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Baricitinib found effective for moderate to severe AD out to 52 weeks
“With long-term therapy, the baricitinib 2 mg response remains stable or slightly improved, compared with week 16 for skin inflammation, itch, sleep, and quality of life,” presenting study author Eric L. Simpson, MD, said during the Revolutionizing Atopic Dermatitis symposium.
Baricitinib is an oral selective Janus kinase 1/JAK2 inhibitor being developed for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. The drug is already approved for AD in Europe at the 2-mg and 4-mg doses. A 16-week placebo-controlled study conducted in North America known as BREEZE-AD5 found that 2 mg of baricitinib improved disease in adults with moderate to severe AD.
For the current analysis, Dr. Simpson, professor of dermatology at Oregon Health and Science University, Portland, and colleagues integrated data from BREEZE-AD5 and BREEZE-AD6, an ongoing, open-label study of BREEZE-AD5, to evaluate the long-term efficacy and safety of baricitinib 2 mg in patients with moderate to severe AD.
At week 16, patients from BREEZE-AD5 who were on baricitinib 2 mg could either continue the trial out to week 52, or they could transition to BREEZE-AD6 if they were nonresponders. The use of low-potency corticosteroids was permitted after week 16 in BREEZE-AD5 and throughout BREEZE-AD6. Endpoints of interest at week 52 in both trials were the proportions of patients with 75% or greater improvement from baseline in the Eczema and Severity Index (EASI75), a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1, a Dermatology Life Quality Index (DLQI) score of 5 or less, as well as mean SCORing AD (SCORAD) visual analog scales of itch and sleeplessness scores, and the mean percent change from baseline in EASI score.
Dr. Simpson presented data on 146 patients from both trials who were randomized to baricitinib 2 mg. Their mean age was 40 years, 53% were female, 58% were White, 21% were Black, 15% were Asian, and the remainder were from other backgrounds. Their mean duration of AD was 16 years and their average EASI score was 26.6. At weeks 16, 32, and 52, the proportion of patients who achieved an EASI75 response was 40%, 51%, and 49%, respectively, while the mean percent change from baseline in EASI score was –50%, –59%, and –57%.
At weeks 16, 32, and 52, the vIGA-AD responses of 0 or 1 were observed in 27%, 38%, and 31% of patients. The mean SCORAD pruritus score improved from 7.7 at baseline to 4.8 at week 16 and was maintained at weeks 32 (3.8) and 52 (4.3). The mean SCORAD sleeplessness score also improved from 6.5 at baseline to 3.9 at week 16 and remained stable through weeks 32 (3.4) and 52 (3.7).
Finally, among 129 patients who had a baseline DLQI of greater than 5, 39% had DLQI scores of 5 or lower at week 16, compared with 49% at week 32 and 45% at week 52, indicating a small or no effect of AD on quality of life.
The study was sponsored by Eli Lilly, which is developing baricitinib. Dr. Simpson disclosed that he is a consultant to and/or an investigator for several pharmaceutical companies, including Eli Lilly.
“With long-term therapy, the baricitinib 2 mg response remains stable or slightly improved, compared with week 16 for skin inflammation, itch, sleep, and quality of life,” presenting study author Eric L. Simpson, MD, said during the Revolutionizing Atopic Dermatitis symposium.
Baricitinib is an oral selective Janus kinase 1/JAK2 inhibitor being developed for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. The drug is already approved for AD in Europe at the 2-mg and 4-mg doses. A 16-week placebo-controlled study conducted in North America known as BREEZE-AD5 found that 2 mg of baricitinib improved disease in adults with moderate to severe AD.
For the current analysis, Dr. Simpson, professor of dermatology at Oregon Health and Science University, Portland, and colleagues integrated data from BREEZE-AD5 and BREEZE-AD6, an ongoing, open-label study of BREEZE-AD5, to evaluate the long-term efficacy and safety of baricitinib 2 mg in patients with moderate to severe AD.
At week 16, patients from BREEZE-AD5 who were on baricitinib 2 mg could either continue the trial out to week 52, or they could transition to BREEZE-AD6 if they were nonresponders. The use of low-potency corticosteroids was permitted after week 16 in BREEZE-AD5 and throughout BREEZE-AD6. Endpoints of interest at week 52 in both trials were the proportions of patients with 75% or greater improvement from baseline in the Eczema and Severity Index (EASI75), a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1, a Dermatology Life Quality Index (DLQI) score of 5 or less, as well as mean SCORing AD (SCORAD) visual analog scales of itch and sleeplessness scores, and the mean percent change from baseline in EASI score.
Dr. Simpson presented data on 146 patients from both trials who were randomized to baricitinib 2 mg. Their mean age was 40 years, 53% were female, 58% were White, 21% were Black, 15% were Asian, and the remainder were from other backgrounds. Their mean duration of AD was 16 years and their average EASI score was 26.6. At weeks 16, 32, and 52, the proportion of patients who achieved an EASI75 response was 40%, 51%, and 49%, respectively, while the mean percent change from baseline in EASI score was –50%, –59%, and –57%.
At weeks 16, 32, and 52, the vIGA-AD responses of 0 or 1 were observed in 27%, 38%, and 31% of patients. The mean SCORAD pruritus score improved from 7.7 at baseline to 4.8 at week 16 and was maintained at weeks 32 (3.8) and 52 (4.3). The mean SCORAD sleeplessness score also improved from 6.5 at baseline to 3.9 at week 16 and remained stable through weeks 32 (3.4) and 52 (3.7).
Finally, among 129 patients who had a baseline DLQI of greater than 5, 39% had DLQI scores of 5 or lower at week 16, compared with 49% at week 32 and 45% at week 52, indicating a small or no effect of AD on quality of life.
The study was sponsored by Eli Lilly, which is developing baricitinib. Dr. Simpson disclosed that he is a consultant to and/or an investigator for several pharmaceutical companies, including Eli Lilly.
“With long-term therapy, the baricitinib 2 mg response remains stable or slightly improved, compared with week 16 for skin inflammation, itch, sleep, and quality of life,” presenting study author Eric L. Simpson, MD, said during the Revolutionizing Atopic Dermatitis symposium.
Baricitinib is an oral selective Janus kinase 1/JAK2 inhibitor being developed for the treatment of moderate to severe AD in adults who are candidates for systemic therapy. The drug is already approved for AD in Europe at the 2-mg and 4-mg doses. A 16-week placebo-controlled study conducted in North America known as BREEZE-AD5 found that 2 mg of baricitinib improved disease in adults with moderate to severe AD.
For the current analysis, Dr. Simpson, professor of dermatology at Oregon Health and Science University, Portland, and colleagues integrated data from BREEZE-AD5 and BREEZE-AD6, an ongoing, open-label study of BREEZE-AD5, to evaluate the long-term efficacy and safety of baricitinib 2 mg in patients with moderate to severe AD.
At week 16, patients from BREEZE-AD5 who were on baricitinib 2 mg could either continue the trial out to week 52, or they could transition to BREEZE-AD6 if they were nonresponders. The use of low-potency corticosteroids was permitted after week 16 in BREEZE-AD5 and throughout BREEZE-AD6. Endpoints of interest at week 52 in both trials were the proportions of patients with 75% or greater improvement from baseline in the Eczema and Severity Index (EASI75), a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1, a Dermatology Life Quality Index (DLQI) score of 5 or less, as well as mean SCORing AD (SCORAD) visual analog scales of itch and sleeplessness scores, and the mean percent change from baseline in EASI score.
