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VIDEO: Immunomodulators for inflammatory skin diseases
WASHINGTON – During a session at the annual meeting of the American Academy of Dermatology, Adam Friedman, MD, presented on off-label use of immunomodulators for inflammatory skin diseases, the highlights of which he shared with fellow George Washington University dermatologist, A. Yasmine Kirkorian, MD, in an interview following the session.
Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington,
For example, as reflected in PubMed searches, low-dose naltrexone, which has to be compounded, is being used for such diseases as Hailey-Hailey and lichen planopilaris, said Dr. Friedman, who is using it for his mast cell activation syndrome patients. During the interview, he also describes his treatment approach for urticaria.
In his final remarks, Dr. Friedman encourages colleagues to “get creative,” publish, and talk about their experiences with off-label treatments in dermatology, citing the example of an article that mentioned using pioglitazone for lichen planopilaris. This article stimulated interest in using the type 2 diabetes agent pioglitazone to treat this skin disease, he notes.
Dr. Friedman and Dr. Kirkorian, a pediatric dermatologist at George Washington University and interim chief of pediatric dermatology at Children’s National in Washington had no relevant disclosures.
WASHINGTON – During a session at the annual meeting of the American Academy of Dermatology, Adam Friedman, MD, presented on off-label use of immunomodulators for inflammatory skin diseases, the highlights of which he shared with fellow George Washington University dermatologist, A. Yasmine Kirkorian, MD, in an interview following the session.
Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington,
For example, as reflected in PubMed searches, low-dose naltrexone, which has to be compounded, is being used for such diseases as Hailey-Hailey and lichen planopilaris, said Dr. Friedman, who is using it for his mast cell activation syndrome patients. During the interview, he also describes his treatment approach for urticaria.
In his final remarks, Dr. Friedman encourages colleagues to “get creative,” publish, and talk about their experiences with off-label treatments in dermatology, citing the example of an article that mentioned using pioglitazone for lichen planopilaris. This article stimulated interest in using the type 2 diabetes agent pioglitazone to treat this skin disease, he notes.
Dr. Friedman and Dr. Kirkorian, a pediatric dermatologist at George Washington University and interim chief of pediatric dermatology at Children’s National in Washington had no relevant disclosures.
WASHINGTON – During a session at the annual meeting of the American Academy of Dermatology, Adam Friedman, MD, presented on off-label use of immunomodulators for inflammatory skin diseases, the highlights of which he shared with fellow George Washington University dermatologist, A. Yasmine Kirkorian, MD, in an interview following the session.
Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington,
For example, as reflected in PubMed searches, low-dose naltrexone, which has to be compounded, is being used for such diseases as Hailey-Hailey and lichen planopilaris, said Dr. Friedman, who is using it for his mast cell activation syndrome patients. During the interview, he also describes his treatment approach for urticaria.
In his final remarks, Dr. Friedman encourages colleagues to “get creative,” publish, and talk about their experiences with off-label treatments in dermatology, citing the example of an article that mentioned using pioglitazone for lichen planopilaris. This article stimulated interest in using the type 2 diabetes agent pioglitazone to treat this skin disease, he notes.
Dr. Friedman and Dr. Kirkorian, a pediatric dermatologist at George Washington University and interim chief of pediatric dermatology at Children’s National in Washington had no relevant disclosures.
Immunomodulators for pediatric skin diseases
WASHINGTON – At the annual meeting of the American Academy of Dermatology, colleagues A. Yasmine Kirkorian, MD, a pediatric dermatologist at George Washington University, Washington, and interim chief of pediatric dermatology at Children’s National Health System, and Adam Friedman, MD, professor and interim chair of dermatology at the university, sat down with Dermatology News and discussed their presentations at a session on the use of immunomodulators for inflammatory and neoplastic skin diseases.
In this video, , with her clinical pearls and practical considerations for treating atopic dermatitis, psoriasis, and hidradenitis suppurativa in pediatric patients, covering both on- and off-label treatments.
“Children sometimes require systemic treatment and we shouldn’t hold it back from them because of their age; if they’re severely ill ... they need to be treated,” she said, summing up one of her main points.
During the interview immediately after the AAD meeting, she mentioned dupilumab, which was approved by the Food and Drug Administration for treatment of moderate to severe AD in patients aged 12-17 years.
Dr. Friedman and Dr. Kirkorian reported having no financial disclosures.
WASHINGTON – At the annual meeting of the American Academy of Dermatology, colleagues A. Yasmine Kirkorian, MD, a pediatric dermatologist at George Washington University, Washington, and interim chief of pediatric dermatology at Children’s National Health System, and Adam Friedman, MD, professor and interim chair of dermatology at the university, sat down with Dermatology News and discussed their presentations at a session on the use of immunomodulators for inflammatory and neoplastic skin diseases.
In this video, , with her clinical pearls and practical considerations for treating atopic dermatitis, psoriasis, and hidradenitis suppurativa in pediatric patients, covering both on- and off-label treatments.
“Children sometimes require systemic treatment and we shouldn’t hold it back from them because of their age; if they’re severely ill ... they need to be treated,” she said, summing up one of her main points.
During the interview immediately after the AAD meeting, she mentioned dupilumab, which was approved by the Food and Drug Administration for treatment of moderate to severe AD in patients aged 12-17 years.
Dr. Friedman and Dr. Kirkorian reported having no financial disclosures.
WASHINGTON – At the annual meeting of the American Academy of Dermatology, colleagues A. Yasmine Kirkorian, MD, a pediatric dermatologist at George Washington University, Washington, and interim chief of pediatric dermatology at Children’s National Health System, and Adam Friedman, MD, professor and interim chair of dermatology at the university, sat down with Dermatology News and discussed their presentations at a session on the use of immunomodulators for inflammatory and neoplastic skin diseases.
In this video, , with her clinical pearls and practical considerations for treating atopic dermatitis, psoriasis, and hidradenitis suppurativa in pediatric patients, covering both on- and off-label treatments.
“Children sometimes require systemic treatment and we shouldn’t hold it back from them because of their age; if they’re severely ill ... they need to be treated,” she said, summing up one of her main points.
During the interview immediately after the AAD meeting, she mentioned dupilumab, which was approved by the Food and Drug Administration for treatment of moderate to severe AD in patients aged 12-17 years.
Dr. Friedman and Dr. Kirkorian reported having no financial disclosures.
New cantharidin formulation alleviates molluscum contagiosum in pivotal trials
WASHINGTON – compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.
VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.
No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.
VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.
To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.
The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.
In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.
At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.
The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.
Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.
SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.
WASHINGTON – compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.
VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.
No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.
VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.
To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.
The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.
In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.
At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.
The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.
Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.
SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.
WASHINGTON – compared with placebo, according to the results of two trials presented at the annual meeting of the American Academy of Dermatology.
VP-102, a drug-device combination, was well tolerated and was not associated with serious adverse events.
No Food and Drug Administration–approved treatment is available for treating molluscum contagiosum, which is routinely treated with cantharidin, a naturally occurring vesicant.
VP-102 is a novel formulation of 0.7% cantharidin solution, provided in a single-use applicator, to provide consistent delivery and long-term drug stability.
To test the efficacy and safety of VP-102, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and his associates conducted the CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2 phase 3 studies, which had similar designs. The studies enrolled patients with molluscum contagiosum aged 2 years and older who had not received any treatment in the 2 weeks before enrollment. Patients were randomized to VP-102 or vehicle for 12 weeks. Treatment was administered topically to each lesion every 3 weeks for a maximum of four applications, and washed off with soap and warm water 24 hours after application.
