Atopic Dermatitis

Key clinical point: Probiotic supplementation reduced the clinical severity of atopic dermatitis (AD) and improved the quality of life (QoL) in adults with AD compared with control intervention.

Major finding: Probiotic vs. control intervention significantly reduced the clinical severity of AD in both the short-term (standard mean difference [SMD] 0.63; P = .04) and long-term (SMD 1.57; P < .001) and significantly improved the long-term QoL (SMD 0.74; P < .001), with a mixture of Lactobacillus salivarius and Bifidobacterium being the best supplementation for both short- and long-term outcomes (surface under the cumulative ranking 95.2%).

Study details: Finding are from a meta-analysis of nine studies including 402 adults who received probiotic supplementation (patients with AD; n = 208) or placebo or standard treatment only (control individuals; n = 194).

Disclosures: This study was supported by the Medical and Health Research Project of China Aerospace Science and Industry Corporation. The authors declared no conflicts of interest.

Source: Li Y et al. The efficacy of probiotics supplementation for the treatment of atopic dermatitis in adults: A systematic review and meta-analysis. J Dermatolog Treat. 2022 (Jun 7). Doi: 10.1080/09546634.2022.2080170

Key clinical point: Probiotic supplementation reduced the clinical severity of atopic dermatitis (AD) and improved the quality of life (QoL) in adults with AD compared with control intervention.

Major finding: Probiotic vs. control intervention significantly reduced the clinical severity of AD in both the short-term (standard mean difference [SMD] 0.63; P = .04) and long-term (SMD 1.57; P < .001) and significantly improved the long-term QoL (SMD 0.74; P < .001), with a mixture of Lactobacillus salivarius and Bifidobacterium being the best supplementation for both short- and long-term outcomes (surface under the cumulative ranking 95.2%).

Study details: Finding are from a meta-analysis of nine studies including 402 adults who received probiotic supplementation (patients with AD; n = 208) or placebo or standard treatment only (control individuals; n = 194).

Disclosures: This study was supported by the Medical and Health Research Project of China Aerospace Science and Industry Corporation. The authors declared no conflicts of interest.

Source: Li Y et al. The efficacy of probiotics supplementation for the treatment of atopic dermatitis in adults: A systematic review and meta-analysis. J Dermatolog Treat. 2022 (Jun 7). Doi: 10.1080/09546634.2022.2080170

Key clinical point: Probiotic supplementation reduced the clinical severity of atopic dermatitis (AD) and improved the quality of life (QoL) in adults with AD compared with control intervention.

Major finding: Probiotic vs. control intervention significantly reduced the clinical severity of AD in both the short-term (standard mean difference [SMD] 0.63; P = .04) and long-term (SMD 1.57; P < .001) and significantly improved the long-term QoL (SMD 0.74; P < .001), with a mixture of Lactobacillus salivarius and Bifidobacterium being the best supplementation for both short- and long-term outcomes (surface under the cumulative ranking 95.2%).

Study details: Finding are from a meta-analysis of nine studies including 402 adults who received probiotic supplementation (patients with AD; n = 208) or placebo or standard treatment only (control individuals; n = 194).

Disclosures: This study was supported by the Medical and Health Research Project of China Aerospace Science and Industry Corporation. The authors declared no conflicts of interest.

Source: Li Y et al. The efficacy of probiotics supplementation for the treatment of atopic dermatitis in adults: A systematic review and meta-analysis. J Dermatolog Treat. 2022 (Jun 7). Doi: 10.1080/09546634.2022.2080170

Key clinical point: Children born to mothers who received probiotics vs. placebo during gestation or 1 year after childbirth showed a lower risk for infantile atopic dermatitis (AD), but a similar risk for immunoglobulin E (IgE)-associated infantile AD or sensitive constitution.

Major finding: Children born to mothers in the probiotics vs. placebo group showed a lower risk for infantile AD (risk ratio [RR] 0.86; 95% CI 0.78-0.95), although the risk for IgE-associated infantile AD (RR 0.98; 95% CI 0.79-1.22) or sensitive constitution (RR 0.93; 95% CI 0.81-1.08) was similar between both the treatment groups.

Study details: Findings are from a meta-analysis of eight randomized controlled trials including 2575 infants born to mothers who received probiotics or placebo during gestation or 1 year after birth.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Pan H, Su J. Association of probiotics with atopic dermatitis among infant: A meta-analysis of randomized controlled trials. Oxid Med Cell Longev. 2022;2022:5080190 (May 23). Doi: 10.1155/2022/5080190

Key clinical point: Children born to mothers who received probiotics vs. placebo during gestation or 1 year after childbirth showed a lower risk for infantile atopic dermatitis (AD), but a similar risk for immunoglobulin E (IgE)-associated infantile AD or sensitive constitution.

Major finding: Children born to mothers in the probiotics vs. placebo group showed a lower risk for infantile AD (risk ratio [RR] 0.86; 95% CI 0.78-0.95), although the risk for IgE-associated infantile AD (RR 0.98; 95% CI 0.79-1.22) or sensitive constitution (RR 0.93; 95% CI 0.81-1.08) was similar between both the treatment groups.

