SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) was associated in a small case series with remarkable overall and progression-free survival of patients with pulmonary sarcomatoid carcinoma (PSC), a rare variant of non–small cell lung cancer (NSCLC) with a grim prognosis.

Among five patients with PSC, three of whom were treatment naive, none experienced disease progression on pembrolizumab after a median follow-up of 13 months – although one died from a fungal infection unrelated to therapy – with the longest overall survival to date out to 33 months.

In contrast, patients with PSC treated before the advent of immunotherapy had a median progression-free survival of just 2 months and median overall survival a brief 4-6 months, reported Vineeth Sukrithan, MD, and his colleagues at the Albert Einstein College of Medicine, New York.

“It’s a uniquely enriched population of patients with lung cancer that have the best prognosis in terms of benefits from checkpoint inhibitors,” he said in an interview at the ASCO-SITC Clinical Immuno-Oncology Symposium.

PSC, a poorly differentiated subtype of NSCLC, accounts for about 0.3%-1.3% of all cases of lung cancer. It is closely associated with a history of heavy cigarette smoking and is rapidly fatal, with a poor response to conventional chemotherapy, although approximately 20% of patients with PSC have MET exon 14–skipping mutations that are “exquisitely” sensitive to crizotinib (Xalkori), Dr. Sukrithan explained.

PSC tumors are also unique in that they have extraordinarily high levels of programmed death-ligand 1 (PD-L1), the target of immune checkpoint inhibitors, with tumor proportion scores exceeding 90% in some cases.

Additionally, up to 43% of PSC tumors have been found to have a high mutational burden, with more than 10 mutations per megabase, suggesting that these tumors may be especially attractive targets for checkpoint inhibitor therapy, he said.

The investigators retrospectively studied surgical pathology and treatment records for all patients with advanced PSC diagnosed at their center from June 2015 to June 2018 who received pembrolizumab. They performed immunohistochemistry testing on tissue samples from the patients to quantify PD-L1 expression.

They compared the results with a cohort of patients with advanced PSC diagnosed from June 2012 to June 2015, prior to the clinical availability of anti-PD-1/PD-L1 checkpoint inhibitors.

The PD-L1-treated cohort included two men and three women, ranging from 48 to 67 years, with smoking pack-years ranging from 24 to 50. Two of the patients had received prior chemotherapy followed by pembrolizumab, and the remaining three received pembrolizumab monotherapy.

Tumor proportion scores ranged from more than 75% of tumor cells examined in one patient to 100% of cells in another.

The objective response rate to pembrolizumab was 80% consisting of one complete response and three partial responses. The fifth patient continued to have stable disease out to more than 17 months.

“This highly treatment-refractory disease now should be carefully assessed for immuno-oncologic and molecularly targeted options, which are associated with significant improvement in outcomes,” the investigators wrote in a poster presentation.

The study was internally funded. Dr. Sukrithan reported having no disclosures.

SOURCE: Sukrithan V et al. ASCO-SITC, Abstract 115.

SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) was associated in a small case series with remarkable overall and progression-free survival of patients with pulmonary sarcomatoid carcinoma (PSC), a rare variant of non–small cell lung cancer (NSCLC) with a grim prognosis.

Among five patients with PSC, three of whom were treatment naive, none experienced disease progression on pembrolizumab after a median follow-up of 13 months – although one died from a fungal infection unrelated to therapy – with the longest overall survival to date out to 33 months.

In contrast, patients with PSC treated before the advent of immunotherapy had a median progression-free survival of just 2 months and median overall survival a brief 4-6 months, reported Vineeth Sukrithan, MD, and his colleagues at the Albert Einstein College of Medicine, New York.

“It’s a uniquely enriched population of patients with lung cancer that have the best prognosis in terms of benefits from checkpoint inhibitors,” he said in an interview at the ASCO-SITC Clinical Immuno-Oncology Symposium.

PSC, a poorly differentiated subtype of NSCLC, accounts for about 0.3%-1.3% of all cases of lung cancer. It is closely associated with a history of heavy cigarette smoking and is rapidly fatal, with a poor response to conventional chemotherapy, although approximately 20% of patients with PSC have MET exon 14–skipping mutations that are “exquisitely” sensitive to crizotinib (Xalkori), Dr. Sukrithan explained.

PSC tumors are also unique in that they have extraordinarily high levels of programmed death-ligand 1 (PD-L1), the target of immune checkpoint inhibitors, with tumor proportion scores exceeding 90% in some cases.

Additionally, up to 43% of PSC tumors have been found to have a high mutational burden, with more than 10 mutations per megabase, suggesting that these tumors may be especially attractive targets for checkpoint inhibitor therapy, he said.

The investigators retrospectively studied surgical pathology and treatment records for all patients with advanced PSC diagnosed at their center from June 2015 to June 2018 who received pembrolizumab. They performed immunohistochemistry testing on tissue samples from the patients to quantify PD-L1 expression.

They compared the results with a cohort of patients with advanced PSC diagnosed from June 2012 to June 2015, prior to the clinical availability of anti-PD-1/PD-L1 checkpoint inhibitors.