Dr. Simpson presented data on 146 patients from both trials who were randomized to baricitinib 2 mg. Their mean age was 40 years, 53% were female, 58% were White, 21% were Black, 15% were Asian, and the remainder were from other backgrounds. Their mean duration of AD was 16 years and their average EASI score was 26.6. At weeks 16, 32, and 52, the proportion of patients who achieved an EASI75 response was 40%, 51%, and 49%, respectively, while the mean percent change from baseline in EASI score was –50%, –59%, and –57%.
At weeks 16, 32, and 52, the vIGA-AD responses of 0 or 1 were observed in 27%, 38%, and 31% of patients. The mean SCORAD pruritus score improved from 7.7 at baseline to 4.8 at week 16 and was maintained at weeks 32 (3.8) and 52 (4.3). The mean SCORAD sleeplessness score also improved from 6.5 at baseline to 3.9 at week 16 and remained stable through weeks 32 (3.4) and 52 (3.7).
Finally, among 129 patients who had a baseline DLQI of greater than 5, 39% had DLQI scores of 5 or lower at week 16, compared with 49% at week 32 and 45% at week 52, indicating a small or no effect of AD on quality of life.
The study was sponsored by Eli Lilly, which is developing baricitinib. Dr. Simpson disclosed that he is a consultant to and/or an investigator for several pharmaceutical companies, including Eli Lilly.
FROM REVOLUTIONIZING AD 2021
Ruxolitinib cream for atopic dermatitis found to be effective, safe up to 52 weeks
results from a long-term analysis of clinical trial data showed.
“The incidence of application-site reactions was low, and there were no clinically meaningful changes or trends in hematologic parameters,” Kim Papp, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium.
Ruxolitinib cream is a selective Janus kinase 1/JAK2 inhibitor being developed by Incyte for the treatment of atopic dermatitis (AD).
According to a press release from the company, the Food and Drug Administration has extended the New Drug Application review period for the agent by 3 months to September 2021. If approved, it would become first topical JAK inhibitor for use in dermatology.
In two phase 3, randomized studies of identical design involving 1,249 patients aged 12 and older with AD – TRuE-AD1 and TRuE-AD2 – ruxolitinib cream demonstrated anti-inflammatory activity, with rapid and sustained antipruritic action, compared with vehicle. To be eligible for the trials patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area (BSA) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks.
A recently published report found that significantly more patients in TRuE-AD1 and TRuE-AD2 achieved IGA treatment success with 0.75% (50% vs. 39%, respectively) and 1.5% ruxolitinib cream (53.8% vs. 51.3%), compared with vehicle (15.1% vs. 7.6%; P < .0001) at week 8. In addition, significant reductions in itch, compared with vehicle, were reported within 12 hours of first applying 1.5% ruxolitinib cream (P < .05).
Longterm data
During the symposium, Dr. Papp presented long-term safety data of ruxolitinib cream in patients who were followed for an additional 44 weeks. Those initially randomized to vehicle were rerandomized 1:1 (blinded) to either ruxolitinib cream regimen. They were instructed to treat skin areas with active AD only and to stop treatment 3 days after clearance of lesions, and to restart treatment with ruxolitinib cream at the first sign of recurrence. Safety and tolerability were assessed by frequency and severity of adverse events, while disease control was measured by the proportion of patients with an IGA score of 0 or 1 and the affected BSA.
Dr. Papp, a dermatologist and founder of Probity Medical Research, Waterloo, Ont., reported that 543 patients from TRuE-AD1 and 530 from TRuE-AD2 entered the long-term analysis and that about 78% of these patients completed the study. From weeks 12 to 52, the proportion of patients with an IGA score of 0 or 1 with 0.75% and 1.5% ruxolitinib cream ranged from 62%-77% and 67%-77%, respectively, in TRuE-AD1 to 60%-77% and 72%-80% in TRuE-AD2.
The measured mean total affected BSA was less than 3% throughout the follow-up period in the 1.5% ruxolitinib cream arm in TRuE-AD1 and TRuE-AD2 and was less than 3% in the 0.75% ruxolitinib cream arm during most of the study period.
In a pooled safety analysis, treatment-emergent adverse events (TEAEs) were reported in 60% and 54% of patients who applied 0.75% and 1.5% ruxolitinib cream, respectively, over 44 weeks. The frequency of application-site reactions remained low. Specifically, treatment-related adverse events were reported in 5% of patients who applied 0.75% ruxolitinib cream and in 3% of patients who applied 1.5% ruxolitinib cream; none were serious. TEAEs led to discontinuation in 2% of patients in the 0.75% ruxolitinib cream group, and no patients in the 1.5% ruxolitinib cream group.
“The most common treatment adverse events were upper respiratory tract infections and nasopharyngitis,” Dr. Papp said. “When looking at exposure-adjusted adverse events, we see that there is a high degree of similarity between any of the TEAEs across all of the treatment groups in both studies. We also see that it was patients on the vehicle who experienced the greatest number of application-site reactions.”
Dr. Papp disclosed that he has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for several pharmaceutical companies, including Incyte.
results from a long-term analysis of clinical trial data showed.
“The incidence of application-site reactions was low, and there were no clinically meaningful changes or trends in hematologic parameters,” Kim Papp, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium.
Ruxolitinib cream is a selective Janus kinase 1/JAK2 inhibitor being developed by Incyte for the treatment of atopic dermatitis (AD).
According to a press release from the company, the Food and Drug Administration has extended the New Drug Application review period for the agent by 3 months to September 2021. If approved, it would become first topical JAK inhibitor for use in dermatology.
In two phase 3, randomized studies of identical design involving 1,249 patients aged 12 and older with AD – TRuE-AD1 and TRuE-AD2 – ruxolitinib cream demonstrated anti-inflammatory activity, with rapid and sustained antipruritic action, compared with vehicle. To be eligible for the trials patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area (BSA) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks.
A recently published report found that significantly more patients in TRuE-AD1 and TRuE-AD2 achieved IGA treatment success with 0.75% (50% vs. 39%, respectively) and 1.5% ruxolitinib cream (53.8% vs. 51.3%), compared with vehicle (15.1% vs. 7.6%; P < .0001) at week 8. In addition, significant reductions in itch, compared with vehicle, were reported within 12 hours of first applying 1.5% ruxolitinib cream (P < .05).
Longterm data
During the symposium, Dr. Papp presented long-term safety data of ruxolitinib cream in patients who were followed for an additional 44 weeks. Those initially randomized to vehicle were rerandomized 1:1 (blinded) to either ruxolitinib cream regimen. They were instructed to treat skin areas with active AD only and to stop treatment 3 days after clearance of lesions, and to restart treatment with ruxolitinib cream at the first sign of recurrence. Safety and tolerability were assessed by frequency and severity of adverse events, while disease control was measured by the proportion of patients with an IGA score of 0 or 1 and the affected BSA.
