural areas or for “disadvantaged patients with limited health care access and literacy.”
 

Education is key

Kisha Davis, MD, MPH, member of the board of directors of the American Academy of Family Physicians, said in an interview that being able to see a provider virtually can make the difference between a person receiving or not receiving medical care. She regards telehealth as another tool in the toolkit her practice offers to provide comprehensive health care.

Dr. Davis, a family physician in Gaithersburg, Md., who wasn’t involved with the study, described a patient with hypertension who was an Uber driver. “During the pandemic, Uber rides were down, and he couldn›t afford to pass up any opportunities, so he pulled over to the side of the road after one of his rides, did his telehealth visit, reviewed his medications, and went on to his next ride.”

The key is to make sure that patients receive adequate follow-up from the office, which Dr. Davis arranged for this patient.

She noted that telehealth “is best done if there’s an established physician-patient relationship but harder to accomplish successfully if you’ve only met the patient on telehealth and never in person.”

The study didn’t specify whether the physicians had an established relationship with their patients.

During the checkout process after an in-person appointment, patients often receive a sheet of paper with the follow-up referrals. “I can see where patients are less likely to follow through if they don’t have someone handing them that paper,” she said.

In her practice, patients’ charts are color-coded “to keep track and make sure it’s not just the ‘squeaky wheels’ that get all the attention,” she said. “The onus is on the physician and the practice, in today’s world of value-based care, to make sure that patients who don’t come into the office are getting the care they need.”

This is facilitated by a “system of care coordination” in which the office team – such as a nurse or medical assistant – follows up with patients to see if they’ve “gotten everything done without barriers,” Dr. Davis said. “Did they have trouble filling that prescription? Did they have difficulty with the referral? Or do they not think it’s necessary – for example, a patient might not go to physical therapy because the injury has improved.”

Dr. Davis wasn’t surprised that patients were less likely to close the loop for colonoscopies compared with seeking out a stress test or treatment for skin lesions.

“People who have a skin lesion may be concerned about their appearance or about skin cancer, and people who need a stress test may have had cardiac symptoms or be worried about their heart.” But a routine screening such as a colonoscopy may not mobilize the patient’s concern to the same degree.

“Additionally, a colonoscopy has an ‘ick factor,’ so there aren’t a whole lot of people who are jumping to have the procedure done.” She suggested considering newer FDA-approved stool tests to screen for colon cancer.

Dr. Amat and Dr. Davis both emphasized that educating patients – both during and after the visit – and making sure they understand the importance of their referral for tests or specialists referrals are key to ensuring that they follow through on the recommendations.

The study was funded by the Agency for Healthcare Research and Quality. Dr. Amat was supported by the Arnold Tofias and Leo Condakes Quality Scholarship Program. Dr. Amat declared no relevant financial relationships. Dr. Davis is the chief health officer for Montgomery County in Maryland.

A version of this article first appeared on Medscape.com.

Telehealth has been a boon for modern-day patients, allowing people who might have difficulty accessing in-person appointments to continue seeing their physicians. But how many patients actually follow through on their physician’s recommendations afterward?

A new study suggests that many patients don’t complete recommended diagnostic tests or specialist referrals after appointments with their primary care physicians, especially when those appointments take place via telehealth.

Investigators retrospectively examined test and referral orders for more than 4,000 patients to see how many complied with recommendations to have a colonoscopy, consult a dermatologist for a suspicious skin lesion, or undergo a cardiac stress test.

Completion of a recommended test or specialty referral was termed “diagnostic loop closure.” In particular, the researchers wanted to compare loop closure after telehealth versus in-person visits.

Rates of loop closure were low across all visit modalities but were lower for tests and referrals ordered during telehealth visits, compared with in-person visits – especially for colonoscopies.

“The take-home message for practicing clinicians is that they should be especially aware of follow-up for tests or referrals ordered during telehealth visits,” said corresponding author Maëlys Amat, MD, MBA, a primary care physician at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston.

The study was published online on in JAMA Network Open.
 

‘Unintended side effects’

“Diagnostic errors present a huge safety concern, impacting many patient lives and costing the health care system billions of dollars, said Dr. Amat, who is also an instructor at Harvard Medical School.

“Telehealth utilization increased rapidly during the COVID pandemic, and although there are clear benefits to utilizing telehealth, our team sought to investigate unintended side effects of this technology and highlight opportunities for improvement,” she said.

To investigate the question, the researchers reviewed medical records of 4,113 patients, with a mean age of 59 years, at two Boston-based primary care sites: an urban hospital–based primary care practice and an affiliated community health center.

Orders for tests or referrals in both centers were placed electronically through the medical record. During an in-person visit, the patient was handed a form with a phone number to call to schedule the test or referral. Patients with limited English proficiency or complex needs may have received help with the scheduling the referral during check-out.

For telehealth visits, the clinician gave the patient the phone number to call to schedule the test or referral during the visit itself. In all scenarios, patients did not receive communication after the visit reminding them about the referral or test.

A loop was considered “closed” if the orders were completed within 365 days, 90 days, or 45 days for colonoscopy, dermatology visits, or cardiac stress testing, respectively.

Of the tests, 52.4% were ordered during an in-person visit, 27.8% were ordered during a telehealth visit, and 19.7% were ordered without a visit.

Tracking systems, virtual checkout

Fewer than half of the orders (42.6%) placed during a telehealth visit were completed within the designated time frame, compared with 58.4% of the orders placed during an in-person visit and 57.4% placed without a visit.

Patients who had telehealth visits were roughly half as likely as those who had in-person visits to close the loop on high-risk tests and referrals, even in an analysis that adjusted for test type, patient demographic characteristics, comorbidities, clinical site, clinician type, and patient engagement (odds ratio, 0.55; 95% confidence interval, 0.47-0.64).

Only 39.8% of colonoscopy referrals ordered during a telehealth visit were completed during the 365-day time period, compared with 56.9% ordered during an in-person visit and 56.7% ordered without a visit.

Follow-through with dermatology referrals within 90 days was roughly the same across all types of visits (63.1% for telehealth, 61.5% for in-person, and 62.9% for no visit). No significant differences were found between telehealth and in-person visits or orders placed without a visit.

Although patients seen via telehealth were less likely than those seen in person to follow through on cardiac stress tests within the 45-day window (59.1% vs. 63.2%), this difference didn’t reach statistical significance.

“Ideally, clinicians would implement automatic tracking systems to help ensure that an ordered test or referral is completed,” Dr. Amat commented. “However, if these systems aren’t yet in place, we strongly encourage clinicians to create their own work flows for tracking tests to completion.”

Additionally, “clinicians should consider implementing a virtual checkout system, similar to what is done during in-person visits, to help patients better understand recommended next steps,” she continued.

Other potentially helpful ways to improve loop closure include automatic tracking for outstanding tests, interventions such as telephone outreach to patients, automated text and email reminders, and the use of referral managers – especially in remote, rural areas or for “disadvantaged patients with limited health care access and literacy.”
 

Education is key

Kisha Davis, MD, MPH, member of the board of directors of the American Academy of Family Physicians, said in an interview that being able to see a provider virtually can make the difference between a person receiving or not receiving medical care. She regards telehealth as another tool in the toolkit her practice offers to provide comprehensive health care.

Dr. Davis, a family physician in Gaithersburg, Md., who wasn’t involved with the study, described a patient with hypertension who was an Uber driver. “During the pandemic, Uber rides were down, and he couldn›t afford to pass up any opportunities, so he pulled over to the side of the road after one of his rides, did his telehealth visit, reviewed his medications, and went on to his next ride.”