Study details: Findings are from a meta-analysis of eight randomized controlled trials including 2575 infants born to mothers who received probiotics or placebo during gestation or 1 year after birth.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Pan H, Su J. Association of probiotics with atopic dermatitis among infant: A meta-analysis of randomized controlled trials. Oxid Med Cell Longev. 2022;2022:5080190 (May 23). Doi: 10.1155/2022/5080190

Key clinical point: Children born to mothers who received probiotics vs. placebo during gestation or 1 year after childbirth showed a lower risk for infantile atopic dermatitis (AD), but a similar risk for immunoglobulin E (IgE)-associated infantile AD or sensitive constitution.

Major finding: Children born to mothers in the probiotics vs. placebo group showed a lower risk for infantile AD (risk ratio [RR] 0.86; 95% CI 0.78-0.95), although the risk for IgE-associated infantile AD (RR 0.98; 95% CI 0.79-1.22) or sensitive constitution (RR 0.93; 95% CI 0.81-1.08) was similar between both the treatment groups.

Study details: Findings are from a meta-analysis of eight randomized controlled trials including 2575 infants born to mothers who received probiotics or placebo during gestation or 1 year after birth.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Pan H, Su J. Association of probiotics with atopic dermatitis among infant: A meta-analysis of randomized controlled trials. Oxid Med Cell Longev. 2022;2022:5080190 (May 23). Doi: 10.1155/2022/5080190

Key clinical point: Dupilumab led to clinically meaningful improvements in atopic dermatitis (AD) severity, extent, and itch severity in a real-world population of adults with moderate-to-severe AD.

Major finding: At 4 months, the Investigator’s Global Assessment score reduced by ≥1 point in 81.8% of patients and by ≥2 points in 62.8% of patients. Additionally, at 4 months, the mean itch severity score and affected body surface area reduced from 7.0 to 2.8 and from 39.3% to 16.3% (both P < .0001), respectively, with improvements being significant regardless of age, sex, or treatment history (all P < .0001).

Study details: Findings are from a retrospective, observational study based on electronic medical records of adults with moderate-to-severe AD who were evaluated at 4 months after initiating dupilumab.

Disclosures: This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Four authors declared being current or former employees and stockholders of Sanofi or Regeneron Pharmaceuticals. The other authors declared ties with various sources, including Regeneron and Sanofi.

Source: Eichenfield LF et al. Real-world effectiveness of dupilumab in atopic dermatitis patients: Analysis of an electronic medical records dataset. Dermatol Ther (Heidelb). 2022 (May 11). Doi: 10.1007/s13555-022-00731-z

Key clinical point: Dupilumab led to clinically meaningful improvements in atopic dermatitis (AD) severity, extent, and itch severity in a real-world population of adults with moderate-to-severe AD.

Major finding: At 4 months, the Investigator’s Global Assessment score reduced by ≥1 point in 81.8% of patients and by ≥2 points in 62.8% of patients. Additionally, at 4 months, the mean itch severity score and affected body surface area reduced from 7.0 to 2.8 and from 39.3% to 16.3% (both P < .0001), respectively, with improvements being significant regardless of age, sex, or treatment history (all P < .0001).

Study details: Findings are from a retrospective, observational study based on electronic medical records of adults with moderate-to-severe AD who were evaluated at 4 months after initiating dupilumab.

Disclosures: This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Four authors declared being current or former employees and stockholders of Sanofi or Regeneron Pharmaceuticals. The other authors declared ties with various sources, including Regeneron and Sanofi.

Source: Eichenfield LF et al. Real-world effectiveness of dupilumab in atopic dermatitis patients: Analysis of an electronic medical records dataset. Dermatol Ther (Heidelb). 2022 (May 11). Doi: 10.1007/s13555-022-00731-z

Key clinical point: Dupilumab led to clinically meaningful improvements in atopic dermatitis (AD) severity, extent, and itch severity in a real-world population of adults with moderate-to-severe AD.

Major finding: At 4 months, the Investigator’s Global Assessment score reduced by ≥1 point in 81.8% of patients and by ≥2 points in 62.8% of patients. Additionally, at 4 months, the mean itch severity score and affected body surface area reduced from 7.0 to 2.8 and from 39.3% to 16.3% (both P < .0001), respectively, with improvements being significant regardless of age, sex, or treatment history (all P < .0001).

Study details: Findings are from a retrospective, observational study based on electronic medical records of adults with moderate-to-severe AD who were evaluated at 4 months after initiating dupilumab.

Disclosures: This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Four authors declared being current or former employees and stockholders of Sanofi or Regeneron Pharmaceuticals. The other authors declared ties with various sources, including Regeneron and Sanofi.

Source: Eichenfield LF et al. Real-world effectiveness of dupilumab in atopic dermatitis patients: Analysis of an electronic medical records dataset. Dermatol Ther (Heidelb). 2022 (May 11). Doi: 10.1007/s13555-022-00731-z

Key clinical point: Patients with atopic dermatitis (AD) experience a fluctuation in depression severity over time, with the likelihood of experiencing depressive symptoms being the highest in patients with severe AD.