Dr. Papp, a dermatologist and founder of Probity Medical Research, Waterloo, Ont., reported that 543 patients from TRuE-AD1 and 530 from TRuE-AD2 entered the long-term analysis and that about 78% of these patients completed the study. From weeks 12 to 52, the proportion of patients with an IGA score of 0 or 1 with 0.75% and 1.5% ruxolitinib cream ranged from 62%-77% and 67%-77%, respectively, in TRuE-AD1 to 60%-77% and 72%-80% in TRuE-AD2.
The measured mean total affected BSA was less than 3% throughout the follow-up period in the 1.5% ruxolitinib cream arm in TRuE-AD1 and TRuE-AD2 and was less than 3% in the 0.75% ruxolitinib cream arm during most of the study period.
In a pooled safety analysis, treatment-emergent adverse events (TEAEs) were reported in 60% and 54% of patients who applied 0.75% and 1.5% ruxolitinib cream, respectively, over 44 weeks. The frequency of application-site reactions remained low. Specifically, treatment-related adverse events were reported in 5% of patients who applied 0.75% ruxolitinib cream and in 3% of patients who applied 1.5% ruxolitinib cream; none were serious. TEAEs led to discontinuation in 2% of patients in the 0.75% ruxolitinib cream group, and no patients in the 1.5% ruxolitinib cream group.
“The most common treatment adverse events were upper respiratory tract infections and nasopharyngitis,” Dr. Papp said. “When looking at exposure-adjusted adverse events, we see that there is a high degree of similarity between any of the TEAEs across all of the treatment groups in both studies. We also see that it was patients on the vehicle who experienced the greatest number of application-site reactions.”
Dr. Papp disclosed that he has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for several pharmaceutical companies, including Incyte.
results from a long-term analysis of clinical trial data showed.
“The incidence of application-site reactions was low, and there were no clinically meaningful changes or trends in hematologic parameters,” Kim Papp, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium.
Ruxolitinib cream is a selective Janus kinase 1/JAK2 inhibitor being developed by Incyte for the treatment of atopic dermatitis (AD).
According to a press release from the company, the Food and Drug Administration has extended the New Drug Application review period for the agent by 3 months to September 2021. If approved, it would become first topical JAK inhibitor for use in dermatology.
In two phase 3, randomized studies of identical design involving 1,249 patients aged 12 and older with AD – TRuE-AD1 and TRuE-AD2 – ruxolitinib cream demonstrated anti-inflammatory activity, with rapid and sustained antipruritic action, compared with vehicle. To be eligible for the trials patients with an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% of affected body surface area (BSA) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks.
A recently published report found that significantly more patients in TRuE-AD1 and TRuE-AD2 achieved IGA treatment success with 0.75% (50% vs. 39%, respectively) and 1.5% ruxolitinib cream (53.8% vs. 51.3%), compared with vehicle (15.1% vs. 7.6%; P < .0001) at week 8. In addition, significant reductions in itch, compared with vehicle, were reported within 12 hours of first applying 1.5% ruxolitinib cream (P < .05).
Longterm data
During the symposium, Dr. Papp presented long-term safety data of ruxolitinib cream in patients who were followed for an additional 44 weeks. Those initially randomized to vehicle were rerandomized 1:1 (blinded) to either ruxolitinib cream regimen. They were instructed to treat skin areas with active AD only and to stop treatment 3 days after clearance of lesions, and to restart treatment with ruxolitinib cream at the first sign of recurrence. Safety and tolerability were assessed by frequency and severity of adverse events, while disease control was measured by the proportion of patients with an IGA score of 0 or 1 and the affected BSA.
Dr. Papp, a dermatologist and founder of Probity Medical Research, Waterloo, Ont., reported that 543 patients from TRuE-AD1 and 530 from TRuE-AD2 entered the long-term analysis and that about 78% of these patients completed the study. From weeks 12 to 52, the proportion of patients with an IGA score of 0 or 1 with 0.75% and 1.5% ruxolitinib cream ranged from 62%-77% and 67%-77%, respectively, in TRuE-AD1 to 60%-77% and 72%-80% in TRuE-AD2.
The measured mean total affected BSA was less than 3% throughout the follow-up period in the 1.5% ruxolitinib cream arm in TRuE-AD1 and TRuE-AD2 and was less than 3% in the 0.75% ruxolitinib cream arm during most of the study period.
In a pooled safety analysis, treatment-emergent adverse events (TEAEs) were reported in 60% and 54% of patients who applied 0.75% and 1.5% ruxolitinib cream, respectively, over 44 weeks. The frequency of application-site reactions remained low. Specifically, treatment-related adverse events were reported in 5% of patients who applied 0.75% ruxolitinib cream and in 3% of patients who applied 1.5% ruxolitinib cream; none were serious. TEAEs led to discontinuation in 2% of patients in the 0.75% ruxolitinib cream group, and no patients in the 1.5% ruxolitinib cream group.
“The most common treatment adverse events were upper respiratory tract infections and nasopharyngitis,” Dr. Papp said. “When looking at exposure-adjusted adverse events, we see that there is a high degree of similarity between any of the TEAEs across all of the treatment groups in both studies. We also see that it was patients on the vehicle who experienced the greatest number of application-site reactions.”
Dr. Papp disclosed that he has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for several pharmaceutical companies, including Incyte.
FROM REVOLUTIONIZING AD 2021
Survey spotlights the out-of-pocket burden on Blacks with atopic dermatitis
They also have significantly poorer disease control and an increased rate of comorbid skin infections.
Those are among the key findings from a 25-question survey administered to members of the National Eczema Association.
“Black individuals with AD have a unique sociodemographic and disease profile,” lead study investigator Raj Chovatiya, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium. “Out-of-pocket expenses are just one component of the real-world burden faced by this population.”
According to Dr. Chovatiya, of the department of dermatology at Northwestern University, Chicago, the clinical phenotype and burden of AD can vary across racial and ethnic groups. Black race, for example, is associated with a higher prevalence of AD, a higher burden of moderate to severe disease, increased rates of allergic comorbidities, greater AD-related impact on health-related quality of life, and more treatment-resistant AD.
“These features can make long-term AD control very difficult,” he said. “Given the variable long-term efficacy and safety of current treatments, health care providers and patients often have to combine therapies, seek new treatments, and consider adjunctive approaches – all of which can contribute to increased costs.”
AD is also associated with a considerable financial burden, he continued, including direct health care costs, lost work productivity and out-of-pocket health care expenses. “Previous population-based studies suggest that there are multifactorial increases in overall out-of-pocket health expenses in AD,” Dr. Chovatiya said. “Black race in particular is thought to be associated with increased health care utilization in AD, but little is known about the out-of-pocket health care expenses.”
To characterize the categories and impact of out-of-pocket health care expenses associated with AD management among Black individuals, he and his colleagues administered a 25-question voluntary survey to 113,502 members of the NEA between Nov. 14 and Dec. 21, 2019. They included adults with a self-reported diagnosis of AD or children, teens, or young adults who had a caregiver responding for them. In all, 1,118 respondents met inclusion criteria. Questions included those about out-of-pocket expenses for AD over the past 30 days and over the past year, as well as the disease impact on household finances.
