Atopic Dermatitis

Myth: Eczema has a minimal impact on patients’ daily activities

Although eczema may be considered a relatively mild skin condition, the effects of the disease can be debilitating for many patients. Low quality of life (QoL) due to eczema flares and trigger avoidance can lead to decreased productivity in this population, and patients often report interference of the disease with participation in daily life, including activities at work and school.

In a series of patient satisfaction surveys administered by the National Eczema Foundation, 75% of adults with eczema said their disease interferes with their job and household chores. A study of 380 adult atopic dermatitis (AD) patients assessing the impact of the disease on QoL showed similar results, as 39.0% of participants said AD impacted shopping, home, and garden activities a lot or very much and 36.8% said it impacted these activities a little. Additionally, reports from caregivers of children with AD indicated that nearly 50% of children miss at least 1 day of the school year due to their disease, and 17% miss 5 or more days. Over time, these limitations can have a serious psychological impact in eczema patients of any age.

In the National Eczema Foundation survey, 71% of respondents said their disease also gets in the way of participating in sports or hobbies. Eczema patients may miss out on the physical and mental health benefits of activities associated with increased body temperature or prolonged contact with sports equipment, which can exacerbate symptoms. In general, outdoor activities in all seasons can be particularly troublesome in this population, as eczema flares can be triggered by cold or hot temperatures, humidity, wind, dry air, sun exposure, pollution, and contact with allergens like pollen or mold.

The impact of eczema treatments on patients’ daily activities also should be considered when evaluating QoL in this population, as it frequently takes considerable time out of a patient’s day to manage his/her disease. Control of symptoms often requires a multistep daily regimen involving medication, bathing, moisturizing, applying wet compresses, ridding the house of allergens, and/or cleaning sheets and clothing. According to the National Eczema Foundation survey, 1 in 3 respondents said it takes 1 or more hours per day to treat their disease. To encourage adherence and ensure optimal outcomes, physicians should work with patients to develop an eczema treatment plan that is both effective and manageable in terms of their daily routines.

Ultimately, the disease burden in eczema patients is multidimensional, extending beyond only cutaneous symptoms; therefore, it is important for clinicians to consider the impact on QoL when choosing treatments for patients with eczema and to initiate appropriate therapy at the onset of disease presentation to mitigate the effects of the condition on patients’ daily lives. Eczema management strategies should include QoL screening to ensure the disease has a minimal impact on patients' daily lives and preferred activities.

Myth: Eczema has a minimal impact on patients’ daily activities

Although eczema may be considered a relatively mild skin condition, the effects of the disease can be debilitating for many patients. Low quality of life (QoL) due to eczema flares and trigger avoidance can lead to decreased productivity in this population, and patients often report interference of the disease with participation in daily life, including activities at work and school.

In a series of patient satisfaction surveys administered by the National Eczema Foundation, 75% of adults with eczema said their disease interferes with their job and household chores. A study of 380 adult atopic dermatitis (AD) patients assessing the impact of the disease on QoL showed similar results, as 39.0% of participants said AD impacted shopping, home, and garden activities a lot or very much and 36.8% said it impacted these activities a little. Additionally, reports from caregivers of children with AD indicated that nearly 50% of children miss at least 1 day of the school year due to their disease, and 17% miss 5 or more days. Over time, these limitations can have a serious psychological impact in eczema patients of any age.

In the National Eczema Foundation survey, 71% of respondents said their disease also gets in the way of participating in sports or hobbies. Eczema patients may miss out on the physical and mental health benefits of activities associated with increased body temperature or prolonged contact with sports equipment, which can exacerbate symptoms. In general, outdoor activities in all seasons can be particularly troublesome in this population, as eczema flares can be triggered by cold or hot temperatures, humidity, wind, dry air, sun exposure, pollution, and contact with allergens like pollen or mold.

The impact of eczema treatments on patients’ daily activities also should be considered when evaluating QoL in this population, as it frequently takes considerable time out of a patient’s day to manage his/her disease. Control of symptoms often requires a multistep daily regimen involving medication, bathing, moisturizing, applying wet compresses, ridding the house of allergens, and/or cleaning sheets and clothing. According to the National Eczema Foundation survey, 1 in 3 respondents said it takes 1 or more hours per day to treat their disease. To encourage adherence and ensure optimal outcomes, physicians should work with patients to develop an eczema treatment plan that is both effective and manageable in terms of their daily routines.

Ultimately, the disease burden in eczema patients is multidimensional, extending beyond only cutaneous symptoms; therefore, it is important for clinicians to consider the impact on QoL when choosing treatments for patients with eczema and to initiate appropriate therapy at the onset of disease presentation to mitigate the effects of the condition on patients’ daily lives. Eczema management strategies should include QoL screening to ensure the disease has a minimal impact on patients' daily lives and preferred activities.

Myth: Eczema has a minimal impact on patients’ daily activities

Although eczema may be considered a relatively mild skin condition, the effects of the disease can be debilitating for many patients. Low quality of life (QoL) due to eczema flares and trigger avoidance can lead to decreased productivity in this population, and patients often report interference of the disease with participation in daily life, including activities at work and school.

In a series of patient satisfaction surveys administered by the National Eczema Foundation, 75% of adults with eczema said their disease interferes with their job and household chores. A study of 380 adult atopic dermatitis (AD) patients assessing the impact of the disease on QoL showed similar results, as 39.0% of participants said AD impacted shopping, home, and garden activities a lot or very much and 36.8% said it impacted these activities a little. Additionally, reports from caregivers of children with AD indicated that nearly 50% of children miss at least 1 day of the school year due to their disease, and 17% miss 5 or more days. Over time, these limitations can have a serious psychological impact in eczema patients of any age.

In the National Eczema Foundation survey, 71% of respondents said their disease also gets in the way of participating in sports or hobbies. Eczema patients may miss out on the physical and mental health benefits of activities associated with increased body temperature or prolonged contact with sports equipment, which can exacerbate symptoms. In general, outdoor activities in all seasons can be particularly troublesome in this population, as eczema flares can be triggered by cold or hot temperatures, humidity, wind, dry air, sun exposure, pollution, and contact with allergens like pollen or mold.

The impact of eczema treatments on patients’ daily activities also should be considered when evaluating QoL in this population, as it frequently takes considerable time out of a patient’s day to manage his/her disease. Control of symptoms often requires a multistep daily regimen involving medication, bathing, moisturizing, applying wet compresses, ridding the house of allergens, and/or cleaning sheets and clothing. According to the National Eczema Foundation survey, 1 in 3 respondents said it takes 1 or more hours per day to treat their disease. To encourage adherence and ensure optimal outcomes, physicians should work with patients to develop an eczema treatment plan that is both effective and manageable in terms of their daily routines.

Ultimately, the disease burden in eczema patients is multidimensional, extending beyond only cutaneous symptoms; therefore, it is important for clinicians to consider the impact on QoL when choosing treatments for patients with eczema and to initiate appropriate therapy at the onset of disease presentation to mitigate the effects of the condition on patients’ daily lives. Eczema management strategies should include QoL screening to ensure the disease has a minimal impact on patients' daily lives and preferred activities.

ORLANDO – Reviewing patient charts for asthma risk factors using natural language processing can be done 8 times faster than reviewing the charts by hand, and with high levels of accuracy, researchers reported here.

Thomas R. Collins/Frontline Medical News

Natural language processing (NLP) is a kind of artificial intelligence in which computers are “trained” through a reiterative process to understand human language.

Researchers at Mayo Clinic previously have shown that a program created in-house can successfully and quickly determine patients’ asthma status. In this study, they turned to assessment of asthma risk factors, Chung-Il Wi, MD, assistant professor of pediatrics at Mayo said in a presentation at the joint congress of the American Academy of Allergy, Asthma and Immunology and the World Asthma Organization.

They used a convenience sample of 177 patient charts to train the NLP system. The system extracted – from key terms and sentences in the electronic health record (EHR) – data such as breastfeeding history and history of atopic conditions such as allergic rhinitis, eczema, and food allergy. From parent charts, the system extracted terms related to family history of asthma and other atopic conditions. The performance of the NLP algorithm was assessed by comparison with results of a manual chart review in a test cohort of 220 patient charts.