The trials’ primary endpoint was the percentage of patients with complete clearance of their lesions. Secondary endpoints were the percentage of patients with complete clearance at 3, 6, and 9 weeks, and decrease in lesions over time. The researchers also assessed safety and tolerability.
In the two studies, 528 patients aged 2-60 years (mean age, approximately 7 years) were randomized to treatment or vehicle. About 30% of participants had prior treatment. The baseline lesion count ranged from 1 to 184.
At day 84, the proportion of patients in the VP-102 arm who achieved complete clearance of lesions was 46% in CAMP-1 and 54% in CAMP-2, compared with 18% and 13%, respectively, among controls (P less than .0001). By day 84, among treated patients, the lesion count had decreased by a mean of 69% in CAMP-1 and 83% in CAMP-2, compared with 20% and 19%, respectively, among controls. Results among controls were “probably consistent with natural history,” Dr. Eichenfield observed.
The researchers observed a high incidence of treatment-emergent adverse events among patients receiving VP-102. “Any crust or vesiculation was considered to be a treatment-emergent adverse event,” Dr. Eichenfield said. Most adverse events were mild, although five patients discontinued the studies because of treatment-emergent adverse events. Vesiculation was a common adverse event in the VP-102 group; pruritus and application-site pain were reported as well.
Verrica Pharmaceuticals developed VP-102 and funded the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica, which plans to submit for FDA approval in the second half of 2019.
SOURCE: Eichenfield L et al. AAD 19, Abstract 11251.
REPORTING FROM AAD 2019
Key clinical point: VP-102 is an effective treatment for molluscum contagiosum.
Major finding: In two studies, 46% and 54% of actively treated patients had complete resolution, compared with 13% and 18% of controls, respectively.
Study details: Two phase 3, randomized, double-blind, placebo-controlled trials of 528 patients with molluscum contagiosum.
Disclosures: Verrica Pharmaceuticals sponsored the study. Dr. Eichenfield reported receiving no funding from the company; several other investigators are employees of Verrica Pharmaceuticals.Source: Eichenfield L et al. AAD 19, Abstract 11251.
Understanding AD as immune-driven disease has opened the door to new therapies
WASHINGTON – The “ of the disease has grown, Emma Guttman-Yassky, MD, PhD, said during a presentation at the annual meeting of the American Academy of Dermatology.
“It’s due to the increased understanding we now have in atopic dermatitis,” Dr. Guttman-Yassky, professor and vice chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in her presentation.
According to Dr. Guttman-Yassky, therapeutic development was prevented in AD because of the abnormalities present in the disease immune responses and barrier abnormalities. “Frankly, pharma[ceutical] companies didn’t know what they should go after,” she said. “Should they go after the immune abnormalities, or should they go after the barrier? I think that’s why we’re so far behind psoriasis – but don’t worry, we are catching up quite fast because now ... we understand what we need to go after.”
It was when researchers began to look at AD in the same way as psoriasis that they realized the two were “polar” immune diseases, with psoriasis having Th17/interleukin-17 involvement while atopic dermatitis had Th2/IL-13 involvement. The same approach of “bedside-to-bench pathogenic dissection and translational testing of therapeutics” that led to successful advancements in therapies for psoriasis can also be applied to AD, Dr. Guttman-Yassky said.
To create a translational approach to AD, researchers need to have a well-defined molecular phenotype and understanding of inflammatory pathways, good baseline biomarkers of disease activity and treatment responses, and drugs that would selectively target the immune system. Th2-type cytokines such as IL-4 and IL-13 could help link the barrier and immune defects in AD. In addition, all variations of AD subtypes across white, black, Asian, and pediatric populations have “robust Th2 activation” but differ in other areas. “We’ll need to stratify biomarkers specific to different atopic dermatitis phenotypes to really develop a personalized medicine approach in atopic dermatitis,” she said.
High-level systemic immune activation shows that AD is emerging as a systemic disease that leads to atopic comorbidities such as allergy and asthma, as well as cardiovascular and infectious comorbidities. “We need to think about it when we treat our patients, because we really need to give them systemic treatment approaches when they have this moderate to severe disease,” Dr. Guttman-Yassky said. “When adult patients have moderate to severe disease, what is nonlesional today may be lesional tomorrow, and to treat them effectively, you have to offer them some systemic approaches.”
There is evidence that dupilumab, a human monoclonal antibody that targets IL-4 receptor alpha, is “proving the immune hypothesis” of AD, Dr. Guttman-Yassky said. She cited a recent study from her own group that found use of dupilumab to inhibit IL-4/IL-13 signaling improved disease activity for patients with AD, including reducing the expression of genes that caused type 2 inflammation, epidermal hyperplasia, T cells, dendritic cells, and Th17/Th22 activity (J Allergy Clin Immunol. 2019 Jan;143(1):155-72).
“We could postulate it before, but we couldn’t prove it,” she said. “Basically, this opened the door to all the therapy that we now have in atopic dermatitis.”
According to Dr. Guttman-Yassky, the future of AD will be in creating personalized treatments for patients by stratifying biomarkers specific to different AD phenotypes.
“It’s a very hopeful time in atopic dermatitis with this growing knowledge that we have of the biology of [the disease],” she said. “We have many more agents to treat our patients, and I think the future will be about personalized medicine so we really are treating the disease very well.”
Dr. Guttman-Yassky reported relationships with AbbVie, Allergan, Almirall, Anacor Pharmaceuticals, Asana BioSciences, Celgene, Dermira, Eli Lilly, Escalier Biosciences, Galderma Research & Development, Glenmark Generics, Janssen, Kyowa Hakko Kirin, Leo Pharma, Medimmune, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sanofi/Regeneron, Stiefel, Theravance Biopharma, and Vitae Pharmaceuticals.
WASHINGTON – The “ of the disease has grown, Emma Guttman-Yassky, MD, PhD, said during a presentation at the annual meeting of the American Academy of Dermatology.
“It’s due to the increased understanding we now have in atopic dermatitis,” Dr. Guttman-Yassky, professor and vice chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in her presentation.
According to Dr. Guttman-Yassky, therapeutic development was prevented in AD because of the abnormalities present in the disease immune responses and barrier abnormalities. “Frankly, pharma[ceutical] companies didn’t know what they should go after,” she said. “Should they go after the immune abnormalities, or should they go after the barrier? I think that’s why we’re so far behind psoriasis – but don’t worry, we are catching up quite fast because now ... we understand what we need to go after.”
It was when researchers began to look at AD in the same way as psoriasis that they realized the two were “polar” immune diseases, with psoriasis having Th17/interleukin-17 involvement while atopic dermatitis had Th2/IL-13 involvement. The same approach of “bedside-to-bench pathogenic dissection and translational testing of therapeutics” that led to successful advancements in therapies for psoriasis can also be applied to AD, Dr. Guttman-Yassky said.
To create a translational approach to AD, researchers need to have a well-defined molecular phenotype and understanding of inflammatory pathways, good baseline biomarkers of disease activity and treatment responses, and drugs that would selectively target the immune system. Th2-type cytokines such as IL-4 and IL-13 could help link the barrier and immune defects in AD. In addition, all variations of AD subtypes across white, black, Asian, and pediatric populations have “robust Th2 activation” but differ in other areas. “We’ll need to stratify biomarkers specific to different atopic dermatitis phenotypes to really develop a personalized medicine approach in atopic dermatitis,” she said.
High-level systemic immune activation shows that AD is emerging as a systemic disease that leads to atopic comorbidities such as allergy and asthma, as well as cardiovascular and infectious comorbidities. “We need to think about it when we treat our patients, because we really need to give them systemic treatment approaches when they have this moderate to severe disease,” Dr. Guttman-Yassky said. “When adult patients have moderate to severe disease, what is nonlesional today may be lesional tomorrow, and to treat them effectively, you have to offer them some systemic approaches.”