The key is to make sure that patients receive adequate follow-up from the office, which Dr. Davis arranged for this patient.

She noted that telehealth “is best done if there’s an established physician-patient relationship but harder to accomplish successfully if you’ve only met the patient on telehealth and never in person.”

The study didn’t specify whether the physicians had an established relationship with their patients.

During the checkout process after an in-person appointment, patients often receive a sheet of paper with the follow-up referrals. “I can see where patients are less likely to follow through if they don’t have someone handing them that paper,” she said.

In her practice, patients’ charts are color-coded “to keep track and make sure it’s not just the ‘squeaky wheels’ that get all the attention,” she said. “The onus is on the physician and the practice, in today’s world of value-based care, to make sure that patients who don’t come into the office are getting the care they need.”

This is facilitated by a “system of care coordination” in which the office team – such as a nurse or medical assistant – follows up with patients to see if they’ve “gotten everything done without barriers,” Dr. Davis said. “Did they have trouble filling that prescription? Did they have difficulty with the referral? Or do they not think it’s necessary – for example, a patient might not go to physical therapy because the injury has improved.”

Dr. Davis wasn’t surprised that patients were less likely to close the loop for colonoscopies compared with seeking out a stress test or treatment for skin lesions.

“People who have a skin lesion may be concerned about their appearance or about skin cancer, and people who need a stress test may have had cardiac symptoms or be worried about their heart.” But a routine screening such as a colonoscopy may not mobilize the patient’s concern to the same degree.

“Additionally, a colonoscopy has an ‘ick factor,’ so there aren’t a whole lot of people who are jumping to have the procedure done.” She suggested considering newer FDA-approved stool tests to screen for colon cancer.

Dr. Amat and Dr. Davis both emphasized that educating patients – both during and after the visit – and making sure they understand the importance of their referral for tests or specialists referrals are key to ensuring that they follow through on the recommendations.

The study was funded by the Agency for Healthcare Research and Quality. Dr. Amat was supported by the Arnold Tofias and Leo Condakes Quality Scholarship Program. Dr. Amat declared no relevant financial relationships. Dr. Davis is the chief health officer for Montgomery County in Maryland.

A version of this article first appeared on Medscape.com.

Telehealth has been a boon for modern-day patients, allowing people who might have difficulty accessing in-person appointments to continue seeing their physicians. But how many patients actually follow through on their physician’s recommendations afterward?

A new study suggests that many patients don’t complete recommended diagnostic tests or specialist referrals after appointments with their primary care physicians, especially when those appointments take place via telehealth.

Investigators retrospectively examined test and referral orders for more than 4,000 patients to see how many complied with recommendations to have a colonoscopy, consult a dermatologist for a suspicious skin lesion, or undergo a cardiac stress test.

Completion of a recommended test or specialty referral was termed “diagnostic loop closure.” In particular, the researchers wanted to compare loop closure after telehealth versus in-person visits.

Rates of loop closure were low across all visit modalities but were lower for tests and referrals ordered during telehealth visits, compared with in-person visits – especially for colonoscopies.

“The take-home message for practicing clinicians is that they should be especially aware of follow-up for tests or referrals ordered during telehealth visits,” said corresponding author Maëlys Amat, MD, MBA, a primary care physician at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston.

The study was published online on in JAMA Network Open.
 

‘Unintended side effects’

“Diagnostic errors present a huge safety concern, impacting many patient lives and costing the health care system billions of dollars, said Dr. Amat, who is also an instructor at Harvard Medical School.

“Telehealth utilization increased rapidly during the COVID pandemic, and although there are clear benefits to utilizing telehealth, our team sought to investigate unintended side effects of this technology and highlight opportunities for improvement,” she said.

To investigate the question, the researchers reviewed medical records of 4,113 patients, with a mean age of 59 years, at two Boston-based primary care sites: an urban hospital–based primary care practice and an affiliated community health center.

Orders for tests or referrals in both centers were placed electronically through the medical record. During an in-person visit, the patient was handed a form with a phone number to call to schedule the test or referral. Patients with limited English proficiency or complex needs may have received help with the scheduling the referral during check-out.

For telehealth visits, the clinician gave the patient the phone number to call to schedule the test or referral during the visit itself. In all scenarios, patients did not receive communication after the visit reminding them about the referral or test.

A loop was considered “closed” if the orders were completed within 365 days, 90 days, or 45 days for colonoscopy, dermatology visits, or cardiac stress testing, respectively.

Of the tests, 52.4% were ordered during an in-person visit, 27.8% were ordered during a telehealth visit, and 19.7% were ordered without a visit.

Tracking systems, virtual checkout

Fewer than half of the orders (42.6%) placed during a telehealth visit were completed within the designated time frame, compared with 58.4% of the orders placed during an in-person visit and 57.4% placed without a visit.

Patients who had telehealth visits were roughly half as likely as those who had in-person visits to close the loop on high-risk tests and referrals, even in an analysis that adjusted for test type, patient demographic characteristics, comorbidities, clinical site, clinician type, and patient engagement (odds ratio, 0.55; 95% confidence interval, 0.47-0.64).

Only 39.8% of colonoscopy referrals ordered during a telehealth visit were completed during the 365-day time period, compared with 56.9% ordered during an in-person visit and 56.7% ordered without a visit.

Follow-through with dermatology referrals within 90 days was roughly the same across all types of visits (63.1% for telehealth, 61.5% for in-person, and 62.9% for no visit). No significant differences were found between telehealth and in-person visits or orders placed without a visit.

Although patients seen via telehealth were less likely than those seen in person to follow through on cardiac stress tests within the 45-day window (59.1% vs. 63.2%), this difference didn’t reach statistical significance.

“Ideally, clinicians would implement automatic tracking systems to help ensure that an ordered test or referral is completed,” Dr. Amat commented. “However, if these systems aren’t yet in place, we strongly encourage clinicians to create their own work flows for tracking tests to completion.”

Additionally, “clinicians should consider implementing a virtual checkout system, similar to what is done during in-person visits, to help patients better understand recommended next steps,” she continued.

Other potentially helpful ways to improve loop closure include automatic tracking for outstanding tests, interventions such as telephone outreach to patients, automated text and email reminders, and the use of referral managers – especially in remote, rural areas or for “disadvantaged patients with limited health care access and literacy.”
 

Education is key

Kisha Davis, MD, MPH, member of the board of directors of the American Academy of Family Physicians, said in an interview that being able to see a provider virtually can make the difference between a person receiving or not receiving medical care. She regards telehealth as another tool in the toolkit her practice offers to provide comprehensive health care.

Dr. Davis, a family physician in Gaithersburg, Md., who wasn’t involved with the study, described a patient with hypertension who was an Uber driver. “During the pandemic, Uber rides were down, and he couldn›t afford to pass up any opportunities, so he pulled over to the side of the road after one of his rides, did his telehealth visit, reviewed his medications, and went on to his next ride.”

The key is to make sure that patients receive adequate follow-up from the office, which Dr. Davis arranged for this patient.

She noted that telehealth “is best done if there’s an established physician-patient relationship but harder to accomplish successfully if you’ve only met the patient on telehealth and never in person.”

The study didn’t specify whether the physicians had an established relationship with their patients.

During the checkout process after an in-person appointment, patients often receive a sheet of paper with the follow-up referrals. “I can see where patients are less likely to follow through if they don’t have someone handing them that paper,” she said.

In her practice, patients’ charts are color-coded “to keep track and make sure it’s not just the ‘squeaky wheels’ that get all the attention,” she said. “The onus is on the physician and the practice, in today’s world of value-based care, to make sure that patients who don’t come into the office are getting the care they need.”