SOURCE: Wi C AAAAI/WAO Joint Congress 2018 abstract 637.

ORLANDO – Reviewing patient charts for asthma risk factors using natural language processing can be done 8 times faster than reviewing the charts by hand, and with high levels of accuracy, researchers reported here.

Thomas R. Collins/Frontline Medical News

Natural language processing (NLP) is a kind of artificial intelligence in which computers are “trained” through a reiterative process to understand human language.

Researchers at Mayo Clinic previously have shown that a program created in-house can successfully and quickly determine patients’ asthma status. In this study, they turned to assessment of asthma risk factors, Chung-Il Wi, MD, assistant professor of pediatrics at Mayo said in a presentation at the joint congress of the American Academy of Allergy, Asthma and Immunology and the World Asthma Organization.

They used a convenience sample of 177 patient charts to train the NLP system. The system extracted – from key terms and sentences in the electronic health record (EHR) – data such as breastfeeding history and history of atopic conditions such as allergic rhinitis, eczema, and food allergy. From parent charts, the system extracted terms related to family history of asthma and other atopic conditions. The performance of the NLP algorithm was assessed by comparison with results of a manual chart review in a test cohort of 220 patient charts.

SOURCE: Wi C AAAAI/WAO Joint Congress 2018 abstract 637.

ORLANDO – Reviewing patient charts for asthma risk factors using natural language processing can be done 8 times faster than reviewing the charts by hand, and with high levels of accuracy, researchers reported here.

Thomas R. Collins/Frontline Medical News

Natural language processing (NLP) is a kind of artificial intelligence in which computers are “trained” through a reiterative process to understand human language.

Researchers at Mayo Clinic previously have shown that a program created in-house can successfully and quickly determine patients’ asthma status. In this study, they turned to assessment of asthma risk factors, Chung-Il Wi, MD, assistant professor of pediatrics at Mayo said in a presentation at the joint congress of the American Academy of Allergy, Asthma and Immunology and the World Asthma Organization.

They used a convenience sample of 177 patient charts to train the NLP system. The system extracted – from key terms and sentences in the electronic health record (EHR) – data such as breastfeeding history and history of atopic conditions such as allergic rhinitis, eczema, and food allergy. From parent charts, the system extracted terms related to family history of asthma and other atopic conditions. The performance of the NLP algorithm was assessed by comparison with results of a manual chart review in a test cohort of 220 patient charts.

SOURCE: Wi C AAAAI/WAO Joint Congress 2018 abstract 637.

SAN DIEGO – A new study finds that primary diagnoses of atopic dermatitis (AD) are made hundreds of thousands of times in United States emergency departments each year.

The numbers appear to be rising along with costs, researchers reported, and there are signs of disparities, with poorer people more likely to have an ED visit with a primary diagnosis of AD. The study was presented in a poster at the annual meeting of the American Academy of Dermatology.

Indeed, he noted, “previous U.S. population–based studies showed that people with AD have higher odds of [ED] utilization than the rest of the population.”

He and Ms. Kwa examined 2006-2012 data from the Nationwide Emergency Department Sample, which includes information on about 20% of all emergency visits in the United States.

During that period, there were 1.86 million ED visits with a primary diagnosis of AD. The annual weighted prevalence of primary diagnoses of AD stayed fairly stable through the period, ranging from 2,589 to 2,769 per 1 million visits. However, the weighted prevalence of secondary AD diagnoses grew steadily from 1,227 per 1 million visits in 2006 to 1,533 per 1 million visits in 2012.

The researchers estimated that the total cost of annual costs of AD-related ED visits grew from $86.9 million in 2006 to $172.8 million in 2012 (P less than .05).

The study also linked primary diagnoses of AD to having Medicaid insurance or being uninsured, being poorer, or visiting hospitals in “micropolitan” areas (small urban communities such as Bozeman, Mont., and Durango, Colo.).

The study did not examine what medications were prescribed in the ED. However, Dr. Silverberg said, “my anecdotal experience has been that many AD patients are prescribed systemic steroids by nondermatologists in the [ED] setting. While these are rapidly effective, they typically have short-lived efficacy and result in rebound flares upon cessation. Patients are rarely counseled on appropriate skin care techniques or given long-term treatment approaches in the [ED] setting, which fails to achieve adequate long-term disease control.”

What’s next? “We are now studying how AD severity, disease course, and treatment impact [ED] utilization for AD,” Dr. Silverberg said.

No specific study funding was reported. He and Ms. Kwa report no relevant disclosures.

SOURCE: Silverberg, J et al. Poster 7021.

SAN DIEGO – A new study finds that primary diagnoses of atopic dermatitis (AD) are made hundreds of thousands of times in United States emergency departments each year.

The numbers appear to be rising along with costs, researchers reported, and there are signs of disparities, with poorer people more likely to have an ED visit with a primary diagnosis of AD. The study was presented in a poster at the annual meeting of the American Academy of Dermatology.

Indeed, he noted, “previous U.S. population–based studies showed that people with AD have higher odds of [ED] utilization than the rest of the population.”

He and Ms. Kwa examined 2006-2012 data from the Nationwide Emergency Department Sample, which includes information on about 20% of all emergency visits in the United States.

During that period, there were 1.86 million ED visits with a primary diagnosis of AD. The annual weighted prevalence of primary diagnoses of AD stayed fairly stable through the period, ranging from 2,589 to 2,769 per 1 million visits. However, the weighted prevalence of secondary AD diagnoses grew steadily from 1,227 per 1 million visits in 2006 to 1,533 per 1 million visits in 2012.

The researchers estimated that the total cost of annual costs of AD-related ED visits grew from $86.9 million in 2006 to $172.8 million in 2012 (P less than .05).

The study also linked primary diagnoses of AD to having Medicaid insurance or being uninsured, being poorer, or visiting hospitals in “micropolitan” areas (small urban communities such as Bozeman, Mont., and Durango, Colo.).

The study did not examine what medications were prescribed in the ED. However, Dr. Silverberg said, “my anecdotal experience has been that many AD patients are prescribed systemic steroids by nondermatologists in the [ED] setting. While these are rapidly effective, they typically have short-lived efficacy and result in rebound flares upon cessation. Patients are rarely counseled on appropriate skin care techniques or given long-term treatment approaches in the [ED] setting, which fails to achieve adequate long-term disease control.”

What’s next? “We are now studying how AD severity, disease course, and treatment impact [ED] utilization for AD,” Dr. Silverberg said.

No specific study funding was reported. He and Ms. Kwa report no relevant disclosures.

SOURCE: Silverberg, J et al. Poster 7021.

SAN DIEGO – A new study finds that primary diagnoses of atopic dermatitis (AD) are made hundreds of thousands of times in United States emergency departments each year.

The numbers appear to be rising along with costs, researchers reported, and there are signs of disparities, with poorer people more likely to have an ED visit with a primary diagnosis of AD. The study was presented in a poster at the annual meeting of the American Academy of Dermatology.

Indeed, he noted, “previous U.S. population–based studies showed that people with AD have higher odds of [ED] utilization than the rest of the population.”

He and Ms. Kwa examined 2006-2012 data from the Nationwide Emergency Department Sample, which includes information on about 20% of all emergency visits in the United States.

During that period, there were 1.86 million ED visits with a primary diagnosis of AD. The annual weighted prevalence of primary diagnoses of AD stayed fairly stable through the period, ranging from 2,589 to 2,769 per 1 million visits. However, the weighted prevalence of secondary AD diagnoses grew steadily from 1,227 per 1 million visits in 2006 to 1,533 per 1 million visits in 2012.

The researchers estimated that the total cost of annual costs of AD-related ED visits grew from $86.9 million in 2006 to $172.8 million in 2012 (P less than .05).

The study also linked primary diagnoses of AD to having Medicaid insurance or being uninsured, being poorer, or visiting hospitals in “micropolitan” areas (small urban communities such as Bozeman, Mont., and Durango, Colo.).