There is evidence that dupilumab, a human monoclonal antibody that targets IL-4 receptor alpha, is “proving the immune hypothesis” of AD, Dr. Guttman-Yassky said. She cited a recent study from her own group that found use of dupilumab to inhibit IL-4/IL-13 signaling improved disease activity for patients with AD, including reducing the expression of genes that caused type 2 inflammation, epidermal hyperplasia, T cells, dendritic cells, and Th17/Th22 activity (J Allergy Clin Immunol. 2019 Jan;143(1):155-72).
“We could postulate it before, but we couldn’t prove it,” she said. “Basically, this opened the door to all the therapy that we now have in atopic dermatitis.”
According to Dr. Guttman-Yassky, the future of AD will be in creating personalized treatments for patients by stratifying biomarkers specific to different AD phenotypes.
“It’s a very hopeful time in atopic dermatitis with this growing knowledge that we have of the biology of [the disease],” she said. “We have many more agents to treat our patients, and I think the future will be about personalized medicine so we really are treating the disease very well.”
Dr. Guttman-Yassky reported relationships with AbbVie, Allergan, Almirall, Anacor Pharmaceuticals, Asana BioSciences, Celgene, Dermira, Eli Lilly, Escalier Biosciences, Galderma Research & Development, Glenmark Generics, Janssen, Kyowa Hakko Kirin, Leo Pharma, Medimmune, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sanofi/Regeneron, Stiefel, Theravance Biopharma, and Vitae Pharmaceuticals.
WASHINGTON – The “ of the disease has grown, Emma Guttman-Yassky, MD, PhD, said during a presentation at the annual meeting of the American Academy of Dermatology.
“It’s due to the increased understanding we now have in atopic dermatitis,” Dr. Guttman-Yassky, professor and vice chair for research in the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in her presentation.
According to Dr. Guttman-Yassky, therapeutic development was prevented in AD because of the abnormalities present in the disease immune responses and barrier abnormalities. “Frankly, pharma[ceutical] companies didn’t know what they should go after,” she said. “Should they go after the immune abnormalities, or should they go after the barrier? I think that’s why we’re so far behind psoriasis – but don’t worry, we are catching up quite fast because now ... we understand what we need to go after.”
It was when researchers began to look at AD in the same way as psoriasis that they realized the two were “polar” immune diseases, with psoriasis having Th17/interleukin-17 involvement while atopic dermatitis had Th2/IL-13 involvement. The same approach of “bedside-to-bench pathogenic dissection and translational testing of therapeutics” that led to successful advancements in therapies for psoriasis can also be applied to AD, Dr. Guttman-Yassky said.
To create a translational approach to AD, researchers need to have a well-defined molecular phenotype and understanding of inflammatory pathways, good baseline biomarkers of disease activity and treatment responses, and drugs that would selectively target the immune system. Th2-type cytokines such as IL-4 and IL-13 could help link the barrier and immune defects in AD. In addition, all variations of AD subtypes across white, black, Asian, and pediatric populations have “robust Th2 activation” but differ in other areas. “We’ll need to stratify biomarkers specific to different atopic dermatitis phenotypes to really develop a personalized medicine approach in atopic dermatitis,” she said.
High-level systemic immune activation shows that AD is emerging as a systemic disease that leads to atopic comorbidities such as allergy and asthma, as well as cardiovascular and infectious comorbidities. “We need to think about it when we treat our patients, because we really need to give them systemic treatment approaches when they have this moderate to severe disease,” Dr. Guttman-Yassky said. “When adult patients have moderate to severe disease, what is nonlesional today may be lesional tomorrow, and to treat them effectively, you have to offer them some systemic approaches.”
There is evidence that dupilumab, a human monoclonal antibody that targets IL-4 receptor alpha, is “proving the immune hypothesis” of AD, Dr. Guttman-Yassky said. She cited a recent study from her own group that found use of dupilumab to inhibit IL-4/IL-13 signaling improved disease activity for patients with AD, including reducing the expression of genes that caused type 2 inflammation, epidermal hyperplasia, T cells, dendritic cells, and Th17/Th22 activity (J Allergy Clin Immunol. 2019 Jan;143(1):155-72).
“We could postulate it before, but we couldn’t prove it,” she said. “Basically, this opened the door to all the therapy that we now have in atopic dermatitis.”
According to Dr. Guttman-Yassky, the future of AD will be in creating personalized treatments for patients by stratifying biomarkers specific to different AD phenotypes.
“It’s a very hopeful time in atopic dermatitis with this growing knowledge that we have of the biology of [the disease],” she said. “We have many more agents to treat our patients, and I think the future will be about personalized medicine so we really are treating the disease very well.”
Dr. Guttman-Yassky reported relationships with AbbVie, Allergan, Almirall, Anacor Pharmaceuticals, Asana BioSciences, Celgene, Dermira, Eli Lilly, Escalier Biosciences, Galderma Research & Development, Glenmark Generics, Janssen, Kyowa Hakko Kirin, Leo Pharma, Medimmune, Novartis, Pfizer, Regeneron, Sanofi-Aventis, Sanofi/Regeneron, Stiefel, Theravance Biopharma, and Vitae Pharmaceuticals.
EXPERT ANALYSIS FROM AAD 19
AAD 2019 meeting wrap-up
Many common dermatologic drugs can be safely used during pregnancy. The 31-GEP test predicts the likelihood of metastasis for cutaneous melanoma. And bermekimab reduces lesions and cuts pain in patients with hidradenitis suppurativa.
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Many common dermatologic drugs can be safely used during pregnancy. The 31-GEP test predicts the likelihood of metastasis for cutaneous melanoma. And bermekimab reduces lesions and cuts pain in patients with hidradenitis suppurativa.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Many common dermatologic drugs can be safely used during pregnancy. The 31-GEP test predicts the likelihood of metastasis for cutaneous melanoma. And bermekimab reduces lesions and cuts pain in patients with hidradenitis suppurativa.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
BTK inhibitor calms pemphigus vulgaris with low-dose steroids
WASHINGTON – An investigational molecule that blocks the downstream proinflammatory effects of B cells controlled disease activity and induced clinical remission in patients with pemphigus by 12 weeks.
At the end of a 24-week, open-label trial, a key driver of the sometimes-fatal blistering disease, Deedee Murrell, MD, said at the annual meeting of the American Academy of Dermatology.
The clinical efficacy plus a favorable safety profile supports the further development of the molecule, designed and manufactured by Principia Biopharma in San Francisco. The company is currently recruiting for a pivotal phase 3 trial of PRN1008 in 120 patients with moderate to severe pemphigus vulgaris.
Despite the recent approval of rituximab (Rituxan) for moderate to severe pemphigus, there remains an unmet need for a quick-acting, steroid-sparing, anti-inflammatory treatment, said Dr. Murrell, professor and head of the department of dermatology at the University of New South Wales, Sydney.
“We need something to use instead of high-dose steroids while we are waiting for rituximab to kick in, which can take 3 months,” and rituximab, which depletes B cells, puts patients at risk for infection, she said. “We need something that has rapid onset, is steroid sparing, safe for chronic administration, avoids B-cell depletion, and is convenient.”
Blocking the BTK receptor on B cells puts the brakes on the B-cell mediated inflammatory pathway, preventing activation of monocytes, macrophages, mast cells, basophils, and neutrophils. At the same time, however, it does not deplete the B-cell population, said Dr. Murrell, the lead investigator.
