Bermekimab reduces lesions, cuts pain in patients with hidradenitis suppurativa

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Bermekimab, a human monoclonal antibody, cleared lesions and improved pain in more than 60% of patients who received it during a 12-week proof-of-concept trial. It was nearly as effective in patients refractory to anti–tumor necrosis factor (TNF) therapy as it was to those naive to the treatment.

The antibody, which is derived directly from healthy human volunteers and then lab expanded, also improved patients’ quality of life in a “clinically meaningful way,” Alice Gottlieb, MD, PhD said at the annual meeting of the American Academy of Dermatology.

“These are sick people, and improvement of this kind is really something very important,” said Dr. Gottlieb of Mount Sinai Medical Center in New York. “I think what we see here supports the movement of bermekimab into phase 3 studies for HS [hidradenitis suppurativa].”

Bermekimab is the first inhibitor of IL-1 alpha to be investigated in HS. An overabundance of the cytokine produces several potentially problematic effects. IL-1 alpha induces inflammatory cells to migrate into the skin, drives neoangiogenesis, potentiates pain, and induces matrix metalloproteinase. The last two are particularly an issue in patients with HS. The abscesses and fistulas cause severe pain, which Dr. Gottlieb said is an undertreated and an underappreciated driver of disease disability. The tissue breakdown characteristic of the disease can also be highly disfiguring. “Many patients, especially my female patients, look as if they are basically autodigesting.”

IL-1 alpha also induces procollagen type I and III and fibroblast proliferation, contributing to the scarring many patients experience.

“Ten years ago, I thought it would be a potential target for HS,” Dr, Gottlieb said, and the idea has finally come to fruition through studies by biopharmaceutical company XBiotech in Austin, Tex. Dr. Gottlieb designed the treatment protocol and was a principal investigator on the study.

A similarly positive 2018 study employed twice-weekly intravenous infusions; this study utilized a more-concentrated form of the antibody delivered subcutaneously from prefilled syringes.

The study comprised 42 patients, 24 of whom had failed a course of anti-TNF therapy and 18 of whom were anti-TNF naive. Each group received bermekimab 400 mg subcutaneous once a week for 12 weeks. The primary endpoint was change on the Hidradenitis Suppurativa Clinical Response Score; good response was deemed at least a 50% reduction in abscesses and inflammatory nodules, with no new abscesses or draining fistulas. Secondary endpoints included pain scores, patient quality of life, and the physicians global clinical assessment.

At baseline, subjects in the anti-TNF–refractory group had a worse clinical profile than the naive patients, with more abscesses and inflammatory nodules (mean, 14 vs. 6) and worse scores on the Physicians Global Assessment. But they reported similar pain on a 10-point scale (around 8) and negative quality of life (17/30). Both groups experienced anxiety and depression.

Eight patients dropped out before finishing the trial for a variety of reasons, including family and transportation issues and comorbid illness. Only one discontinued for a reaction to the study drug (injection site redness). These patients were included in the final analysis in a last observation carried forward.

About 10% of patients began to experience improvement as soon as 2 weeks after the first injection. By week 6, 40% of the refractory patients and 10% of the naive patents had experienced a lesion reduction of at least 50%. By the end of the study, however, about 62% of patients in each group achieved that goal.

By week 12, the mean improvement in the Physicians Global Assessment was about 23% in the refractory group and 53% in the naive group. Both results were significant improvements over baseline.

The mean improvement in the pain score was about 54% in the refractory group and 65% in the naive group. In a scale that measured patients’ view of their disease severity, refractory patients reported a mean 40% improvement, and naive patients, a mean 67% improvement.

There were 57 adverse events recorded; 94% were grade 1 or 2. There were two serious adverse events requiring hospitalization – a fall and an admission for HS pain. Neither were judged related to the study drug. Two patients experienced injection site reactions and one patient experienced six bouts of nausea. There were no serious infections, no major cardiovascular events, and no neoplasms.

Dr. Gottlieb designed the study protocol and was a principal investigator. She did not receive financial compensation from the company.

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Bermekimab, a human monoclonal antibody, cleared lesions and improved pain in more than 60% of patients who received it during a 12-week proof-of-concept trial. It was nearly as effective in patients refractory to anti–tumor necrosis factor (TNF) therapy as it was to those naive to the treatment.

The antibody, which is derived directly from healthy human volunteers and then lab expanded, also improved patients’ quality of life in a “clinically meaningful way,” Alice Gottlieb, MD, PhD said at the annual meeting of the American Academy of Dermatology.

“These are sick people, and improvement of this kind is really something very important,” said Dr. Gottlieb of Mount Sinai Medical Center in New York. “I think what we see here supports the movement of bermekimab into phase 3 studies for HS [hidradenitis suppurativa].”

Bermekimab is the first inhibitor of IL-1 alpha to be investigated in HS. An overabundance of the cytokine produces several potentially problematic effects. IL-1 alpha induces inflammatory cells to migrate into the skin, drives neoangiogenesis, potentiates pain, and induces matrix metalloproteinase. The last two are particularly an issue in patients with HS. The abscesses and fistulas cause severe pain, which Dr. Gottlieb said is an undertreated and an underappreciated driver of disease disability. The tissue breakdown characteristic of the disease can also be highly disfiguring. “Many patients, especially my female patients, look as if they are basically autodigesting.”

IL-1 alpha also induces procollagen type I and III and fibroblast proliferation, contributing to the scarring many patients experience.

“Ten years ago, I thought it would be a potential target for HS,” Dr, Gottlieb said, and the idea has finally come to fruition through studies by biopharmaceutical company XBiotech in Austin, Tex. Dr. Gottlieb designed the treatment protocol and was a principal investigator on the study.

A similarly positive 2018 study employed twice-weekly intravenous infusions; this study utilized a more-concentrated form of the antibody delivered subcutaneously from prefilled syringes.

The study comprised 42 patients, 24 of whom had failed a course of anti-TNF therapy and 18 of whom were anti-TNF naive. Each group received bermekimab 400 mg subcutaneous once a week for 12 weeks. The primary endpoint was change on the Hidradenitis Suppurativa Clinical Response Score; good response was deemed at least a 50% reduction in abscesses and inflammatory nodules, with no new abscesses or draining fistulas. Secondary endpoints included pain scores, patient quality of life, and the physicians global clinical assessment.

At baseline, subjects in the anti-TNF–refractory group had a worse clinical profile than the naive patients, with more abscesses and inflammatory nodules (mean, 14 vs. 6) and worse scores on the Physicians Global Assessment. But they reported similar pain on a 10-point scale (around 8) and negative quality of life (17/30). Both groups experienced anxiety and depression.

Eight patients dropped out before finishing the trial for a variety of reasons, including family and transportation issues and comorbid illness. Only one discontinued for a reaction to the study drug (injection site redness). These patients were included in the final analysis in a last observation carried forward.

About 10% of patients began to experience improvement as soon as 2 weeks after the first injection. By week 6, 40% of the refractory patients and 10% of the naive patents had experienced a lesion reduction of at least 50%. By the end of the study, however, about 62% of patients in each group achieved that goal.

By week 12, the mean improvement in the Physicians Global Assessment was about 23% in the refractory group and 53% in the naive group. Both results were significant improvements over baseline.

The mean improvement in the pain score was about 54% in the refractory group and 65% in the naive group. In a scale that measured patients’ view of their disease severity, refractory patients reported a mean 40% improvement, and naive patients, a mean 67% improvement.

There were 57 adverse events recorded; 94% were grade 1 or 2. There were two serious adverse events requiring hospitalization – a fall and an admission for HS pain. Neither were judged related to the study drug. Two patients experienced injection site reactions and one patient experienced six bouts of nausea. There were no serious infections, no major cardiovascular events, and no neoplasms.

Dr. Gottlieb designed the study protocol and was a principal investigator. She did not receive financial compensation from the company.

 

Bermekimab, a human monoclonal antibody, cleared lesions and improved pain in more than 60% of patients who received it during a 12-week proof-of-concept trial. It was nearly as effective in patients refractory to anti–tumor necrosis factor (TNF) therapy as it was to those naive to the treatment.

The antibody, which is derived directly from healthy human volunteers and then lab expanded, also improved patients’ quality of life in a “clinically meaningful way,” Alice Gottlieb, MD, PhD said at the annual meeting of the American Academy of Dermatology.

“These are sick people, and improvement of this kind is really something very important,” said Dr. Gottlieb of Mount Sinai Medical Center in New York. “I think what we see here supports the movement of bermekimab into phase 3 studies for HS [hidradenitis suppurativa].”

Bermekimab is the first inhibitor of IL-1 alpha to be investigated in HS. An overabundance of the cytokine produces several potentially problematic effects. IL-1 alpha induces inflammatory cells to migrate into the skin, drives neoangiogenesis, potentiates pain, and induces matrix metalloproteinase. The last two are particularly an issue in patients with HS. The abscesses and fistulas cause severe pain, which Dr. Gottlieb said is an undertreated and an underappreciated driver of disease disability. The tissue breakdown characteristic of the disease can also be highly disfiguring. “Many patients, especially my female patients, look as if they are basically autodigesting.”

IL-1 alpha also induces procollagen type I and III and fibroblast proliferation, contributing to the scarring many patients experience.

“Ten years ago, I thought it would be a potential target for HS,” Dr, Gottlieb said, and the idea has finally come to fruition through studies by biopharmaceutical company XBiotech in Austin, Tex. Dr. Gottlieb designed the treatment protocol and was a principal investigator on the study.

A similarly positive 2018 study employed twice-weekly intravenous infusions; this study utilized a more-concentrated form of the antibody delivered subcutaneously from prefilled syringes.

The study comprised 42 patients, 24 of whom had failed a course of anti-TNF therapy and 18 of whom were anti-TNF naive. Each group received bermekimab 400 mg subcutaneous once a week for 12 weeks. The primary endpoint was change on the Hidradenitis Suppurativa Clinical Response Score; good response was deemed at least a 50% reduction in abscesses and inflammatory nodules, with no new abscesses or draining fistulas. Secondary endpoints included pain scores, patient quality of life, and the physicians global clinical assessment.

At baseline, subjects in the anti-TNF–refractory group had a worse clinical profile than the naive patients, with more abscesses and inflammatory nodules (mean, 14 vs. 6) and worse scores on the Physicians Global Assessment. But they reported similar pain on a 10-point scale (around 8) and negative quality of life (17/30). Both groups experienced anxiety and depression.

Eight patients dropped out before finishing the trial for a variety of reasons, including family and transportation issues and comorbid illness. Only one discontinued for a reaction to the study drug (injection site redness). These patients were included in the final analysis in a last observation carried forward.

About 10% of patients began to experience improvement as soon as 2 weeks after the first injection. By week 6, 40% of the refractory patients and 10% of the naive patents had experienced a lesion reduction of at least 50%. By the end of the study, however, about 62% of patients in each group achieved that goal.

By week 12, the mean improvement in the Physicians Global Assessment was about 23% in the refractory group and 53% in the naive group. Both results were significant improvements over baseline.