The cohort included 75% of individuals with AD; 25% were primary caregivers of children, teens, and young adults with AD. More than three-quarters of respondents (77%) were female, 73% were White, 11% were Black, 6% were Asian, and the remainder were from other ethnic backgrounds. More than half of respondents (58%) had employer-sponsored insurance coverage and the median annual household income was between $50,000 and $75,000.
Nearly three-quarters of respondents (74%) classified their AD severity as moderate or severe, and 63% reported minimally controlled or somewhat-controlled AD. Black respondents were significantly more likely to be younger, have lower household incomes, live in an urban setting, use Medicaid or state assistance, have poor disease control, and frequent skin infections (P ≤ .02). “A numerically higher proportion of Black respondents also had increased AD severity and reported the use of step-up therapy with systemic agents, prescription polypharmacy with three or more prescriptions, and a higher monthly out-of-pocket cost,” Dr. Chovatiya said.
Compared with their non-Black counterparts, Black survey respondents reported more out-of-pocket costs for prescription medications covered by insurance (74.2% vs. 63.6%, P = .04), prescription medications not covered by insurance (65.1% vs. 46.5%, P = .0004), ED visits (22.1% vs. 11.8%, P = .005), and outpatient laboratory testing (33.3% vs. 21.8%, P = .01). Black race was associated with increased household financial impact from out-of-pocket expenses (P = .0009), and predictors of financial impact included minimally controlled AD (adjusted odds ratio, 13.88; P = .02), comorbid anxiety and/or depression (aOR, 4.34; P = .01), systemic therapy (aOR, 4.34; P = .003), out-of-pocket costs that exceeded $200 per month (aOR, 14.28; P = .0003), and Medicaid insurance (aOR, 4.02; P = .03). Blacks with Medicaid had higher odds of harmful financial impact (aOR, 3.32; P = .0002) than respondents who were Black (aOR, 1.81; P = .04) or those with Medicaid alone (aOR, 1.39; P = .04).
“I looked at some of the findings from recent studies that have talked about this burden, including an increased prevalence among Black children, a higher likelihood of moderate to severe disease, higher rates of ED visits and hospitalizations, and increased prescription medications,” Dr. Chovatiya said.“Our findings reflect these racial and socioeconomic disparities and provide another piece of evidence for increased financial burden among Black individuals with AD and support the need for targeted strategies to address these inequities.”
The study received funding support from the NEA. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Incyte, and Regeneron/Sanofi-Genzyme.
They also have significantly poorer disease control and an increased rate of comorbid skin infections.
Those are among the key findings from a 25-question survey administered to members of the National Eczema Association.
“Black individuals with AD have a unique sociodemographic and disease profile,” lead study investigator Raj Chovatiya, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium. “Out-of-pocket expenses are just one component of the real-world burden faced by this population.”
According to Dr. Chovatiya, of the department of dermatology at Northwestern University, Chicago, the clinical phenotype and burden of AD can vary across racial and ethnic groups. Black race, for example, is associated with a higher prevalence of AD, a higher burden of moderate to severe disease, increased rates of allergic comorbidities, greater AD-related impact on health-related quality of life, and more treatment-resistant AD.
“These features can make long-term AD control very difficult,” he said. “Given the variable long-term efficacy and safety of current treatments, health care providers and patients often have to combine therapies, seek new treatments, and consider adjunctive approaches – all of which can contribute to increased costs.”
AD is also associated with a considerable financial burden, he continued, including direct health care costs, lost work productivity and out-of-pocket health care expenses. “Previous population-based studies suggest that there are multifactorial increases in overall out-of-pocket health expenses in AD,” Dr. Chovatiya said. “Black race in particular is thought to be associated with increased health care utilization in AD, but little is known about the out-of-pocket health care expenses.”
To characterize the categories and impact of out-of-pocket health care expenses associated with AD management among Black individuals, he and his colleagues administered a 25-question voluntary survey to 113,502 members of the NEA between Nov. 14 and Dec. 21, 2019. They included adults with a self-reported diagnosis of AD or children, teens, or young adults who had a caregiver responding for them. In all, 1,118 respondents met inclusion criteria. Questions included those about out-of-pocket expenses for AD over the past 30 days and over the past year, as well as the disease impact on household finances.
The cohort included 75% of individuals with AD; 25% were primary caregivers of children, teens, and young adults with AD. More than three-quarters of respondents (77%) were female, 73% were White, 11% were Black, 6% were Asian, and the remainder were from other ethnic backgrounds. More than half of respondents (58%) had employer-sponsored insurance coverage and the median annual household income was between $50,000 and $75,000.
Nearly three-quarters of respondents (74%) classified their AD severity as moderate or severe, and 63% reported minimally controlled or somewhat-controlled AD. Black respondents were significantly more likely to be younger, have lower household incomes, live in an urban setting, use Medicaid or state assistance, have poor disease control, and frequent skin infections (P ≤ .02). “A numerically higher proportion of Black respondents also had increased AD severity and reported the use of step-up therapy with systemic agents, prescription polypharmacy with three or more prescriptions, and a higher monthly out-of-pocket cost,” Dr. Chovatiya said.
Compared with their non-Black counterparts, Black survey respondents reported more out-of-pocket costs for prescription medications covered by insurance (74.2% vs. 63.6%, P = .04), prescription medications not covered by insurance (65.1% vs. 46.5%, P = .0004), ED visits (22.1% vs. 11.8%, P = .005), and outpatient laboratory testing (33.3% vs. 21.8%, P = .01). Black race was associated with increased household financial impact from out-of-pocket expenses (P = .0009), and predictors of financial impact included minimally controlled AD (adjusted odds ratio, 13.88; P = .02), comorbid anxiety and/or depression (aOR, 4.34; P = .01), systemic therapy (aOR, 4.34; P = .003), out-of-pocket costs that exceeded $200 per month (aOR, 14.28; P = .0003), and Medicaid insurance (aOR, 4.02; P = .03). Blacks with Medicaid had higher odds of harmful financial impact (aOR, 3.32; P = .0002) than respondents who were Black (aOR, 1.81; P = .04) or those with Medicaid alone (aOR, 1.39; P = .04).
“I looked at some of the findings from recent studies that have talked about this burden, including an increased prevalence among Black children, a higher likelihood of moderate to severe disease, higher rates of ED visits and hospitalizations, and increased prescription medications,” Dr. Chovatiya said.“Our findings reflect these racial and socioeconomic disparities and provide another piece of evidence for increased financial burden among Black individuals with AD and support the need for targeted strategies to address these inequities.”
The study received funding support from the NEA. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Incyte, and Regeneron/Sanofi-Genzyme.
They also have significantly poorer disease control and an increased rate of comorbid skin infections.
Those are among the key findings from a 25-question survey administered to members of the National Eczema Association.
“Black individuals with AD have a unique sociodemographic and disease profile,” lead study investigator Raj Chovatiya, MD, PhD, said during the Revolutionizing Atopic Dermatitis symposium. “Out-of-pocket expenses are just one component of the real-world burden faced by this population.”
According to Dr. Chovatiya, of the department of dermatology at Northwestern University, Chicago, the clinical phenotype and burden of AD can vary across racial and ethnic groups. Black race, for example, is associated with a higher prevalence of AD, a higher burden of moderate to severe disease, increased rates of allergic comorbidities, greater AD-related impact on health-related quality of life, and more treatment-resistant AD.