The study did not examine what medications were prescribed in the ED. However, Dr. Silverberg said, “my anecdotal experience has been that many AD patients are prescribed systemic steroids by nondermatologists in the [ED] setting. While these are rapidly effective, they typically have short-lived efficacy and result in rebound flares upon cessation. Patients are rarely counseled on appropriate skin care techniques or given long-term treatment approaches in the [ED] setting, which fails to achieve adequate long-term disease control.”

What’s next? “We are now studying how AD severity, disease course, and treatment impact [ED] utilization for AD,” Dr. Silverberg said.

No specific study funding was reported. He and Ms. Kwa report no relevant disclosures.

SOURCE: Silverberg, J et al. Poster 7021.

SAN DIEGO – To date, most of the research on cannabinoids has been outside of dermatology, but these agents may eventually play an important role in the treatment of dermatologic diseases, according to Adam Friedman, MD, director of translational research, department of dermatology, at George Washington University, Washington.

In dermatology, “the greatest potential impact for the cannabinoids beyond acne, eczema, even skin cancer is in the collagen vascular disease space,” for diseases like dermatomyositis, scleroderma, and lupus, Dr. Friedman said in a video interview at the annual meeting of the American Academy of Dermatology.

In this area, most progress has been made with a synthetic cannabinoid, ajulemic acid (also known as anabasum), which is designed to go after CB₂ cannabinoid receptors, which have the anti-inflammatory effects, and not the CB₁ receptors, which have the psychoactive effects, he explained. Results of phase 2 studies of ajulemic acid in dermatomyositis and systemic sclerosis have been “very promising,” he noted.

In collaboration with Albert Einstein College of Medicine, New York, he and his associates have studied the topical application of an endocannabinoid, anandamide (AEA), in nanoparticles in an animal model of cutaneous lupus. “We found that we can actually reverse the very classic, almost chronic cutaneous-like symptoms that we see in these animals if they go untreated,” he said.

In the interview, Dr. Friedman, who spoke about the potential of cannabinoids for the treatment of inflammatory and neoplastic diseases of the skin at the meeting, said that it is actually surprising that most research with cannabinoids to date has been outside of dermatology, “because our skin is chock full of cannabinoids; chock full of expression of cannabinoid receptors.”

Dr. Friedman disclosed that he has invented the nanotechnology licensed to Zylo Therapeutics. He is a member of the Dermatology News advisory board.

Vidyard Video

emechcatie@frontlinemedcom.com

SAN DIEGO – To date, most of the research on cannabinoids has been outside of dermatology, but these agents may eventually play an important role in the treatment of dermatologic diseases, according to Adam Friedman, MD, director of translational research, department of dermatology, at George Washington University, Washington.

In dermatology, “the greatest potential impact for the cannabinoids beyond acne, eczema, even skin cancer is in the collagen vascular disease space,” for diseases like dermatomyositis, scleroderma, and lupus, Dr. Friedman said in a video interview at the annual meeting of the American Academy of Dermatology.

In this area, most progress has been made with a synthetic cannabinoid, ajulemic acid (also known as anabasum), which is designed to go after CB₂ cannabinoid receptors, which have the anti-inflammatory effects, and not the CB₁ receptors, which have the psychoactive effects, he explained. Results of phase 2 studies of ajulemic acid in dermatomyositis and systemic sclerosis have been “very promising,” he noted.

In collaboration with Albert Einstein College of Medicine, New York, he and his associates have studied the topical application of an endocannabinoid, anandamide (AEA), in nanoparticles in an animal model of cutaneous lupus. “We found that we can actually reverse the very classic, almost chronic cutaneous-like symptoms that we see in these animals if they go untreated,” he said.

In the interview, Dr. Friedman, who spoke about the potential of cannabinoids for the treatment of inflammatory and neoplastic diseases of the skin at the meeting, said that it is actually surprising that most research with cannabinoids to date has been outside of dermatology, “because our skin is chock full of cannabinoids; chock full of expression of cannabinoid receptors.”

Dr. Friedman disclosed that he has invented the nanotechnology licensed to Zylo Therapeutics. He is a member of the Dermatology News advisory board.

Vidyard Video

emechcatie@frontlinemedcom.com

SAN DIEGO – To date, most of the research on cannabinoids has been outside of dermatology, but these agents may eventually play an important role in the treatment of dermatologic diseases, according to Adam Friedman, MD, director of translational research, department of dermatology, at George Washington University, Washington.

In dermatology, “the greatest potential impact for the cannabinoids beyond acne, eczema, even skin cancer is in the collagen vascular disease space,” for diseases like dermatomyositis, scleroderma, and lupus, Dr. Friedman said in a video interview at the annual meeting of the American Academy of Dermatology.

In this area, most progress has been made with a synthetic cannabinoid, ajulemic acid (also known as anabasum), which is designed to go after CB₂ cannabinoid receptors, which have the anti-inflammatory effects, and not the CB₁ receptors, which have the psychoactive effects, he explained. Results of phase 2 studies of ajulemic acid in dermatomyositis and systemic sclerosis have been “very promising,” he noted.

In collaboration with Albert Einstein College of Medicine, New York, he and his associates have studied the topical application of an endocannabinoid, anandamide (AEA), in nanoparticles in an animal model of cutaneous lupus. “We found that we can actually reverse the very classic, almost chronic cutaneous-like symptoms that we see in these animals if they go untreated,” he said.

In the interview, Dr. Friedman, who spoke about the potential of cannabinoids for the treatment of inflammatory and neoplastic diseases of the skin at the meeting, said that it is actually surprising that most research with cannabinoids to date has been outside of dermatology, “because our skin is chock full of cannabinoids; chock full of expression of cannabinoid receptors.”

Dr. Friedman disclosed that he has invented the nanotechnology licensed to Zylo Therapeutics. He is a member of the Dermatology News advisory board.

Vidyard Video

emechcatie@frontlinemedcom.com

SAN DIEGO – A novel molecule that inhibits two major inflammatory pathways acquitted itself well in its first safety and efficacy clinical trial in patients with moderate to severe atopic dermatitis.

After 29 days, 100% of those taking the highest dose of the molecule, ASN002, achieved a 50% improvement in skin involvement.

ASN002 (Asana BioSciences) is a dual inhibitor of Janus kinase (JAK) and spleen tyrosine kinase (SYK).

“This is an interesting molecule,” Robert Bissonnette, MD, said at the annual meeting of the American Academy of Dermatology. “By targeting the entire JAK family, it inhibits cytokine signaling through IL-4 [interleukin-4], IL-13, IL-23, and thymic stromal lymphopoietin,” which plays a role in maturing T cells. The SYK inhibition targets IL-17, increases the terminal differentiation of keratinocytes, and inhibits B-cell signaling.

Dr. Bissonnette, president of Innovaderm Research presented the results in a late-breaking session at the meeting. Innovaderm designs, conducts, and analyzes dermatology clinical trials, and ran the study for Asana BioSciences.

In an Asana press release about the study results, CEO Sandeep Gupta, PhD, said that ASN002 “is the only oral compound in clinical development targeting JAK [including Tyk2] and SYK signaling, two clinically validated mechanisms.” He added that inhibition of JAK and SYK pathways “diminishes cytokine production and signaling including those mediated by Th2 and Th22 cytokines. Dysregulation of Th2 and Th22 cytokine pathways is implicated in the pathogenesis of atopic dermatitis.”

Safety was the primary endpoint in the phase 1b dose-ranging trial, but there were also several efficacy endpoints, Dr. Bissonnette said at the meeting. The study comprised 36 patients separated into three 12-patient groups. In each group, nine received the active drug every day, and three received a placebo. The first group received 20 mg ASN002 or placebo for 28 days, followed by the 14-day safety period. The next group received 40 mg ASN002 or placebo for 28 days, followed by the safety analysis. The third group followed the same treatment pattern, but received 80 mg of the drug.