The mean improvement in the pain score was about 54% in the refractory group and 65% in the naive group. In a scale that measured patients’ view of their disease severity, refractory patients reported a mean 40% improvement, and naive patients, a mean 67% improvement.

There were 57 adverse events recorded; 94% were grade 1 or 2. There were two serious adverse events requiring hospitalization – a fall and an admission for HS pain. Neither were judged related to the study drug. Two patients experienced injection site reactions and one patient experienced six bouts of nausea. There were no serious infections, no major cardiovascular events, and no neoplasms.

Dr. Gottlieb designed the study protocol and was a principal investigator. She did not receive financial compensation from the company.

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Eczema increases the risk of impaired mental health among children

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Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

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Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

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Management of acne duration, severity can improve rate of scar repair

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Mon, 06/24/2019 - 13:21

 

Addressing modifiable risk factors of acne scarring such as the duration, severity, and manipulation of lesions improves the rate of scar repair, Jerry Tan, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Jerry Tan

A “large majority” of patients present with active acne scarring, even those with mild and moderate disease, said Dr. Tan of the University of Western Ontario, London. The stigma associated with acne and scarring is real – in one survey, 41% of respondents noted that acne was the first thing they noticed about a person’s face (Dermatol Ther. 2016;6[2]:207-18).

“Patients with scars are stigmatized because they are perceived as being less attractive,” Dr. Tan said. “They’re perceived as being less healthy, less confident, all those negative attributes because they have developed something that was not of their own making.”

Dr. Tan presented results from his own group that estimated the risk factors of scarring. They found factors such as acne severity (odds ratio, 3.68; 95% confidence interval, 2.58-5.23), a family history of acne scarring (OR, 2.14; 95% CI, 1.67-2.76), acne duration (OR, 1.63; 1.09-2.47), and manipulation (picking and squeezing) behaviors (OR, 1.70; 95% CI, 1.27-2.29) increased the risk of acne scarring (J Eur Acad Dermatol Venereol. 2017 Sep;31[9]:1547-54). However, in a separate study, they found acne scarring and repair was an ongoing process: Of 32 patients with moderate inflammatory acne studied for 6 months, 36% of scars that were discovered within the study period were not present at follow up (J Drugs Dermatol. 2017 Jun 1;16[6]:566-72).

“I came from an era where we were taught that acne scars, when they developed, were permanent. This suggests based on good evidence that it’s not,” Dr. Tan said.

Adapalene has been successful in improving the skin texture and severity of acne scars, Dr. Tan said, citing a study that showed once-daily adapalene 0.3% gel showed a moderate to complete improvement in scar severity in 77.8% of patients and a slight improvement in 22.2% of patients (Dermatol Ther. 2018;8[2]:245-57). Increasing the dose helped: 32.9% of patients using topical adapalene 0.3% combined with benzoyl peroxide 2.5% gel at 24 weeks were clear or almost clear according to Scar Global Assessment scores, compared with 16.4% of patients randomized to vehicle (Am J Clin Dermatol. 2018 Apr;19[2]:275-86).

For established scars, many treatment modalities are available, with varying levels of evidence supporting their use. Ice pick scars are commonly treated with chemical reconstruction of skin scars (CROSS), punch techniques, and radiofrequency (RF). Rolling acne scares can be treated with dermabrasion, dermal fillers, RF, skin needling, subcision as well as ablative, nonablative and fractional lasers. Shallow boxcar scars are treated with dermabrasion, dermal fillers, RF, skin needling and subcision as well as ablative, nonablative, fractional lasers; deeper boxcar scars can be treated with RF and punch techniques.

Among these techniques, Dr. Tan said there is level I evidence to use subcision and dermal fillers with rolling acne scars and CROSS with trichloroacetic acid for ice pick and boxcar scars; and for boxcar and rolling scars, ablative and nonablative lasers, microneedling in combination with platelet-rich plasma, RF microneedle or fractional bipolar therapy.

“Remarkably atrophic acne scars can repair spontaneously. Our job is to get more willing to repair spontaneously,” Dr. Tan said. “And we think we can push that to that end with topical retinoids. Topical retinoids can reduce scar formation and certainly there are lots of corrective procedures that can help our patients.”

Dr. Tan reported relationships with Abbott Laboratories, Allergan, Avene, Bayer, Boots, Cipher Pharmaceuticals, Dermira, Eli Lilly, Galderma Laboratories, Galderma Research & Development, F. Hoffman–La Roche, Janssen Pharmaceuticals, Leo Pharma, Lilly ICOS, Pfizer, Proctor & Gamble, Stiefel, and Valeant Pharmaceuticals International.

SOURCE: Tan J et al. AAD 19, Symposium 012.

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Addressing modifiable risk factors of acne scarring such as the duration, severity, and manipulation of lesions improves the rate of scar repair, Jerry Tan, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Jerry Tan

A “large majority” of patients present with active acne scarring, even those with mild and moderate disease, said Dr. Tan of the University of Western Ontario, London. The stigma associated with acne and scarring is real – in one survey, 41% of respondents noted that acne was the first thing they noticed about a person’s face (Dermatol Ther. 2016;6[2]:207-18).

“Patients with scars are stigmatized because they are perceived as being less attractive,” Dr. Tan said. “They’re perceived as being less healthy, less confident, all those negative attributes because they have developed something that was not of their own making.”

Dr. Tan presented results from his own group that estimated the risk factors of scarring. They found factors such as acne severity (odds ratio, 3.68; 95% confidence interval, 2.58-5.23), a family history of acne scarring (OR, 2.14; 95% CI, 1.67-2.76), acne duration (OR, 1.63; 1.09-2.47), and manipulation (picking and squeezing) behaviors (OR, 1.70; 95% CI, 1.27-2.29) increased the risk of acne scarring (J Eur Acad Dermatol Venereol. 2017 Sep;31[9]:1547-54). However, in a separate study, they found acne scarring and repair was an ongoing process: Of 32 patients with moderate inflammatory acne studied for 6 months, 36% of scars that were discovered within the study period were not present at follow up (J Drugs Dermatol. 2017 Jun 1;16[6]:566-72).

“I came from an era where we were taught that acne scars, when they developed, were permanent. This suggests based on good evidence that it’s not,” Dr. Tan said.

Adapalene has been successful in improving the skin texture and severity of acne scars, Dr. Tan said, citing a study that showed once-daily adapalene 0.3% gel showed a moderate to complete improvement in scar severity in 77.8% of patients and a slight improvement in 22.2% of patients (Dermatol Ther. 2018;8[2]:245-57). Increasing the dose helped: 32.9% of patients using topical adapalene 0.3% combined with benzoyl peroxide 2.5% gel at 24 weeks were clear or almost clear according to Scar Global Assessment scores, compared with 16.4% of patients randomized to vehicle (Am J Clin Dermatol. 2018 Apr;19[2]:275-86).

For established scars, many treatment modalities are available, with varying levels of evidence supporting their use. Ice pick scars are commonly treated with chemical reconstruction of skin scars (CROSS), punch techniques, and radiofrequency (RF). Rolling acne scares can be treated with dermabrasion, dermal fillers, RF, skin needling, subcision as well as ablative, nonablative and fractional lasers. Shallow boxcar scars are treated with dermabrasion, dermal fillers, RF, skin needling and subcision as well as ablative, nonablative, fractional lasers; deeper boxcar scars can be treated with RF and punch techniques.

Among these techniques, Dr. Tan said there is level I evidence to use subcision and dermal fillers with rolling acne scars and CROSS with trichloroacetic acid for ice pick and boxcar scars; and for boxcar and rolling scars, ablative and nonablative lasers, microneedling in combination with platelet-rich plasma, RF microneedle or fractional bipolar therapy.

“Remarkably atrophic acne scars can repair spontaneously. Our job is to get more willing to repair spontaneously,” Dr. Tan said. “And we think we can push that to that end with topical retinoids. Topical retinoids can reduce scar formation and certainly there are lots of corrective procedures that can help our patients.”

Dr. Tan reported relationships with Abbott Laboratories, Allergan, Avene, Bayer, Boots, Cipher Pharmaceuticals, Dermira, Eli Lilly, Galderma Laboratories, Galderma Research & Development, F. Hoffman–La Roche, Janssen Pharmaceuticals, Leo Pharma, Lilly ICOS, Pfizer, Proctor & Gamble, Stiefel, and Valeant Pharmaceuticals International.

SOURCE: Tan J et al. AAD 19, Symposium 012.

 

Addressing modifiable risk factors of acne scarring such as the duration, severity, and manipulation of lesions improves the rate of scar repair, Jerry Tan, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Jerry Tan

A “large majority” of patients present with active acne scarring, even those with mild and moderate disease, said Dr. Tan of the University of Western Ontario, London. The stigma associated with acne and scarring is real – in one survey, 41% of respondents noted that acne was the first thing they noticed about a person’s face (Dermatol Ther. 2016;6[2]:207-18).

“Patients with scars are stigmatized because they are perceived as being less attractive,” Dr. Tan said. “They’re perceived as being less healthy, less confident, all those negative attributes because they have developed something that was not of their own making.”

Dr. Tan presented results from his own group that estimated the risk factors of scarring. They found factors such as acne severity (odds ratio, 3.68; 95% confidence interval, 2.58-5.23), a family history of acne scarring (OR, 2.14; 95% CI, 1.67-2.76), acne duration (OR, 1.63; 1.09-2.47), and manipulation (picking and squeezing) behaviors (OR, 1.70; 95% CI, 1.27-2.29) increased the risk of acne scarring (J Eur Acad Dermatol Venereol. 2017 Sep;31[9]:1547-54). However, in a separate study, they found acne scarring and repair was an ongoing process: Of 32 patients with moderate inflammatory acne studied for 6 months, 36% of scars that were discovered within the study period were not present at follow up (J Drugs Dermatol. 2017 Jun 1;16[6]:566-72).

“I came from an era where we were taught that acne scars, when they developed, were permanent. This suggests based on good evidence that it’s not,” Dr. Tan said.

Adapalene has been successful in improving the skin texture and severity of acne scars, Dr. Tan said, citing a study that showed once-daily adapalene 0.3% gel showed a moderate to complete improvement in scar severity in 77.8% of patients and a slight improvement in 22.2% of patients (Dermatol Ther. 2018;8[2]:245-57). Increasing the dose helped: 32.9% of patients using topical adapalene 0.3% combined with benzoyl peroxide 2.5% gel at 24 weeks were clear or almost clear according to Scar Global Assessment scores, compared with 16.4% of patients randomized to vehicle (Am J Clin Dermatol. 2018 Apr;19[2]:275-86).

For established scars, many treatment modalities are available, with varying levels of evidence supporting their use. Ice pick scars are commonly treated with chemical reconstruction of skin scars (CROSS), punch techniques, and radiofrequency (RF). Rolling acne scares can be treated with dermabrasion, dermal fillers, RF, skin needling, subcision as well as ablative, nonablative and fractional lasers. Shallow boxcar scars are treated with dermabrasion, dermal fillers, RF, skin needling and subcision as well as ablative, nonablative, fractional lasers; deeper boxcar scars can be treated with RF and punch techniques.