The BELIEVE study comprised 27 patients with mild to severe pemphigus of an average 6 years’ duration. Most (18) had relapsing disease; the remainder had newly diagnosed pemphigus. A majority (16) had severe disease, as measured by a score of 15 or more on the Pemphigus Disease Activity Index (PDAI). Almost all (23) were positive for antidesmoglein antibodies. Only one patient was negative for antibodies.
The mean corticosteroid dose at baseline was 14 mg/day, although that ranged from no steroids to 30 mg/day.
The study consisted of a 12-week treatment phase and a 12-week follow-up phase. During treatment, patients could take no more than 0.5 mg/kg of prednisone daily, although with 400 mg PRN1008 twice a day. They were allowed to undertake rescue immunosuppression if they experienced a disease flare.
The primary endpoint was disease control by day 29 as evidenced by no new lesions. Secondary endpoints were complete remission, minimization of prednisone, quality of life, antibody levels, and clinician measures including the PDAI and the Autoimmune Bullous Skin Disorder Intensity Score.
By the end of week 4, 54% of patients had achieved the primary endpoint. The benefit continued to expand, with 73% reaching that response by the end of week 12. During this period, the mean prednisone dose was 12 mg/day.
Among the 24 patients who completed the study, complete remission occurred in 17% by week 12. However, patients continued to respond through the follow-up period, even after the study medication was stopped. By week 24, 25% of these patients experienced a complete remission. At the point of remission, the mean steroid dose was 8 mg/day. The median duration of remission was 2 months after stopping PRN1008.
The PDAI fell by a median of 70% by week 12 and was maintained at that level by the end of week 24. The median level of antidesmoglein autoantibodies fell by up to 65%. Again, the improvement continued throughout the off-drug follow-up period. In subgroup analyses, PRN1008 was more effective in patients with moderate to severe disease than those with mild disease (80% response vs. 64%). It was equally effective in those with newly diagnosed disease (75% vs. 72%) and regardless of antibody level at baseline.
The adverse event profile was relatively benign. Most side effects were mild and transient, and included upper abdominal pain, headache, and nausea. There were two mild infections and one serious infection, which presented in a patient with a long-standing localized cellulitis that activated and was associated a high fever. It was culture negative and PRN1008 was restarted without issue.
There was also one serious adverse event and one death, both unrelated to the study drug. One patient developed a pancreatic cyst that was discovered on day 29. The patient dropped out of the study to have elective surgery. The death occurred in a patient who developed acute respiratory failure on day 8 of treatment, caused by an undiagnosed congenital pulmonary sequestration. The patient died of a brain embolism shortly after lung surgery.
Dr. Murrell designed the study and was an investigator. She reported a financial relationship with Principia, as well as with numerous other pharmaceutical companies.
SOURCE: Murrell D et al. AAD 2019, Session S034.
WASHINGTON – An investigational molecule that blocks the downstream proinflammatory effects of B cells controlled disease activity and induced clinical remission in patients with pemphigus by 12 weeks.
At the end of a 24-week, open-label trial, a key driver of the sometimes-fatal blistering disease, Deedee Murrell, MD, said at the annual meeting of the American Academy of Dermatology.
The clinical efficacy plus a favorable safety profile supports the further development of the molecule, designed and manufactured by Principia Biopharma in San Francisco. The company is currently recruiting for a pivotal phase 3 trial of PRN1008 in 120 patients with moderate to severe pemphigus vulgaris.
Despite the recent approval of rituximab (Rituxan) for moderate to severe pemphigus, there remains an unmet need for a quick-acting, steroid-sparing, anti-inflammatory treatment, said Dr. Murrell, professor and head of the department of dermatology at the University of New South Wales, Sydney.
“We need something to use instead of high-dose steroids while we are waiting for rituximab to kick in, which can take 3 months,” and rituximab, which depletes B cells, puts patients at risk for infection, she said. “We need something that has rapid onset, is steroid sparing, safe for chronic administration, avoids B-cell depletion, and is convenient.”
Blocking the BTK receptor on B cells puts the brakes on the B-cell mediated inflammatory pathway, preventing activation of monocytes, macrophages, mast cells, basophils, and neutrophils. At the same time, however, it does not deplete the B-cell population, said Dr. Murrell, the lead investigator.
The BELIEVE study comprised 27 patients with mild to severe pemphigus of an average 6 years’ duration. Most (18) had relapsing disease; the remainder had newly diagnosed pemphigus. A majority (16) had severe disease, as measured by a score of 15 or more on the Pemphigus Disease Activity Index (PDAI). Almost all (23) were positive for antidesmoglein antibodies. Only one patient was negative for antibodies.
The mean corticosteroid dose at baseline was 14 mg/day, although that ranged from no steroids to 30 mg/day.
The study consisted of a 12-week treatment phase and a 12-week follow-up phase. During treatment, patients could take no more than 0.5 mg/kg of prednisone daily, although with 400 mg PRN1008 twice a day. They were allowed to undertake rescue immunosuppression if they experienced a disease flare.
The primary endpoint was disease control by day 29 as evidenced by no new lesions. Secondary endpoints were complete remission, minimization of prednisone, quality of life, antibody levels, and clinician measures including the PDAI and the Autoimmune Bullous Skin Disorder Intensity Score.
By the end of week 4, 54% of patients had achieved the primary endpoint. The benefit continued to expand, with 73% reaching that response by the end of week 12. During this period, the mean prednisone dose was 12 mg/day.
Among the 24 patients who completed the study, complete remission occurred in 17% by week 12. However, patients continued to respond through the follow-up period, even after the study medication was stopped. By week 24, 25% of these patients experienced a complete remission. At the point of remission, the mean steroid dose was 8 mg/day. The median duration of remission was 2 months after stopping PRN1008.
The PDAI fell by a median of 70% by week 12 and was maintained at that level by the end of week 24. The median level of antidesmoglein autoantibodies fell by up to 65%. Again, the improvement continued throughout the off-drug follow-up period. In subgroup analyses, PRN1008 was more effective in patients with moderate to severe disease than those with mild disease (80% response vs. 64%). It was equally effective in those with newly diagnosed disease (75% vs. 72%) and regardless of antibody level at baseline.
The adverse event profile was relatively benign. Most side effects were mild and transient, and included upper abdominal pain, headache, and nausea. There were two mild infections and one serious infection, which presented in a patient with a long-standing localized cellulitis that activated and was associated a high fever. It was culture negative and PRN1008 was restarted without issue.
There was also one serious adverse event and one death, both unrelated to the study drug. One patient developed a pancreatic cyst that was discovered on day 29. The patient dropped out of the study to have elective surgery. The death occurred in a patient who developed acute respiratory failure on day 8 of treatment, caused by an undiagnosed congenital pulmonary sequestration. The patient died of a brain embolism shortly after lung surgery.
Dr. Murrell designed the study and was an investigator. She reported a financial relationship with Principia, as well as with numerous other pharmaceutical companies.
SOURCE: Murrell D et al. AAD 2019, Session S034.
WASHINGTON – An investigational molecule that blocks the downstream proinflammatory effects of B cells controlled disease activity and induced clinical remission in patients with pemphigus by 12 weeks.
At the end of a 24-week, open-label trial, a key driver of the sometimes-fatal blistering disease, Deedee Murrell, MD, said at the annual meeting of the American Academy of Dermatology.
The clinical efficacy plus a favorable safety profile supports the further development of the molecule, designed and manufactured by Principia Biopharma in San Francisco. The company is currently recruiting for a pivotal phase 3 trial of PRN1008 in 120 patients with moderate to severe pemphigus vulgaris.