“These features can make long-term AD control very difficult,” he said. “Given the variable long-term efficacy and safety of current treatments, health care providers and patients often have to combine therapies, seek new treatments, and consider adjunctive approaches – all of which can contribute to increased costs.”
AD is also associated with a considerable financial burden, he continued, including direct health care costs, lost work productivity and out-of-pocket health care expenses. “Previous population-based studies suggest that there are multifactorial increases in overall out-of-pocket health expenses in AD,” Dr. Chovatiya said. “Black race in particular is thought to be associated with increased health care utilization in AD, but little is known about the out-of-pocket health care expenses.”
To characterize the categories and impact of out-of-pocket health care expenses associated with AD management among Black individuals, he and his colleagues administered a 25-question voluntary survey to 113,502 members of the NEA between Nov. 14 and Dec. 21, 2019. They included adults with a self-reported diagnosis of AD or children, teens, or young adults who had a caregiver responding for them. In all, 1,118 respondents met inclusion criteria. Questions included those about out-of-pocket expenses for AD over the past 30 days and over the past year, as well as the disease impact on household finances.
The cohort included 75% of individuals with AD; 25% were primary caregivers of children, teens, and young adults with AD. More than three-quarters of respondents (77%) were female, 73% were White, 11% were Black, 6% were Asian, and the remainder were from other ethnic backgrounds. More than half of respondents (58%) had employer-sponsored insurance coverage and the median annual household income was between $50,000 and $75,000.
Nearly three-quarters of respondents (74%) classified their AD severity as moderate or severe, and 63% reported minimally controlled or somewhat-controlled AD. Black respondents were significantly more likely to be younger, have lower household incomes, live in an urban setting, use Medicaid or state assistance, have poor disease control, and frequent skin infections (P ≤ .02). “A numerically higher proportion of Black respondents also had increased AD severity and reported the use of step-up therapy with systemic agents, prescription polypharmacy with three or more prescriptions, and a higher monthly out-of-pocket cost,” Dr. Chovatiya said.
Compared with their non-Black counterparts, Black survey respondents reported more out-of-pocket costs for prescription medications covered by insurance (74.2% vs. 63.6%, P = .04), prescription medications not covered by insurance (65.1% vs. 46.5%, P = .0004), ED visits (22.1% vs. 11.8%, P = .005), and outpatient laboratory testing (33.3% vs. 21.8%, P = .01). Black race was associated with increased household financial impact from out-of-pocket expenses (P = .0009), and predictors of financial impact included minimally controlled AD (adjusted odds ratio, 13.88; P = .02), comorbid anxiety and/or depression (aOR, 4.34; P = .01), systemic therapy (aOR, 4.34; P = .003), out-of-pocket costs that exceeded $200 per month (aOR, 14.28; P = .0003), and Medicaid insurance (aOR, 4.02; P = .03). Blacks with Medicaid had higher odds of harmful financial impact (aOR, 3.32; P = .0002) than respondents who were Black (aOR, 1.81; P = .04) or those with Medicaid alone (aOR, 1.39; P = .04).
“I looked at some of the findings from recent studies that have talked about this burden, including an increased prevalence among Black children, a higher likelihood of moderate to severe disease, higher rates of ED visits and hospitalizations, and increased prescription medications,” Dr. Chovatiya said.“Our findings reflect these racial and socioeconomic disparities and provide another piece of evidence for increased financial burden among Black individuals with AD and support the need for targeted strategies to address these inequities.”
The study received funding support from the NEA. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Incyte, and Regeneron/Sanofi-Genzyme.
FROM REVOLUTIONIZING AD 2021
12-month follow-up shows monthly maintenance dose of tralokinumab maintains response in some AD patients
without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.
“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.
Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.
The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.
Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.
Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.
The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”
He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).
Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.
LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.
without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.
“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.
Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.
The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.
Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.
Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.
The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”
He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).
Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.
LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.
without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.
“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.
Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.
The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.
Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.
Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.
The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”
He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).
Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.
LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.
FROM REVOLUTIONIZING AD 2021
1 in 15 patients who start dupilumab may develop conjunctivitis, large analysis finds
showed.
“About 4 years after dupilumab’s approval, we’re interested in how conjunctivitis has played out in our daily clinical practice,” lead study investigator Maria C. Schneeweiss, MD, said during the Revolutionizing Atopic Dermatitis symposium.
Drawing from two nationwide U.S. databases, MarketScan and Optum, Dr. Schneeweiss, of the department of dermatology at Brigham and Women’s Hospital, Boston, and colleagues sought to characterize the incidence of bacterial and nonbacterial conjunctivitis among 6,730 patients with AD who started treatment with either dupilumab, methotrexate, mycophenolate, or cyclosporine between March 2017 and January 2020. They also wanted to identify patient subgroups at increased or decreased risk of dupilumab-related conjunctivitis in clinical practice.
Of the 6,730 patients, 3,755 started treatment with dupilumab, while 2,010 started with methotrexate, 536 started with mycophenolate, and 429 started with cyclosporine. Using a new-user, active-comparator study design, the researchers identified patients with AD from both databases and selected three dupilumab cohorts: dupilumab versus methotrexate (MTX), dupilumab versus mycophenolate (MMF), and dupilumab versus cyclosporine (CsA). Follow-up lasted 6 months and 1:1 propensity score matching was used to account for conjunctivitis risk factor differences. Patients with a history of conjunctivitis were excluded from the study, except one subgroup limited to those with prior conjunctivitis.
Dr. Schneeweiss reported that the overall incidence rate of conjunctivitis within 6 months of treatment initiation was 6.6% in dupilumab users, or 1 in 15 patients, compared with 3.3% in MTX users, 4.2% in MMF users, and 2.8% in CsA users. The incidence rates for the different types of conjunctivitis were as follows:
- Bacterial conjunctivitis: 1.5% in dupilumab users versus 0.95% in MTX, 0.4% in MMF, and 0.7% in CsA users.
- Allergic conjunctivitis: 2.2% in dupilumab users versus 0.8% in MTX, 0.2% in MMF, and 1.6% in CsA users.
- Keratoconjunctivitis: 0.8% in dupilumab users versus 1.1% in MTX, 1.5% in MMF, and 0.5% in CsA users.
In addition, the rate of conjunctivitis requiring ophthalmic medication was 2.6% in dupilumab users versus 0.7% in MTX, 1% in MMF, and 0.5% in CsA users.
After the researchers applied 1:1 propensity score matching, they observed that the risk of conjunctivitis within 6 months of starting treatment was increased in dupilumab users versus MTX users (relative risk, 2.12), dupilumab versus MMF users (RR, 2.43), and dupilumab versus CsA users (RR, 1.83). Among dupilumab users, the risk of conjunctivitis requiring ophthalmic medication was increased six to eightfold, compared with those who used MTX, MMF or CsA. In addition, bacterial conjunctivitis was increased 1.6- to 4.0-fold, compared with those who used MTX, MMF or CsA, but the confidence intervals were wide and included the null, while allergic conjunctivitis was increased 2.7- to 7-fold when compared with those who used MTX and MMF.