Among these techniques, Dr. Tan said there is level I evidence to use subcision and dermal fillers with rolling acne scars and CROSS with trichloroacetic acid for ice pick and boxcar scars; and for boxcar and rolling scars, ablative and nonablative lasers, microneedling in combination with platelet-rich plasma, RF microneedle or fractional bipolar therapy.

“Remarkably atrophic acne scars can repair spontaneously. Our job is to get more willing to repair spontaneously,” Dr. Tan said. “And we think we can push that to that end with topical retinoids. Topical retinoids can reduce scar formation and certainly there are lots of corrective procedures that can help our patients.”

Dr. Tan reported relationships with Abbott Laboratories, Allergan, Avene, Bayer, Boots, Cipher Pharmaceuticals, Dermira, Eli Lilly, Galderma Laboratories, Galderma Research & Development, F. Hoffman–La Roche, Janssen Pharmaceuticals, Leo Pharma, Lilly ICOS, Pfizer, Proctor & Gamble, Stiefel, and Valeant Pharmaceuticals International.

SOURCE: Tan J et al. AAD 19, Symposium 012.

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Many common dermatologic drugs can be safely used during pregnancy

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– With proper counseling and oversight, many drugs used for psoriasis, pemphigus, and atopic dermatitis are safe to use during pregnancy, Jenny Murase, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Jenny Murase

But it’s important to have an early talk about potential pregnancies, because most dermatologists don’t think about it unless a patient is taking a known teratogen, like isotretinoin, said Dr. Murase of the University of California, San Francisco. “It’s only about 10% of the time that the dermatologist brings it up. In patients with these chronic skin diseases, we need to address family planning proactively. Most women don’t discover they’re pregnant until they’re 2-5 weeks along, and by that time the development of major organs has already started.”

As part of her expertise in this topic, Dr. Murase published two comprehensive reports on the safety of dermatologic drugs in pregnancy and lactation. They were grouped according to the newest federal guidance, the Food and Drug Administration Pregnancy and Lactation Label Ruling. Issued in 2014, it requires the inclusion of any contact information for drug registries and covers reproductive risks or both males and females. Slowly being phased in as new drugs are approved, the ruling is replacing the old category A, B, and C.

The articles were published in the Journal of the American Academy of Dermatology and in the international Journal of Women’s Dermatology, an open-access journal Dr. Murase founded.

 

 

Corticosteroids

These dermatology workhorses are largely safe in pregnancy, Dr. Murase said. Some very early reports suggested that systemic cortisone might be associated with oral clefts, but that has never been borne out in prospective data. Prednisone may be the safest as it has the most limited placental transport; betamethasone and dexamethasone cross the placenta easily.

In a Cochrane review, only one study showed an increased risk of orofacial clefts. A 2013 study of about 10,000 women suggested an increased risk of low birth weight associated with a total dose of more than 300 grams during the pregnancy.

 

 

Antihistamines

First-generation antihistamines, including hydroxyzine, have been used as antiemetics in pregnant women. Hydroxyzine is generally considered safe, but should be discussed carefully, as it carries a slightly increased risk of congenital malformations (5.8% vs. 2.3% background risk).

Newborns exposed to large doses of hydroxyzine (150 mg or more daily) have also exhibited withdrawal symptoms at birth, including irritability, poor feeding, and tonic-clinic seizures.

“Antihistamines can exert oxytocin-like effects, especially in overdose or when given intravenously, so please avoid using them in the last month of pregnancy. There have also been a few reports of retrolental fibroplasia in preterm infants who were exposed to antihistamines within 2 weeks of delivery,” Dr. Murase said.

 

 

Immunosuppressants

Mycophenolate is not compatible with pregnancy. In 2007, the FDA changed the labeling of mycophenolate from category C to D, because of reports of congenital malformations arising from the U.S. National Transplantation Pregnancy Registry and other sources.

“You need to treat these patients like you do someone who is going on isotretinoin,” Dr. Murase said. “Any woman prescribed it should be on mandatory contraception at least 4 weeks before beginning the medication and for 6 weeks after completing treatment.”

Thus far there are no reported pregnancy-related safety issues with dupilumab, although data are scarce.

Pregnancy itself exerts a positive effect on psoriasis in many women, but not all. “About half the time a women will improve,” Dr. Murase said. “A quarter of the time, there’s no change and a quarter of the time, she’ll get worse. But the ones who do improve, often improve dramatically with about 80% body surface area clearance.”

She considers light therapy to be the safest treatment during pregnancy, with one caveat: Ultraviolet light can degrade some vitamins, including folic acid. “Every one of my patients of childbearing age I have on folic acid or a prenatal vitamin just in case. You have to be proactive here.”

Cyclosporine appears to be “quite safe,” she said. The possibility of intrauterine growth restriction seen in some studies is tough to tease out, because it was reported mainly in transplant populations among women with other medical comorbidities. Children from these pregnancies have been followed through toddlerhood and showed no neurodevelopmental or kidney issues.

Apremilast is a category C drug. Some animal data suggested increased spontaneous abortions and fetal demise with doses given at two to four times the human dose.

 

 

Biologics

Antibodies are an interesting lot, Dr. Murase noted. Maternal antibodies are transported to the fetus across the villi by Fc receptor; most of this transfer happens during the third trimester. The large, hydrophilic monoclonal antibodies infliximab, adalimumab, and ustekinumab travel this way as well. Cord blood can contain 50% higher serum levels than in maternal blood. Etanercept, however, is a fusion protein that diffuses across the placenta. Cord blood levels generally exceed maternal levels by less than 7%.

There is one published report of a fetal death associated with maternal infliximab for Crohn’s disease. The infant was healthy until it received a Bacillus Calmette–Guerin vaccine. It then developed widespread eczematous dermatitis, head lag, and poor weight gain and died at 4.5 months.

“This is another important counseling point,” Dr. Murase said. “Babies who have been exposed to infliximab in utero can’t have that vaccination in the first 9 months of life.”

Perhaps the safest bet for a pregnant women who needs a biologic is PEGylated certolizumab. “Certolizumab is the only PEGylated anti-TNF [tumor necrosis factor] without an Fc region; study of patients greater than 30 weeks pregnant certolizumab levels were below 0.032 mcg/mL in 13 of 14 infant samples at birth.”

 

 

Pemphigus

Pemphigus (impetigo herpetiformous) is a serious dermatologic disorder that can manifest in the third trimester, and affect the fetus as well as the mother. “You have to take even mild cases very seriously, because there’s no distinct correlation between the extent of neonatal involvement and the extent of maternal disease,” Dr. Murase said

Oral pemphigus in the mother is especially worrisome, she added. “Fetal skin shares the same desmoglein-3 profile as adult oral mucosa, and neonatal pemphigus is more likely if mother has oral disease. There’s an increased risk of fetal demise as well.”

Treatment would generally start with topical steroids, progressing to systemic low-dose corticosteroids. If more than 20 mg of prednisone a day is required, consider intravenous immunoglobulin (IVIG), azathioprine, dapsone, or rituximab.

“IVIG is very safe for pregnant women, and in fact reproductive endocrinologists use this to increase the chance of pregnancy for infertility cases,” Dr. Murase said.

She reported relationships with Regeneron, UCB, Dermira, and Genzyme/Sanofi.

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– With proper counseling and oversight, many drugs used for psoriasis, pemphigus, and atopic dermatitis are safe to use during pregnancy, Jenny Murase, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Jenny Murase

But it’s important to have an early talk about potential pregnancies, because most dermatologists don’t think about it unless a patient is taking a known teratogen, like isotretinoin, said Dr. Murase of the University of California, San Francisco. “It’s only about 10% of the time that the dermatologist brings it up. In patients with these chronic skin diseases, we need to address family planning proactively. Most women don’t discover they’re pregnant until they’re 2-5 weeks along, and by that time the development of major organs has already started.”

As part of her expertise in this topic, Dr. Murase published two comprehensive reports on the safety of dermatologic drugs in pregnancy and lactation. They were grouped according to the newest federal guidance, the Food and Drug Administration Pregnancy and Lactation Label Ruling. Issued in 2014, it requires the inclusion of any contact information for drug registries and covers reproductive risks or both males and females. Slowly being phased in as new drugs are approved, the ruling is replacing the old category A, B, and C.

The articles were published in the Journal of the American Academy of Dermatology and in the international Journal of Women’s Dermatology, an open-access journal Dr. Murase founded.

 

 

Corticosteroids

These dermatology workhorses are largely safe in pregnancy, Dr. Murase said. Some very early reports suggested that systemic cortisone might be associated with oral clefts, but that has never been borne out in prospective data. Prednisone may be the safest as it has the most limited placental transport; betamethasone and dexamethasone cross the placenta easily.

In a Cochrane review, only one study showed an increased risk of orofacial clefts. A 2013 study of about 10,000 women suggested an increased risk of low birth weight associated with a total dose of more than 300 grams during the pregnancy.

 

 

Antihistamines

First-generation antihistamines, including hydroxyzine, have been used as antiemetics in pregnant women. Hydroxyzine is generally considered safe, but should be discussed carefully, as it carries a slightly increased risk of congenital malformations (5.8% vs. 2.3% background risk).

Newborns exposed to large doses of hydroxyzine (150 mg or more daily) have also exhibited withdrawal symptoms at birth, including irritability, poor feeding, and tonic-clinic seizures.

“Antihistamines can exert oxytocin-like effects, especially in overdose or when given intravenously, so please avoid using them in the last month of pregnancy. There have also been a few reports of retrolental fibroplasia in preterm infants who were exposed to antihistamines within 2 weeks of delivery,” Dr. Murase said.

 

 

Immunosuppressants

Mycophenolate is not compatible with pregnancy. In 2007, the FDA changed the labeling of mycophenolate from category C to D, because of reports of congenital malformations arising from the U.S. National Transplantation Pregnancy Registry and other sources.

“You need to treat these patients like you do someone who is going on isotretinoin,” Dr. Murase said. “Any woman prescribed it should be on mandatory contraception at least 4 weeks before beginning the medication and for 6 weeks after completing treatment.”

Thus far there are no reported pregnancy-related safety issues with dupilumab, although data are scarce.

Pregnancy itself exerts a positive effect on psoriasis in many women, but not all. “About half the time a women will improve,” Dr. Murase said. “A quarter of the time, there’s no change and a quarter of the time, she’ll get worse. But the ones who do improve, often improve dramatically with about 80% body surface area clearance.”

She considers light therapy to be the safest treatment during pregnancy, with one caveat: Ultraviolet light can degrade some vitamins, including folic acid. “Every one of my patients of childbearing age I have on folic acid or a prenatal vitamin just in case. You have to be proactive here.”

Cyclosporine appears to be “quite safe,” she said. The possibility of intrauterine growth restriction seen in some studies is tough to tease out, because it was reported mainly in transplant populations among women with other medical comorbidities. Children from these pregnancies have been followed through toddlerhood and showed no neurodevelopmental or kidney issues.