This is facilitated by a “system of care coordination” in which the office team – such as a nurse or medical assistant – follows up with patients to see if they’ve “gotten everything done without barriers,” Dr. Davis said. “Did they have trouble filling that prescription? Did they have difficulty with the referral? Or do they not think it’s necessary – for example, a patient might not go to physical therapy because the injury has improved.”

Dr. Davis wasn’t surprised that patients were less likely to close the loop for colonoscopies compared with seeking out a stress test or treatment for skin lesions.

“People who have a skin lesion may be concerned about their appearance or about skin cancer, and people who need a stress test may have had cardiac symptoms or be worried about their heart.” But a routine screening such as a colonoscopy may not mobilize the patient’s concern to the same degree.

“Additionally, a colonoscopy has an ‘ick factor,’ so there aren’t a whole lot of people who are jumping to have the procedure done.” She suggested considering newer FDA-approved stool tests to screen for colon cancer.

Dr. Amat and Dr. Davis both emphasized that educating patients – both during and after the visit – and making sure they understand the importance of their referral for tests or specialists referrals are key to ensuring that they follow through on the recommendations.

The study was funded by the Agency for Healthcare Research and Quality. Dr. Amat was supported by the Arnold Tofias and Leo Condakes Quality Scholarship Program. Dr. Amat declared no relevant financial relationships. Dr. Davis is the chief health officer for Montgomery County in Maryland.

A version of this article first appeared on Medscape.com.

UnitedHealthcare (UHC) is the latest payer accused of using artificial intelligence (AI) to deny patient claims by trading “real doctors’ recommendations” for a flawed algorithm to save money.

In a class action suit filed in Minnesota district court, the attorneys for the families of two deceased UHC Medicare Advantage plan policyholders say that the company uses the technology to systematically deny skilled nursing facility (SNF) claims and shirk its responsibility to adhere to Medicare’s coverage determination standards.

The case raises ethical and legal questions about whether AI can replace or supplement human tasks and interactions, particularly in a field as complex as health care. California-based public advocacy firm Clarkson Law filed a similar complaint against Cigna earlier this year and has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ data to train their AI systems.

Clarkson Law represents the plaintiffs and says that the policyholders had to pay thousands in out-of-pocket costs or forgo the recommended postacute care owing to UHC’s faulty AI model, nH Predict. The tool has a 90% error rate, says the lawsuit, as evidenced by the number of claims that are reversed following review by a medical professional. Still, just 0.2% of policyholders appeal the denials.

nH Predict was created by naviHealth and was acquired by UnitedHealth Group, UHC’s parent company, in 2020. In a statement to Bloomberg Law, a spokesperson for naviHealth said that the lawsuit has no merit and the model was not used for making coverage determinations.

According to the complaint, nH Predict determines the appropriate amount of SNF, home health, or rehabilitation services a patient requires on the basis of the diagnosis, age, and living situation. The model compares the patient with its database of 6 million patients and estimates the ideal length of stay and target discharge date, “pinpointing the precise moment when [UHC] will cut off payment for a patient’s treatment.”

The lawsuit says that employees are instructed to strictly adhere to the AI model’s predictions, and those who do not are disciplined and terminated, even when additional care for the patient is warranted. Employees are told that the generated reports contain proprietary information and that they cannot share them with physicians and patients who inquire about extending care.

“Every patient is entitled to a nuanced evaluation of their health care needs,” Zarrina Ozari, senior associate at Clarkson Law, said in a prepared statement. “By replacing licensed practitioners with unchecked AI, UHC is telling its patients that they are completely interchangeable with one another and undervaluing the expertise of the physicians devoted to key elements of care.”

According to the complaint, Gene Lokken fell in May 2022 and fractured his leg and ankle. After a 1-month SNF stay, the 91-year-old man’s doctor ordered physical therapy. However, the insurer said Mr. Lokken was safe to be discharged home two and a half weeks later, conflicting with a physical therapist’s notes that indicated he still had paralyzed and weak muscles. The insurer denied Mr. Lokken’s appeal. He remained in the facility for another year until his death, paying about $150,000 in out-of-pocket expenses, according to the lawsuit.

Another patient, Dale H. Tetzloff, initially spent just 20 days in a SNF for stroke rehabilitation before UHC denied coverage. An appeal later extended the stay to 40 days, short of the 100 days recommended by his physician. Requests for further extensions were unsuccessful, and Mr. Tetzloff ultimately paid about $70,000 in out-of-pocket expenses over the next 10 months, according to the complaint.

New federal rules prohibit Medicare Advantage plans from relying on an algorithm or software to make medically necessary determinations instead of an individual’s specific circumstances. Any medical necessity denial must be “reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.”

Clarkson is demanding a jury trial and has asked the court to certify the case as a federal class action, which could open the suit to any U.S. resident who purchased a UHC Medicare Advantage plan in the past 4 years.

A version of this article appeared on Medscape.com.

UnitedHealthcare (UHC) is the latest payer accused of using artificial intelligence (AI) to deny patient claims by trading “real doctors’ recommendations” for a flawed algorithm to save money.

In a class action suit filed in Minnesota district court, the attorneys for the families of two deceased UHC Medicare Advantage plan policyholders say that the company uses the technology to systematically deny skilled nursing facility (SNF) claims and shirk its responsibility to adhere to Medicare’s coverage determination standards.

The case raises ethical and legal questions about whether AI can replace or supplement human tasks and interactions, particularly in a field as complex as health care. California-based public advocacy firm Clarkson Law filed a similar complaint against Cigna earlier this year and has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ data to train their AI systems.

Clarkson Law represents the plaintiffs and says that the policyholders had to pay thousands in out-of-pocket costs or forgo the recommended postacute care owing to UHC’s faulty AI model, nH Predict. The tool has a 90% error rate, says the lawsuit, as evidenced by the number of claims that are reversed following review by a medical professional. Still, just 0.2% of policyholders appeal the denials.

nH Predict was created by naviHealth and was acquired by UnitedHealth Group, UHC’s parent company, in 2020. In a statement to Bloomberg Law, a spokesperson for naviHealth said that the lawsuit has no merit and the model was not used for making coverage determinations.

According to the complaint, nH Predict determines the appropriate amount of SNF, home health, or rehabilitation services a patient requires on the basis of the diagnosis, age, and living situation. The model compares the patient with its database of 6 million patients and estimates the ideal length of stay and target discharge date, “pinpointing the precise moment when [UHC] will cut off payment for a patient’s treatment.”

The lawsuit says that employees are instructed to strictly adhere to the AI model’s predictions, and those who do not are disciplined and terminated, even when additional care for the patient is warranted. Employees are told that the generated reports contain proprietary information and that they cannot share them with physicians and patients who inquire about extending care.

“Every patient is entitled to a nuanced evaluation of their health care needs,” Zarrina Ozari, senior associate at Clarkson Law, said in a prepared statement. “By replacing licensed practitioners with unchecked AI, UHC is telling its patients that they are completely interchangeable with one another and undervaluing the expertise of the physicians devoted to key elements of care.”

According to the complaint, Gene Lokken fell in May 2022 and fractured his leg and ankle. After a 1-month SNF stay, the 91-year-old man’s doctor ordered physical therapy. However, the insurer said Mr. Lokken was safe to be discharged home two and a half weeks later, conflicting with a physical therapist’s notes that indicated he still had paralyzed and weak muscles. The insurer denied Mr. Lokken’s appeal. He remained in the facility for another year until his death, paying about $150,000 in out-of-pocket expenses, according to the lawsuit.