Despite the recent approval of rituximab (Rituxan) for moderate to severe pemphigus, there remains an unmet need for a quick-acting, steroid-sparing, anti-inflammatory treatment, said Dr. Murrell, professor and head of the department of dermatology at the University of New South Wales, Sydney.
“We need something to use instead of high-dose steroids while we are waiting for rituximab to kick in, which can take 3 months,” and rituximab, which depletes B cells, puts patients at risk for infection, she said. “We need something that has rapid onset, is steroid sparing, safe for chronic administration, avoids B-cell depletion, and is convenient.”
Blocking the BTK receptor on B cells puts the brakes on the B-cell mediated inflammatory pathway, preventing activation of monocytes, macrophages, mast cells, basophils, and neutrophils. At the same time, however, it does not deplete the B-cell population, said Dr. Murrell, the lead investigator.
The BELIEVE study comprised 27 patients with mild to severe pemphigus of an average 6 years’ duration. Most (18) had relapsing disease; the remainder had newly diagnosed pemphigus. A majority (16) had severe disease, as measured by a score of 15 or more on the Pemphigus Disease Activity Index (PDAI). Almost all (23) were positive for antidesmoglein antibodies. Only one patient was negative for antibodies.
The mean corticosteroid dose at baseline was 14 mg/day, although that ranged from no steroids to 30 mg/day.
The study consisted of a 12-week treatment phase and a 12-week follow-up phase. During treatment, patients could take no more than 0.5 mg/kg of prednisone daily, although with 400 mg PRN1008 twice a day. They were allowed to undertake rescue immunosuppression if they experienced a disease flare.
The primary endpoint was disease control by day 29 as evidenced by no new lesions. Secondary endpoints were complete remission, minimization of prednisone, quality of life, antibody levels, and clinician measures including the PDAI and the Autoimmune Bullous Skin Disorder Intensity Score.
By the end of week 4, 54% of patients had achieved the primary endpoint. The benefit continued to expand, with 73% reaching that response by the end of week 12. During this period, the mean prednisone dose was 12 mg/day.
Among the 24 patients who completed the study, complete remission occurred in 17% by week 12. However, patients continued to respond through the follow-up period, even after the study medication was stopped. By week 24, 25% of these patients experienced a complete remission. At the point of remission, the mean steroid dose was 8 mg/day. The median duration of remission was 2 months after stopping PRN1008.
The PDAI fell by a median of 70% by week 12 and was maintained at that level by the end of week 24. The median level of antidesmoglein autoantibodies fell by up to 65%. Again, the improvement continued throughout the off-drug follow-up period. In subgroup analyses, PRN1008 was more effective in patients with moderate to severe disease than those with mild disease (80% response vs. 64%). It was equally effective in those with newly diagnosed disease (75% vs. 72%) and regardless of antibody level at baseline.
The adverse event profile was relatively benign. Most side effects were mild and transient, and included upper abdominal pain, headache, and nausea. There were two mild infections and one serious infection, which presented in a patient with a long-standing localized cellulitis that activated and was associated a high fever. It was culture negative and PRN1008 was restarted without issue.
There was also one serious adverse event and one death, both unrelated to the study drug. One patient developed a pancreatic cyst that was discovered on day 29. The patient dropped out of the study to have elective surgery. The death occurred in a patient who developed acute respiratory failure on day 8 of treatment, caused by an undiagnosed congenital pulmonary sequestration. The patient died of a brain embolism shortly after lung surgery.
Dr. Murrell designed the study and was an investigator. She reported a financial relationship with Principia, as well as with numerous other pharmaceutical companies.
SOURCE: Murrell D et al. AAD 2019, Session S034.
REPORTING FROM AAD 2019
Teledermatology can increase efficiency
WASHINGTON – , according to a retrospective study presented at the annual meeting of the American Academy of Dermatology
Investigators previously have found that teledermatology systems, used by dermatologists to triage and manage patients, do improve patient access. Analyses of the clinical efficiency of these systems have demonstrated mixed results, however, and few such studies have been conducted in large, closed health care settings such as VA and county hospitals.
To investigate these open questions, Adam Zakaria, a third-year medical student at the University of California, San Francisco, and colleagues created a direct efficiency measure to analyze the teledermatology system at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), which was established in January 2015. ZSFG is a public safety net hospital that serves approximately 150,000 patients annually, according to Mr. Zakaria.
Before the teledermatology system was implemented, each patient seeking to consult a ZSFG dermatologist needed a referral from a primary care provider. Appointments were given on a first-come, first-served basis, “with little consideration for the acuity or the severity of the patient’s complaint,” Mr. Zakaria said at the meeting. Since the teledermatology system has been put in place, referring providers have submitted brief clinical histories and relevant photographs to the system. Once per week, a UCSF dermatology provider and three to four UCSF dermatology residents meet to review cases and decide whether patients can be treated by their primary care providers with recommendations from teledermatology, or whether they need to be seen in person at the dermatology clinic for further evaluation.
The investigators compared data for two patient cohorts: Patients scheduled for in-person clinic visits between June 2014 and December 2014 (the preteledermatology sample), and the second cohort, patients who were triaged through the teledermatology system between June 2017 and December 2017 and who only received a clinic appointment if they could not be managed by their referring provider with teledermatology recommendations (the postteledermatology sample). Data came from chart review, administrative record review, and records from the specialty care and diagnostics department at ZSFG.
Patient wait times for the live clinic and total patient cases handled per month were chosen as measures of accessibility. The measures of efficiency were the number of cases handled per dermatologist hour and the percentage of referrals managed without a live visit. Mr. Zakaria and colleagues performed two-tailed t-tests for each measure.
The analysis included 11,586 patients. Approximately 50% of the sample identified as nonwhite, approximately one-third of patients had a native language other than English, and more than three-quarters of patients had a form of public health insurance.
After the hospital implemented teledermatology, patient wait times decreased significantly (84.6 days vs. 6.7 days; P less than .001), total cases handled per month increased significantly (754 vs. 902; P = .008). In the postteledermatology period, 61.8% of teledermatology consults were handled without a live visit.
After the implementation of teledermatology, the number of cases handled per dermatologist hour increased from 2.27 to 2.63, which was statistically significant (P = .01). The total time that dermatologists spent reviewing teledermatology cases or seeing patients in the live dermatology clinic increased from 332 hours per month to 342 hours per month, an increase that was not statistically significant, however. When the researchers compared provider hours and resident hours, they again found no statistically significant difference.
The results indicate that “the benefits of teledermatology did carry over when applied in a large, closed health care setting,” said Mr. Zakaria. “Two future areas of investigation include evaluating the impact of teledermatology on the quality of resident education and assessing the costs and benefits that teledermatology imposes upon referring primary care providers.” Mr. Zakaria and his colleagues also are analyzing the costs of teledermatology.
SOURCE: Zakaria A et al. AAD 19, Abstract 10087.
WASHINGTON – , according to a retrospective study presented at the annual meeting of the American Academy of Dermatology
Investigators previously have found that teledermatology systems, used by dermatologists to triage and manage patients, do improve patient access. Analyses of the clinical efficiency of these systems have demonstrated mixed results, however, and few such studies have been conducted in large, closed health care settings such as VA and county hospitals.
To investigate these open questions, Adam Zakaria, a third-year medical student at the University of California, San Francisco, and colleagues created a direct efficiency measure to analyze the teledermatology system at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), which was established in January 2015. ZSFG is a public safety net hospital that serves approximately 150,000 patients annually, according to Mr. Zakaria.