Apremilast is a category C drug. Some animal data suggested increased spontaneous abortions and fetal demise with doses given at two to four times the human dose.

 

 

Biologics

Antibodies are an interesting lot, Dr. Murase noted. Maternal antibodies are transported to the fetus across the villi by Fc receptor; most of this transfer happens during the third trimester. The large, hydrophilic monoclonal antibodies infliximab, adalimumab, and ustekinumab travel this way as well. Cord blood can contain 50% higher serum levels than in maternal blood. Etanercept, however, is a fusion protein that diffuses across the placenta. Cord blood levels generally exceed maternal levels by less than 7%.

There is one published report of a fetal death associated with maternal infliximab for Crohn’s disease. The infant was healthy until it received a Bacillus Calmette–Guerin vaccine. It then developed widespread eczematous dermatitis, head lag, and poor weight gain and died at 4.5 months.

“This is another important counseling point,” Dr. Murase said. “Babies who have been exposed to infliximab in utero can’t have that vaccination in the first 9 months of life.”

Perhaps the safest bet for a pregnant women who needs a biologic is PEGylated certolizumab. “Certolizumab is the only PEGylated anti-TNF [tumor necrosis factor] without an Fc region; study of patients greater than 30 weeks pregnant certolizumab levels were below 0.032 mcg/mL in 13 of 14 infant samples at birth.”

 

 

Pemphigus

Pemphigus (impetigo herpetiformous) is a serious dermatologic disorder that can manifest in the third trimester, and affect the fetus as well as the mother. “You have to take even mild cases very seriously, because there’s no distinct correlation between the extent of neonatal involvement and the extent of maternal disease,” Dr. Murase said

Oral pemphigus in the mother is especially worrisome, she added. “Fetal skin shares the same desmoglein-3 profile as adult oral mucosa, and neonatal pemphigus is more likely if mother has oral disease. There’s an increased risk of fetal demise as well.”

Treatment would generally start with topical steroids, progressing to systemic low-dose corticosteroids. If more than 20 mg of prednisone a day is required, consider intravenous immunoglobulin (IVIG), azathioprine, dapsone, or rituximab.

“IVIG is very safe for pregnant women, and in fact reproductive endocrinologists use this to increase the chance of pregnancy for infertility cases,” Dr. Murase said.

She reported relationships with Regeneron, UCB, Dermira, and Genzyme/Sanofi.

 

– With proper counseling and oversight, many drugs used for psoriasis, pemphigus, and atopic dermatitis are safe to use during pregnancy, Jenny Murase, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Jenny Murase

But it’s important to have an early talk about potential pregnancies, because most dermatologists don’t think about it unless a patient is taking a known teratogen, like isotretinoin, said Dr. Murase of the University of California, San Francisco. “It’s only about 10% of the time that the dermatologist brings it up. In patients with these chronic skin diseases, we need to address family planning proactively. Most women don’t discover they’re pregnant until they’re 2-5 weeks along, and by that time the development of major organs has already started.”

As part of her expertise in this topic, Dr. Murase published two comprehensive reports on the safety of dermatologic drugs in pregnancy and lactation. They were grouped according to the newest federal guidance, the Food and Drug Administration Pregnancy and Lactation Label Ruling. Issued in 2014, it requires the inclusion of any contact information for drug registries and covers reproductive risks or both males and females. Slowly being phased in as new drugs are approved, the ruling is replacing the old category A, B, and C.

The articles were published in the Journal of the American Academy of Dermatology and in the international Journal of Women’s Dermatology, an open-access journal Dr. Murase founded.

 

 

Corticosteroids

These dermatology workhorses are largely safe in pregnancy, Dr. Murase said. Some very early reports suggested that systemic cortisone might be associated with oral clefts, but that has never been borne out in prospective data. Prednisone may be the safest as it has the most limited placental transport; betamethasone and dexamethasone cross the placenta easily.

In a Cochrane review, only one study showed an increased risk of orofacial clefts. A 2013 study of about 10,000 women suggested an increased risk of low birth weight associated with a total dose of more than 300 grams during the pregnancy.

 

 

Antihistamines

First-generation antihistamines, including hydroxyzine, have been used as antiemetics in pregnant women. Hydroxyzine is generally considered safe, but should be discussed carefully, as it carries a slightly increased risk of congenital malformations (5.8% vs. 2.3% background risk).

Newborns exposed to large doses of hydroxyzine (150 mg or more daily) have also exhibited withdrawal symptoms at birth, including irritability, poor feeding, and tonic-clinic seizures.

“Antihistamines can exert oxytocin-like effects, especially in overdose or when given intravenously, so please avoid using them in the last month of pregnancy. There have also been a few reports of retrolental fibroplasia in preterm infants who were exposed to antihistamines within 2 weeks of delivery,” Dr. Murase said.

 

 

Immunosuppressants

Mycophenolate is not compatible with pregnancy. In 2007, the FDA changed the labeling of mycophenolate from category C to D, because of reports of congenital malformations arising from the U.S. National Transplantation Pregnancy Registry and other sources.

“You need to treat these patients like you do someone who is going on isotretinoin,” Dr. Murase said. “Any woman prescribed it should be on mandatory contraception at least 4 weeks before beginning the medication and for 6 weeks after completing treatment.”

Thus far there are no reported pregnancy-related safety issues with dupilumab, although data are scarce.

Pregnancy itself exerts a positive effect on psoriasis in many women, but not all. “About half the time a women will improve,” Dr. Murase said. “A quarter of the time, there’s no change and a quarter of the time, she’ll get worse. But the ones who do improve, often improve dramatically with about 80% body surface area clearance.”

She considers light therapy to be the safest treatment during pregnancy, with one caveat: Ultraviolet light can degrade some vitamins, including folic acid. “Every one of my patients of childbearing age I have on folic acid or a prenatal vitamin just in case. You have to be proactive here.”

Cyclosporine appears to be “quite safe,” she said. The possibility of intrauterine growth restriction seen in some studies is tough to tease out, because it was reported mainly in transplant populations among women with other medical comorbidities. Children from these pregnancies have been followed through toddlerhood and showed no neurodevelopmental or kidney issues.

Apremilast is a category C drug. Some animal data suggested increased spontaneous abortions and fetal demise with doses given at two to four times the human dose.

 

 

Biologics

Antibodies are an interesting lot, Dr. Murase noted. Maternal antibodies are transported to the fetus across the villi by Fc receptor; most of this transfer happens during the third trimester. The large, hydrophilic monoclonal antibodies infliximab, adalimumab, and ustekinumab travel this way as well. Cord blood can contain 50% higher serum levels than in maternal blood. Etanercept, however, is a fusion protein that diffuses across the placenta. Cord blood levels generally exceed maternal levels by less than 7%.

There is one published report of a fetal death associated with maternal infliximab for Crohn’s disease. The infant was healthy until it received a Bacillus Calmette–Guerin vaccine. It then developed widespread eczematous dermatitis, head lag, and poor weight gain and died at 4.5 months.

“This is another important counseling point,” Dr. Murase said. “Babies who have been exposed to infliximab in utero can’t have that vaccination in the first 9 months of life.”

Perhaps the safest bet for a pregnant women who needs a biologic is PEGylated certolizumab. “Certolizumab is the only PEGylated anti-TNF [tumor necrosis factor] without an Fc region; study of patients greater than 30 weeks pregnant certolizumab levels were below 0.032 mcg/mL in 13 of 14 infant samples at birth.”

 

 

Pemphigus

Pemphigus (impetigo herpetiformous) is a serious dermatologic disorder that can manifest in the third trimester, and affect the fetus as well as the mother. “You have to take even mild cases very seriously, because there’s no distinct correlation between the extent of neonatal involvement and the extent of maternal disease,” Dr. Murase said

Oral pemphigus in the mother is especially worrisome, she added. “Fetal skin shares the same desmoglein-3 profile as adult oral mucosa, and neonatal pemphigus is more likely if mother has oral disease. There’s an increased risk of fetal demise as well.”

Treatment would generally start with topical steroids, progressing to systemic low-dose corticosteroids. If more than 20 mg of prednisone a day is required, consider intravenous immunoglobulin (IVIG), azathioprine, dapsone, or rituximab.

“IVIG is very safe for pregnant women, and in fact reproductive endocrinologists use this to increase the chance of pregnancy for infertility cases,” Dr. Murase said.

She reported relationships with Regeneron, UCB, Dermira, and Genzyme/Sanofi.

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Migraine associated with more severe disability in patients with MS

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In a cohort of patients with multiple sclerosis, a history of migraine was associated with more severe disability and significantly slower walking speeds, researchers reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Anne M. Damian, MD, of Johns Hopkins University School of Medicine in Baltimore
Dr. Anne M. Damian

“Traditional migraine risk factors such as obesity, anxiety, and depression were also overrepresented in our cohort” of patients with multiple sclerosis (MS) and migraine, said Anne M. Damian, MD, of Johns Hopkins University, Baltimore, and her research colleagues.

Migraine is common in patients with MS, but whether migraine plays a role in MS disease course or MS symptom severity is unknown. Dr. Damian and her colleagues conducted an observational study to examine the associations between migraine history, disability, and neurologic function in patients with MS and whether migraine tends to occur with other comorbid conditions in MS.

They analyzed data from 289 patients (79% female; mean age, 49.2 years) patients with MS who completed the Multiple Sclerosis Performance Test (MSPT), an iPad version of the MS Functional Composite. MS outcome measures included disability (such as the Patient Determined Disease Steps) and objective neurologic outcomes (such as walking speed, manual dexterity, and processing speed). Patients also completed a questionnaire about comorbidities, including history of physician-diagnosed migraine, diabetes, hypertension, hypercholesterolemia, heart disease, sleep apnea, depression, and anxiety.

The researchers used generalized linear models adjusted for age, sex, MS subtype, MS duration, years of education, and body mass index to evaluate the association between history of migraine and MS outcomes.

Compared with patients with MS without migraine, migraineurs (n = 65) tended to be younger (mean age, 44.3 years vs. 50.4 years) and were more likely to be overweight or obese (73.9% vs. 51.6%). In addition, patients with MS and migraine were more likely to have a history of depression (46.2% vs. 24.2%), anxiety (30.8% vs. 18.8%), and severe rather than mild disability (odds ratio, 3.08; 95% confidence, 1.04-9.20). Migraine also was associated with significantly slower walking speeds (9.08% slower; 95% CI, 0.82%-18.77%). Migraine was not associated with processing speed or manual dexterity, however.

If an association between migraine history and worse MS disability is confirmed, migraine history may be a factor that neurologists could consider when making MS treatment decisions, Dr. Damian said. The researchers noted that migraine was reported by patients and not detected using a validated questionnaire. Future studies should investigate whether MS lesions on MRI differ in migraineurs and whether migraine predicts future neurologic disability in patients with MS.

Collection of the MSPT outcomes was sponsored by Biogen.

SOURCE: Damian AM et al. ACTRIMS Forum 2019, Abstract 78.