All patients were aged 29-42 years. The Eczema Area and Severity Index (EASI) was imbalanced among the groups, ranging from 21 in the placebo group and 40-mg group, to 29 in the 20-mg and 80-mg groups. The Body Surface Area (BSA) index also differed between groups: 25% among the placebo patients, 45% in the 20-mg group, 32% in the 40-mg group, and 29% in the 80-mg group. The average Investigator Global Assessment (IGA) score was 3.

A pharmacokinetic analysis showed rapid uptake of the drug with a half-life of 10-14 hours depending on dose.

There were no concerning safety signals, Dr. Bissonnette said and no thromboembolic events, serious infections, or opportunistic infections. The most common adverse event was headache, which occurred at equal rates among the groups. The single serious adverse event was anxiety, which occurred in one patient taking 80 mg ASN002, 4 days after the medication was stopped, and was judged unrelated to ASN002.

There were no significant changes in any lab parameters, no changes in lipid profiles, and no hematologic abnormalities. One patient experienced an increase in creatinine phosphokinase, something that has been seen in other studies of JAK inhibitors, Dr. Bissonnette said.

The molecule performed well on secondary efficacy endpoints. By day 15, 63% of the 40-mg group and 75% of the 80-mg group had achieved EASI-50, and by day 29, these rates were 88% and 100%, respectively. These doses also performed well on the EASI-75 endpoint. By day 29, 63% of the 40-mg group and 50% of the 80-mg group had achieved a 75% improvement in EASI score.

The 40- and 80-mg groups also did well with regards to BSA improvement. By day 29, the 80-mg group had achieved a mean BSA reduction of 58%, and the 40-mg group a mean reduction of 64%. IGA tracked that improvement, with 25% of the 80-mg group and 38% of the 40-mg group achieving an IGA score of 1 or 0.

Itching responded well to ASN002, but here, the 20-mg dose threw investigators a bit of a curve ball. Pruritus decreased most in the 80-mg group (about 70% by the end of the study). But at 3 weeks, patients taking 20 mg and 40 mg were experiencing the same 30% decrease in itch. By 4 weeks, however, the scores had separated, with the 40-mg group landing at about a 40% reduction, and the 20-mg group rebounding to about a 20% reduction.

“I would say that this first trial of ASN002 showed clear efficacy in patients with moderate to severe atopic dermatitis, with rapid improvement itch and a large proportion of patients reaching EASI-50 as early as 2 weeks,” Dr. Bissonnette said.

Asana will soon initiate a phase 2b study of ASN002 in moderate to severe atopic dermatitis patients. Clinical studies in other dermatologic and autoimmune indications are under consideration, according to the company website.

Dr. Bissonnette is the president of Innovaderm Research, which was paid to run the ASN002 study.

msullivan@frontlinemedcom.com

SOURCE: Bissonnette R et al. AAD 2018, Abstract 6777

SAN DIEGO – A novel molecule that inhibits two major inflammatory pathways acquitted itself well in its first safety and efficacy clinical trial in patients with moderate to severe atopic dermatitis.

After 29 days, 100% of those taking the highest dose of the molecule, ASN002, achieved a 50% improvement in skin involvement.

ASN002 (Asana BioSciences) is a dual inhibitor of Janus kinase (JAK) and spleen tyrosine kinase (SYK).

“This is an interesting molecule,” Robert Bissonnette, MD, said at the annual meeting of the American Academy of Dermatology. “By targeting the entire JAK family, it inhibits cytokine signaling through IL-4 [interleukin-4], IL-13, IL-23, and thymic stromal lymphopoietin,” which plays a role in maturing T cells. The SYK inhibition targets IL-17, increases the terminal differentiation of keratinocytes, and inhibits B-cell signaling.

Dr. Bissonnette, president of Innovaderm Research presented the results in a late-breaking session at the meeting. Innovaderm designs, conducts, and analyzes dermatology clinical trials, and ran the study for Asana BioSciences.

In an Asana press release about the study results, CEO Sandeep Gupta, PhD, said that ASN002 “is the only oral compound in clinical development targeting JAK [including Tyk2] and SYK signaling, two clinically validated mechanisms.” He added that inhibition of JAK and SYK pathways “diminishes cytokine production and signaling including those mediated by Th2 and Th22 cytokines. Dysregulation of Th2 and Th22 cytokine pathways is implicated in the pathogenesis of atopic dermatitis.”

Safety was the primary endpoint in the phase 1b dose-ranging trial, but there were also several efficacy endpoints, Dr. Bissonnette said at the meeting. The study comprised 36 patients separated into three 12-patient groups. In each group, nine received the active drug every day, and three received a placebo. The first group received 20 mg ASN002 or placebo for 28 days, followed by the 14-day safety period. The next group received 40 mg ASN002 or placebo for 28 days, followed by the safety analysis. The third group followed the same treatment pattern, but received 80 mg of the drug.

All patients were aged 29-42 years. The Eczema Area and Severity Index (EASI) was imbalanced among the groups, ranging from 21 in the placebo group and 40-mg group, to 29 in the 20-mg and 80-mg groups. The Body Surface Area (BSA) index also differed between groups: 25% among the placebo patients, 45% in the 20-mg group, 32% in the 40-mg group, and 29% in the 80-mg group. The average Investigator Global Assessment (IGA) score was 3.

A pharmacokinetic analysis showed rapid uptake of the drug with a half-life of 10-14 hours depending on dose.

There were no concerning safety signals, Dr. Bissonnette said and no thromboembolic events, serious infections, or opportunistic infections. The most common adverse event was headache, which occurred at equal rates among the groups. The single serious adverse event was anxiety, which occurred in one patient taking 80 mg ASN002, 4 days after the medication was stopped, and was judged unrelated to ASN002.

There were no significant changes in any lab parameters, no changes in lipid profiles, and no hematologic abnormalities. One patient experienced an increase in creatinine phosphokinase, something that has been seen in other studies of JAK inhibitors, Dr. Bissonnette said.

The molecule performed well on secondary efficacy endpoints. By day 15, 63% of the 40-mg group and 75% of the 80-mg group had achieved EASI-50, and by day 29, these rates were 88% and 100%, respectively. These doses also performed well on the EASI-75 endpoint. By day 29, 63% of the 40-mg group and 50% of the 80-mg group had achieved a 75% improvement in EASI score.

The 40- and 80-mg groups also did well with regards to BSA improvement. By day 29, the 80-mg group had achieved a mean BSA reduction of 58%, and the 40-mg group a mean reduction of 64%. IGA tracked that improvement, with 25% of the 80-mg group and 38% of the 40-mg group achieving an IGA score of 1 or 0.

Itching responded well to ASN002, but here, the 20-mg dose threw investigators a bit of a curve ball. Pruritus decreased most in the 80-mg group (about 70% by the end of the study). But at 3 weeks, patients taking 20 mg and 40 mg were experiencing the same 30% decrease in itch. By 4 weeks, however, the scores had separated, with the 40-mg group landing at about a 40% reduction, and the 20-mg group rebounding to about a 20% reduction.

“I would say that this first trial of ASN002 showed clear efficacy in patients with moderate to severe atopic dermatitis, with rapid improvement itch and a large proportion of patients reaching EASI-50 as early as 2 weeks,” Dr. Bissonnette said.

Asana will soon initiate a phase 2b study of ASN002 in moderate to severe atopic dermatitis patients. Clinical studies in other dermatologic and autoimmune indications are under consideration, according to the company website.

Dr. Bissonnette is the president of Innovaderm Research, which was paid to run the ASN002 study.

msullivan@frontlinemedcom.com

SOURCE: Bissonnette R et al. AAD 2018, Abstract 6777

SAN DIEGO – A novel molecule that inhibits two major inflammatory pathways acquitted itself well in its first safety and efficacy clinical trial in patients with moderate to severe atopic dermatitis.

After 29 days, 100% of those taking the highest dose of the molecule, ASN002, achieved a 50% improvement in skin involvement.

ASN002 (Asana BioSciences) is a dual inhibitor of Janus kinase (JAK) and spleen tyrosine kinase (SYK).