Before the teledermatology system was implemented, each patient seeking to consult a ZSFG dermatologist needed a referral from a primary care provider. Appointments were given on a first-come, first-served basis, “with little consideration for the acuity or the severity of the patient’s complaint,” Mr. Zakaria said at the meeting. Since the teledermatology system has been put in place, referring providers have submitted brief clinical histories and relevant photographs to the system. Once per week, a UCSF dermatology provider and three to four UCSF dermatology residents meet to review cases and decide whether patients can be treated by their primary care providers with recommendations from teledermatology, or whether they need to be seen in person at the dermatology clinic for further evaluation.
The investigators compared data for two patient cohorts: Patients scheduled for in-person clinic visits between June 2014 and December 2014 (the preteledermatology sample), and the second cohort, patients who were triaged through the teledermatology system between June 2017 and December 2017 and who only received a clinic appointment if they could not be managed by their referring provider with teledermatology recommendations (the postteledermatology sample). Data came from chart review, administrative record review, and records from the specialty care and diagnostics department at ZSFG.
Patient wait times for the live clinic and total patient cases handled per month were chosen as measures of accessibility. The measures of efficiency were the number of cases handled per dermatologist hour and the percentage of referrals managed without a live visit. Mr. Zakaria and colleagues performed two-tailed t-tests for each measure.
The analysis included 11,586 patients. Approximately 50% of the sample identified as nonwhite, approximately one-third of patients had a native language other than English, and more than three-quarters of patients had a form of public health insurance.
After the hospital implemented teledermatology, patient wait times decreased significantly (84.6 days vs. 6.7 days; P less than .001), total cases handled per month increased significantly (754 vs. 902; P = .008). In the postteledermatology period, 61.8% of teledermatology consults were handled without a live visit.
After the implementation of teledermatology, the number of cases handled per dermatologist hour increased from 2.27 to 2.63, which was statistically significant (P = .01). The total time that dermatologists spent reviewing teledermatology cases or seeing patients in the live dermatology clinic increased from 332 hours per month to 342 hours per month, an increase that was not statistically significant, however. When the researchers compared provider hours and resident hours, they again found no statistically significant difference.
The results indicate that “the benefits of teledermatology did carry over when applied in a large, closed health care setting,” said Mr. Zakaria. “Two future areas of investigation include evaluating the impact of teledermatology on the quality of resident education and assessing the costs and benefits that teledermatology imposes upon referring primary care providers.” Mr. Zakaria and his colleagues also are analyzing the costs of teledermatology.
SOURCE: Zakaria A et al. AAD 19, Abstract 10087.
WASHINGTON – , according to a retrospective study presented at the annual meeting of the American Academy of Dermatology
Investigators previously have found that teledermatology systems, used by dermatologists to triage and manage patients, do improve patient access. Analyses of the clinical efficiency of these systems have demonstrated mixed results, however, and few such studies have been conducted in large, closed health care settings such as VA and county hospitals.
To investigate these open questions, Adam Zakaria, a third-year medical student at the University of California, San Francisco, and colleagues created a direct efficiency measure to analyze the teledermatology system at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), which was established in January 2015. ZSFG is a public safety net hospital that serves approximately 150,000 patients annually, according to Mr. Zakaria.
Before the teledermatology system was implemented, each patient seeking to consult a ZSFG dermatologist needed a referral from a primary care provider. Appointments were given on a first-come, first-served basis, “with little consideration for the acuity or the severity of the patient’s complaint,” Mr. Zakaria said at the meeting. Since the teledermatology system has been put in place, referring providers have submitted brief clinical histories and relevant photographs to the system. Once per week, a UCSF dermatology provider and three to four UCSF dermatology residents meet to review cases and decide whether patients can be treated by their primary care providers with recommendations from teledermatology, or whether they need to be seen in person at the dermatology clinic for further evaluation.
The investigators compared data for two patient cohorts: Patients scheduled for in-person clinic visits between June 2014 and December 2014 (the preteledermatology sample), and the second cohort, patients who were triaged through the teledermatology system between June 2017 and December 2017 and who only received a clinic appointment if they could not be managed by their referring provider with teledermatology recommendations (the postteledermatology sample). Data came from chart review, administrative record review, and records from the specialty care and diagnostics department at ZSFG.
Patient wait times for the live clinic and total patient cases handled per month were chosen as measures of accessibility. The measures of efficiency were the number of cases handled per dermatologist hour and the percentage of referrals managed without a live visit. Mr. Zakaria and colleagues performed two-tailed t-tests for each measure.
The analysis included 11,586 patients. Approximately 50% of the sample identified as nonwhite, approximately one-third of patients had a native language other than English, and more than three-quarters of patients had a form of public health insurance.
After the hospital implemented teledermatology, patient wait times decreased significantly (84.6 days vs. 6.7 days; P less than .001), total cases handled per month increased significantly (754 vs. 902; P = .008). In the postteledermatology period, 61.8% of teledermatology consults were handled without a live visit.
After the implementation of teledermatology, the number of cases handled per dermatologist hour increased from 2.27 to 2.63, which was statistically significant (P = .01). The total time that dermatologists spent reviewing teledermatology cases or seeing patients in the live dermatology clinic increased from 332 hours per month to 342 hours per month, an increase that was not statistically significant, however. When the researchers compared provider hours and resident hours, they again found no statistically significant difference.
The results indicate that “the benefits of teledermatology did carry over when applied in a large, closed health care setting,” said Mr. Zakaria. “Two future areas of investigation include evaluating the impact of teledermatology on the quality of resident education and assessing the costs and benefits that teledermatology imposes upon referring primary care providers.” Mr. Zakaria and his colleagues also are analyzing the costs of teledermatology.
SOURCE: Zakaria A et al. AAD 19, Abstract 10087.
REPORTING FROM AAD 19
Food allergies and atopic dermatitis: What is the evidence?
WASHINGTON – The and brings up an interesting discussion, Peter Lio, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
Patients are often convinced that food is the main driver of their AD, or parents believe it is a trigger in their children with AD, according to Dr. Lio of the departments of dermatology and pediatrics at Northwestern University, Chicago.
There is an increased risk of true food allergy in patients with AD, which “seems to get worse with increasing severity of the disease,” he pointed out. However, he added, many patients believe that food allergy is what is driving their eczema, “and that’s the part we don’t really think bears out” in clinical trials.
In the interview, Dr. Lio reviewed some of the clinical trial data and discussed other issues, including foods that seem to have an inflammatory effect in the body, the concepts of “transcutaneous sensitization” in children with AD and the “leaky gut,” and why he tends to recommend probiotics for patients with AD.
Dr. Lio spoke on diet and AD during a session titled “Dietary Triggers and Modifications of Common Dermatologic Conditions – An Evidence Based Approach,” at the meeting, He had no relevant disclosures.
WASHINGTON – The and brings up an interesting discussion, Peter Lio, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
Patients are often convinced that food is the main driver of their AD, or parents believe it is a trigger in their children with AD, according to Dr. Lio of the departments of dermatology and pediatrics at Northwestern University, Chicago.
There is an increased risk of true food allergy in patients with AD, which “seems to get worse with increasing severity of the disease,” he pointed out. However, he added, many patients believe that food allergy is what is driving their eczema, “and that’s the part we don’t really think bears out” in clinical trials.
In the interview, Dr. Lio reviewed some of the clinical trial data and discussed other issues, including foods that seem to have an inflammatory effect in the body, the concepts of “transcutaneous sensitization” in children with AD and the “leaky gut,” and why he tends to recommend probiotics for patients with AD.
Dr. Lio spoke on diet and AD during a session titled “Dietary Triggers and Modifications of Common Dermatologic Conditions – An Evidence Based Approach,” at the meeting, He had no relevant disclosures.