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In a cohort of patients with multiple sclerosis, a history of migraine was associated with more severe disability and significantly slower walking speeds, researchers reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Anne M. Damian, MD, of Johns Hopkins University School of Medicine in Baltimore
Dr. Anne M. Damian

“Traditional migraine risk factors such as obesity, anxiety, and depression were also overrepresented in our cohort” of patients with multiple sclerosis (MS) and migraine, said Anne M. Damian, MD, of Johns Hopkins University, Baltimore, and her research colleagues.

Migraine is common in patients with MS, but whether migraine plays a role in MS disease course or MS symptom severity is unknown. Dr. Damian and her colleagues conducted an observational study to examine the associations between migraine history, disability, and neurologic function in patients with MS and whether migraine tends to occur with other comorbid conditions in MS.

They analyzed data from 289 patients (79% female; mean age, 49.2 years) patients with MS who completed the Multiple Sclerosis Performance Test (MSPT), an iPad version of the MS Functional Composite. MS outcome measures included disability (such as the Patient Determined Disease Steps) and objective neurologic outcomes (such as walking speed, manual dexterity, and processing speed). Patients also completed a questionnaire about comorbidities, including history of physician-diagnosed migraine, diabetes, hypertension, hypercholesterolemia, heart disease, sleep apnea, depression, and anxiety.

The researchers used generalized linear models adjusted for age, sex, MS subtype, MS duration, years of education, and body mass index to evaluate the association between history of migraine and MS outcomes.

Compared with patients with MS without migraine, migraineurs (n = 65) tended to be younger (mean age, 44.3 years vs. 50.4 years) and were more likely to be overweight or obese (73.9% vs. 51.6%). In addition, patients with MS and migraine were more likely to have a history of depression (46.2% vs. 24.2%), anxiety (30.8% vs. 18.8%), and severe rather than mild disability (odds ratio, 3.08; 95% confidence, 1.04-9.20). Migraine also was associated with significantly slower walking speeds (9.08% slower; 95% CI, 0.82%-18.77%). Migraine was not associated with processing speed or manual dexterity, however.

If an association between migraine history and worse MS disability is confirmed, migraine history may be a factor that neurologists could consider when making MS treatment decisions, Dr. Damian said. The researchers noted that migraine was reported by patients and not detected using a validated questionnaire. Future studies should investigate whether MS lesions on MRI differ in migraineurs and whether migraine predicts future neurologic disability in patients with MS.

Collection of the MSPT outcomes was sponsored by Biogen.

SOURCE: Damian AM et al. ACTRIMS Forum 2019, Abstract 78.

 

In a cohort of patients with multiple sclerosis, a history of migraine was associated with more severe disability and significantly slower walking speeds, researchers reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Anne M. Damian, MD, of Johns Hopkins University School of Medicine in Baltimore
Dr. Anne M. Damian

“Traditional migraine risk factors such as obesity, anxiety, and depression were also overrepresented in our cohort” of patients with multiple sclerosis (MS) and migraine, said Anne M. Damian, MD, of Johns Hopkins University, Baltimore, and her research colleagues.

Migraine is common in patients with MS, but whether migraine plays a role in MS disease course or MS symptom severity is unknown. Dr. Damian and her colleagues conducted an observational study to examine the associations between migraine history, disability, and neurologic function in patients with MS and whether migraine tends to occur with other comorbid conditions in MS.

They analyzed data from 289 patients (79% female; mean age, 49.2 years) patients with MS who completed the Multiple Sclerosis Performance Test (MSPT), an iPad version of the MS Functional Composite. MS outcome measures included disability (such as the Patient Determined Disease Steps) and objective neurologic outcomes (such as walking speed, manual dexterity, and processing speed). Patients also completed a questionnaire about comorbidities, including history of physician-diagnosed migraine, diabetes, hypertension, hypercholesterolemia, heart disease, sleep apnea, depression, and anxiety.

The researchers used generalized linear models adjusted for age, sex, MS subtype, MS duration, years of education, and body mass index to evaluate the association between history of migraine and MS outcomes.

Compared with patients with MS without migraine, migraineurs (n = 65) tended to be younger (mean age, 44.3 years vs. 50.4 years) and were more likely to be overweight or obese (73.9% vs. 51.6%). In addition, patients with MS and migraine were more likely to have a history of depression (46.2% vs. 24.2%), anxiety (30.8% vs. 18.8%), and severe rather than mild disability (odds ratio, 3.08; 95% confidence, 1.04-9.20). Migraine also was associated with significantly slower walking speeds (9.08% slower; 95% CI, 0.82%-18.77%). Migraine was not associated with processing speed or manual dexterity, however.

If an association between migraine history and worse MS disability is confirmed, migraine history may be a factor that neurologists could consider when making MS treatment decisions, Dr. Damian said. The researchers noted that migraine was reported by patients and not detected using a validated questionnaire. Future studies should investigate whether MS lesions on MRI differ in migraineurs and whether migraine predicts future neurologic disability in patients with MS.

Collection of the MSPT outcomes was sponsored by Biogen.

SOURCE: Damian AM et al. ACTRIMS Forum 2019, Abstract 78.

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Post-HCT azithromycin doesn’t increase relapse risk, study suggests

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HOUSTON — When given after transplant, azithromycin does not increase the risk of relapse in patients with moderate to severe chronic graft-versus-host disease (cGVHD) and bronchiolitis obliterans syndrome (BOS), according to a retrospective study.

A prior study, ALLOZITHRO (JAMA. 2017 Aug 8;318[6]:557-66), showed an increased risk of relapse and death in patients who received azithromycin as BOS prophylaxis prior to hematopoietic cell transplant (HCT).

That discovery prompted the Food and Drug Administration to release a safety communication warning prescribers about the risks associated with azithromycin as BOS prophylaxis. However, it wasn’t clear if the same risks exist when azithromycin is given for cGVHD management after HCT.

To gain some insight, Mark Shamoun, MD, of the University of Michigan, Ann Arbor, and his colleagues examined data on patients with moderate to severe cGVHD and BOS who received azithromycin after undergoing HCT to treat a hematologic malignancy.

Dr. Shamoun presented the group’s findings at the Transplantation & Cellular Therapy Meetings.

The researchers reviewed data on 239 patients enrolled in the University of Michigan’s HCT database from 2010 to 2017. The median age at baseline was 55 years (range, 4-72 years).

The patients received transplants to treat acute myeloid leukemia or myelodysplastic syndromes (n = 141), acute lymphoblastic leukemia (n = 40), lymphoma (n = 26), chronic leukemia (n = 24), multiple myeloma (n = 6), and myeloproliferative neoplasms (n = 2).

The patients had matched related donors (43%) or matched unrelated donors (57%). Most patients received peripheral blood transplants (84%), though some received bone marrow (14%) or cord blood (2%). All patients had moderate (38%) or severe (62%) cGVHD.

Patients were split into two cohorts. Patients in cohort A (n = 86) had BOS and received azithromycin for more than 14 days.

Patients in cohort B (n = 153) either did not receive azithromycin or received it for 14 days or less. Fewer than 5% of patients in cohort B had BOS.

Most other baseline characteristics were similar between the cohorts. However, severe cGVHD was more prevalent in cohort A than B — 78% and 51%, respectively.

In cohort A, the median time to the start of azithromycin was 15 months after HCT (range, 3-68 months). The median duration of azithromycin treatment was 26 months (range, 1-77 months).

Results

The 2-year relapse rate was significantly lower in patients who received azithromycin than in those who did not — 4% and 17%, respectively (P = .001).

There was a significant difference in relapse rate both from the time of HCT (P = .001) and from the start of azithromycin or cGVHD (P = .011).

There was no significant difference in overall survival between the cohorts, either from the time of HCT (P = .294) or from the start of azithromycin or cGVHD (P = .428).

Dr. Shamoun said these results suggest azithromycin does not increase the risk of relapse when it is used to manage cGVHD. However, this study is limited by its retrospective nature. In addition, most patients in cohort B did not have BOS, severe cGVHD was more common in cohort A, and the incidence of relapse was not calculated from the time of azithromycin initiation in both cohorts. Therefore, additional investigation is needed.

Dr. Shamoun presented these results at Transplantation & Cellular Therapy Meetings, which is held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At the meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society, the American Society for Transplantation and Cellular Therapy (ASTCT).

Dr. Shamoun reported no conflicts of interest.

SOURCE: Shamoun M et al. TCT 2019, Abstract 33.

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HOUSTON — When given after transplant, azithromycin does not increase the risk of relapse in patients with moderate to severe chronic graft-versus-host disease (cGVHD) and bronchiolitis obliterans syndrome (BOS), according to a retrospective study.

A prior study, ALLOZITHRO (JAMA. 2017 Aug 8;318[6]:557-66), showed an increased risk of relapse and death in patients who received azithromycin as BOS prophylaxis prior to hematopoietic cell transplant (HCT).

That discovery prompted the Food and Drug Administration to release a safety communication warning prescribers about the risks associated with azithromycin as BOS prophylaxis. However, it wasn’t clear if the same risks exist when azithromycin is given for cGVHD management after HCT.

To gain some insight, Mark Shamoun, MD, of the University of Michigan, Ann Arbor, and his colleagues examined data on patients with moderate to severe cGVHD and BOS who received azithromycin after undergoing HCT to treat a hematologic malignancy.

Dr. Shamoun presented the group’s findings at the Transplantation & Cellular Therapy Meetings.

The researchers reviewed data on 239 patients enrolled in the University of Michigan’s HCT database from 2010 to 2017. The median age at baseline was 55 years (range, 4-72 years).

The patients received transplants to treat acute myeloid leukemia or myelodysplastic syndromes (n = 141), acute lymphoblastic leukemia (n = 40), lymphoma (n = 26), chronic leukemia (n = 24), multiple myeloma (n = 6), and myeloproliferative neoplasms (n = 2).

The patients had matched related donors (43%) or matched unrelated donors (57%). Most patients received peripheral blood transplants (84%), though some received bone marrow (14%) or cord blood (2%). All patients had moderate (38%) or severe (62%) cGVHD.

Patients were split into two cohorts. Patients in cohort A (n = 86) had BOS and received azithromycin for more than 14 days.

Patients in cohort B (n = 153) either did not receive azithromycin or received it for 14 days or less. Fewer than 5% of patients in cohort B had BOS.

Most other baseline characteristics were similar between the cohorts. However, severe cGVHD was more prevalent in cohort A than B — 78% and 51%, respectively.

In cohort A, the median time to the start of azithromycin was 15 months after HCT (range, 3-68 months). The median duration of azithromycin treatment was 26 months (range, 1-77 months).

Results

The 2-year relapse rate was significantly lower in patients who received azithromycin than in those who did not — 4% and 17%, respectively (P = .001).

There was a significant difference in relapse rate both from the time of HCT (P = .001) and from the start of azithromycin or cGVHD (P = .011).

There was no significant difference in overall survival between the cohorts, either from the time of HCT (P = .294) or from the start of azithromycin or cGVHD (P = .428).