In other findings, the risk of allergic conjunctivitis was similar between dupilumab and CsA users (RR, 1.14), and there was no increased risk of keratoconjunctivitis in dupilumab users, compared with those who used MTX, MMF, or CsA. The relative risk of conjunctivitis in those who used dupilumab was further increased when the analysis was limited to AD patients with comorbid asthma (RR, 2.86), those who used systemic glucocorticoids fewer than 30 days prior (RR, 2.88), and those age 65 and older (RR, 2.57), compared with those who used methotrexate.
“Compared to AD patients who received treatment with other systemic agents, dupilumab treatment doubled the risk of conjunctivitis in clinical practice,” Dr. Schneeweiss concluded. “Risk factors that further increase the risk include comorbid asthma, use of systemic corticosteroids, and older age. It should be noted that conjunctivitis does not require treatment discontinuation and is manageable with ophthalmic medications.”
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the work “verifies what we see clinically: that conjunctivitis is increased among dupilumab users even when it is compared to immunosuppressive agents used to treat other conditions. Because the study is retrospective, one cannot assume all diagnosis of types of conjunctivitis or even of skin disease is entirely accurate. But, with the large numbers of claims looked at and compared, one would think its conclusions are accurate.”
Dr. Schneeweiss reported having no relevant financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for Amgen, AbbVie, Arcutis, Brickell, Candescent, Cassiopeia, Dermavant, Galderma, Janssen, Forte, Incyte, MC-2, Lilly, Novartis, Novan, Ortho Dermatologics, Revance, Sun Pharma, UCB, and Vyne.
showed.
“About 4 years after dupilumab’s approval, we’re interested in how conjunctivitis has played out in our daily clinical practice,” lead study investigator Maria C. Schneeweiss, MD, said during the Revolutionizing Atopic Dermatitis symposium.
Drawing from two nationwide U.S. databases, MarketScan and Optum, Dr. Schneeweiss, of the department of dermatology at Brigham and Women’s Hospital, Boston, and colleagues sought to characterize the incidence of bacterial and nonbacterial conjunctivitis among 6,730 patients with AD who started treatment with either dupilumab, methotrexate, mycophenolate, or cyclosporine between March 2017 and January 2020. They also wanted to identify patient subgroups at increased or decreased risk of dupilumab-related conjunctivitis in clinical practice.
Of the 6,730 patients, 3,755 started treatment with dupilumab, while 2,010 started with methotrexate, 536 started with mycophenolate, and 429 started with cyclosporine. Using a new-user, active-comparator study design, the researchers identified patients with AD from both databases and selected three dupilumab cohorts: dupilumab versus methotrexate (MTX), dupilumab versus mycophenolate (MMF), and dupilumab versus cyclosporine (CsA). Follow-up lasted 6 months and 1:1 propensity score matching was used to account for conjunctivitis risk factor differences. Patients with a history of conjunctivitis were excluded from the study, except one subgroup limited to those with prior conjunctivitis.
Dr. Schneeweiss reported that the overall incidence rate of conjunctivitis within 6 months of treatment initiation was 6.6% in dupilumab users, or 1 in 15 patients, compared with 3.3% in MTX users, 4.2% in MMF users, and 2.8% in CsA users. The incidence rates for the different types of conjunctivitis were as follows:
- Bacterial conjunctivitis: 1.5% in dupilumab users versus 0.95% in MTX, 0.4% in MMF, and 0.7% in CsA users.
- Allergic conjunctivitis: 2.2% in dupilumab users versus 0.8% in MTX, 0.2% in MMF, and 1.6% in CsA users.
- Keratoconjunctivitis: 0.8% in dupilumab users versus 1.1% in MTX, 1.5% in MMF, and 0.5% in CsA users.
In addition, the rate of conjunctivitis requiring ophthalmic medication was 2.6% in dupilumab users versus 0.7% in MTX, 1% in MMF, and 0.5% in CsA users.
After the researchers applied 1:1 propensity score matching, they observed that the risk of conjunctivitis within 6 months of starting treatment was increased in dupilumab users versus MTX users (relative risk, 2.12), dupilumab versus MMF users (RR, 2.43), and dupilumab versus CsA users (RR, 1.83). Among dupilumab users, the risk of conjunctivitis requiring ophthalmic medication was increased six to eightfold, compared with those who used MTX, MMF or CsA. In addition, bacterial conjunctivitis was increased 1.6- to 4.0-fold, compared with those who used MTX, MMF or CsA, but the confidence intervals were wide and included the null, while allergic conjunctivitis was increased 2.7- to 7-fold when compared with those who used MTX and MMF.
In other findings, the risk of allergic conjunctivitis was similar between dupilumab and CsA users (RR, 1.14), and there was no increased risk of keratoconjunctivitis in dupilumab users, compared with those who used MTX, MMF, or CsA. The relative risk of conjunctivitis in those who used dupilumab was further increased when the analysis was limited to AD patients with comorbid asthma (RR, 2.86), those who used systemic glucocorticoids fewer than 30 days prior (RR, 2.88), and those age 65 and older (RR, 2.57), compared with those who used methotrexate.
“Compared to AD patients who received treatment with other systemic agents, dupilumab treatment doubled the risk of conjunctivitis in clinical practice,” Dr. Schneeweiss concluded. “Risk factors that further increase the risk include comorbid asthma, use of systemic corticosteroids, and older age. It should be noted that conjunctivitis does not require treatment discontinuation and is manageable with ophthalmic medications.”
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the work “verifies what we see clinically: that conjunctivitis is increased among dupilumab users even when it is compared to immunosuppressive agents used to treat other conditions. Because the study is retrospective, one cannot assume all diagnosis of types of conjunctivitis or even of skin disease is entirely accurate. But, with the large numbers of claims looked at and compared, one would think its conclusions are accurate.”
Dr. Schneeweiss reported having no relevant financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for Amgen, AbbVie, Arcutis, Brickell, Candescent, Cassiopeia, Dermavant, Galderma, Janssen, Forte, Incyte, MC-2, Lilly, Novartis, Novan, Ortho Dermatologics, Revance, Sun Pharma, UCB, and Vyne.
showed.
“About 4 years after dupilumab’s approval, we’re interested in how conjunctivitis has played out in our daily clinical practice,” lead study investigator Maria C. Schneeweiss, MD, said during the Revolutionizing Atopic Dermatitis symposium.
Drawing from two nationwide U.S. databases, MarketScan and Optum, Dr. Schneeweiss, of the department of dermatology at Brigham and Women’s Hospital, Boston, and colleagues sought to characterize the incidence of bacterial and nonbacterial conjunctivitis among 6,730 patients with AD who started treatment with either dupilumab, methotrexate, mycophenolate, or cyclosporine between March 2017 and January 2020. They also wanted to identify patient subgroups at increased or decreased risk of dupilumab-related conjunctivitis in clinical practice.