Another patient, Dale H. Tetzloff, initially spent just 20 days in a SNF for stroke rehabilitation before UHC denied coverage. An appeal later extended the stay to 40 days, short of the 100 days recommended by his physician. Requests for further extensions were unsuccessful, and Mr. Tetzloff ultimately paid about $70,000 in out-of-pocket expenses over the next 10 months, according to the complaint.

New federal rules prohibit Medicare Advantage plans from relying on an algorithm or software to make medically necessary determinations instead of an individual’s specific circumstances. Any medical necessity denial must be “reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.”

Clarkson is demanding a jury trial and has asked the court to certify the case as a federal class action, which could open the suit to any U.S. resident who purchased a UHC Medicare Advantage plan in the past 4 years.

A version of this article appeared on Medscape.com.

UnitedHealthcare (UHC) is the latest payer accused of using artificial intelligence (AI) to deny patient claims by trading “real doctors’ recommendations” for a flawed algorithm to save money.

In a class action suit filed in Minnesota district court, the attorneys for the families of two deceased UHC Medicare Advantage plan policyholders say that the company uses the technology to systematically deny skilled nursing facility (SNF) claims and shirk its responsibility to adhere to Medicare’s coverage determination standards.

The case raises ethical and legal questions about whether AI can replace or supplement human tasks and interactions, particularly in a field as complex as health care. California-based public advocacy firm Clarkson Law filed a similar complaint against Cigna earlier this year and has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ data to train their AI systems.

Clarkson Law represents the plaintiffs and says that the policyholders had to pay thousands in out-of-pocket costs or forgo the recommended postacute care owing to UHC’s faulty AI model, nH Predict. The tool has a 90% error rate, says the lawsuit, as evidenced by the number of claims that are reversed following review by a medical professional. Still, just 0.2% of policyholders appeal the denials.

nH Predict was created by naviHealth and was acquired by UnitedHealth Group, UHC’s parent company, in 2020. In a statement to Bloomberg Law, a spokesperson for naviHealth said that the lawsuit has no merit and the model was not used for making coverage determinations.

According to the complaint, nH Predict determines the appropriate amount of SNF, home health, or rehabilitation services a patient requires on the basis of the diagnosis, age, and living situation. The model compares the patient with its database of 6 million patients and estimates the ideal length of stay and target discharge date, “pinpointing the precise moment when [UHC] will cut off payment for a patient’s treatment.”

The lawsuit says that employees are instructed to strictly adhere to the AI model’s predictions, and those who do not are disciplined and terminated, even when additional care for the patient is warranted. Employees are told that the generated reports contain proprietary information and that they cannot share them with physicians and patients who inquire about extending care.

“Every patient is entitled to a nuanced evaluation of their health care needs,” Zarrina Ozari, senior associate at Clarkson Law, said in a prepared statement. “By replacing licensed practitioners with unchecked AI, UHC is telling its patients that they are completely interchangeable with one another and undervaluing the expertise of the physicians devoted to key elements of care.”

According to the complaint, Gene Lokken fell in May 2022 and fractured his leg and ankle. After a 1-month SNF stay, the 91-year-old man’s doctor ordered physical therapy. However, the insurer said Mr. Lokken was safe to be discharged home two and a half weeks later, conflicting with a physical therapist’s notes that indicated he still had paralyzed and weak muscles. The insurer denied Mr. Lokken’s appeal. He remained in the facility for another year until his death, paying about $150,000 in out-of-pocket expenses, according to the lawsuit.

Another patient, Dale H. Tetzloff, initially spent just 20 days in a SNF for stroke rehabilitation before UHC denied coverage. An appeal later extended the stay to 40 days, short of the 100 days recommended by his physician. Requests for further extensions were unsuccessful, and Mr. Tetzloff ultimately paid about $70,000 in out-of-pocket expenses over the next 10 months, according to the complaint.

New federal rules prohibit Medicare Advantage plans from relying on an algorithm or software to make medically necessary determinations instead of an individual’s specific circumstances. Any medical necessity denial must be “reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.”

Clarkson is demanding a jury trial and has asked the court to certify the case as a federal class action, which could open the suit to any U.S. resident who purchased a UHC Medicare Advantage plan in the past 4 years.

A version of this article appeared on Medscape.com.

You’ve just received an offer letter from that job you interviewed for. Sometimes you want to let the employer know right away how interested you are. The verbiage says the letter isn’t “binding.” So you eagerly sign on the dotted line. Everything looks great ... until it isn’t.

Attorney Ericka Adler, JD, LLM, a partner at Roetzel & Andress, a Chicago-based law firm that represents physicians and health care professionals nationwide, described her client who was in this predicament. The physician, a dermatologist, left a practice where she had been employed because she had received an “amazing” offer letter that included promises about her new work location, staffing, equipment, and hours. She signed and immediately gave notice to her previous employer.

“When she received the actual employment contract, none of those details from the offer letter – which is also called a letter of intent [LOI] – were included,” Ms. Adler told this news organization. The physician wanted to have the details from the LOI formally spelled out in the contract, but the employer refused.

“Basically, they said, ‘This is our standard contract and you’ll just have to trust us that we’ll keep our word. We meant what we said in the LOI, but we cannot include those details in the actual agreement because everyone has the same form of agreement.’ “ The physician decided to sign the contract and accept the position.

She contacted Ms. Adler after she had been at her new position for a month. “She had received none of the things they had promised her in the LOI,” Ms. Adler reported. “She lacked the NP and PA support, she lacked the equipment, she didn’t have enough exam rooms. As soon as she started, someone with whom she was sharing call coverage left, and she was expected to take over. The LOI had a cap on the amount of call she would be required to take, but that verbiage didn’t make it into the contract.”

Ms. Adler tried to address this issue with the employer. “We couldn’t say they had literally breached the agreement, but we did list the things that were mentioned in the LOI but on which they hadn’t delivered. We asked them to fix the issue within 10 days.”

The employer argued “that they didn’t have to fulfill anything that wasn’t spelled out in the contract, even if it was in the LOI. In fact, the contract specified clearly that the signed employment agreement was the only agreement and replaced any previous written or oral agreements between the parties.”

The dermatologist ultimately left the new position. “She might have been able to have a legal claim against the employer for breach or perhaps ‘detrimental reliance’ – meaning, she might have argued that she had been financially harmed due to the false promises made to her. But it would have been difficult and expensive for her to litigate the issue,” said Ms. Adler.

“It also didn’t seem like the physician could remain in the job and develop a positive work relationship with the employer, given that she felt betrayed and misled, and didn’t like the terms of employment, which didn’t match her needs or expectations,” said Ms. Adler.

She added that “most employers are not as unscrupulous and dishonest as this one was. But some employers do play on the fact that younger doctors – especially residents and fellows – tend to be trusting or feel they don’t have negotiation power. They’re often excited to get an offer and sign it without a second thought.”

That’s why she advises physicians to “review the terms of the LOI carefully and make sure you’re comfortable with them before signing it; but know that the real contract to negotiate will be the actual Employment Agreement.”

She also advises physicians not to give notice at their current place of employment until they’ve signed the final contract with the new employer.
 

On the same page?

Anu Murthy, JD, an attorney and associate contract review specialist at Contract Diagnostics, explained that the LOI is a document that the candidate receives after an interview but before a full contract. Sometimes, the LOI is preceded by a verbal or e-mailed offer, which is less formal.