The PD-L1-treated cohort included two men and three women, ranging from 48 to 67 years, with smoking pack-years ranging from 24 to 50. Two of the patients had received prior chemotherapy followed by pembrolizumab, and the remaining three received pembrolizumab monotherapy.

Tumor proportion scores ranged from more than 75% of tumor cells examined in one patient to 100% of cells in another.

The objective response rate to pembrolizumab was 80% consisting of one complete response and three partial responses. The fifth patient continued to have stable disease out to more than 17 months.

“This highly treatment-refractory disease now should be carefully assessed for immuno-oncologic and molecularly targeted options, which are associated with significant improvement in outcomes,” the investigators wrote in a poster presentation.

The study was internally funded. Dr. Sukrithan reported having no disclosures.

SOURCE: Sukrithan V et al. ASCO-SITC, Abstract 115.

SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) was associated in a small case series with remarkable overall and progression-free survival of patients with pulmonary sarcomatoid carcinoma (PSC), a rare variant of non–small cell lung cancer (NSCLC) with a grim prognosis.

Among five patients with PSC, three of whom were treatment naive, none experienced disease progression on pembrolizumab after a median follow-up of 13 months – although one died from a fungal infection unrelated to therapy – with the longest overall survival to date out to 33 months.

In contrast, patients with PSC treated before the advent of immunotherapy had a median progression-free survival of just 2 months and median overall survival a brief 4-6 months, reported Vineeth Sukrithan, MD, and his colleagues at the Albert Einstein College of Medicine, New York.

“It’s a uniquely enriched population of patients with lung cancer that have the best prognosis in terms of benefits from checkpoint inhibitors,” he said in an interview at the ASCO-SITC Clinical Immuno-Oncology Symposium.

PSC, a poorly differentiated subtype of NSCLC, accounts for about 0.3%-1.3% of all cases of lung cancer. It is closely associated with a history of heavy cigarette smoking and is rapidly fatal, with a poor response to conventional chemotherapy, although approximately 20% of patients with PSC have MET exon 14–skipping mutations that are “exquisitely” sensitive to crizotinib (Xalkori), Dr. Sukrithan explained.

PSC tumors are also unique in that they have extraordinarily high levels of programmed death-ligand 1 (PD-L1), the target of immune checkpoint inhibitors, with tumor proportion scores exceeding 90% in some cases.

Additionally, up to 43% of PSC tumors have been found to have a high mutational burden, with more than 10 mutations per megabase, suggesting that these tumors may be especially attractive targets for checkpoint inhibitor therapy, he said.

The investigators retrospectively studied surgical pathology and treatment records for all patients with advanced PSC diagnosed at their center from June 2015 to June 2018 who received pembrolizumab. They performed immunohistochemistry testing on tissue samples from the patients to quantify PD-L1 expression.

They compared the results with a cohort of patients with advanced PSC diagnosed from June 2012 to June 2015, prior to the clinical availability of anti-PD-1/PD-L1 checkpoint inhibitors.

The PD-L1-treated cohort included two men and three women, ranging from 48 to 67 years, with smoking pack-years ranging from 24 to 50. Two of the patients had received prior chemotherapy followed by pembrolizumab, and the remaining three received pembrolizumab monotherapy.

Tumor proportion scores ranged from more than 75% of tumor cells examined in one patient to 100% of cells in another.

The objective response rate to pembrolizumab was 80% consisting of one complete response and three partial responses. The fifth patient continued to have stable disease out to more than 17 months.

“This highly treatment-refractory disease now should be carefully assessed for immuno-oncologic and molecularly targeted options, which are associated with significant improvement in outcomes,” the investigators wrote in a poster presentation.

The study was internally funded. Dr. Sukrithan reported having no disclosures.

SOURCE: Sukrithan V et al. ASCO-SITC, Abstract 115.

WASHINGTON – Treating pruritus in children necessitates different approaches than those typically used to treat adult pruritus, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.

Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity  (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.

Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.

The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.

Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.

Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.

Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).

In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).

Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.

In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.

Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”

Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.

egreb@mdedge.com

WASHINGTON – Treating pruritus in children necessitates different approaches than those typically used to treat adult pruritus, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.

Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity  (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.

Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.

The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.

Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.

Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.

Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).

In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).

Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.

In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.

Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”

Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.

egreb@mdedge.com

WASHINGTON – Treating pruritus in children necessitates different approaches than those typically used to treat adult pruritus, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.

Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity  (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.

Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.

The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.

Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.

Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.

Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).

In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).

Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.

In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.

Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”

Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.

egreb@mdedge.com

DALLAS – The time is right to bring big data and high-horsepower computation to the thorniest problems in multiple sclerosis (MS) research, said Jennifer Graves, MD, who cochaired the closing session at the meeting held by the Americas Committee for Research and Treatment in Multiple Sclerosis. The session focused on harnessing machine learning, deep learning, and the newest noninvasive observational techniques to move research and clinical care forward.

“We’ve reached a point in MS research where we’re hitting some stumbling blocks. And a lot of those stumbling blocks are related to how well and how precisely we can measure phenotype in MS. The reason that’s important is that our next frontier is treating progressive MS – and what that requires is finding things that let us know what’s happening at the biological level, so that we can screen drugs faster. We can’t afford to have 3- to 5-year clinical trials. ... Because our patients can’t wait,” said Dr. Graves, an associate professor of neuroscience at the University of California, San Diego.