Dr. Shamoun said these results suggest azithromycin does not increase the risk of relapse when it is used to manage cGVHD. However, this study is limited by its retrospective nature. In addition, most patients in cohort B did not have BOS, severe cGVHD was more common in cohort A, and the incidence of relapse was not calculated from the time of azithromycin initiation in both cohorts. Therefore, additional investigation is needed.

Dr. Shamoun presented these results at Transplantation & Cellular Therapy Meetings, which is held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At the meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society, the American Society for Transplantation and Cellular Therapy (ASTCT).

Dr. Shamoun reported no conflicts of interest.

SOURCE: Shamoun M et al. TCT 2019, Abstract 33.

HOUSTON — When given after transplant, azithromycin does not increase the risk of relapse in patients with moderate to severe chronic graft-versus-host disease (cGVHD) and bronchiolitis obliterans syndrome (BOS), according to a retrospective study.

A prior study, ALLOZITHRO (JAMA. 2017 Aug 8;318[6]:557-66), showed an increased risk of relapse and death in patients who received azithromycin as BOS prophylaxis prior to hematopoietic cell transplant (HCT).

That discovery prompted the Food and Drug Administration to release a safety communication warning prescribers about the risks associated with azithromycin as BOS prophylaxis. However, it wasn’t clear if the same risks exist when azithromycin is given for cGVHD management after HCT.

To gain some insight, Mark Shamoun, MD, of the University of Michigan, Ann Arbor, and his colleagues examined data on patients with moderate to severe cGVHD and BOS who received azithromycin after undergoing HCT to treat a hematologic malignancy.

Dr. Shamoun presented the group’s findings at the Transplantation & Cellular Therapy Meetings.

The researchers reviewed data on 239 patients enrolled in the University of Michigan’s HCT database from 2010 to 2017. The median age at baseline was 55 years (range, 4-72 years).

The patients received transplants to treat acute myeloid leukemia or myelodysplastic syndromes (n = 141), acute lymphoblastic leukemia (n = 40), lymphoma (n = 26), chronic leukemia (n = 24), multiple myeloma (n = 6), and myeloproliferative neoplasms (n = 2).

The patients had matched related donors (43%) or matched unrelated donors (57%). Most patients received peripheral blood transplants (84%), though some received bone marrow (14%) or cord blood (2%). All patients had moderate (38%) or severe (62%) cGVHD.

Patients were split into two cohorts. Patients in cohort A (n = 86) had BOS and received azithromycin for more than 14 days.

Patients in cohort B (n = 153) either did not receive azithromycin or received it for 14 days or less. Fewer than 5% of patients in cohort B had BOS.

Most other baseline characteristics were similar between the cohorts. However, severe cGVHD was more prevalent in cohort A than B — 78% and 51%, respectively.

In cohort A, the median time to the start of azithromycin was 15 months after HCT (range, 3-68 months). The median duration of azithromycin treatment was 26 months (range, 1-77 months).

Results

The 2-year relapse rate was significantly lower in patients who received azithromycin than in those who did not — 4% and 17%, respectively (P = .001).

There was a significant difference in relapse rate both from the time of HCT (P = .001) and from the start of azithromycin or cGVHD (P = .011).

There was no significant difference in overall survival between the cohorts, either from the time of HCT (P = .294) or from the start of azithromycin or cGVHD (P = .428).

Dr. Shamoun said these results suggest azithromycin does not increase the risk of relapse when it is used to manage cGVHD. However, this study is limited by its retrospective nature. In addition, most patients in cohort B did not have BOS, severe cGVHD was more common in cohort A, and the incidence of relapse was not calculated from the time of azithromycin initiation in both cohorts. Therefore, additional investigation is needed.

Dr. Shamoun presented these results at Transplantation & Cellular Therapy Meetings, which is held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research. At the meeting, the American Society for Blood and Marrow Transplantation announced a new name for the society, the American Society for Transplantation and Cellular Therapy (ASTCT).

Dr. Shamoun reported no conflicts of interest.

SOURCE: Shamoun M et al. TCT 2019, Abstract 33.

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Medical tourism for MS stem cell therapy is common

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– “Stem cell therapy is something that has been a topic of interest for neurologists for a while,” said Wijdan Rai, MD, speaking at the meeting presented by the American Committee for Treatment and Research in Multiple Sclerosis.

However, “stem cell tourism is notoriously difficult to study, because it’s not regulated; there’s no database we can access to try to figure out what exactly is going on in these clinics,” said Dr. Rai.

Dr. Rai, a neurology resident at the Ohio State University, Columbus, said that she and her colleagues had noticed patients with multiple sclerosis (MS) were asking more frequently about stem cell therapies, and mesenchymal stem cell therapy in particular.

To translate these anecdotal observations into more concrete data, Dr. Rai and her colleagues surveyed academic neurologists in the outpatient setting to see if their patients were asking them about medical tourism for stem cell therapy. Additionally, they were asked about patients who actually had sought out the therapy and if there were adverse reactions from stem cell therapy.

The 25-item questionnaire was sent to academic neurologists via an online survey tool called Synapse through the American Academy of Neurology. Dr. Rai and her colleagues found that over 90% of respondents had been asked about stem cell therapies and that 25% of respondents said their patients had some kind of complication from the treatment.

“Most commonly, it was some variation of an infection, like meningitis, encephalitis, or hepatitis C,” said Dr. Rai. Other physicians reported that their patients had spinal cord tumors, deterioration of MS, or stroke.

Dr. Rai said the survey data show that stem cell tourism is common and that patients can experience adverse events; with this evidence in hand, she hopes that a fact sheet can be developed and hosted on a website so physicians can point their patients to evidence-based information about stem cell therapies in MS.

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– “Stem cell therapy is something that has been a topic of interest for neurologists for a while,” said Wijdan Rai, MD, speaking at the meeting presented by the American Committee for Treatment and Research in Multiple Sclerosis.

However, “stem cell tourism is notoriously difficult to study, because it’s not regulated; there’s no database we can access to try to figure out what exactly is going on in these clinics,” said Dr. Rai.

Dr. Rai, a neurology resident at the Ohio State University, Columbus, said that she and her colleagues had noticed patients with multiple sclerosis (MS) were asking more frequently about stem cell therapies, and mesenchymal stem cell therapy in particular.

To translate these anecdotal observations into more concrete data, Dr. Rai and her colleagues surveyed academic neurologists in the outpatient setting to see if their patients were asking them about medical tourism for stem cell therapy. Additionally, they were asked about patients who actually had sought out the therapy and if there were adverse reactions from stem cell therapy.

The 25-item questionnaire was sent to academic neurologists via an online survey tool called Synapse through the American Academy of Neurology. Dr. Rai and her colleagues found that over 90% of respondents had been asked about stem cell therapies and that 25% of respondents said their patients had some kind of complication from the treatment.

“Most commonly, it was some variation of an infection, like meningitis, encephalitis, or hepatitis C,” said Dr. Rai. Other physicians reported that their patients had spinal cord tumors, deterioration of MS, or stroke.

Dr. Rai said the survey data show that stem cell tourism is common and that patients can experience adverse events; with this evidence in hand, she hopes that a fact sheet can be developed and hosted on a website so physicians can point their patients to evidence-based information about stem cell therapies in MS.

– “Stem cell therapy is something that has been a topic of interest for neurologists for a while,” said Wijdan Rai, MD, speaking at the meeting presented by the American Committee for Treatment and Research in Multiple Sclerosis.

However, “stem cell tourism is notoriously difficult to study, because it’s not regulated; there’s no database we can access to try to figure out what exactly is going on in these clinics,” said Dr. Rai.

Dr. Rai, a neurology resident at the Ohio State University, Columbus, said that she and her colleagues had noticed patients with multiple sclerosis (MS) were asking more frequently about stem cell therapies, and mesenchymal stem cell therapy in particular.

To translate these anecdotal observations into more concrete data, Dr. Rai and her colleagues surveyed academic neurologists in the outpatient setting to see if their patients were asking them about medical tourism for stem cell therapy. Additionally, they were asked about patients who actually had sought out the therapy and if there were adverse reactions from stem cell therapy.

The 25-item questionnaire was sent to academic neurologists via an online survey tool called Synapse through the American Academy of Neurology. Dr. Rai and her colleagues found that over 90% of respondents had been asked about stem cell therapies and that 25% of respondents said their patients had some kind of complication from the treatment.

“Most commonly, it was some variation of an infection, like meningitis, encephalitis, or hepatitis C,” said Dr. Rai. Other physicians reported that their patients had spinal cord tumors, deterioration of MS, or stroke.

Dr. Rai said the survey data show that stem cell tourism is common and that patients can experience adverse events; with this evidence in hand, she hopes that a fact sheet can be developed and hosted on a website so physicians can point their patients to evidence-based information about stem cell therapies in MS.

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Smartphone assessment of motor, cognitive function in MS extends clinicians’ reach

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A smartphone can be a valuable extension of clinician assessment in multiple sclerosis and other neurologic disorders, affording the opportunity for patients to complete some assessments at home.

Alexandra Boukhvalova, a medical student at the University of Maryland School of Medicine, Baltimore, and her collaborators developed an interactive smartphone app to assess some aspects of cognitive and motor function for patients with multiple sclerosis (MS). Their findings were reported during a poster session at the meeting held by the American Society for Prevention and Treatment in Multiple Sclerosis.

“The clinician assessment is an hour-long assessment; it requires a trained neurologist,” Ms. Boukhvalova pointed out. In thinking about how app-based assessment could augment the clinical exam, she and her collaborators realized that “a lot of the neurologic exam is still quite subjective – so is there a way that we can make that exam more objective and quantifiable and also add a little bit of ease with accessibility and mobility?

“We created a suite of test apps ... to assess different neurological systems, ranging from motor function, cognitive and visual dysfunction, general fatigue, and strength,” she said. The apps included tapping tests and balloon-popping tasks, along with measures to give some indication of spasticity by assessing the smoothness of movements.

Participants completed the testing both in the clinic and from home. “We did not need an investigator present for patients to be able to complete the tests,” said Ms. Boukhvalova.

Ms. Boukhvalova and her colleagues compared performance on the gamified tasks between patients with MS and healthy controls. For all tasks, the participants with MS could clearly be differentiated from the healthy participants.

A further plus was that “The patients almost viewed these tests as games.” They reported that they enjoyed completing them, said Ms. Boukhvalova, adding that app-based assessments also offer an additional point of connection between MS patients and specialists, whom they may only see annually or semiannually.

Further app development may focus on utilizing sensor and accelerometer functions in smartphones to perform more natural and sophisticated motor analysis to look at gait and gross motor functioning, she said.

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A smartphone can be a valuable extension of clinician assessment in multiple sclerosis and other neurologic disorders, affording the opportunity for patients to complete some assessments at home.

Alexandra Boukhvalova, a medical student at the University of Maryland School of Medicine, Baltimore, and her collaborators developed an interactive smartphone app to assess some aspects of cognitive and motor function for patients with multiple sclerosis (MS). Their findings were reported during a poster session at the meeting held by the American Society for Prevention and Treatment in Multiple Sclerosis.