“This is an interesting molecule,” Robert Bissonnette, MD, said at the annual meeting of the American Academy of Dermatology. “By targeting the entire JAK family, it inhibits cytokine signaling through IL-4 [interleukin-4], IL-13, IL-23, and thymic stromal lymphopoietin,” which plays a role in maturing T cells. The SYK inhibition targets IL-17, increases the terminal differentiation of keratinocytes, and inhibits B-cell signaling.

Dr. Bissonnette, president of Innovaderm Research presented the results in a late-breaking session at the meeting. Innovaderm designs, conducts, and analyzes dermatology clinical trials, and ran the study for Asana BioSciences.

In an Asana press release about the study results, CEO Sandeep Gupta, PhD, said that ASN002 “is the only oral compound in clinical development targeting JAK [including Tyk2] and SYK signaling, two clinically validated mechanisms.” He added that inhibition of JAK and SYK pathways “diminishes cytokine production and signaling including those mediated by Th2 and Th22 cytokines. Dysregulation of Th2 and Th22 cytokine pathways is implicated in the pathogenesis of atopic dermatitis.”

Safety was the primary endpoint in the phase 1b dose-ranging trial, but there were also several efficacy endpoints, Dr. Bissonnette said at the meeting. The study comprised 36 patients separated into three 12-patient groups. In each group, nine received the active drug every day, and three received a placebo. The first group received 20 mg ASN002 or placebo for 28 days, followed by the 14-day safety period. The next group received 40 mg ASN002 or placebo for 28 days, followed by the safety analysis. The third group followed the same treatment pattern, but received 80 mg of the drug.

All patients were aged 29-42 years. The Eczema Area and Severity Index (EASI) was imbalanced among the groups, ranging from 21 in the placebo group and 40-mg group, to 29 in the 20-mg and 80-mg groups. The Body Surface Area (BSA) index also differed between groups: 25% among the placebo patients, 45% in the 20-mg group, 32% in the 40-mg group, and 29% in the 80-mg group. The average Investigator Global Assessment (IGA) score was 3.

A pharmacokinetic analysis showed rapid uptake of the drug with a half-life of 10-14 hours depending on dose.

There were no concerning safety signals, Dr. Bissonnette said and no thromboembolic events, serious infections, or opportunistic infections. The most common adverse event was headache, which occurred at equal rates among the groups. The single serious adverse event was anxiety, which occurred in one patient taking 80 mg ASN002, 4 days after the medication was stopped, and was judged unrelated to ASN002.

There were no significant changes in any lab parameters, no changes in lipid profiles, and no hematologic abnormalities. One patient experienced an increase in creatinine phosphokinase, something that has been seen in other studies of JAK inhibitors, Dr. Bissonnette said.

The molecule performed well on secondary efficacy endpoints. By day 15, 63% of the 40-mg group and 75% of the 80-mg group had achieved EASI-50, and by day 29, these rates were 88% and 100%, respectively. These doses also performed well on the EASI-75 endpoint. By day 29, 63% of the 40-mg group and 50% of the 80-mg group had achieved a 75% improvement in EASI score.

The 40- and 80-mg groups also did well with regards to BSA improvement. By day 29, the 80-mg group had achieved a mean BSA reduction of 58%, and the 40-mg group a mean reduction of 64%. IGA tracked that improvement, with 25% of the 80-mg group and 38% of the 40-mg group achieving an IGA score of 1 or 0.

Itching responded well to ASN002, but here, the 20-mg dose threw investigators a bit of a curve ball. Pruritus decreased most in the 80-mg group (about 70% by the end of the study). But at 3 weeks, patients taking 20 mg and 40 mg were experiencing the same 30% decrease in itch. By 4 weeks, however, the scores had separated, with the 40-mg group landing at about a 40% reduction, and the 20-mg group rebounding to about a 20% reduction.

“I would say that this first trial of ASN002 showed clear efficacy in patients with moderate to severe atopic dermatitis, with rapid improvement itch and a large proportion of patients reaching EASI-50 as early as 2 weeks,” Dr. Bissonnette said.

Asana will soon initiate a phase 2b study of ASN002 in moderate to severe atopic dermatitis patients. Clinical studies in other dermatologic and autoimmune indications are under consideration, according to the company website.

Dr. Bissonnette is the president of Innovaderm Research, which was paid to run the ASN002 study.

msullivan@frontlinemedcom.com

SOURCE: Bissonnette R et al. AAD 2018, Abstract 6777

SAN DIEGO – A long dry spell in the development of new atopic dermatitis (AD) medications came to an end in 2016 with the approval of a topical treatment, and last year brought the first biologic for AD to the market. With more targets and potential treatments being studied, “it’s the decade of eczema,” according to a leading researcher.

“This revolution in atopic dermatitis, or eczema, stems from our increased knowledge of the disease. We understand ... the immune molecules that are involved in the disease, and we are going after them. And I think we’ll have many more approvals in the next few years,” said Emma Guttman, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she was presenting a talk on the translational revolution in atopic dermatitis.

In the interview, she also discussed research showing that children with AD don’t have the same distribution of lesions as adults, and a study of young children, which found that during an early stage of the disease, when compared with adults, they showed much higher increases in Th17 similar to that seen in psoriasis. It will be interesting to see if “some drugs that work for psoriasis may work in children,” said Dr. Guttman, professor of dermatology and director of the laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Guttman disclosed research support, consulting, or lecture fees from Regeneron, Sanofi, Pfizer, and other companies developing AD treatments.

dermnews@frontlinemedcom.com

SAN DIEGO – A long dry spell in the development of new atopic dermatitis (AD) medications came to an end in 2016 with the approval of a topical treatment, and last year brought the first biologic for AD to the market. With more targets and potential treatments being studied, “it’s the decade of eczema,” according to a leading researcher.

“This revolution in atopic dermatitis, or eczema, stems from our increased knowledge of the disease. We understand ... the immune molecules that are involved in the disease, and we are going after them. And I think we’ll have many more approvals in the next few years,” said Emma Guttman, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she was presenting a talk on the translational revolution in atopic dermatitis.

In the interview, she also discussed research showing that children with AD don’t have the same distribution of lesions as adults, and a study of young children, which found that during an early stage of the disease, when compared with adults, they showed much higher increases in Th17 similar to that seen in psoriasis. It will be interesting to see if “some drugs that work for psoriasis may work in children,” said Dr. Guttman, professor of dermatology and director of the laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Guttman disclosed research support, consulting, or lecture fees from Regeneron, Sanofi, Pfizer, and other companies developing AD treatments.

dermnews@frontlinemedcom.com

SAN DIEGO – A long dry spell in the development of new atopic dermatitis (AD) medications came to an end in 2016 with the approval of a topical treatment, and last year brought the first biologic for AD to the market. With more targets and potential treatments being studied, “it’s the decade of eczema,” according to a leading researcher.

“This revolution in atopic dermatitis, or eczema, stems from our increased knowledge of the disease. We understand ... the immune molecules that are involved in the disease, and we are going after them. And I think we’ll have many more approvals in the next few years,” said Emma Guttman, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she was presenting a talk on the translational revolution in atopic dermatitis.

In the interview, she also discussed research showing that children with AD don’t have the same distribution of lesions as adults, and a study of young children, which found that during an early stage of the disease, when compared with adults, they showed much higher increases in Th17 similar to that seen in psoriasis. It will be interesting to see if “some drugs that work for psoriasis may work in children,” said Dr. Guttman, professor of dermatology and director of the laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Guttman disclosed research support, consulting, or lecture fees from Regeneron, Sanofi, Pfizer, and other companies developing AD treatments.

dermnews@frontlinemedcom.com

SAN DIEGO – An anti–interleukin-33 antibody aimed at atopic dermatitis performed reasonably well in a small, proof-of-concept phase 2a study, and will proceed along its developmental pathway.

All 12 patients who received one intravenous infusion of ANB020 achieved at least a 50% reduction in their Eczema Area and Severity Index (EASI) by day 29, Graham Ogg, MD, said at the annual meeting of the American Academy of Dermatology. Most of the improvement occurred in the first 2 weeks, was largely sustained for 2 months, then gradually began to fade, said Dr. Ogg, professor of dermatology at Oxford University, England.