Major finding: Among patients with ≥2 follow-up visits, most (49.46%) experienced a fluctuation in depression severity, whereas 45.65% experienced a persistent severity of depression. High Eczema Area Severity Index (adjusted odds ratio [aOR] 7.622; 95% CI 3.881-14.968) and itch (aOR 14.745; 95% CI 4.696-46.297) scores were strongly associated with difficulty in concentrating over time.

Study details: Findings are from a longitudinal, dermatology practice-based study including 695 adults with AD who were evaluated at baseline and at every 6-month follow-up visits.

Disclosures: This study was funded by the US Agency for Healthcare Research and Quality, the Dermatology Foundation, and Galderma. R Chavda and S Gabriel declared being employees of Galderma, and JI Silverberg declared serving as a consultant for Galderma.

Source: Chatrath S et al. Longitudinal course and predictors of depressive symptoms in atopic dermatitis.  J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

Key clinical point: Patients with atopic dermatitis (AD) experience a fluctuation in depression severity over time, with the likelihood of experiencing depressive symptoms being the highest in patients with severe AD.

Major finding: Among patients with ≥2 follow-up visits, most (49.46%) experienced a fluctuation in depression severity, whereas 45.65% experienced a persistent severity of depression. High Eczema Area Severity Index (adjusted odds ratio [aOR] 7.622; 95% CI 3.881-14.968) and itch (aOR 14.745; 95% CI 4.696-46.297) scores were strongly associated with difficulty in concentrating over time.

Study details: Findings are from a longitudinal, dermatology practice-based study including 695 adults with AD who were evaluated at baseline and at every 6-month follow-up visits.

Disclosures: This study was funded by the US Agency for Healthcare Research and Quality, the Dermatology Foundation, and Galderma. R Chavda and S Gabriel declared being employees of Galderma, and JI Silverberg declared serving as a consultant for Galderma.

Source: Chatrath S et al. Longitudinal course and predictors of depressive symptoms in atopic dermatitis.  J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

Key clinical point: Patients with atopic dermatitis (AD) experience a fluctuation in depression severity over time, with the likelihood of experiencing depressive symptoms being the highest in patients with severe AD.

Major finding: Among patients with ≥2 follow-up visits, most (49.46%) experienced a fluctuation in depression severity, whereas 45.65% experienced a persistent severity of depression. High Eczema Area Severity Index (adjusted odds ratio [aOR] 7.622; 95% CI 3.881-14.968) and itch (aOR 14.745; 95% CI 4.696-46.297) scores were strongly associated with difficulty in concentrating over time.

Study details: Findings are from a longitudinal, dermatology practice-based study including 695 adults with AD who were evaluated at baseline and at every 6-month follow-up visits.

Disclosures: This study was funded by the US Agency for Healthcare Research and Quality, the Dermatology Foundation, and Galderma. R Chavda and S Gabriel declared being employees of Galderma, and JI Silverberg declared serving as a consultant for Galderma.

Source: Chatrath S et al. Longitudinal course and predictors of depressive symptoms in atopic dermatitis.  J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

Key clinical point: Baricitinib vs. dupilumab demonstrated similar efficacy in reducing atopic dermatitis (AD) severity and improving quality of life (QoL), with more rapid improvement in itch.

Major finding: A dose of 4 mg baricitinib vs. dupilumab as monotherapy or with topical corticosteroids (TCS) was more likely to show ≥4-point improvement in itch scores at 4 weeks among patients with inadequate response or intolerance to topical treatments (dupliumab: relative risk [RR] 2.62; P = .013; TCS: RR 2.16; P = .029). However, both drugs showed similar efficacy across Eczema Area and Severity Index 75, itch, and QoL scores at 16 weeks.

Study details: This data comes from an indirect treatment comparison analysis of nine placebo-controlled trials included 3364 adults with moderate-to-severe AD and inadequate response or intolerance to topical treatments or cyclosporine who received dupilumab ± TCS or baricitinib ± TCS.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees or shareholders of Eli Lilly. The other authors reported ties with various sources, including Eli Lilly.

Source: de Bruin-Weller MS et al. Indirect treatment comparison of baricitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2022 (May 11). Doi: 10.1007/s13555-022-00734-w

Key clinical point: Baricitinib vs. dupilumab demonstrated similar efficacy in reducing atopic dermatitis (AD) severity and improving quality of life (QoL), with more rapid improvement in itch.

Major finding: A dose of 4 mg baricitinib vs. dupilumab as monotherapy or with topical corticosteroids (TCS) was more likely to show ≥4-point improvement in itch scores at 4 weeks among patients with inadequate response or intolerance to topical treatments (dupliumab: relative risk [RR] 2.62; P = .013; TCS: RR 2.16; P = .029). However, both drugs showed similar efficacy across Eczema Area and Severity Index 75, itch, and QoL scores at 16 weeks.

Study details: This data comes from an indirect treatment comparison analysis of nine placebo-controlled trials included 3364 adults with moderate-to-severe AD and inadequate response or intolerance to topical treatments or cyclosporine who received dupilumab ± TCS or baricitinib ± TCS.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees or shareholders of Eli Lilly. The other authors reported ties with various sources, including Eli Lilly.