“An LOI is sometimes called a Term Sheet or Memorandum of Understanding,“ Ms. Murthy told this news organization. “Typically, it lays out key provisions, such as compensation, initial term of the contract, location, and recruitment incentives.” Sometimes it includes mention of staffing, call schedule, malpractice, noncompete covenants, and other components of the position.

Justin Nabity, founder and CEO of Physicians Thrive, a physician financial advisory group, said that LOIs are “a way for employers to gauge a prospective employee’s level of interest.”

The employer “doesn’t want to send a contract with a lot of details before determining whether the candidate is really serious about the position, so the offer letter doesn’t show the whole picture,” Mr. Nabity told this news organization.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, agreed.

“Another way of putting it is that the employer wants to see whether the prospective employee is on the same page. The LOI will typically include some key components that will later appear in a more complete and formal contract, together with other topics and details. Agreeing to those key components signals that indeed you and the employer are in accord,” said Mr. Hursh.

But are you really on the same page with your prospective employer? And if you seem to be on the same page, and you sign the LOI, is that a guarantee that the employer will honor its terms?

Not necessarily, according to the experts. In fact, many LOIs contain some verbiage stating that the letter isn’t binding, which can be confusing. Others suggest that it is binding, but the candidate doesn’t realize that the letter isn’t a formal contract and that the contract may contain details not included in the LOI or may omit details mentioned in the LOI, as happened to Ms. Adler’s unfortunate client.

“One of the pitfalls I see is that doctors sign the LOI without recognizing whether it’s binding or nonbinding,” Ms. Murthy said. “If it’s binding, it creates a legal obligation on your part and could preclude you from further negotiation once you see the contract and feel you’d like to negotiate some of its terms.”

Binding letters are typically offered to candidates after some back-and-forth between the parties, and important terms have been agreed to, which can happen either verbally or via e-mail. Once these agreements have been reached, they’re summarized in a “binding” letter before being extended into a full contract.

“But even if you’ve agreed on the terms verbally, it’s still important to have someone more experienced review the offer letter before signing it,” Ms. Murthy said. “It’s important to understand the ‘legalese’ and what your rights and obligations are before agreeing to anything.”

And certainly, if you receive a binding LOI, you shouldn’t sign anything until you’re sure you’re comfortable with its contents and have more details.
 

Are “nonbinding” LOIs really not binding?

Even if the LOI is nonbinding, that doesn’t necessarily mean you can sign it and expect to negotiate later. “I see people tripped up when they sign the LOI, thinking they’ll negotiate later,” said Mr. Hursh. “They may not like the terms – for example, they think the compensation is too low – and they figure they’ll work it out at the contract stage, because the LOI is ‘not legally binding.’ “

But because the candidate signed the LOI, “the employer is under the impression that the compensation was acceptable, so now you’ve tied your hands – and the hands of any attorney you may consult down the road – to negotiate those terms.”

Mr. Hursh said he is often consulted by physicians who signed the contract “to get the ball rolling,” thinking that the LOI was “just a meaningless bureaucratic paper.” They need to understand “that the employer wants to make sure they’re in agreement on the basic points before getting into the details,” he said. “Large hospitals with in-house counsel may not want to use their legal department’s valuable time in redrafting terms they thought were acceptable to the candidate, and most practices don’t want to pay a lawyer to draft an LOI and then come back and say, ‘Actually, the physician wants more compensation.’ “

Mr. Nabity summarized: “The LOI is essentially a negotiation tactic to take some of the cards out of the hands of the doctor and commit him or her to something they’re not ready to commit to.” Employers may be playing on the sense of pressure and candidate’s fear that the job will slip through their fingers if they wait too long to sign. “But it’s better to wait longer at this stage before signing even a nonbinding LOI,” he said.

What to do before signing

So how should physicians relate to the LOI? Mr. Nabity advises “working through the details of the offer letter first, going through it carefully and identifying areas of concern, bearing in mind that employers never begin with their best offer.”

He pointed out that physicians “rarely know their value and usually don’t know how to work through the dynamics of compensation, call schedules, additional incentives, bonuses, and productivity,” so they need to be informed about these areas before signing anything.

Ms. Murthy recommended “going back and saying [to the prospective employer], ‘Thank you, but I need time to consider and evaluate this offer.’ Then, do some due diligence.”

At that point, you can hire an attorney to go over the offer, educate yourself about compensation benchmarks and what your worth actually is, or consult another trained professional or more experienced individual who can review the LOI before you sign it.

That’s what Dominique Cleveland, MD, a Texas-based ob.gyn., did when she received an LOI 5 years ago.

“The offer letter from the group practice contained a statement that the group wanted me to come on board, what the salary would be, and the time frame that would be covered in the contract,” she told this news organization. “It mentioned benefits and incentives and relocation, but it was only a short document – maybe one or two pages long.”

At the time that she received her LOI, Dr. Cleveland was completing her residency. She consulted experienced faculty members from her institution to find out whether the terms laid out in the LOI “were the norm and were reasonable.” She was “fairly certain” that the salary was low and this was confirmed by the faculty members she talked to. “So I felt comfortable asking for more [compensation],” she said.

The employer was receptive to her proposed changes, which were included in the more detailed contract that followed. “I can’t say there were any surprises per se in the contract because I had negotiated my salary after receiving the offer letter,” she said. She accepted the position and has been working there ever since.

Dr. Cleveland advises physicians “not to make a decision without speaking to someone who’s experienced and can help you compare what’s out there.”

She also encourages physicians to ask for what they want, whether it’s compensation or something else, such as call schedule or vacation time, without being afraid. “I’m a firm believer that you won’t know what you can get if you don’t ask for it,” she said.
 

Negotiation tips

Mr. Nabity recommended not agreeing to any terms until you are ready to enter into negotiation, recognizing that negotiation is an “art” that requires skill and training. “Either get trained in negotiation, perhaps taking courses to advocate for yourself – which is rare, and most doctors aren’t likely to do this – or go to a trained advocate, such as a lawyer, who can do so on your behalf.”

You might share your concerns with the person who interviewed you, with the person whose name is on the LOI, or with the recruiter who can advocate on your behalf, Ms. Murthy said. “You can reach out to the recruiter and say, ‘I really appreciate the opportunity, but there are some things in the offer letter I’d like to continue discussing.’ “

When you’re ready to negotiate, be sure to assemble all of your “asks” in a single document rather than going back to the prospective employer with “multiple individual questions multiple times,” Ms. Murthy advised. It’s more efficient and the employer or recruiter will appreciate that.

She also advised couching your request in language that expresses your appreciation for the offer and stating that you would like the agreement to serve the best interests of both parties. “Use open-ended language like that, and ask if it’s all right for you to send back some questions, ask for clarification, or share concerns.”

Most employers “will be fine with that,” Ms. Murthy said. “Most won’t say, ‘This is it, take it or leave it.’ If they do, that’s a red flag for you to reconsider whether you really want to work for this particular employer.”

Mr. Hursh suggested that if you choose to sign the LOI immediately, so as to rapidly let the prospective employer know of your interest, “you should add some type of qualification such as, ‘I’m signing this to express my interest, but accepting the position will be dependent upon a more thorough review of compensation benchmarks,’ for example.”

Mr. Nabity agreed: “You can add a handwritten note to the signed LOI expressing that you’re eager to move forward and proceed with the position, but it shouldn’t be construed as accepting the terms of the LOI until you’ve seen the full contract.

“Remember, health care can’t exist without doctors,” Mr. Nabity said. “Doctors are the star players and should go into the negotiation process recognizing their true worth.”
 

A version of this article appeared on Medscape.com.