“We can use all sorts of big data sources, whether it’s the rich imaging data we get on patients when they go into the MRI scanner, whether it’s wearable sensors,” or even newer technology, Dr. Graves said. “We can use technology to give us the sensitivity that we’ve been missing.”

Wearable technology, including accelerometers, can track physical activity that tracks with outcomes in MS, she added. As the tech armament increases, so will data available for analysis and correlation.

However, the key to progress will be to focus on technology that measures change over time. “This is the key: sensitivity to change over time. A lot of things can be associated with disability,” said Dr. Graves, but the key is tracking what changes in an individual patient with disease progression, “so that we can detect treatment effects or side effects.”

koakes@mdedge.com

DALLAS – The time is right to bring big data and high-horsepower computation to the thorniest problems in multiple sclerosis (MS) research, said Jennifer Graves, MD, who cochaired the closing session at the meeting held by the Americas Committee for Research and Treatment in Multiple Sclerosis. The session focused on harnessing machine learning, deep learning, and the newest noninvasive observational techniques to move research and clinical care forward.

“We’ve reached a point in MS research where we’re hitting some stumbling blocks. And a lot of those stumbling blocks are related to how well and how precisely we can measure phenotype in MS. The reason that’s important is that our next frontier is treating progressive MS – and what that requires is finding things that let us know what’s happening at the biological level, so that we can screen drugs faster. We can’t afford to have 3- to 5-year clinical trials. ... Because our patients can’t wait,” said Dr. Graves, an associate professor of neuroscience at the University of California, San Diego.

“We can use all sorts of big data sources, whether it’s the rich imaging data we get on patients when they go into the MRI scanner, whether it’s wearable sensors,” or even newer technology, Dr. Graves said. “We can use technology to give us the sensitivity that we’ve been missing.”

Wearable technology, including accelerometers, can track physical activity that tracks with outcomes in MS, she added. As the tech armament increases, so will data available for analysis and correlation.

However, the key to progress will be to focus on technology that measures change over time. “This is the key: sensitivity to change over time. A lot of things can be associated with disability,” said Dr. Graves, but the key is tracking what changes in an individual patient with disease progression, “so that we can detect treatment effects or side effects.”

koakes@mdedge.com

DALLAS – The time is right to bring big data and high-horsepower computation to the thorniest problems in multiple sclerosis (MS) research, said Jennifer Graves, MD, who cochaired the closing session at the meeting held by the Americas Committee for Research and Treatment in Multiple Sclerosis. The session focused on harnessing machine learning, deep learning, and the newest noninvasive observational techniques to move research and clinical care forward.

“We’ve reached a point in MS research where we’re hitting some stumbling blocks. And a lot of those stumbling blocks are related to how well and how precisely we can measure phenotype in MS. The reason that’s important is that our next frontier is treating progressive MS – and what that requires is finding things that let us know what’s happening at the biological level, so that we can screen drugs faster. We can’t afford to have 3- to 5-year clinical trials. ... Because our patients can’t wait,” said Dr. Graves, an associate professor of neuroscience at the University of California, San Diego.

“We can use all sorts of big data sources, whether it’s the rich imaging data we get on patients when they go into the MRI scanner, whether it’s wearable sensors,” or even newer technology, Dr. Graves said. “We can use technology to give us the sensitivity that we’ve been missing.”

Wearable technology, including accelerometers, can track physical activity that tracks with outcomes in MS, she added. As the tech armament increases, so will data available for analysis and correlation.

However, the key to progress will be to focus on technology that measures change over time. “This is the key: sensitivity to change over time. A lot of things can be associated with disability,” said Dr. Graves, but the key is tracking what changes in an individual patient with disease progression, “so that we can detect treatment effects or side effects.”

koakes@mdedge.com

WASHINGTON – 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.

msullivan@mdege.com

WASHINGTON – 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.

msullivan@mdege.com

WASHINGTON – 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.

msullivan@mdege.com

WASHINGTON – 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.

egreb@mdedge.com

WASHINGTON – 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.

egreb@mdedge.com

WASHINGTON – 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.

egreb@mdedge.com

WASHINGTON – 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.

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.

WASHINGTON – 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.

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.

WASHINGTON – 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.

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.

WASHINGTON – 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.

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.

msullivan@mdedge.com

WASHINGTON – 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.

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.

msullivan@mdedge.com

WASHINGTON – 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.

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.

msullivan@mdedge.com

DALLAS – 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.

“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.

jremaly@mdedge.com

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

DALLAS – 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.

“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.

jremaly@mdedge.com

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

DALLAS – 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.

“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.

jremaly@mdedge.com

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

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.

jensmith@mdedge.com

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.

jensmith@mdedge.com

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.

jensmith@mdedge.com

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

DALLAS – “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.

koakes@mdedge.com

DALLAS – “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.

koakes@mdedge.com

DALLAS – “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.

koakes@mdedge.com