WASHINGTON – The and brings up an interesting discussion, Peter Lio, MD, said in a video interview at the annual meeting of the American Academy of Dermatology.
Patients are often convinced that food is the main driver of their AD, or parents believe it is a trigger in their children with AD, according to Dr. Lio of the departments of dermatology and pediatrics at Northwestern University, Chicago.
There is an increased risk of true food allergy in patients with AD, which “seems to get worse with increasing severity of the disease,” he pointed out. However, he added, many patients believe that food allergy is what is driving their eczema, “and that’s the part we don’t really think bears out” in clinical trials.
In the interview, Dr. Lio reviewed some of the clinical trial data and discussed other issues, including foods that seem to have an inflammatory effect in the body, the concepts of “transcutaneous sensitization” in children with AD and the “leaky gut,” and why he tends to recommend probiotics for patients with AD.
Dr. Lio spoke on diet and AD during a session titled “Dietary Triggers and Modifications of Common Dermatologic Conditions – An Evidence Based Approach,” at the meeting, He had no relevant disclosures.
REPORTING FROM AAD 2019
SPD president discusses pediatric research, and more
WASHINGTON – in an interview at the annual meeting of the American Academy of Dermatology.
Dr. Davis, a pediatric dermatologist at the Mayo Clinic, Rochester, Minn., said that the SPD had a strategic retreat prior to the AAD annual meeting to look at goals attained over the last 3 years “and where we’re going for the next 3 years.” Goals that have been accomplished “move us forward as a society for patient advocacy, specialty advocacy, workforce strengthening, research advancement, patient care, and education,” she noted. The education arena, for example, includes not only educating patients and their families, so they can get the best health care possible, “but we want to educate the pipeline of trainees coming through medical school so ... they have exposure to pediatric dermatology and they can hopefully develop an interest in pediatric dermatology as a future career.”
The SPD now has more than 1,200 members, and has a research arm, the Pediatric Dermatology Research Alliance (PeDRA), which has multiple projects, the largest of which is looking at the stigma of skin diseases, a study that involves patients with severe skin diseases and their families, said Dr. Davis. Watch the video above for more on PeDRA and SPD.
Dr. Davis disclosed that she is involved in a study for Regeneron but has not received any personal financial compensation.
WASHINGTON – in an interview at the annual meeting of the American Academy of Dermatology.
Dr. Davis, a pediatric dermatologist at the Mayo Clinic, Rochester, Minn., said that the SPD had a strategic retreat prior to the AAD annual meeting to look at goals attained over the last 3 years “and where we’re going for the next 3 years.” Goals that have been accomplished “move us forward as a society for patient advocacy, specialty advocacy, workforce strengthening, research advancement, patient care, and education,” she noted. The education arena, for example, includes not only educating patients and their families, so they can get the best health care possible, “but we want to educate the pipeline of trainees coming through medical school so ... they have exposure to pediatric dermatology and they can hopefully develop an interest in pediatric dermatology as a future career.”
The SPD now has more than 1,200 members, and has a research arm, the Pediatric Dermatology Research Alliance (PeDRA), which has multiple projects, the largest of which is looking at the stigma of skin diseases, a study that involves patients with severe skin diseases and their families, said Dr. Davis. Watch the video above for more on PeDRA and SPD.
Dr. Davis disclosed that she is involved in a study for Regeneron but has not received any personal financial compensation.
WASHINGTON – in an interview at the annual meeting of the American Academy of Dermatology.
Dr. Davis, a pediatric dermatologist at the Mayo Clinic, Rochester, Minn., said that the SPD had a strategic retreat prior to the AAD annual meeting to look at goals attained over the last 3 years “and where we’re going for the next 3 years.” Goals that have been accomplished “move us forward as a society for patient advocacy, specialty advocacy, workforce strengthening, research advancement, patient care, and education,” she noted. The education arena, for example, includes not only educating patients and their families, so they can get the best health care possible, “but we want to educate the pipeline of trainees coming through medical school so ... they have exposure to pediatric dermatology and they can hopefully develop an interest in pediatric dermatology as a future career.”
The SPD now has more than 1,200 members, and has a research arm, the Pediatric Dermatology Research Alliance (PeDRA), which has multiple projects, the largest of which is looking at the stigma of skin diseases, a study that involves patients with severe skin diseases and their families, said Dr. Davis. Watch the video above for more on PeDRA and SPD.
Dr. Davis disclosed that she is involved in a study for Regeneron but has not received any personal financial compensation.
REPORTING FROM AAD 2019
31-GEP test predicts likelihood of metastasis for cutaneous melanoma
WASHINGTON – The for accurately predicting recurrence-free survival and distant metastasis-free survival and melanoma-specific survival, according to results presented by Bradley N. Greenhaw, MD, at a late-breaking research session at the annual meeting of the American Academy of Dermatology.
Dr. Greenhaw, a dermatologist affiliated with the North Mississippi Medical Center-Tupelo, and his colleagues pooled together 1,268 patients from the following studies that analyzed results from melanoma patients who had their disease classified with the 31-gene expression profile (31-GEP) test.
- A single-center study, conducted by Dr. Greenhaw and his associates (Greenhaw BN et al. Dermatol Surg. 2018 Dec. doi: 10.1097/DSS.0000000000001588.
- A multicenter prospective study (J Hematol Oncol. 2017 Aug. doi: 10.1186/s13045-017-0520-1.
- A retrospective archival study (J Am Acad Dermatol. 2019 Jan. doi: 10.1016/j.jaad.2018.07.028.
The 31-GEP test stratifies an individual’s likelihood of developing metastasis within 5 years as low and high risk. In the three studies, the test was used to identify tumors with low-risk (class 1A, class 1B), higher-risk (class 2A), and highest-risk (class 2B) melanoma based on tumor gene expression. In these individual studies, class 2B melanoma independently predicted recurrence-free survival (RFS), distant metastasis–free, and melanoma-specific survival.
Dr. Greenhaw and colleagues performed a meta-analysis of 1,268 patients with stage I through stage III melanoma from those three studies, using fixed and random effects weighting to account for study differences and heterogeneity, respectively. For class 2B tumors, they found a 2.96 increased risk for recurrent metastases and a 2.88 increased risk for distant metastases. The researchers also found no heterogeneity across the studies.
Melanoma-specific survival was not included in the meta-analysis because one paper did not contain any mortality events in class 1A melanoma patients.
“The meta-analysis demonstrated that the GEP test was able to accurately identify those melanoma patients who were at higher risk of metastasis, and we saw a consistent effect across multiple studies,” Dr. Greenhaw said.
Since publication of the 2019 JAAD paper, there were an additional 211 patients who met inclusion criteria and were included in an additional meta-analysis to determine whether inclusion of these patients affected the results. Dr. Greenhaw and colleagues found a 91.4% recurrence-free survival rate and a 94.1% distant metastasis–free survival rate for class 1A melanomas, compared with 45.7% and 55.5% , respectively, for class 2B tumors.
“You can see a big divergence,” Dr. Greenhaw said at the meeting. “Just by using this one test, it’s able to separate out melanomas that otherwise may be grouped in together under current AJCC [American Joint Committee on Cancer] staging,” he added. “The class 2B designation really did confirm a higher risk for recurrence in distant metastasis.”
The researchers used the SORT method to rate the quality of the data across all three studies. Level 1 evidence under the SORT method represents a systematic review or meta-analysis of good-quality studies and/or a prospective study with good follow-up, while an A-level recommendation represents good, quality evidence. Based on the meta-analysis results, the 31-GEP test meets level 1A evidence under the SORT method, Dr. Greenhaw said.