You’ve just received an offer letter from that job you interviewed for. Sometimes you want to let the employer know right away how interested you are. The verbiage says the letter isn’t “binding.” So you eagerly sign on the dotted line. Everything looks great ... until it isn’t.

Attorney Ericka Adler, JD, LLM, a partner at Roetzel & Andress, a Chicago-based law firm that represents physicians and health care professionals nationwide, described her client who was in this predicament. The physician, a dermatologist, left a practice where she had been employed because she had received an “amazing” offer letter that included promises about her new work location, staffing, equipment, and hours. She signed and immediately gave notice to her previous employer.

“When she received the actual employment contract, none of those details from the offer letter – which is also called a letter of intent [LOI] – were included,” Ms. Adler told this news organization. The physician wanted to have the details from the LOI formally spelled out in the contract, but the employer refused.

“Basically, they said, ‘This is our standard contract and you’ll just have to trust us that we’ll keep our word. We meant what we said in the LOI, but we cannot include those details in the actual agreement because everyone has the same form of agreement.’ “ The physician decided to sign the contract and accept the position.

She contacted Ms. Adler after she had been at her new position for a month. “She had received none of the things they had promised her in the LOI,” Ms. Adler reported. “She lacked the NP and PA support, she lacked the equipment, she didn’t have enough exam rooms. As soon as she started, someone with whom she was sharing call coverage left, and she was expected to take over. The LOI had a cap on the amount of call she would be required to take, but that verbiage didn’t make it into the contract.”

Ms. Adler tried to address this issue with the employer. “We couldn’t say they had literally breached the agreement, but we did list the things that were mentioned in the LOI but on which they hadn’t delivered. We asked them to fix the issue within 10 days.”

The employer argued “that they didn’t have to fulfill anything that wasn’t spelled out in the contract, even if it was in the LOI. In fact, the contract specified clearly that the signed employment agreement was the only agreement and replaced any previous written or oral agreements between the parties.”

The dermatologist ultimately left the new position. “She might have been able to have a legal claim against the employer for breach or perhaps ‘detrimental reliance’ – meaning, she might have argued that she had been financially harmed due to the false promises made to her. But it would have been difficult and expensive for her to litigate the issue,” said Ms. Adler.

“It also didn’t seem like the physician could remain in the job and develop a positive work relationship with the employer, given that she felt betrayed and misled, and didn’t like the terms of employment, which didn’t match her needs or expectations,” said Ms. Adler.

She added that “most employers are not as unscrupulous and dishonest as this one was. But some employers do play on the fact that younger doctors – especially residents and fellows – tend to be trusting or feel they don’t have negotiation power. They’re often excited to get an offer and sign it without a second thought.”

That’s why she advises physicians to “review the terms of the LOI carefully and make sure you’re comfortable with them before signing it; but know that the real contract to negotiate will be the actual Employment Agreement.”

She also advises physicians not to give notice at their current place of employment until they’ve signed the final contract with the new employer.
 

On the same page?

Anu Murthy, JD, an attorney and associate contract review specialist at Contract Diagnostics, explained that the LOI is a document that the candidate receives after an interview but before a full contract. Sometimes, the LOI is preceded by a verbal or e-mailed offer, which is less formal.

“An LOI is sometimes called a Term Sheet or Memorandum of Understanding,“ Ms. Murthy told this news organization. “Typically, it lays out key provisions, such as compensation, initial term of the contract, location, and recruitment incentives.” Sometimes it includes mention of staffing, call schedule, malpractice, noncompete covenants, and other components of the position.

Justin Nabity, founder and CEO of Physicians Thrive, a physician financial advisory group, said that LOIs are “a way for employers to gauge a prospective employee’s level of interest.”

The employer “doesn’t want to send a contract with a lot of details before determining whether the candidate is really serious about the position, so the offer letter doesn’t show the whole picture,” Mr. Nabity told this news organization.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, agreed.

“Another way of putting it is that the employer wants to see whether the prospective employee is on the same page. The LOI will typically include some key components that will later appear in a more complete and formal contract, together with other topics and details. Agreeing to those key components signals that indeed you and the employer are in accord,” said Mr. Hursh.

But are you really on the same page with your prospective employer? And if you seem to be on the same page, and you sign the LOI, is that a guarantee that the employer will honor its terms?

Not necessarily, according to the experts. In fact, many LOIs contain some verbiage stating that the letter isn’t binding, which can be confusing. Others suggest that it is binding, but the candidate doesn’t realize that the letter isn’t a formal contract and that the contract may contain details not included in the LOI or may omit details mentioned in the LOI, as happened to Ms. Adler’s unfortunate client.

“One of the pitfalls I see is that doctors sign the LOI without recognizing whether it’s binding or nonbinding,” Ms. Murthy said. “If it’s binding, it creates a legal obligation on your part and could preclude you from further negotiation once you see the contract and feel you’d like to negotiate some of its terms.”

Binding letters are typically offered to candidates after some back-and-forth between the parties, and important terms have been agreed to, which can happen either verbally or via e-mail. Once these agreements have been reached, they’re summarized in a “binding” letter before being extended into a full contract.

“But even if you’ve agreed on the terms verbally, it’s still important to have someone more experienced review the offer letter before signing it,” Ms. Murthy said. “It’s important to understand the ‘legalese’ and what your rights and obligations are before agreeing to anything.”

And certainly, if you receive a binding LOI, you shouldn’t sign anything until you’re sure you’re comfortable with its contents and have more details.
 

Are “nonbinding” LOIs really not binding?

Even if the LOI is nonbinding, that doesn’t necessarily mean you can sign it and expect to negotiate later. “I see people tripped up when they sign the LOI, thinking they’ll negotiate later,” said Mr. Hursh. “They may not like the terms – for example, they think the compensation is too low – and they figure they’ll work it out at the contract stage, because the LOI is ‘not legally binding.’ “

But because the candidate signed the LOI, “the employer is under the impression that the compensation was acceptable, so now you’ve tied your hands – and the hands of any attorney you may consult down the road – to negotiate those terms.”

Mr. Hursh said he is often consulted by physicians who signed the contract “to get the ball rolling,” thinking that the LOI was “just a meaningless bureaucratic paper.” They need to understand “that the employer wants to make sure they’re in agreement on the basic points before getting into the details,” he said. “Large hospitals with in-house counsel may not want to use their legal department’s valuable time in redrafting terms they thought were acceptable to the candidate, and most practices don’t want to pay a lawyer to draft an LOI and then come back and say, ‘Actually, the physician wants more compensation.’ “

Mr. Nabity summarized: “The LOI is essentially a negotiation tactic to take some of the cards out of the hands of the doctor and commit him or her to something they’re not ready to commit to.” Employers may be playing on the sense of pressure and candidate’s fear that the job will slip through their fingers if they wait too long to sign. “But it’s better to wait longer at this stage before signing even a nonbinding LOI,” he said.

What to do before signing

So how should physicians relate to the LOI? Mr. Nabity advises “working through the details of the offer letter first, going through it carefully and identifying areas of concern, bearing in mind that employers never begin with their best offer.”

He pointed out that physicians “rarely know their value and usually don’t know how to work through the dynamics of compensation, call schedules, additional incentives, bonuses, and productivity,” so they need to be informed about these areas before signing anything.

Ms. Murthy recommended “going back and saying [to the prospective employer], ‘Thank you, but I need time to consider and evaluate this offer.’ Then, do some due diligence.”

At that point, you can hire an attorney to go over the offer, educate yourself about compensation benchmarks and what your worth actually is, or consult another trained professional or more experienced individual who can review the LOI before you sign it.