Of the 6,730 patients, 3,755 started treatment with dupilumab, while 2,010 started with methotrexate, 536 started with mycophenolate, and 429 started with cyclosporine. Using a new-user, active-comparator study design, the researchers identified patients with AD from both databases and selected three dupilumab cohorts: dupilumab versus methotrexate (MTX), dupilumab versus mycophenolate (MMF), and dupilumab versus cyclosporine (CsA). Follow-up lasted 6 months and 1:1 propensity score matching was used to account for conjunctivitis risk factor differences. Patients with a history of conjunctivitis were excluded from the study, except one subgroup limited to those with prior conjunctivitis.
Dr. Schneeweiss reported that the overall incidence rate of conjunctivitis within 6 months of treatment initiation was 6.6% in dupilumab users, or 1 in 15 patients, compared with 3.3% in MTX users, 4.2% in MMF users, and 2.8% in CsA users. The incidence rates for the different types of conjunctivitis were as follows:
- Bacterial conjunctivitis: 1.5% in dupilumab users versus 0.95% in MTX, 0.4% in MMF, and 0.7% in CsA users.
- Allergic conjunctivitis: 2.2% in dupilumab users versus 0.8% in MTX, 0.2% in MMF, and 1.6% in CsA users.
- Keratoconjunctivitis: 0.8% in dupilumab users versus 1.1% in MTX, 1.5% in MMF, and 0.5% in CsA users.
In addition, the rate of conjunctivitis requiring ophthalmic medication was 2.6% in dupilumab users versus 0.7% in MTX, 1% in MMF, and 0.5% in CsA users.
After the researchers applied 1:1 propensity score matching, they observed that the risk of conjunctivitis within 6 months of starting treatment was increased in dupilumab users versus MTX users (relative risk, 2.12), dupilumab versus MMF users (RR, 2.43), and dupilumab versus CsA users (RR, 1.83). Among dupilumab users, the risk of conjunctivitis requiring ophthalmic medication was increased six to eightfold, compared with those who used MTX, MMF or CsA. In addition, bacterial conjunctivitis was increased 1.6- to 4.0-fold, compared with those who used MTX, MMF or CsA, but the confidence intervals were wide and included the null, while allergic conjunctivitis was increased 2.7- to 7-fold when compared with those who used MTX and MMF.
In other findings, the risk of allergic conjunctivitis was similar between dupilumab and CsA users (RR, 1.14), and there was no increased risk of keratoconjunctivitis in dupilumab users, compared with those who used MTX, MMF, or CsA. The relative risk of conjunctivitis in those who used dupilumab was further increased when the analysis was limited to AD patients with comorbid asthma (RR, 2.86), those who used systemic glucocorticoids fewer than 30 days prior (RR, 2.88), and those age 65 and older (RR, 2.57), compared with those who used methotrexate.
“Compared to AD patients who received treatment with other systemic agents, dupilumab treatment doubled the risk of conjunctivitis in clinical practice,” Dr. Schneeweiss concluded. “Risk factors that further increase the risk include comorbid asthma, use of systemic corticosteroids, and older age. It should be noted that conjunctivitis does not require treatment discontinuation and is manageable with ophthalmic medications.”
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the work “verifies what we see clinically: that conjunctivitis is increased among dupilumab users even when it is compared to immunosuppressive agents used to treat other conditions. Because the study is retrospective, one cannot assume all diagnosis of types of conjunctivitis or even of skin disease is entirely accurate. But, with the large numbers of claims looked at and compared, one would think its conclusions are accurate.”
Dr. Schneeweiss reported having no relevant financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for Amgen, AbbVie, Arcutis, Brickell, Candescent, Cassiopeia, Dermavant, Galderma, Janssen, Forte, Incyte, MC-2, Lilly, Novartis, Novan, Ortho Dermatologics, Revance, Sun Pharma, UCB, and Vyne.
FROM REVOLUTIONIZING AD 2021
Trial offers first look at how tralokinumab-treated patients weather COVID-19
and all patients continued tralokinumab treatment following their diagnosis.
“This is a great first look at COVID-19 outcomes in this population,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium. “This suggests that tralokinumab does not significantly impact the ability to respond to SARS-CoV-2, the virus that causes COVID-19. It’s encouraging and promising.”
Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, which is a key driver of underlying inflammation in AD. An ongoing, open-label extension trial called ECZTEND is investigating the long-term safety and efficacy of tralokinumab in patients with AD who participated in previous tralokinumab trials. The purpose of the current case series is to describe the outcomes of patients diagnosed with COVID-19 while participating in ECZTEND, which is a 5-year study.
“Patients are receiving tralokinumab 300 mg every 2 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “They’re allowed to use topical steroids, but they’re not allowed to use other AD treatments. We do regular clinical and safety assessments throughout the study.”
As of Feb. 26, 2021, there were 51 adults with moderate to severe AD who had confirmed COVID-19 infection during treatment with tralokinumab every 2 weeks. “Patients were not required to discontinue tralokinumab treatment following a COVID-19 diagnosis, if continuation was deemed appropriate by the investigator,” Dr. Blauvelt said. Of the 51 patients, 22 were male, 29 were female, their mean age was 38 years, and their baseline body mass index was 27.6 kg/m2. Most of the patients (36, or 71%) were from Europe, 15 (29%) were from North America, and 30 (59%) had a history of asthma.
The average duration of COVID-19 infection was 15 days and severity of disease was mild in 35 patients (69%), moderate in 14 (27%), and severe in 2 (4%). According to the study abstract, those two patients had multiple risk factors and comorbidities, including obesity, chronic obstructive pulmonary disease, and cardiovascular disease. They were hospitalized for a mean of 7 days, but subsequently recovered – one with sequelae. None of the patients died.
Of the 51 COVID-19 cases, 2 were deemed to be possibly related to tralokinumab treatment by the investigator, Dr. Blauvelt said. Both were mild or moderate cases that occurred in patients younger than age 30. “Interestingly, 75% of the COVID-19 patients had no dose interruption; they continued dosing their tralokinumab every 2 weeks during and around the time they had COVID-19,” he said. “However, 25% of patients did interrupt their dosing during COVID-19 infection. That means that they either delayed or stopped dosing while they were sick.”
Of the 51 patients, 19 (37%) had received their first dose of the COVID-19 vaccine and 6 (12%) had received their second dose. “So, 12% of patients were fully vaccinated,” Dr. Blauvelt said. “We do know that the mRNA vaccines are about 95% effective in preventing COVID-19. Currently in Oregon, about 98% of our cases are in unvaccinated patients and about 2% of COVID-19 patients are fully vaccinated.”
In addition, the recently published ECZTRA5 vaccine study showed that nonlive vaccines (tetanus, diphtheria, and pertussis; and meningococcal vaccines) could be safely administered and can elicit normal immune responses in patients treated with tralokinumab.
“We sorely need COVID-19–related safety data for all of our current and emerging systemic and biologic therapies used to treat atopic dermatitis,” said Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, who was asked to comment about these results. “This study is important because it shows that tralokinumab was not associated with any obvious safety signals with respect to COVID-19 infections. The major limitation is that it is not a prospective study designed to assess tralokinumab efficacy in COVID-19 patients per se. However, this post hoc study provides reassuring data. We need similar or even more robust studies for other systemic therapies in AD.”
Dr. Blauvelt reported that he is an investigator and a scientific advisor for LEO Pharma, which is developing tralokinumab, and for several other pharmaceutical companies developing treatments for AD. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies, including LEO Pharma.
and all patients continued tralokinumab treatment following their diagnosis.