The EASI improvement, along with improvements in itch and clinical assessment, are enough to propel ANB020 into a phase 2b, placebo-controlled, randomized trial, which Dr. Ogg said would recruit 200 to 300 adults with moderate to severe atomic dermatitis (AD).

ANB020 is a selective inhibitor of interleukin-33 (IL-33), which is highly expressed in the lesions of AD, Dr. Ogg said. “IL-33 is produced by a number of cells, including keratinocytes and epithelial cells. It’s an alarm molecule predominately produced after damage to keratinocytes; for example, after an allergenic challenge to the skin.”

The antibody has already passed its phase 1 trials, which included both a fixed and ascending dose study of 10 mg to 750 mg in healthy adults. ANB020 has a long half-life of 16 days after IV infusion or subcutaneous injection, inhibits IL-33 for up to 85 days, and has no apparent dose-limiting toxicities.

The phase 2a study comprised 12 adults (mean age 40 years) with a mean EASI score of 32, Dr. Ogg reported. The mean Investigator’s Global Assessment score was 4, and the mean Severity Scoring of Atopic Dermatitis almost 65. Patients had high itch scores and scored a mean of 13 on the Dermatology Life Quality Index. All were inadequately controlled on topical corticosteroids, and about half had failed at least one systemic immunomodulator.

Following a washout period, all subjects received an initial placebo infusion, and 1 week later received a single 300-mg infusion of ANB020. The primary endpoint – at least a 50% reduction in EASI score (EASI-50) – was assessed at day 29, with close follow-up until day 140.

By day 15, nine patients (75%) had achieved EASI-50, and three (25%) had achieved a 75% reduction in EASI score (EASI-75). The average EASI score reduction was 58% at that point. By day 29, 10 (83%) had achieved EASI-50, and 4 (33%), EASI-75. This benefit was largely maintained until day 78, when it began to tail off somewhat. By day 140, five patients (42%) still had an EASI-50 and three (25%), an EASI-75.

Three patients (25%) achieved an Investigator’s Global Assessment score of 0 or 1, indicating clear or almost clear skin. On day 29, the average pruritus decrease was 32%, which dropped to 21% by day 140. The average Severity Scoring of Atopic Dermatitis reduction was 40% on day 29 and 32% on day 140. The average Dermatology Life Quality Index reduction was 45% on day 29 and 43% on day 140.

ANB020 was well tolerated with no drug-related safety signals. Dizziness occurred in 17% of subjects, and mild headache in 25%. There was one serious adverse event, a case of major depression that occurred on day 140. This was consistent with the patient’s baseline health history and deemed unrelated to the study drug.

According to an AnaptysBio press release, ANB020 is also being investigated in a double-blind, placebo-controlled study of 20 adults with severe peanut allergy. The company also is enrolling a 24-patient randomized, double-blind, placebo-controlled, phase 2a trial in adults with severe eosinophilic asthma.

Topline data from both of these studies are expected soon, the website noted.

AnaptysBio funded Dr. Ogg’s travel and registration fees for the meeting. He said he had no other financial disclosures relevant to ANB020.

msullivan@frontlinemedcom.com

SOURCE: Ogg G et al. AAD 2018. Abstract 6658.

SAN DIEGO – An anti–interleukin-33 antibody aimed at atopic dermatitis performed reasonably well in a small, proof-of-concept phase 2a study, and will proceed along its developmental pathway.

All 12 patients who received one intravenous infusion of ANB020 achieved at least a 50% reduction in their Eczema Area and Severity Index (EASI) by day 29, Graham Ogg, MD, said at the annual meeting of the American Academy of Dermatology. Most of the improvement occurred in the first 2 weeks, was largely sustained for 2 months, then gradually began to fade, said Dr. Ogg, professor of dermatology at Oxford University, England.

The EASI improvement, along with improvements in itch and clinical assessment, are enough to propel ANB020 into a phase 2b, placebo-controlled, randomized trial, which Dr. Ogg said would recruit 200 to 300 adults with moderate to severe atomic dermatitis (AD).

ANB020 is a selective inhibitor of interleukin-33 (IL-33), which is highly expressed in the lesions of AD, Dr. Ogg said. “IL-33 is produced by a number of cells, including keratinocytes and epithelial cells. It’s an alarm molecule predominately produced after damage to keratinocytes; for example, after an allergenic challenge to the skin.”

The antibody has already passed its phase 1 trials, which included both a fixed and ascending dose study of 10 mg to 750 mg in healthy adults. ANB020 has a long half-life of 16 days after IV infusion or subcutaneous injection, inhibits IL-33 for up to 85 days, and has no apparent dose-limiting toxicities.

The phase 2a study comprised 12 adults (mean age 40 years) with a mean EASI score of 32, Dr. Ogg reported. The mean Investigator’s Global Assessment score was 4, and the mean Severity Scoring of Atopic Dermatitis almost 65. Patients had high itch scores and scored a mean of 13 on the Dermatology Life Quality Index. All were inadequately controlled on topical corticosteroids, and about half had failed at least one systemic immunomodulator.

Following a washout period, all subjects received an initial placebo infusion, and 1 week later received a single 300-mg infusion of ANB020. The primary endpoint – at least a 50% reduction in EASI score (EASI-50) – was assessed at day 29, with close follow-up until day 140.

By day 15, nine patients (75%) had achieved EASI-50, and three (25%) had achieved a 75% reduction in EASI score (EASI-75). The average EASI score reduction was 58% at that point. By day 29, 10 (83%) had achieved EASI-50, and 4 (33%), EASI-75. This benefit was largely maintained until day 78, when it began to tail off somewhat. By day 140, five patients (42%) still had an EASI-50 and three (25%), an EASI-75.

Three patients (25%) achieved an Investigator’s Global Assessment score of 0 or 1, indicating clear or almost clear skin. On day 29, the average pruritus decrease was 32%, which dropped to 21% by day 140. The average Severity Scoring of Atopic Dermatitis reduction was 40% on day 29 and 32% on day 140. The average Dermatology Life Quality Index reduction was 45% on day 29 and 43% on day 140.

ANB020 was well tolerated with no drug-related safety signals. Dizziness occurred in 17% of subjects, and mild headache in 25%. There was one serious adverse event, a case of major depression that occurred on day 140. This was consistent with the patient’s baseline health history and deemed unrelated to the study drug.

According to an AnaptysBio press release, ANB020 is also being investigated in a double-blind, placebo-controlled study of 20 adults with severe peanut allergy. The company also is enrolling a 24-patient randomized, double-blind, placebo-controlled, phase 2a trial in adults with severe eosinophilic asthma.

Topline data from both of these studies are expected soon, the website noted.

AnaptysBio funded Dr. Ogg’s travel and registration fees for the meeting. He said he had no other financial disclosures relevant to ANB020.

msullivan@frontlinemedcom.com

SOURCE: Ogg G et al. AAD 2018. Abstract 6658.

SAN DIEGO – An anti–interleukin-33 antibody aimed at atopic dermatitis performed reasonably well in a small, proof-of-concept phase 2a study, and will proceed along its developmental pathway.

All 12 patients who received one intravenous infusion of ANB020 achieved at least a 50% reduction in their Eczema Area and Severity Index (EASI) by day 29, Graham Ogg, MD, said at the annual meeting of the American Academy of Dermatology. Most of the improvement occurred in the first 2 weeks, was largely sustained for 2 months, then gradually began to fade, said Dr. Ogg, professor of dermatology at Oxford University, England.

The EASI improvement, along with improvements in itch and clinical assessment, are enough to propel ANB020 into a phase 2b, placebo-controlled, randomized trial, which Dr. Ogg said would recruit 200 to 300 adults with moderate to severe atomic dermatitis (AD).