Source: de Bruin-Weller MS et al. Indirect treatment comparison of baricitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2022 (May 11). Doi: 10.1007/s13555-022-00734-w

Key clinical point: Baricitinib vs. dupilumab demonstrated similar efficacy in reducing atopic dermatitis (AD) severity and improving quality of life (QoL), with more rapid improvement in itch.

Major finding: A dose of 4 mg baricitinib vs. dupilumab as monotherapy or with topical corticosteroids (TCS) was more likely to show ≥4-point improvement in itch scores at 4 weeks among patients with inadequate response or intolerance to topical treatments (dupliumab: relative risk [RR] 2.62; P = .013; TCS: RR 2.16; P = .029). However, both drugs showed similar efficacy across Eczema Area and Severity Index 75, itch, and QoL scores at 16 weeks.

Study details: This data comes from an indirect treatment comparison analysis of nine placebo-controlled trials included 3364 adults with moderate-to-severe AD and inadequate response or intolerance to topical treatments or cyclosporine who received dupilumab ± TCS or baricitinib ± TCS.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees or shareholders of Eli Lilly. The other authors reported ties with various sources, including Eli Lilly.

Source: de Bruin-Weller MS et al. Indirect treatment comparison of baricitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis. Dermatol Ther (Heidelb). 2022 (May 11). Doi: 10.1007/s13555-022-00734-w

Key clinical point: Dupilumab showed an acceptable safety profile and sustained efficacy through 52 weeks in adolescents with inadequately controlled moderate-to-severe atopic dermatitis (AD).

Major finding: Rate of treatment emergent adverse events was 370.2 events/100 patient-years, with most being mild/moderate. At least 75% improvement in Eczema Area and Severity Index scores was achieved by 81.2% of patients receiving dupilumab at week 52 and 51.9% of patients who were uptitrated from every-4-week (q4w) to every-2-week (q2w) dosing regimen at week 48 after the first uptitration visit.

Study details: Findings are from an ongoing open-label extension study, LIBERTY AD PED-OLE, including 294 adolescents with moderate-to-severe AD who participated in previous dupilumab trials, received dupilumab q4w, and were uptitrated to the weight-tiered q2w dose regimen upon inadequate clinical response.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Eight authors declared being employees or shareholders of Regeneron Pharmaceuticals or Sanofi, and the other authors reported ties with various sources, including Sanofi and Regeneron.

Source: Blauvelt A et al. Long-term efficacy and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis: Results through week 52 from a phase III open-label extension trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022;23:365–383  (May 14). Doi: 10.1007/s40257-022-00683-2

Key clinical point: Dupilumab showed an acceptable safety profile and sustained efficacy through 52 weeks in adolescents with inadequately controlled moderate-to-severe atopic dermatitis (AD).

Major finding: Rate of treatment emergent adverse events was 370.2 events/100 patient-years, with most being mild/moderate. At least 75% improvement in Eczema Area and Severity Index scores was achieved by 81.2% of patients receiving dupilumab at week 52 and 51.9% of patients who were uptitrated from every-4-week (q4w) to every-2-week (q2w) dosing regimen at week 48 after the first uptitration visit.

Study details: Findings are from an ongoing open-label extension study, LIBERTY AD PED-OLE, including 294 adolescents with moderate-to-severe AD who participated in previous dupilumab trials, received dupilumab q4w, and were uptitrated to the weight-tiered q2w dose regimen upon inadequate clinical response.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Eight authors declared being employees or shareholders of Regeneron Pharmaceuticals or Sanofi, and the other authors reported ties with various sources, including Sanofi and Regeneron.

Source: Blauvelt A et al. Long-term efficacy and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis: Results through week 52 from a phase III open-label extension trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022;23:365–383  (May 14). Doi: 10.1007/s40257-022-00683-2

Key clinical point: Dupilumab showed an acceptable safety profile and sustained efficacy through 52 weeks in adolescents with inadequately controlled moderate-to-severe atopic dermatitis (AD).

Major finding: Rate of treatment emergent adverse events was 370.2 events/100 patient-years, with most being mild/moderate. At least 75% improvement in Eczema Area and Severity Index scores was achieved by 81.2% of patients receiving dupilumab at week 52 and 51.9% of patients who were uptitrated from every-4-week (q4w) to every-2-week (q2w) dosing regimen at week 48 after the first uptitration visit.

Study details: Findings are from an ongoing open-label extension study, LIBERTY AD PED-OLE, including 294 adolescents with moderate-to-severe AD who participated in previous dupilumab trials, received dupilumab q4w, and were uptitrated to the weight-tiered q2w dose regimen upon inadequate clinical response.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Eight authors declared being employees or shareholders of Regeneron Pharmaceuticals or Sanofi, and the other authors reported ties with various sources, including Sanofi and Regeneron.

Source: Blauvelt A et al. Long-term efficacy and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis: Results through week 52 from a phase III open-label extension trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022;23:365–383  (May 14). Doi: 10.1007/s40257-022-00683-2

For dermatologists and others treating patients with atopic dermatitis (AD), it is “an incredible time,” Lawrence F. Eichenfield, MD, said at MedscapeLive’s Women’s & Pediatric Dermatology Seminar.