“This is a great first look at COVID-19 outcomes in this population,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium. “This suggests that tralokinumab does not significantly impact the ability to respond to SARS-CoV-2, the virus that causes COVID-19. It’s encouraging and promising.”
Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, which is a key driver of underlying inflammation in AD. An ongoing, open-label extension trial called ECZTEND is investigating the long-term safety and efficacy of tralokinumab in patients with AD who participated in previous tralokinumab trials. The purpose of the current case series is to describe the outcomes of patients diagnosed with COVID-19 while participating in ECZTEND, which is a 5-year study.
“Patients are receiving tralokinumab 300 mg every 2 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “They’re allowed to use topical steroids, but they’re not allowed to use other AD treatments. We do regular clinical and safety assessments throughout the study.”
As of Feb. 26, 2021, there were 51 adults with moderate to severe AD who had confirmed COVID-19 infection during treatment with tralokinumab every 2 weeks. “Patients were not required to discontinue tralokinumab treatment following a COVID-19 diagnosis, if continuation was deemed appropriate by the investigator,” Dr. Blauvelt said. Of the 51 patients, 22 were male, 29 were female, their mean age was 38 years, and their baseline body mass index was 27.6 kg/m2. Most of the patients (36, or 71%) were from Europe, 15 (29%) were from North America, and 30 (59%) had a history of asthma.
The average duration of COVID-19 infection was 15 days and severity of disease was mild in 35 patients (69%), moderate in 14 (27%), and severe in 2 (4%). According to the study abstract, those two patients had multiple risk factors and comorbidities, including obesity, chronic obstructive pulmonary disease, and cardiovascular disease. They were hospitalized for a mean of 7 days, but subsequently recovered – one with sequelae. None of the patients died.
Of the 51 COVID-19 cases, 2 were deemed to be possibly related to tralokinumab treatment by the investigator, Dr. Blauvelt said. Both were mild or moderate cases that occurred in patients younger than age 30. “Interestingly, 75% of the COVID-19 patients had no dose interruption; they continued dosing their tralokinumab every 2 weeks during and around the time they had COVID-19,” he said. “However, 25% of patients did interrupt their dosing during COVID-19 infection. That means that they either delayed or stopped dosing while they were sick.”
Of the 51 patients, 19 (37%) had received their first dose of the COVID-19 vaccine and 6 (12%) had received their second dose. “So, 12% of patients were fully vaccinated,” Dr. Blauvelt said. “We do know that the mRNA vaccines are about 95% effective in preventing COVID-19. Currently in Oregon, about 98% of our cases are in unvaccinated patients and about 2% of COVID-19 patients are fully vaccinated.”
In addition, the recently published ECZTRA5 vaccine study showed that nonlive vaccines (tetanus, diphtheria, and pertussis; and meningococcal vaccines) could be safely administered and can elicit normal immune responses in patients treated with tralokinumab.
“We sorely need COVID-19–related safety data for all of our current and emerging systemic and biologic therapies used to treat atopic dermatitis,” said Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, who was asked to comment about these results. “This study is important because it shows that tralokinumab was not associated with any obvious safety signals with respect to COVID-19 infections. The major limitation is that it is not a prospective study designed to assess tralokinumab efficacy in COVID-19 patients per se. However, this post hoc study provides reassuring data. We need similar or even more robust studies for other systemic therapies in AD.”
Dr. Blauvelt reported that he is an investigator and a scientific advisor for LEO Pharma, which is developing tralokinumab, and for several other pharmaceutical companies developing treatments for AD. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies, including LEO Pharma.
and all patients continued tralokinumab treatment following their diagnosis.
“This is a great first look at COVID-19 outcomes in this population,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium. “This suggests that tralokinumab does not significantly impact the ability to respond to SARS-CoV-2, the virus that causes COVID-19. It’s encouraging and promising.”
Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, which is a key driver of underlying inflammation in AD. An ongoing, open-label extension trial called ECZTEND is investigating the long-term safety and efficacy of tralokinumab in patients with AD who participated in previous tralokinumab trials. The purpose of the current case series is to describe the outcomes of patients diagnosed with COVID-19 while participating in ECZTEND, which is a 5-year study.
“Patients are receiving tralokinumab 300 mg every 2 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “They’re allowed to use topical steroids, but they’re not allowed to use other AD treatments. We do regular clinical and safety assessments throughout the study.”
As of Feb. 26, 2021, there were 51 adults with moderate to severe AD who had confirmed COVID-19 infection during treatment with tralokinumab every 2 weeks. “Patients were not required to discontinue tralokinumab treatment following a COVID-19 diagnosis, if continuation was deemed appropriate by the investigator,” Dr. Blauvelt said. Of the 51 patients, 22 were male, 29 were female, their mean age was 38 years, and their baseline body mass index was 27.6 kg/m2. Most of the patients (36, or 71%) were from Europe, 15 (29%) were from North America, and 30 (59%) had a history of asthma.
The average duration of COVID-19 infection was 15 days and severity of disease was mild in 35 patients (69%), moderate in 14 (27%), and severe in 2 (4%). According to the study abstract, those two patients had multiple risk factors and comorbidities, including obesity, chronic obstructive pulmonary disease, and cardiovascular disease. They were hospitalized for a mean of 7 days, but subsequently recovered – one with sequelae. None of the patients died.
Of the 51 COVID-19 cases, 2 were deemed to be possibly related to tralokinumab treatment by the investigator, Dr. Blauvelt said. Both were mild or moderate cases that occurred in patients younger than age 30. “Interestingly, 75% of the COVID-19 patients had no dose interruption; they continued dosing their tralokinumab every 2 weeks during and around the time they had COVID-19,” he said. “However, 25% of patients did interrupt their dosing during COVID-19 infection. That means that they either delayed or stopped dosing while they were sick.”
Of the 51 patients, 19 (37%) had received their first dose of the COVID-19 vaccine and 6 (12%) had received their second dose. “So, 12% of patients were fully vaccinated,” Dr. Blauvelt said. “We do know that the mRNA vaccines are about 95% effective in preventing COVID-19. Currently in Oregon, about 98% of our cases are in unvaccinated patients and about 2% of COVID-19 patients are fully vaccinated.”
In addition, the recently published ECZTRA5 vaccine study showed that nonlive vaccines (tetanus, diphtheria, and pertussis; and meningococcal vaccines) could be safely administered and can elicit normal immune responses in patients treated with tralokinumab.
“We sorely need COVID-19–related safety data for all of our current and emerging systemic and biologic therapies used to treat atopic dermatitis,” said Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, who was asked to comment about these results. “This study is important because it shows that tralokinumab was not associated with any obvious safety signals with respect to COVID-19 infections. The major limitation is that it is not a prospective study designed to assess tralokinumab efficacy in COVID-19 patients per se. However, this post hoc study provides reassuring data. We need similar or even more robust studies for other systemic therapies in AD.”
Dr. Blauvelt reported that he is an investigator and a scientific advisor for LEO Pharma, which is developing tralokinumab, and for several other pharmaceutical companies developing treatments for AD. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies, including LEO Pharma.
FROM REVOLUTIONIZING AD 2021