“The clinician assessment is an hour-long assessment; it requires a trained neurologist,” Ms. Boukhvalova pointed out. In thinking about how app-based assessment could augment the clinical exam, she and her collaborators realized that “a lot of the neurologic exam is still quite subjective – so is there a way that we can make that exam more objective and quantifiable and also add a little bit of ease with accessibility and mobility?

“We created a suite of test apps ... to assess different neurological systems, ranging from motor function, cognitive and visual dysfunction, general fatigue, and strength,” she said. The apps included tapping tests and balloon-popping tasks, along with measures to give some indication of spasticity by assessing the smoothness of movements.

Participants completed the testing both in the clinic and from home. “We did not need an investigator present for patients to be able to complete the tests,” said Ms. Boukhvalova.

Ms. Boukhvalova and her colleagues compared performance on the gamified tasks between patients with MS and healthy controls. For all tasks, the participants with MS could clearly be differentiated from the healthy participants.

A further plus was that “The patients almost viewed these tests as games.” They reported that they enjoyed completing them, said Ms. Boukhvalova, adding that app-based assessments also offer an additional point of connection between MS patients and specialists, whom they may only see annually or semiannually.

Further app development may focus on utilizing sensor and accelerometer functions in smartphones to perform more natural and sophisticated motor analysis to look at gait and gross motor functioning, she said.

A smartphone can be a valuable extension of clinician assessment in multiple sclerosis and other neurologic disorders, affording the opportunity for patients to complete some assessments at home.

Alexandra Boukhvalova, a medical student at the University of Maryland School of Medicine, Baltimore, and her collaborators developed an interactive smartphone app to assess some aspects of cognitive and motor function for patients with multiple sclerosis (MS). Their findings were reported during a poster session at the meeting held by the American Society for Prevention and Treatment in Multiple Sclerosis.

“The clinician assessment is an hour-long assessment; it requires a trained neurologist,” Ms. Boukhvalova pointed out. In thinking about how app-based assessment could augment the clinical exam, she and her collaborators realized that “a lot of the neurologic exam is still quite subjective – so is there a way that we can make that exam more objective and quantifiable and also add a little bit of ease with accessibility and mobility?

“We created a suite of test apps ... to assess different neurological systems, ranging from motor function, cognitive and visual dysfunction, general fatigue, and strength,” she said. The apps included tapping tests and balloon-popping tasks, along with measures to give some indication of spasticity by assessing the smoothness of movements.

Participants completed the testing both in the clinic and from home. “We did not need an investigator present for patients to be able to complete the tests,” said Ms. Boukhvalova.

Ms. Boukhvalova and her colleagues compared performance on the gamified tasks between patients with MS and healthy controls. For all tasks, the participants with MS could clearly be differentiated from the healthy participants.

A further plus was that “The patients almost viewed these tests as games.” They reported that they enjoyed completing them, said Ms. Boukhvalova, adding that app-based assessments also offer an additional point of connection between MS patients and specialists, whom they may only see annually or semiannually.

Further app development may focus on utilizing sensor and accelerometer functions in smartphones to perform more natural and sophisticated motor analysis to look at gait and gross motor functioning, she said.

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Texting improves postpregnancy hypertension monitoring in black women

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A text messaging program connected black women at risk of postnatal hypertension with the care they needed to avoid blood pressure complications, Adi Hirshberg, MD, reported at the Pregnancy Meeting.

Violet Karyn
Dr. Adi Hirshberg

The text messaging system increased the compliance rate to 93%, compared with just 30% of those asked to return to the office after hospital discharge. Just as importantly, it completely erased racial disparity in compliance rates, compared with white women, with more than 90% of both groups complying, said Dr. Hirshberg of the University of Pennsylvania, Philadelphia.

“Our study shows that text-based monitoring eliminated the observed racial disparity in postpregnancy hypertension care,” she said at the meeting sponsored by the Society for Maternal-Fetal Medicine. “Using texts as a standard of care would have likely led to medication initiation or adjustment for an additional 20% or more women who missed an office visit. This is an innovative way to equally engage all women in the postpregnancy period.”

Dr. Hirshberg presented a preplanned subanalysis of the Remote Surveillance of Hypertension (TextBP) trial, published last year (BMJ Qual Saf. 2018;27:871-7). The publication gave overall data; this analysis broke results down by race.

TextBP equally randomized 206 postpartum women with pregnancy-induced hypertension to the usual practice of office-based BP monitoring, or to 2 weeks of text-based surveillance using a home BP cuff. It was open to all women with pregnancy-related hypertension who delivered in the Hospital of the University of Pennsylvania. Hypertension classes included gestational hypertension, preeclampsia, chronic hypertension with superimposed preeclampsia, and HELLP syndrome before or during the delivery admission. Women were randomized to usual care or to an office-based BP check within the first postpartum week.

The texting platform was developed through Way to Health, a web-based platform within the institution, with secure technological infrastructure. A starting introductory text message was sent by the Way to Health platform to the phone number provided on day of discharge.

Patients received reminders to text message their blood pressure twice daily for 2 weeks post partum, starting on the day after discharge. If the patient reported a systolic BP of more than 160 mm Hg or diastolic more than 110 mm Hg, the clinician received an alert.

The overall results showed that significantly more women in the texting group reported their blood pressure (92% vs. 44%), compared with the controls. Almost everyone in the texting group (84%) met the established criteria for BP measurement.

Dr. Hirshberg and her colleagues wanted to zero in on black women, to discover if the text reminders could help boost their compliance. This is important for a couple of reasons, she said. For one thing, black women face a higher baseline risk of hypertensive disorders and cardiovascular disease, both in general and during and after pregnancy. Second, “for every 100 black women who require postpartum hypertension surveillance, only about a third are likely to attended an office visit after discharge,” leaving them vulnerable to potentially preventable complications of hypertension.

Even in the original analysis, return rates for postpregnancy BP checks were low in both groups and, in fact, seemed to be declining over several years. In 2012, 56% of nonblack and 33% of black women returned for their checks. By 2014, that number had declined to 34% and 20%. The numbers parallel the increasing disparity in U.S. maternal death rate between black women and nonblack women. From 1989 to 2013, the death rate for black mothers doubled, jumping from 20 to 40 deaths per 100,000 live births. During the same period, the death rate for nonblack mothers increased from about 8 to about 11 per 10,000. Dr. Hirshberg said.

In the subanalysis, the primary outcomes were the percentage of patients in whom a blood pressure was obtained in the first 10 days following discharge. In the control office visit group, about 33% of black women had a measurement, compared with 70% of nonblack women – a significant difference. Text messaging, however, completely eliminated the disparity. In the texting group, 91% of nonblack women and 93% of black women had a BP measurement.

There were no hypertension readmissions in the texting arm; there were four in the office-visit arm, three of which occurred in black women.

“This suggests that the traditional office-based follow-up may have resulted in missed opportunities to start an antihypertensive in about 10 of the 55 women who missed their office visit,” Dr. Hirshberg said, adding that “these kinds of early interventions can reduce maternal morbidity and mortality and increase overall health in all.”

She reported no relevant financial disclosures.

SOURCE: Hirshberg A et al. Am J Obstet Gynecol. 2019 Jan;220(1):S6, Abstract 7.

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A text messaging program connected black women at risk of postnatal hypertension with the care they needed to avoid blood pressure complications, Adi Hirshberg, MD, reported at the Pregnancy Meeting.

Violet Karyn
Dr. Adi Hirshberg

The text messaging system increased the compliance rate to 93%, compared with just 30% of those asked to return to the office after hospital discharge. Just as importantly, it completely erased racial disparity in compliance rates, compared with white women, with more than 90% of both groups complying, said Dr. Hirshberg of the University of Pennsylvania, Philadelphia.

“Our study shows that text-based monitoring eliminated the observed racial disparity in postpregnancy hypertension care,” she said at the meeting sponsored by the Society for Maternal-Fetal Medicine. “Using texts as a standard of care would have likely led to medication initiation or adjustment for an additional 20% or more women who missed an office visit. This is an innovative way to equally engage all women in the postpregnancy period.”

Dr. Hirshberg presented a preplanned subanalysis of the Remote Surveillance of Hypertension (TextBP) trial, published last year (BMJ Qual Saf. 2018;27:871-7). The publication gave overall data; this analysis broke results down by race.

TextBP equally randomized 206 postpartum women with pregnancy-induced hypertension to the usual practice of office-based BP monitoring, or to 2 weeks of text-based surveillance using a home BP cuff. It was open to all women with pregnancy-related hypertension who delivered in the Hospital of the University of Pennsylvania. Hypertension classes included gestational hypertension, preeclampsia, chronic hypertension with superimposed preeclampsia, and HELLP syndrome before or during the delivery admission. Women were randomized to usual care or to an office-based BP check within the first postpartum week.

The texting platform was developed through Way to Health, a web-based platform within the institution, with secure technological infrastructure. A starting introductory text message was sent by the Way to Health platform to the phone number provided on day of discharge.

Patients received reminders to text message their blood pressure twice daily for 2 weeks post partum, starting on the day after discharge. If the patient reported a systolic BP of more than 160 mm Hg or diastolic more than 110 mm Hg, the clinician received an alert.

The overall results showed that significantly more women in the texting group reported their blood pressure (92% vs. 44%), compared with the controls. Almost everyone in the texting group (84%) met the established criteria for BP measurement.

Dr. Hirshberg and her colleagues wanted to zero in on black women, to discover if the text reminders could help boost their compliance. This is important for a couple of reasons, she said. For one thing, black women face a higher baseline risk of hypertensive disorders and cardiovascular disease, both in general and during and after pregnancy. Second, “for every 100 black women who require postpartum hypertension surveillance, only about a third are likely to attended an office visit after discharge,” leaving them vulnerable to potentially preventable complications of hypertension.

Even in the original analysis, return rates for postpregnancy BP checks were low in both groups and, in fact, seemed to be declining over several years. In 2012, 56% of nonblack and 33% of black women returned for their checks. By 2014, that number had declined to 34% and 20%. The numbers parallel the increasing disparity in U.S. maternal death rate between black women and nonblack women. From 1989 to 2013, the death rate for black mothers doubled, jumping from 20 to 40 deaths per 100,000 live births. During the same period, the death rate for nonblack mothers increased from about 8 to about 11 per 10,000. Dr. Hirshberg said.

In the subanalysis, the primary outcomes were the percentage of patients in whom a blood pressure was obtained in the first 10 days following discharge. In the control office visit group, about 33% of black women had a measurement, compared with 70% of nonblack women – a significant difference. Text messaging, however, completely eliminated the disparity. In the texting group, 91% of nonblack women and 93% of black women had a BP measurement.

There were no hypertension readmissions in the texting arm; there were four in the office-visit arm, three of which occurred in black women.

“This suggests that the traditional office-based follow-up may have resulted in missed opportunities to start an antihypertensive in about 10 of the 55 women who missed their office visit,” Dr. Hirshberg said, adding that “these kinds of early interventions can reduce maternal morbidity and mortality and increase overall health in all.”