As a prognostic tool, 31-GEP has the potential to change how dermatologists manage their patients with regard to follow-up and adjuvant therapy. “It is being used not just as this novel test that gives us more information, it’s being used clinically,” said Dr. Greenhaw, who noted he regularly uses the 31-GEP test in his practice.
This is the first time that a meta-analysis has been performed for this test, he noted.
Dr. Greenhaw reports a pending relationship with Castle Biosciences.
SOURCE: Greenhaw BN et al. AAD 19. Session F055, Abstract 11370.
WASHINGTON – The for accurately predicting recurrence-free survival and distant metastasis-free survival and melanoma-specific survival, according to results presented by Bradley N. Greenhaw, MD, at a late-breaking research session at the annual meeting of the American Academy of Dermatology.
Dr. Greenhaw, a dermatologist affiliated with the North Mississippi Medical Center-Tupelo, and his colleagues pooled together 1,268 patients from the following studies that analyzed results from melanoma patients who had their disease classified with the 31-gene expression profile (31-GEP) test.
- A single-center study, conducted by Dr. Greenhaw and his associates (Greenhaw BN et al. Dermatol Surg. 2018 Dec. doi: 10.1097/DSS.0000000000001588.
- A multicenter prospective study (J Hematol Oncol. 2017 Aug. doi: 10.1186/s13045-017-0520-1.
- A retrospective archival study (J Am Acad Dermatol. 2019 Jan. doi: 10.1016/j.jaad.2018.07.028.
The 31-GEP test stratifies an individual’s likelihood of developing metastasis within 5 years as low and high risk. In the three studies, the test was used to identify tumors with low-risk (class 1A, class 1B), higher-risk (class 2A), and highest-risk (class 2B) melanoma based on tumor gene expression. In these individual studies, class 2B melanoma independently predicted recurrence-free survival (RFS), distant metastasis–free, and melanoma-specific survival.
Dr. Greenhaw and colleagues performed a meta-analysis of 1,268 patients with stage I through stage III melanoma from those three studies, using fixed and random effects weighting to account for study differences and heterogeneity, respectively. For class 2B tumors, they found a 2.96 increased risk for recurrent metastases and a 2.88 increased risk for distant metastases. The researchers also found no heterogeneity across the studies.
Melanoma-specific survival was not included in the meta-analysis because one paper did not contain any mortality events in class 1A melanoma patients.
“The meta-analysis demonstrated that the GEP test was able to accurately identify those melanoma patients who were at higher risk of metastasis, and we saw a consistent effect across multiple studies,” Dr. Greenhaw said.
Since publication of the 2019 JAAD paper, there were an additional 211 patients who met inclusion criteria and were included in an additional meta-analysis to determine whether inclusion of these patients affected the results. Dr. Greenhaw and colleagues found a 91.4% recurrence-free survival rate and a 94.1% distant metastasis–free survival rate for class 1A melanomas, compared with 45.7% and 55.5% , respectively, for class 2B tumors.
“You can see a big divergence,” Dr. Greenhaw said at the meeting. “Just by using this one test, it’s able to separate out melanomas that otherwise may be grouped in together under current AJCC [American Joint Committee on Cancer] staging,” he added. “The class 2B designation really did confirm a higher risk for recurrence in distant metastasis.”
The researchers used the SORT method to rate the quality of the data across all three studies. Level 1 evidence under the SORT method represents a systematic review or meta-analysis of good-quality studies and/or a prospective study with good follow-up, while an A-level recommendation represents good, quality evidence. Based on the meta-analysis results, the 31-GEP test meets level 1A evidence under the SORT method, Dr. Greenhaw said.
As a prognostic tool, 31-GEP has the potential to change how dermatologists manage their patients with regard to follow-up and adjuvant therapy. “It is being used not just as this novel test that gives us more information, it’s being used clinically,” said Dr. Greenhaw, who noted he regularly uses the 31-GEP test in his practice.
This is the first time that a meta-analysis has been performed for this test, he noted.
Dr. Greenhaw reports a pending relationship with Castle Biosciences.
SOURCE: Greenhaw BN et al. AAD 19. Session F055, Abstract 11370.
WASHINGTON – The for accurately predicting recurrence-free survival and distant metastasis-free survival and melanoma-specific survival, according to results presented by Bradley N. Greenhaw, MD, at a late-breaking research session at the annual meeting of the American Academy of Dermatology.
Dr. Greenhaw, a dermatologist affiliated with the North Mississippi Medical Center-Tupelo, and his colleagues pooled together 1,268 patients from the following studies that analyzed results from melanoma patients who had their disease classified with the 31-gene expression profile (31-GEP) test.
- A single-center study, conducted by Dr. Greenhaw and his associates (Greenhaw BN et al. Dermatol Surg. 2018 Dec. doi: 10.1097/DSS.0000000000001588.
- A multicenter prospective study (J Hematol Oncol. 2017 Aug. doi: 10.1186/s13045-017-0520-1.
- A retrospective archival study (J Am Acad Dermatol. 2019 Jan. doi: 10.1016/j.jaad.2018.07.028.
The 31-GEP test stratifies an individual’s likelihood of developing metastasis within 5 years as low and high risk. In the three studies, the test was used to identify tumors with low-risk (class 1A, class 1B), higher-risk (class 2A), and highest-risk (class 2B) melanoma based on tumor gene expression. In these individual studies, class 2B melanoma independently predicted recurrence-free survival (RFS), distant metastasis–free, and melanoma-specific survival.
Dr. Greenhaw and colleagues performed a meta-analysis of 1,268 patients with stage I through stage III melanoma from those three studies, using fixed and random effects weighting to account for study differences and heterogeneity, respectively. For class 2B tumors, they found a 2.96 increased risk for recurrent metastases and a 2.88 increased risk for distant metastases. The researchers also found no heterogeneity across the studies.
Melanoma-specific survival was not included in the meta-analysis because one paper did not contain any mortality events in class 1A melanoma patients.
“The meta-analysis demonstrated that the GEP test was able to accurately identify those melanoma patients who were at higher risk of metastasis, and we saw a consistent effect across multiple studies,” Dr. Greenhaw said.
Since publication of the 2019 JAAD paper, there were an additional 211 patients who met inclusion criteria and were included in an additional meta-analysis to determine whether inclusion of these patients affected the results. Dr. Greenhaw and colleagues found a 91.4% recurrence-free survival rate and a 94.1% distant metastasis–free survival rate for class 1A melanomas, compared with 45.7% and 55.5% , respectively, for class 2B tumors.
“You can see a big divergence,” Dr. Greenhaw said at the meeting. “Just by using this one test, it’s able to separate out melanomas that otherwise may be grouped in together under current AJCC [American Joint Committee on Cancer] staging,” he added. “The class 2B designation really did confirm a higher risk for recurrence in distant metastasis.”
The researchers used the SORT method to rate the quality of the data across all three studies. Level 1 evidence under the SORT method represents a systematic review or meta-analysis of good-quality studies and/or a prospective study with good follow-up, while an A-level recommendation represents good, quality evidence. Based on the meta-analysis results, the 31-GEP test meets level 1A evidence under the SORT method, Dr. Greenhaw said.
As a prognostic tool, 31-GEP has the potential to change how dermatologists manage their patients with regard to follow-up and adjuvant therapy. “It is being used not just as this novel test that gives us more information, it’s being used clinically,” said Dr. Greenhaw, who noted he regularly uses the 31-GEP test in his practice.
This is the first time that a meta-analysis has been performed for this test, he noted.
Dr. Greenhaw reports a pending relationship with Castle Biosciences.
SOURCE: Greenhaw BN et al. AAD 19. Session F055, Abstract 11370.
REPORTING FROM AAD 19