ANB020 is a selective inhibitor of interleukin-33 (IL-33), which is highly expressed in the lesions of AD, Dr. Ogg said. “IL-33 is produced by a number of cells, including keratinocytes and epithelial cells. It’s an alarm molecule predominately produced after damage to keratinocytes; for example, after an allergenic challenge to the skin.”

The antibody has already passed its phase 1 trials, which included both a fixed and ascending dose study of 10 mg to 750 mg in healthy adults. ANB020 has a long half-life of 16 days after IV infusion or subcutaneous injection, inhibits IL-33 for up to 85 days, and has no apparent dose-limiting toxicities.

The phase 2a study comprised 12 adults (mean age 40 years) with a mean EASI score of 32, Dr. Ogg reported. The mean Investigator’s Global Assessment score was 4, and the mean Severity Scoring of Atopic Dermatitis almost 65. Patients had high itch scores and scored a mean of 13 on the Dermatology Life Quality Index. All were inadequately controlled on topical corticosteroids, and about half had failed at least one systemic immunomodulator.

Following a washout period, all subjects received an initial placebo infusion, and 1 week later received a single 300-mg infusion of ANB020. The primary endpoint – at least a 50% reduction in EASI score (EASI-50) – was assessed at day 29, with close follow-up until day 140.

By day 15, nine patients (75%) had achieved EASI-50, and three (25%) had achieved a 75% reduction in EASI score (EASI-75). The average EASI score reduction was 58% at that point. By day 29, 10 (83%) had achieved EASI-50, and 4 (33%), EASI-75. This benefit was largely maintained until day 78, when it began to tail off somewhat. By day 140, five patients (42%) still had an EASI-50 and three (25%), an EASI-75.

Three patients (25%) achieved an Investigator’s Global Assessment score of 0 or 1, indicating clear or almost clear skin. On day 29, the average pruritus decrease was 32%, which dropped to 21% by day 140. The average Severity Scoring of Atopic Dermatitis reduction was 40% on day 29 and 32% on day 140. The average Dermatology Life Quality Index reduction was 45% on day 29 and 43% on day 140.

ANB020 was well tolerated with no drug-related safety signals. Dizziness occurred in 17% of subjects, and mild headache in 25%. There was one serious adverse event, a case of major depression that occurred on day 140. This was consistent with the patient’s baseline health history and deemed unrelated to the study drug.

According to an AnaptysBio press release, ANB020 is also being investigated in a double-blind, placebo-controlled study of 20 adults with severe peanut allergy. The company also is enrolling a 24-patient randomized, double-blind, placebo-controlled, phase 2a trial in adults with severe eosinophilic asthma.

Topline data from both of these studies are expected soon, the website noted.

AnaptysBio funded Dr. Ogg’s travel and registration fees for the meeting. He said he had no other financial disclosures relevant to ANB020.

msullivan@frontlinemedcom.com

SOURCE: Ogg G et al. AAD 2018. Abstract 6658.

SAN DIEGO – Upadacitinib, a selective inhibitor of the Janus kinase 1 enzyme, affected up to 90% skin clearance in a phase 2 study in patients with moderate to severe atopic dermatitis (AD).

The molecule significantly outperformed placebo with all three of the doses tested, with patients experiencing improvement in itch and skin are involved in the first week of use. During the 16-week trial, there were none of the thromboembolic events that have proven a concern with other inhibitors of the Janus kinase family of enzymes, Emma Guttman, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

The study’s primary endpoint was the mean percent EASI improvement from baseline. Dr. Guttman reported several of the key secondary endpoints as well.

On the primary endpoint, all three doses of upadacitinib separated from placebo quickly and dramatically. Patients began to see some skin clearance after 1 week; by 2 weeks, the 7.5-mg group had achieved a 39% improvement and the 15- and 30-mg groups, 56% and 59% improvement, respectively.

Efficacy in the 7.5-mg group peaked at a 50% improvement by week 4, and then trailed off somewhat, with a mean 39% improvement by week 16.

Efficacy in the two higher dose groups also peaked around 4 weeks, with a 66% improvement in the 15-mg group and a 78% improvement in the 30-mg group. There was some tailing off of effect in each of these groups as well. By 16 weeks, the mean EASI improvement was 61.7% in the 15-mg group and 74.4% in the 30-mg group.

A good number of patients in each dosing group even achieved 90% skin clearance, Dr. Guttman noted.

“We generally say that we like to see an EASI 50, but now we are talking about EASI 75 and even 90. More than 60% on the highest dose achieved an EASI 75 and 60% an EASI 90. Even the 15-mg group achieved a nice EASI 90 response, at around 26%.”

Itching also responded well to upadacitinib, Dr. Guttman said. Within 1 week, all three active groups had separated significantly from the placebo group. By 2 weeks, the 7.5-mg group had a mean 29% improvement on the pruritus numerical rating scale. The improvement was 46% in the 15-mg group and 57.6% in the 30-mg group. By 16 weeks, the improvements were 39.6%, 48%, and 68.9%, respectively, compared with 9.7% among those on placebo.

The most common treatment-emergent adverse event was upper respiratory infection, which Dr. Guttman noted has been seen with JAK inhibitors. This occurred in 10% of those taking placebo and in 16.7% of the 7.5-mg group and 11.9% of both the 15-mg and 30-mg groups. A few patients experienced exacerbation of their AD on the medication (16.7%, 7% and 11.9% of the active groups, compared with 7.5% of those on placebo). New acne developed in 2.5% of placebo patients and in 9.5%, 4.8%, and 14.3% of those taking upadacitinib. The acne was on the body, considered mild, and resolved, Dr. Guttman said.

Two patients taking 7.5 mg and one taking 15 mg developed a serious infection, although she did not elaborate on the illnesses. Two taking 15 mg developed a liver disorder. There were four cases of neutropenia and one lymphopenia, all among the active groups. Creatine phosphokinase elevations occurred in one taking placebo and seven taking the study drug.

There were no pulmonary or deep vein thromboses; no opportunistic infections or malignancies; and no cases of herpes zoster, tuberculosis, or renal dysfunction. There were no deaths during the trial.

Phase 3 studies of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease are underway, according to AbbVie.

AbbVie sponsored the AD study. Dr. Guttman is a consultant for the company.
 

msullivan@frontlinemedcom.com

SOURCE: Guttman E et al. AAD late-breaking clinical trials, Abstract 6533

SAN DIEGO – Upadacitinib, a selective inhibitor of the Janus kinase 1 enzyme, affected up to 90% skin clearance in a phase 2 study in patients with moderate to severe atopic dermatitis (AD).

The molecule significantly outperformed placebo with all three of the doses tested, with patients experiencing improvement in itch and skin are involved in the first week of use. During the 16-week trial, there were none of the thromboembolic events that have proven a concern with other inhibitors of the Janus kinase family of enzymes, Emma Guttman, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

The study’s primary endpoint was the mean percent EASI improvement from baseline. Dr. Guttman reported several of the key secondary endpoints as well.

On the primary endpoint, all three doses of upadacitinib separated from placebo quickly and dramatically. Patients began to see some skin clearance after 1 week; by 2 weeks, the 7.5-mg group had achieved a 39% improvement and the 15- and 30-mg groups, 56% and 59% improvement, respectively.

Efficacy in the 7.5-mg group peaked at a 50% improvement by week 4, and then trailed off somewhat, with a mean 39% improvement by week 16.

Efficacy in the two higher dose groups also peaked around 4 weeks, with a 66% improvement in the 15-mg group and a 78% improvement in the 30-mg group. There was some tailing off of effect in each of these groups as well. By 16 weeks, the mean EASI improvement was 61.7% in the 15-mg group and 74.4% in the 30-mg group.

A good number of patients in each dosing group even achieved 90% skin clearance, Dr. Guttman noted.

“We generally say that we like to see an EASI 50, but now we are talking about EASI 75 and even 90. More than 60% on the highest dose achieved an EASI 75 and 60% an EASI 90. Even the 15-mg group achieved a nice EASI 90 response, at around 26%.”