More and more treatment options are available and even more are in the pipeline, said Dr. Eichenfield, professor of dermatology and pediatrics and vice chair of dermatology at the University of California, San Diego and Rady Children’s Hospital. As he put it: “We got pills, injections, things to smear on the skin.”

Those options are welcome and needed, as AD affects up to 20% of children and up to 10% of adults. The course is variable, as is severity, and quality of life is impacted.

Besides new treatment options, there is a new understanding about comorbidities, environmental effects, and triggers, Dr. Eichenfield said. Among the potential comorbidities health care providers should be aware of are allergies, such as food allergies; asthma; rhinitis; mental health issues (depression, anxiety, ADHD, learning disabilities, or in adults, substance abuse); bone health; skin infections; immune disorders such as alopecia areata or urticaria; and cardiovascular issues that could affect adults.

Environmental effects can play a role in aggravating AD, as providers learned after visits for AD increased after Northern California wildfires and also in other areas with high air pollution, Dr. Eichenfield said. “I actually discuss this with my families,” when making them aware of factors that may affect AD, he noted.

Dr. Eichenfield provided an overview of available treatment options, and what treatments may be coming next. Among the highlights:

Topical ruxolitinib: A JAK1,2 inhibitor in a cream formulation, it is now approved for patients with mild to moderate AD aged 12 years and older in the United States. Of the two strengths studied, the higher strength, 1.5%, was approved, Dr. Eichenfield said. How well did it work? In two phase 3 studies in patients aged 12 and older, of those on 1.5%, 53% were clear or almost clear at 8 weeks, versus 11% in the control group given the vehicle; 52% had at least a 4-point reduction in itch from baseline, versus 15.4% on vehicle. Quality of life improved in up to 73.2% of those given the medication versus 19.7% of those on the vehicle. There was a marked and quick improvement in itch, as early as 12 hours, and safety measures also look good, he said.

Topical tapinarof: Approved in May 2022, for adults with plaque psoriasis, phase 3 trials began in September, 2021, for adults and children with AD, according to the manufacturer. Activation of the aryl hydrocarbon receptor mediates its anti-inflammatory properties.

Topical roflumilast: A potent PDE-4 inhibitor, phase 3 AD studies are underway. It appears to be well tolerated, Dr. Eichenfield said.

Dupilumab: An IL-4/13 blocker, this biologic produced an itch reduction of 50% and EASI of 80%, improved quality of life, and reduced anxiety and depression. The drug “led the revolution in systemic therapy for atopic dermatitis,” he said. First approved for treating AD in patients aged 18 years and up in 2017, approval for patients 12 years and up followed in March 2019, then for age 6 years and up May 2020.

At the meeting on June 3, Dr. Eichenfield said that approval in children 5 years and under was imminent, and on June 7, the FDA approved dupilumab for use in children aged 6 months to 5 years. In a phase 3, 16-week trial, 28% of children treated with dupilumab added on to low-potency topical corticosteroids met the endpoint of clear or nearly clear skin, compared with 4% of those on the corticosteroids alone (P < .0001).

Tralokinumab: There is no approved indication yet for adolescents, but the injected biologic, an interleukin-13 antagonist, is approved for adults with moderate to severe AD who are not well-controlled with topicals, or who cannot use topicals.

Oral JAK inhibitors: These include abrocitinib and upadacitinib, both approved by the FDA in January 2022 for treating moderate to severe AD, and baricitinib (the latter not in the United States). “For AD, you probably won’t see it in the U.S.,” Dr. Eichenfield said, referring to baricitinib. However, it might get approved for alopecia areata, he noted.

Upadacitinib is approved for adolescents 12 and older with AD. Abrocitinib is approved for adults 18 and older with AD.

Regarding safety and tolerance concerns with oral JAK inhibitors, Dr. Eichenfield cites headache, acne, nausea, and upper respiratory tract infections as relatively common, while herpes zoster, venous thromboembolism, and lab anomalies (neutropenia, elevated CPK) are uncommon.

As the options for AD treatments increase, and expectations by families and clinicians change, Dr. Eichenfield said he often focuses on “bucket duty” – whether a specific patient should be in the topical bucket or the systemic one. It’s a decision that will continue to be crucial, he said.

When presented with treatment options, patients – and parents – often worry about side effects, said Vivian Shi, MD, associate professor of dermatology at the University of Arkansas Medical Center, Little Rock, who also spoke at the meeting. She gently tells them: “The worst side effect you can have is probably not treating the disease itself.”

Medscape Live and this news organization are owned by the same parent company. Dr. Eichenfield is a consultant or investigator for numerous companies that manufacture treatments for AD, but based his discussion on evidence-based recommendations and public presentations or publications.

For dermatologists and others treating patients with atopic dermatitis (AD), it is “an incredible time,” Lawrence F. Eichenfield, MD, said at MedscapeLive’s Women’s & Pediatric Dermatology Seminar.

More and more treatment options are available and even more are in the pipeline, said Dr. Eichenfield, professor of dermatology and pediatrics and vice chair of dermatology at the University of California, San Diego and Rady Children’s Hospital. As he put it: “We got pills, injections, things to smear on the skin.”