That’s what Dominique Cleveland, MD, a Texas-based ob.gyn., did when she received an LOI 5 years ago.

“The offer letter from the group practice contained a statement that the group wanted me to come on board, what the salary would be, and the time frame that would be covered in the contract,” she told this news organization. “It mentioned benefits and incentives and relocation, but it was only a short document – maybe one or two pages long.”

At the time that she received her LOI, Dr. Cleveland was completing her residency. She consulted experienced faculty members from her institution to find out whether the terms laid out in the LOI “were the norm and were reasonable.” She was “fairly certain” that the salary was low and this was confirmed by the faculty members she talked to. “So I felt comfortable asking for more [compensation],” she said.

The employer was receptive to her proposed changes, which were included in the more detailed contract that followed. “I can’t say there were any surprises per se in the contract because I had negotiated my salary after receiving the offer letter,” she said. She accepted the position and has been working there ever since.

Dr. Cleveland advises physicians “not to make a decision without speaking to someone who’s experienced and can help you compare what’s out there.”

She also encourages physicians to ask for what they want, whether it’s compensation or something else, such as call schedule or vacation time, without being afraid. “I’m a firm believer that you won’t know what you can get if you don’t ask for it,” she said.
 

Negotiation tips

Mr. Nabity recommended not agreeing to any terms until you are ready to enter into negotiation, recognizing that negotiation is an “art” that requires skill and training. “Either get trained in negotiation, perhaps taking courses to advocate for yourself – which is rare, and most doctors aren’t likely to do this – or go to a trained advocate, such as a lawyer, who can do so on your behalf.”

You might share your concerns with the person who interviewed you, with the person whose name is on the LOI, or with the recruiter who can advocate on your behalf, Ms. Murthy said. “You can reach out to the recruiter and say, ‘I really appreciate the opportunity, but there are some things in the offer letter I’d like to continue discussing.’ “

When you’re ready to negotiate, be sure to assemble all of your “asks” in a single document rather than going back to the prospective employer with “multiple individual questions multiple times,” Ms. Murthy advised. It’s more efficient and the employer or recruiter will appreciate that.

She also advised couching your request in language that expresses your appreciation for the offer and stating that you would like the agreement to serve the best interests of both parties. “Use open-ended language like that, and ask if it’s all right for you to send back some questions, ask for clarification, or share concerns.”

Most employers “will be fine with that,” Ms. Murthy said. “Most won’t say, ‘This is it, take it or leave it.’ If they do, that’s a red flag for you to reconsider whether you really want to work for this particular employer.”

Mr. Hursh suggested that if you choose to sign the LOI immediately, so as to rapidly let the prospective employer know of your interest, “you should add some type of qualification such as, ‘I’m signing this to express my interest, but accepting the position will be dependent upon a more thorough review of compensation benchmarks,’ for example.”

Mr. Nabity agreed: “You can add a handwritten note to the signed LOI expressing that you’re eager to move forward and proceed with the position, but it shouldn’t be construed as accepting the terms of the LOI until you’ve seen the full contract.

“Remember, health care can’t exist without doctors,” Mr. Nabity said. “Doctors are the star players and should go into the negotiation process recognizing their true worth.”
 

A version of this article appeared on Medscape.com.

You’ve just received an offer letter from that job you interviewed for. Sometimes you want to let the employer know right away how interested you are. The verbiage says the letter isn’t “binding.” So you eagerly sign on the dotted line. Everything looks great ... until it isn’t.

Attorney Ericka Adler, JD, LLM, a partner at Roetzel & Andress, a Chicago-based law firm that represents physicians and health care professionals nationwide, described her client who was in this predicament. The physician, a dermatologist, left a practice where she had been employed because she had received an “amazing” offer letter that included promises about her new work location, staffing, equipment, and hours. She signed and immediately gave notice to her previous employer.

“When she received the actual employment contract, none of those details from the offer letter – which is also called a letter of intent [LOI] – were included,” Ms. Adler told this news organization. The physician wanted to have the details from the LOI formally spelled out in the contract, but the employer refused.

“Basically, they said, ‘This is our standard contract and you’ll just have to trust us that we’ll keep our word. We meant what we said in the LOI, but we cannot include those details in the actual agreement because everyone has the same form of agreement.’ “ The physician decided to sign the contract and accept the position.

She contacted Ms. Adler after she had been at her new position for a month. “She had received none of the things they had promised her in the LOI,” Ms. Adler reported. “She lacked the NP and PA support, she lacked the equipment, she didn’t have enough exam rooms. As soon as she started, someone with whom she was sharing call coverage left, and she was expected to take over. The LOI had a cap on the amount of call she would be required to take, but that verbiage didn’t make it into the contract.”

Ms. Adler tried to address this issue with the employer. “We couldn’t say they had literally breached the agreement, but we did list the things that were mentioned in the LOI but on which they hadn’t delivered. We asked them to fix the issue within 10 days.”

The employer argued “that they didn’t have to fulfill anything that wasn’t spelled out in the contract, even if it was in the LOI. In fact, the contract specified clearly that the signed employment agreement was the only agreement and replaced any previous written or oral agreements between the parties.”

The dermatologist ultimately left the new position. “She might have been able to have a legal claim against the employer for breach or perhaps ‘detrimental reliance’ – meaning, she might have argued that she had been financially harmed due to the false promises made to her. But it would have been difficult and expensive for her to litigate the issue,” said Ms. Adler.

“It also didn’t seem like the physician could remain in the job and develop a positive work relationship with the employer, given that she felt betrayed and misled, and didn’t like the terms of employment, which didn’t match her needs or expectations,” said Ms. Adler.

She added that “most employers are not as unscrupulous and dishonest as this one was. But some employers do play on the fact that younger doctors – especially residents and fellows – tend to be trusting or feel they don’t have negotiation power. They’re often excited to get an offer and sign it without a second thought.”

That’s why she advises physicians to “review the terms of the LOI carefully and make sure you’re comfortable with them before signing it; but know that the real contract to negotiate will be the actual Employment Agreement.”

She also advises physicians not to give notice at their current place of employment until they’ve signed the final contract with the new employer.
 

On the same page?

Anu Murthy, JD, an attorney and associate contract review specialist at Contract Diagnostics, explained that the LOI is a document that the candidate receives after an interview but before a full contract. Sometimes, the LOI is preceded by a verbal or e-mailed offer, which is less formal.

“An LOI is sometimes called a Term Sheet or Memorandum of Understanding,“ Ms. Murthy told this news organization. “Typically, it lays out key provisions, such as compensation, initial term of the contract, location, and recruitment incentives.” Sometimes it includes mention of staffing, call schedule, malpractice, noncompete covenants, and other components of the position.

Justin Nabity, founder and CEO of Physicians Thrive, a physician financial advisory group, said that LOIs are “a way for employers to gauge a prospective employee’s level of interest.”

The employer “doesn’t want to send a contract with a lot of details before determining whether the candidate is really serious about the position, so the offer letter doesn’t show the whole picture,” Mr. Nabity told this news organization.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, agreed.

“Another way of putting it is that the employer wants to see whether the prospective employee is on the same page. The LOI will typically include some key components that will later appear in a more complete and formal contract, together with other topics and details. Agreeing to those key components signals that indeed you and the employer are in accord,” said Mr. Hursh.

But are you really on the same page with your prospective employer? And if you seem to be on the same page, and you sign the LOI, is that a guarantee that the employer will honor its terms?