She reported no relevant financial disclosures.

SOURCE: Hirshberg A et al. Am J Obstet Gynecol. 2019 Jan;220(1):S6, Abstract 7.

A text messaging program connected black women at risk of postnatal hypertension with the care they needed to avoid blood pressure complications, Adi Hirshberg, MD, reported at the Pregnancy Meeting.

Violet Karyn
Dr. Adi Hirshberg

The text messaging system increased the compliance rate to 93%, compared with just 30% of those asked to return to the office after hospital discharge. Just as importantly, it completely erased racial disparity in compliance rates, compared with white women, with more than 90% of both groups complying, said Dr. Hirshberg of the University of Pennsylvania, Philadelphia.

“Our study shows that text-based monitoring eliminated the observed racial disparity in postpregnancy hypertension care,” she said at the meeting sponsored by the Society for Maternal-Fetal Medicine. “Using texts as a standard of care would have likely led to medication initiation or adjustment for an additional 20% or more women who missed an office visit. This is an innovative way to equally engage all women in the postpregnancy period.”

Dr. Hirshberg presented a preplanned subanalysis of the Remote Surveillance of Hypertension (TextBP) trial, published last year (BMJ Qual Saf. 2018;27:871-7). The publication gave overall data; this analysis broke results down by race.

TextBP equally randomized 206 postpartum women with pregnancy-induced hypertension to the usual practice of office-based BP monitoring, or to 2 weeks of text-based surveillance using a home BP cuff. It was open to all women with pregnancy-related hypertension who delivered in the Hospital of the University of Pennsylvania. Hypertension classes included gestational hypertension, preeclampsia, chronic hypertension with superimposed preeclampsia, and HELLP syndrome before or during the delivery admission. Women were randomized to usual care or to an office-based BP check within the first postpartum week.

The texting platform was developed through Way to Health, a web-based platform within the institution, with secure technological infrastructure. A starting introductory text message was sent by the Way to Health platform to the phone number provided on day of discharge.

Patients received reminders to text message their blood pressure twice daily for 2 weeks post partum, starting on the day after discharge. If the patient reported a systolic BP of more than 160 mm Hg or diastolic more than 110 mm Hg, the clinician received an alert.

The overall results showed that significantly more women in the texting group reported their blood pressure (92% vs. 44%), compared with the controls. Almost everyone in the texting group (84%) met the established criteria for BP measurement.

Dr. Hirshberg and her colleagues wanted to zero in on black women, to discover if the text reminders could help boost their compliance. This is important for a couple of reasons, she said. For one thing, black women face a higher baseline risk of hypertensive disorders and cardiovascular disease, both in general and during and after pregnancy. Second, “for every 100 black women who require postpartum hypertension surveillance, only about a third are likely to attended an office visit after discharge,” leaving them vulnerable to potentially preventable complications of hypertension.

Even in the original analysis, return rates for postpregnancy BP checks were low in both groups and, in fact, seemed to be declining over several years. In 2012, 56% of nonblack and 33% of black women returned for their checks. By 2014, that number had declined to 34% and 20%. The numbers parallel the increasing disparity in U.S. maternal death rate between black women and nonblack women. From 1989 to 2013, the death rate for black mothers doubled, jumping from 20 to 40 deaths per 100,000 live births. During the same period, the death rate for nonblack mothers increased from about 8 to about 11 per 10,000. Dr. Hirshberg said.

In the subanalysis, the primary outcomes were the percentage of patients in whom a blood pressure was obtained in the first 10 days following discharge. In the control office visit group, about 33% of black women had a measurement, compared with 70% of nonblack women – a significant difference. Text messaging, however, completely eliminated the disparity. In the texting group, 91% of nonblack women and 93% of black women had a BP measurement.

There were no hypertension readmissions in the texting arm; there were four in the office-visit arm, three of which occurred in black women.

“This suggests that the traditional office-based follow-up may have resulted in missed opportunities to start an antihypertensive in about 10 of the 55 women who missed their office visit,” Dr. Hirshberg said, adding that “these kinds of early interventions can reduce maternal morbidity and mortality and increase overall health in all.”

She reported no relevant financial disclosures.

SOURCE: Hirshberg A et al. Am J Obstet Gynecol. 2019 Jan;220(1):S6, Abstract 7.

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Incidence of treated depression nearly 100% higher in patients with MS

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Patients with multiple sclerosis (MS) have a nearly 100% higher incidence of new treated depression, compared with matched patients without MS, according to an analysis of data from patients in the United Kingdom.

Neil Minton, MD, head of drug safety at Celgene.
Dr. Neil Minton

After a diagnosis of MS, the incidence of new treated depression is 229 per 10,000 person-years. In comparison, the incidence of new treated depression among matched patients without MS is 121 per 10,000 person-years, Neil Minton, MD, drug safety head at Celgene, reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

MS causes changes in the CNS that are associated with depression, but “data on rates of incident depression after MS diagnosis ... are limited,” Dr. Minton and his research colleagues said. To examine rates of treated incident depression in patients with MS after an MS diagnosis, compared with rates in a matched population of patients without MS, the researchers analyzed data from the U.K. Clinical Practice Research Datalink.

Their analysis included patients with MS who received a diagnosis of MS between 2001 and 2016, had at least 1 year of history available before the MS diagnosis, and had no history of treated depression. The researchers matched these patients with as many as 10 patients without MS by age, sex, general practice, record history length, and no history of treated depression. Treated depression was defined as a diagnosis code for depression and a prescription for an antidepressant treatment within 90 days. They used Byar’s method to estimate incidence rates and incidence rate ratios, the Kaplan-Meier method to generate cumulative incidence curves, and a log-rank test to compare the curves.

In all, 5,456 patients with MS and 45,712 matched patients without MS were included in the study. Patients’ median age was 42 years; 65% were female. Compared with patients without MS, patients with MS were more likely to have a history of untreated depression (9.6% vs. 7.5%) and to have received an antidepressant treatment for any indication before cohort entry (28.0% vs. 15.5%). Diagnoses for other psychiatric conditions were similar between the groups.

Incidence rates of treated depression were higher among women with MS, compared with men with MS – 241 versus 202 per 10,000 person-years. Compared with patients without MS, however, men with MS had a higher relative risk of treated depression (2.40 vs. 1.73).

The incidence rate ratios were similar in sensitivity analyses that excluded patients with a history of any psychiatric disorder at cohort entry and that did not require treatment to confirm a depression diagnosis.

The study was funded by a grant from Celgene.

SOURCE: Minton N et al. ACTRIMS Forum 2019, Abstract 82.

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Patients with multiple sclerosis (MS) have a nearly 100% higher incidence of new treated depression, compared with matched patients without MS, according to an analysis of data from patients in the United Kingdom.

Neil Minton, MD, head of drug safety at Celgene.
Dr. Neil Minton

After a diagnosis of MS, the incidence of new treated depression is 229 per 10,000 person-years. In comparison, the incidence of new treated depression among matched patients without MS is 121 per 10,000 person-years, Neil Minton, MD, drug safety head at Celgene, reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

MS causes changes in the CNS that are associated with depression, but “data on rates of incident depression after MS diagnosis ... are limited,” Dr. Minton and his research colleagues said. To examine rates of treated incident depression in patients with MS after an MS diagnosis, compared with rates in a matched population of patients without MS, the researchers analyzed data from the U.K. Clinical Practice Research Datalink.

Their analysis included patients with MS who received a diagnosis of MS between 2001 and 2016, had at least 1 year of history available before the MS diagnosis, and had no history of treated depression. The researchers matched these patients with as many as 10 patients without MS by age, sex, general practice, record history length, and no history of treated depression. Treated depression was defined as a diagnosis code for depression and a prescription for an antidepressant treatment within 90 days. They used Byar’s method to estimate incidence rates and incidence rate ratios, the Kaplan-Meier method to generate cumulative incidence curves, and a log-rank test to compare the curves.

In all, 5,456 patients with MS and 45,712 matched patients without MS were included in the study. Patients’ median age was 42 years; 65% were female. Compared with patients without MS, patients with MS were more likely to have a history of untreated depression (9.6% vs. 7.5%) and to have received an antidepressant treatment for any indication before cohort entry (28.0% vs. 15.5%). Diagnoses for other psychiatric conditions were similar between the groups.

Incidence rates of treated depression were higher among women with MS, compared with men with MS – 241 versus 202 per 10,000 person-years. Compared with patients without MS, however, men with MS had a higher relative risk of treated depression (2.40 vs. 1.73).

The incidence rate ratios were similar in sensitivity analyses that excluded patients with a history of any psychiatric disorder at cohort entry and that did not require treatment to confirm a depression diagnosis.

The study was funded by a grant from Celgene.

SOURCE: Minton N et al. ACTRIMS Forum 2019, Abstract 82.

 

Patients with multiple sclerosis (MS) have a nearly 100% higher incidence of new treated depression, compared with matched patients without MS, according to an analysis of data from patients in the United Kingdom.

Neil Minton, MD, head of drug safety at Celgene.
Dr. Neil Minton

After a diagnosis of MS, the incidence of new treated depression is 229 per 10,000 person-years. In comparison, the incidence of new treated depression among matched patients without MS is 121 per 10,000 person-years, Neil Minton, MD, drug safety head at Celgene, reported at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

MS causes changes in the CNS that are associated with depression, but “data on rates of incident depression after MS diagnosis ... are limited,” Dr. Minton and his research colleagues said. To examine rates of treated incident depression in patients with MS after an MS diagnosis, compared with rates in a matched population of patients without MS, the researchers analyzed data from the U.K. Clinical Practice Research Datalink.

Their analysis included patients with MS who received a diagnosis of MS between 2001 and 2016, had at least 1 year of history available before the MS diagnosis, and had no history of treated depression. The researchers matched these patients with as many as 10 patients without MS by age, sex, general practice, record history length, and no history of treated depression. Treated depression was defined as a diagnosis code for depression and a prescription for an antidepressant treatment within 90 days. They used Byar’s method to estimate incidence rates and incidence rate ratios, the Kaplan-Meier method to generate cumulative incidence curves, and a log-rank test to compare the curves.

In all, 5,456 patients with MS and 45,712 matched patients without MS were included in the study. Patients’ median age was 42 years; 65% were female. Compared with patients without MS, patients with MS were more likely to have a history of untreated depression (9.6% vs. 7.5%) and to have received an antidepressant treatment for any indication before cohort entry (28.0% vs. 15.5%). Diagnoses for other psychiatric conditions were similar between the groups.

Incidence rates of treated depression were higher among women with MS, compared with men with MS – 241 versus 202 per 10,000 person-years. Compared with patients without MS, however, men with MS had a higher relative risk of treated depression (2.40 vs. 1.73).

The incidence rate ratios were similar in sensitivity analyses that excluded patients with a history of any psychiatric disorder at cohort entry and that did not require treatment to confirm a depression diagnosis.

The study was funded by a grant from Celgene.

SOURCE: Minton N et al. ACTRIMS Forum 2019, Abstract 82.

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