Those options are welcome and needed, as AD affects up to 20% of children and up to 10% of adults. The course is variable, as is severity, and quality of life is impacted.

Besides new treatment options, there is a new understanding about comorbidities, environmental effects, and triggers, Dr. Eichenfield said. Among the potential comorbidities health care providers should be aware of are allergies, such as food allergies; asthma; rhinitis; mental health issues (depression, anxiety, ADHD, learning disabilities, or in adults, substance abuse); bone health; skin infections; immune disorders such as alopecia areata or urticaria; and cardiovascular issues that could affect adults.

Environmental effects can play a role in aggravating AD, as providers learned after visits for AD increased after Northern California wildfires and also in other areas with high air pollution, Dr. Eichenfield said. “I actually discuss this with my families,” when making them aware of factors that may affect AD, he noted.

Dr. Eichenfield provided an overview of available treatment options, and what treatments may be coming next. Among the highlights:

Topical ruxolitinib: A JAK1,2 inhibitor in a cream formulation, it is now approved for patients with mild to moderate AD aged 12 years and older in the United States. Of the two strengths studied, the higher strength, 1.5%, was approved, Dr. Eichenfield said. How well did it work? In two phase 3 studies in patients aged 12 and older, of those on 1.5%, 53% were clear or almost clear at 8 weeks, versus 11% in the control group given the vehicle; 52% had at least a 4-point reduction in itch from baseline, versus 15.4% on vehicle. Quality of life improved in up to 73.2% of those given the medication versus 19.7% of those on the vehicle. There was a marked and quick improvement in itch, as early as 12 hours, and safety measures also look good, he said.

Topical tapinarof: Approved in May 2022, for adults with plaque psoriasis, phase 3 trials began in September, 2021, for adults and children with AD, according to the manufacturer. Activation of the aryl hydrocarbon receptor mediates its anti-inflammatory properties.

Topical roflumilast: A potent PDE-4 inhibitor, phase 3 AD studies are underway. It appears to be well tolerated, Dr. Eichenfield said.

Dupilumab: An IL-4/13 blocker, this biologic produced an itch reduction of 50% and EASI of 80%, improved quality of life, and reduced anxiety and depression. The drug “led the revolution in systemic therapy for atopic dermatitis,” he said. First approved for treating AD in patients aged 18 years and up in 2017, approval for patients 12 years and up followed in March 2019, then for age 6 years and up May 2020.

At the meeting on June 3, Dr. Eichenfield said that approval in children 5 years and under was imminent, and on June 7, the FDA approved dupilumab for use in children aged 6 months to 5 years. In a phase 3, 16-week trial, 28% of children treated with dupilumab added on to low-potency topical corticosteroids met the endpoint of clear or nearly clear skin, compared with 4% of those on the corticosteroids alone (P < .0001).

Tralokinumab: There is no approved indication yet for adolescents, but the injected biologic, an interleukin-13 antagonist, is approved for adults with moderate to severe AD who are not well-controlled with topicals, or who cannot use topicals.

Oral JAK inhibitors: These include abrocitinib and upadacitinib, both approved by the FDA in January 2022 for treating moderate to severe AD, and baricitinib (the latter not in the United States). “For AD, you probably won’t see it in the U.S.,” Dr. Eichenfield said, referring to baricitinib. However, it might get approved for alopecia areata, he noted.

Upadacitinib is approved for adolescents 12 and older with AD. Abrocitinib is approved for adults 18 and older with AD.

Regarding safety and tolerance concerns with oral JAK inhibitors, Dr. Eichenfield cites headache, acne, nausea, and upper respiratory tract infections as relatively common, while herpes zoster, venous thromboembolism, and lab anomalies (neutropenia, elevated CPK) are uncommon.

As the options for AD treatments increase, and expectations by families and clinicians change, Dr. Eichenfield said he often focuses on “bucket duty” – whether a specific patient should be in the topical bucket or the systemic one. It’s a decision that will continue to be crucial, he said.

When presented with treatment options, patients – and parents – often worry about side effects, said Vivian Shi, MD, associate professor of dermatology at the University of Arkansas Medical Center, Little Rock, who also spoke at the meeting. She gently tells them: “The worst side effect you can have is probably not treating the disease itself.”

Medscape Live and this news organization are owned by the same parent company. Dr. Eichenfield is a consultant or investigator for numerous companies that manufacture treatments for AD, but based his discussion on evidence-based recommendations and public presentations or publications.

For dermatologists and others treating patients with atopic dermatitis (AD), it is “an incredible time,” Lawrence F. Eichenfield, MD, said at MedscapeLive’s Women’s & Pediatric Dermatology Seminar.

More and more treatment options are available and even more are in the pipeline, said Dr. Eichenfield, professor of dermatology and pediatrics and vice chair of dermatology at the University of California, San Diego and Rady Children’s Hospital. As he put it: “We got pills, injections, things to smear on the skin.”

Those options are welcome and needed, as AD affects up to 20% of children and up to 10% of adults. The course is variable, as is severity, and quality of life is impacted.