Itching also responded well to upadacitinib, Dr. Guttman said. Within 1 week, all three active groups had separated significantly from the placebo group. By 2 weeks, the 7.5-mg group had a mean 29% improvement on the pruritus numerical rating scale. The improvement was 46% in the 15-mg group and 57.6% in the 30-mg group. By 16 weeks, the improvements were 39.6%, 48%, and 68.9%, respectively, compared with 9.7% among those on placebo.

The most common treatment-emergent adverse event was upper respiratory infection, which Dr. Guttman noted has been seen with JAK inhibitors. This occurred in 10% of those taking placebo and in 16.7% of the 7.5-mg group and 11.9% of both the 15-mg and 30-mg groups. A few patients experienced exacerbation of their AD on the medication (16.7%, 7% and 11.9% of the active groups, compared with 7.5% of those on placebo). New acne developed in 2.5% of placebo patients and in 9.5%, 4.8%, and 14.3% of those taking upadacitinib. The acne was on the body, considered mild, and resolved, Dr. Guttman said.

Two patients taking 7.5 mg and one taking 15 mg developed a serious infection, although she did not elaborate on the illnesses. Two taking 15 mg developed a liver disorder. There were four cases of neutropenia and one lymphopenia, all among the active groups. Creatine phosphokinase elevations occurred in one taking placebo and seven taking the study drug.

There were no pulmonary or deep vein thromboses; no opportunistic infections or malignancies; and no cases of herpes zoster, tuberculosis, or renal dysfunction. There were no deaths during the trial.

Phase 3 studies of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease are underway, according to AbbVie.

AbbVie sponsored the AD study. Dr. Guttman is a consultant for the company.
 

msullivan@frontlinemedcom.com

SOURCE: Guttman E et al. AAD late-breaking clinical trials, Abstract 6533

SAN DIEGO – Upadacitinib, a selective inhibitor of the Janus kinase 1 enzyme, affected up to 90% skin clearance in a phase 2 study in patients with moderate to severe atopic dermatitis (AD).

The molecule significantly outperformed placebo with all three of the doses tested, with patients experiencing improvement in itch and skin are involved in the first week of use. During the 16-week trial, there were none of the thromboembolic events that have proven a concern with other inhibitors of the Janus kinase family of enzymes, Emma Guttman, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

The study’s primary endpoint was the mean percent EASI improvement from baseline. Dr. Guttman reported several of the key secondary endpoints as well.

On the primary endpoint, all three doses of upadacitinib separated from placebo quickly and dramatically. Patients began to see some skin clearance after 1 week; by 2 weeks, the 7.5-mg group had achieved a 39% improvement and the 15- and 30-mg groups, 56% and 59% improvement, respectively.

Efficacy in the 7.5-mg group peaked at a 50% improvement by week 4, and then trailed off somewhat, with a mean 39% improvement by week 16.

Efficacy in the two higher dose groups also peaked around 4 weeks, with a 66% improvement in the 15-mg group and a 78% improvement in the 30-mg group. There was some tailing off of effect in each of these groups as well. By 16 weeks, the mean EASI improvement was 61.7% in the 15-mg group and 74.4% in the 30-mg group.

A good number of patients in each dosing group even achieved 90% skin clearance, Dr. Guttman noted.

“We generally say that we like to see an EASI 50, but now we are talking about EASI 75 and even 90. More than 60% on the highest dose achieved an EASI 75 and 60% an EASI 90. Even the 15-mg group achieved a nice EASI 90 response, at around 26%.”

Itching also responded well to upadacitinib, Dr. Guttman said. Within 1 week, all three active groups had separated significantly from the placebo group. By 2 weeks, the 7.5-mg group had a mean 29% improvement on the pruritus numerical rating scale. The improvement was 46% in the 15-mg group and 57.6% in the 30-mg group. By 16 weeks, the improvements were 39.6%, 48%, and 68.9%, respectively, compared with 9.7% among those on placebo.

The most common treatment-emergent adverse event was upper respiratory infection, which Dr. Guttman noted has been seen with JAK inhibitors. This occurred in 10% of those taking placebo and in 16.7% of the 7.5-mg group and 11.9% of both the 15-mg and 30-mg groups. A few patients experienced exacerbation of their AD on the medication (16.7%, 7% and 11.9% of the active groups, compared with 7.5% of those on placebo). New acne developed in 2.5% of placebo patients and in 9.5%, 4.8%, and 14.3% of those taking upadacitinib. The acne was on the body, considered mild, and resolved, Dr. Guttman said.

Two patients taking 7.5 mg and one taking 15 mg developed a serious infection, although she did not elaborate on the illnesses. Two taking 15 mg developed a liver disorder. There were four cases of neutropenia and one lymphopenia, all among the active groups. Creatine phosphokinase elevations occurred in one taking placebo and seven taking the study drug.

There were no pulmonary or deep vein thromboses; no opportunistic infections or malignancies; and no cases of herpes zoster, tuberculosis, or renal dysfunction. There were no deaths during the trial.

Phase 3 studies of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease are underway, according to AbbVie.

AbbVie sponsored the AD study. Dr. Guttman is a consultant for the company.
 

msullivan@frontlinemedcom.com

SOURCE: Guttman E et al. AAD late-breaking clinical trials, Abstract 6533

SAN DIEGO – Patch testing may be in order for some patients with atopic dermatitis, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.

Allergic contact dermatitis is a common comorbid condition in people with AD “and sometimes, can flare up the severity of the disease,” he said in a video interview at the American Academy of Dermatology annual meeting.

Patch testing can ferret out a trigger in atopic dermatitis patients with atypical disease distribution or refractory disease, and help avoid the need for systemic therapy, Dr. Silverman pointed out.

In the interview, he discussed these and other clinical scenarios, as well as how patch testing differs in these patients and what screening series to consider using.

Dr. Silverberg had no relevant financial disclosures.

emechcatie@frontlinemedcom.com

SOURCE: Silverberg, J. et al, Session 061.

SAN DIEGO – Patch testing may be in order for some patients with atopic dermatitis, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.

Allergic contact dermatitis is a common comorbid condition in people with AD “and sometimes, can flare up the severity of the disease,” he said in a video interview at the American Academy of Dermatology annual meeting.

Patch testing can ferret out a trigger in atopic dermatitis patients with atypical disease distribution or refractory disease, and help avoid the need for systemic therapy, Dr. Silverman pointed out.

In the interview, he discussed these and other clinical scenarios, as well as how patch testing differs in these patients and what screening series to consider using.

Dr. Silverberg had no relevant financial disclosures.

emechcatie@frontlinemedcom.com

SOURCE: Silverberg, J. et al, Session 061.

SAN DIEGO – Patch testing may be in order for some patients with atopic dermatitis, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.

Allergic contact dermatitis is a common comorbid condition in people with AD “and sometimes, can flare up the severity of the disease,” he said in a video interview at the American Academy of Dermatology annual meeting.

Patch testing can ferret out a trigger in atopic dermatitis patients with atypical disease distribution or refractory disease, and help avoid the need for systemic therapy, Dr. Silverman pointed out.

In the interview, he discussed these and other clinical scenarios, as well as how patch testing differs in these patients and what screening series to consider using.

Dr. Silverberg had no relevant financial disclosures.

emechcatie@frontlinemedcom.com

SOURCE: Silverberg, J. et al, Session 061.

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in San Diego. Look for the latest news and video interviews from the meeting in medical, surgical, and aesthetic dermatology at edermatologynews.com starting Friday February 16.

Coverage will include the late-breaker sessions, which will be presented on Saturday February 17.

f11photo/Thinkstock

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in San Diego. Look for the latest news and video interviews from the meeting in medical, surgical, and aesthetic dermatology at edermatologynews.com starting Friday February 16.

Coverage will include the late-breaker sessions, which will be presented on Saturday February 17.

f11photo/Thinkstock

Dermatology News will be on site later this week at the annual meeting of the American Academy of Dermatology in San Diego. Look for the latest news and video interviews from the meeting in medical, surgical, and aesthetic dermatology at edermatologynews.com starting Friday February 16.

Coverage will include the late-breaker sessions, which will be presented on Saturday February 17.

f11photo/Thinkstock