Not necessarily, according to the experts. In fact, many LOIs contain some verbiage stating that the letter isn’t binding, which can be confusing. Others suggest that it is binding, but the candidate doesn’t realize that the letter isn’t a formal contract and that the contract may contain details not included in the LOI or may omit details mentioned in the LOI, as happened to Ms. Adler’s unfortunate client.

“One of the pitfalls I see is that doctors sign the LOI without recognizing whether it’s binding or nonbinding,” Ms. Murthy said. “If it’s binding, it creates a legal obligation on your part and could preclude you from further negotiation once you see the contract and feel you’d like to negotiate some of its terms.”

Binding letters are typically offered to candidates after some back-and-forth between the parties, and important terms have been agreed to, which can happen either verbally or via e-mail. Once these agreements have been reached, they’re summarized in a “binding” letter before being extended into a full contract.

“But even if you’ve agreed on the terms verbally, it’s still important to have someone more experienced review the offer letter before signing it,” Ms. Murthy said. “It’s important to understand the ‘legalese’ and what your rights and obligations are before agreeing to anything.”

And certainly, if you receive a binding LOI, you shouldn’t sign anything until you’re sure you’re comfortable with its contents and have more details.
 

Are “nonbinding” LOIs really not binding?

Even if the LOI is nonbinding, that doesn’t necessarily mean you can sign it and expect to negotiate later. “I see people tripped up when they sign the LOI, thinking they’ll negotiate later,” said Mr. Hursh. “They may not like the terms – for example, they think the compensation is too low – and they figure they’ll work it out at the contract stage, because the LOI is ‘not legally binding.’ “

But because the candidate signed the LOI, “the employer is under the impression that the compensation was acceptable, so now you’ve tied your hands – and the hands of any attorney you may consult down the road – to negotiate those terms.”

Mr. Hursh said he is often consulted by physicians who signed the contract “to get the ball rolling,” thinking that the LOI was “just a meaningless bureaucratic paper.” They need to understand “that the employer wants to make sure they’re in agreement on the basic points before getting into the details,” he said. “Large hospitals with in-house counsel may not want to use their legal department’s valuable time in redrafting terms they thought were acceptable to the candidate, and most practices don’t want to pay a lawyer to draft an LOI and then come back and say, ‘Actually, the physician wants more compensation.’ “

Mr. Nabity summarized: “The LOI is essentially a negotiation tactic to take some of the cards out of the hands of the doctor and commit him or her to something they’re not ready to commit to.” Employers may be playing on the sense of pressure and candidate’s fear that the job will slip through their fingers if they wait too long to sign. “But it’s better to wait longer at this stage before signing even a nonbinding LOI,” he said.

What to do before signing

So how should physicians relate to the LOI? Mr. Nabity advises “working through the details of the offer letter first, going through it carefully and identifying areas of concern, bearing in mind that employers never begin with their best offer.”

He pointed out that physicians “rarely know their value and usually don’t know how to work through the dynamics of compensation, call schedules, additional incentives, bonuses, and productivity,” so they need to be informed about these areas before signing anything.

Ms. Murthy recommended “going back and saying [to the prospective employer], ‘Thank you, but I need time to consider and evaluate this offer.’ Then, do some due diligence.”

At that point, you can hire an attorney to go over the offer, educate yourself about compensation benchmarks and what your worth actually is, or consult another trained professional or more experienced individual who can review the LOI before you sign it.

That’s what Dominique Cleveland, MD, a Texas-based ob.gyn., did when she received an LOI 5 years ago.

“The offer letter from the group practice contained a statement that the group wanted me to come on board, what the salary would be, and the time frame that would be covered in the contract,” she told this news organization. “It mentioned benefits and incentives and relocation, but it was only a short document – maybe one or two pages long.”

At the time that she received her LOI, Dr. Cleveland was completing her residency. She consulted experienced faculty members from her institution to find out whether the terms laid out in the LOI “were the norm and were reasonable.” She was “fairly certain” that the salary was low and this was confirmed by the faculty members she talked to. “So I felt comfortable asking for more [compensation],” she said.

The employer was receptive to her proposed changes, which were included in the more detailed contract that followed. “I can’t say there were any surprises per se in the contract because I had negotiated my salary after receiving the offer letter,” she said. She accepted the position and has been working there ever since.

Dr. Cleveland advises physicians “not to make a decision without speaking to someone who’s experienced and can help you compare what’s out there.”

She also encourages physicians to ask for what they want, whether it’s compensation or something else, such as call schedule or vacation time, without being afraid. “I’m a firm believer that you won’t know what you can get if you don’t ask for it,” she said.
 

Negotiation tips

Mr. Nabity recommended not agreeing to any terms until you are ready to enter into negotiation, recognizing that negotiation is an “art” that requires skill and training. “Either get trained in negotiation, perhaps taking courses to advocate for yourself – which is rare, and most doctors aren’t likely to do this – or go to a trained advocate, such as a lawyer, who can do so on your behalf.”

You might share your concerns with the person who interviewed you, with the person whose name is on the LOI, or with the recruiter who can advocate on your behalf, Ms. Murthy said. “You can reach out to the recruiter and say, ‘I really appreciate the opportunity, but there are some things in the offer letter I’d like to continue discussing.’ “

When you’re ready to negotiate, be sure to assemble all of your “asks” in a single document rather than going back to the prospective employer with “multiple individual questions multiple times,” Ms. Murthy advised. It’s more efficient and the employer or recruiter will appreciate that.

She also advised couching your request in language that expresses your appreciation for the offer and stating that you would like the agreement to serve the best interests of both parties. “Use open-ended language like that, and ask if it’s all right for you to send back some questions, ask for clarification, or share concerns.”

Most employers “will be fine with that,” Ms. Murthy said. “Most won’t say, ‘This is it, take it or leave it.’ If they do, that’s a red flag for you to reconsider whether you really want to work for this particular employer.”

Mr. Hursh suggested that if you choose to sign the LOI immediately, so as to rapidly let the prospective employer know of your interest, “you should add some type of qualification such as, ‘I’m signing this to express my interest, but accepting the position will be dependent upon a more thorough review of compensation benchmarks,’ for example.”

Mr. Nabity agreed: “You can add a handwritten note to the signed LOI expressing that you’re eager to move forward and proceed with the position, but it shouldn’t be construed as accepting the terms of the LOI until you’ve seen the full contract.

“Remember, health care can’t exist without doctors,” Mr. Nabity said. “Doctors are the star players and should go into the negotiation process recognizing their true worth.”
 

A version of this article appeared on Medscape.com.

In a recently published Medscape report, 26% of American physicians said they were considering a career away from practicing medicine, for various reasons. Becoming a teacher was one of the nonclinical careers that most enthused them. What were the others?

This infographic shows the five potential new careers that most interested U.S. physicians considering a change. For more details, check out the Medscape Physicians and Nonclinical Careers Report 2023.

A version of this article first appeared on Medscape.com.

In a recently published Medscape report, 26% of American physicians said they were considering a career away from practicing medicine, for various reasons. Becoming a teacher was one of the nonclinical careers that most enthused them. What were the others?

This infographic shows the five potential new careers that most interested U.S. physicians considering a change. For more details, check out the Medscape Physicians and Nonclinical Careers Report 2023.

A version of this article first appeared on Medscape.com.

In a recently published Medscape report, 26% of American physicians said they were considering a career away from practicing medicine, for various reasons. Becoming a teacher was one of the nonclinical careers that most enthused them. What were the others?

This infographic shows the five potential new careers that most interested U.S. physicians considering a change. For more details, check out the Medscape Physicians and Nonclinical Careers Report 2023.

A version of this article first appeared on Medscape.com.