Besides new treatment options, there is a new understanding about comorbidities, environmental effects, and triggers, Dr. Eichenfield said. Among the potential comorbidities health care providers should be aware of are allergies, such as food allergies; asthma; rhinitis; mental health issues (depression, anxiety, ADHD, learning disabilities, or in adults, substance abuse); bone health; skin infections; immune disorders such as alopecia areata or urticaria; and cardiovascular issues that could affect adults.

Environmental effects can play a role in aggravating AD, as providers learned after visits for AD increased after Northern California wildfires and also in other areas with high air pollution, Dr. Eichenfield said. “I actually discuss this with my families,” when making them aware of factors that may affect AD, he noted.

Dr. Eichenfield provided an overview of available treatment options, and what treatments may be coming next. Among the highlights:

Topical ruxolitinib: A JAK1,2 inhibitor in a cream formulation, it is now approved for patients with mild to moderate AD aged 12 years and older in the United States. Of the two strengths studied, the higher strength, 1.5%, was approved, Dr. Eichenfield said. How well did it work? In two phase 3 studies in patients aged 12 and older, of those on 1.5%, 53% were clear or almost clear at 8 weeks, versus 11% in the control group given the vehicle; 52% had at least a 4-point reduction in itch from baseline, versus 15.4% on vehicle. Quality of life improved in up to 73.2% of those given the medication versus 19.7% of those on the vehicle. There was a marked and quick improvement in itch, as early as 12 hours, and safety measures also look good, he said.

Topical tapinarof: Approved in May 2022, for adults with plaque psoriasis, phase 3 trials began in September, 2021, for adults and children with AD, according to the manufacturer. Activation of the aryl hydrocarbon receptor mediates its anti-inflammatory properties.

Topical roflumilast: A potent PDE-4 inhibitor, phase 3 AD studies are underway. It appears to be well tolerated, Dr. Eichenfield said.

Dupilumab: An IL-4/13 blocker, this biologic produced an itch reduction of 50% and EASI of 80%, improved quality of life, and reduced anxiety and depression. The drug “led the revolution in systemic therapy for atopic dermatitis,” he said. First approved for treating AD in patients aged 18 years and up in 2017, approval for patients 12 years and up followed in March 2019, then for age 6 years and up May 2020.

At the meeting on June 3, Dr. Eichenfield said that approval in children 5 years and under was imminent, and on June 7, the FDA approved dupilumab for use in children aged 6 months to 5 years. In a phase 3, 16-week trial, 28% of children treated with dupilumab added on to low-potency topical corticosteroids met the endpoint of clear or nearly clear skin, compared with 4% of those on the corticosteroids alone (P < .0001).

Tralokinumab: There is no approved indication yet for adolescents, but the injected biologic, an interleukin-13 antagonist, is approved for adults with moderate to severe AD who are not well-controlled with topicals, or who cannot use topicals.

Oral JAK inhibitors: These include abrocitinib and upadacitinib, both approved by the FDA in January 2022 for treating moderate to severe AD, and baricitinib (the latter not in the United States). “For AD, you probably won’t see it in the U.S.,” Dr. Eichenfield said, referring to baricitinib. However, it might get approved for alopecia areata, he noted.

Upadacitinib is approved for adolescents 12 and older with AD. Abrocitinib is approved for adults 18 and older with AD.

Regarding safety and tolerance concerns with oral JAK inhibitors, Dr. Eichenfield cites headache, acne, nausea, and upper respiratory tract infections as relatively common, while herpes zoster, venous thromboembolism, and lab anomalies (neutropenia, elevated CPK) are uncommon.

As the options for AD treatments increase, and expectations by families and clinicians change, Dr. Eichenfield said he often focuses on “bucket duty” – whether a specific patient should be in the topical bucket or the systemic one. It’s a decision that will continue to be crucial, he said.

When presented with treatment options, patients – and parents – often worry about side effects, said Vivian Shi, MD, associate professor of dermatology at the University of Arkansas Medical Center, Little Rock, who also spoke at the meeting. She gently tells them: “The worst side effect you can have is probably not treating the disease itself.”

Medscape Live and this news organization are owned by the same parent company. Dr. Eichenfield is a consultant or investigator for numerous companies that manufacture treatments for AD, but based his discussion on evidence-based recommendations and public presentations or publications.

Therapeutic patient education is an important, effective, and well-defined intervention for patients with atopic dermatitis (AD), Andreas Wollenberg, MD, said at the Revolutionizing Atopic Dermatitis symposium.

A major goal of patient education is increasing medication adherence, noted Dr. Wollenberg, professor in the department of dermatology and allergy at Ludwig Maximilian University of Munich. Quoting former U.S. Surgeon General C. Everett Koop, MD, he said, “drugs don’t work in patients who don’t take them.”

While this is a simple message, it is important, Dr. Wollenberg said, noting that there can be a gap between a physician’s well-intentioned message and how it is interpreted by the patient. “Our messages may not be heard, not understood, not accepted, and even if they are put into place, how long will they last?” he asked. “We need to find a way [to] place sticky messages in the brains of our patients who are sitting and interacting with us.”

One way to improve treatment adherence is through patient education, such as using a written action plan or graphics; simplifying treatment regimens; minimizing treatment costs; setting up reminder programs, early follow-up visits, and short-term treatment goals; and minimizing nocebo effects. “This is more than providing just leaflets to patients. It is a complete program. It is a holistic approach. It should be structured and should be interdisciplinary, and it should contain a psychological component,” Dr. Wollenberg said.

Therapeutic patient education is recommended at baseline for children and adults with moderate to severe AD in the 2020 European Task Force on Atopic Dermatitis (ETFAD) and European Academy of Dermatology and Venereology (EADV) position paper on the diagnosis and treatment of AD in adults and children, alongside other interventions, such as emollients, bath oils, and avoidance of clinically relevant allergens, noted Dr. Wollenberg, the first author . “Therapeutic patient education is an extremely helpful tool to address patient beliefs and questions regarding disease and treatment,” he and his coauthors wrote in the paper.

When considering a therapeutic patient education program for AD, content is key, but just as important is consideration of legal and cultural conditions in the local area, Dr. Wollenberg explained. Every country will need some degree of standardization of content, he noted. Clinicians interested in adopting a patient education program need to consider who will pay for it – patients, foundations, or insurance companies – as well as the time commitment needed.

Dr. Wollenberg said that his team uses an evidence-based education program for AD in Germany that works across patients with different personalities, with a multidisciplinary team that includes a dermatologist, a specialist nurse, a nutrition expert, and a psychologist. “Sometimes we replace the specialized nurse with the dermatology resident because, in Germany, it’s difficult to find any type of specialized nurse,” although this is not an issue in many other countries, he said.

The model for children involves six 90-minute sessions, which cover topics that include emollients and basic care, food allergies and diet, medical treatment, and psychology of itch. The program for adults involves six 2-hour sessions, which cover topics that include psychology, skin care/nutrition, and medical treatment.

While this education program improves adherence in patients with AD, he acknowledged it is time consuming, and may not work for people who live far away from a clinic or who have other time commitments, making an alternative format necessary.

In terms of improving patient adherence to a doctor’s recommendations regarding chronic skin disease, “we cannot change our patients, we cannot change the disease, but we can strongly influence the treatment that we choose and how we interact as physicians with our patients,” said Dr. Wollenberg.

“Therapeutic patient education is virtually free of side effects, but evidence based. Have a look [at] it and adapt it to your own practice,” he added.

Dr. Wollenberg is a consultant, speaker and receives fees from numerous pharmaceutical companies.

Therapeutic patient education is an important, effective, and well-defined intervention for patients with atopic dermatitis (AD), Andreas Wollenberg, MD, said at the Revolutionizing Atopic Dermatitis symposium.

A major goal of patient education is increasing medication adherence, noted Dr. Wollenberg, professor in the department of dermatology and allergy at Ludwig Maximilian University of Munich. Quoting former U.S. Surgeon General C. Everett Koop, MD, he said, “drugs don’t work in patients who don’t take them.”

While this is a simple message, it is important, Dr. Wollenberg said, noting that there can be a gap between a physician’s well-intentioned message and how it is interpreted by the patient. “Our messages may not be heard, not understood, not accepted, and even if they are put into place, how long will they last?” he asked. “We need to find a way [to] place sticky messages in the brains of our patients who are sitting and interacting with us.”

One way to improve treatment adherence is through patient education, such as using a written action plan or graphics; simplifying treatment regimens; minimizing treatment costs; setting up reminder programs, early follow-up visits, and short-term treatment goals; and minimizing nocebo effects. “This is more than providing just leaflets to patients. It is a complete program. It is a holistic approach. It should be structured and should be interdisciplinary, and it should contain a psychological component,” Dr. Wollenberg said.

Therapeutic patient education is recommended at baseline for children and adults with moderate to severe AD in the 2020 European Task Force on Atopic Dermatitis (ETFAD) and European Academy of Dermatology and Venereology (EADV) position paper on the diagnosis and treatment of AD in adults and children, alongside other interventions, such as emollients, bath oils, and avoidance of clinically relevant allergens, noted Dr. Wollenberg, the first author . “Therapeutic patient education is an extremely helpful tool to address patient beliefs and questions regarding disease and treatment,” he and his coauthors wrote in the paper.

When considering a therapeutic patient education program for AD, content is key, but just as important is consideration of legal and cultural conditions in the local area, Dr. Wollenberg explained. Every country will need some degree of standardization of content, he noted. Clinicians interested in adopting a patient education program need to consider who will pay for it – patients, foundations, or insurance companies – as well as the time commitment needed.

Dr. Wollenberg said that his team uses an evidence-based education program for AD in Germany that works across patients with different personalities, with a multidisciplinary team that includes a dermatologist, a specialist nurse, a nutrition expert, and a psychologist. “Sometimes we replace the specialized nurse with the dermatology resident because, in Germany, it’s difficult to find any type of specialized nurse,” although this is not an issue in many other countries, he said.

The model for children involves six 90-minute sessions, which cover topics that include emollients and basic care, food allergies and diet, medical treatment, and psychology of itch. The program for adults involves six 2-hour sessions, which cover topics that include psychology, skin care/nutrition, and medical treatment.

While this education program improves adherence in patients with AD, he acknowledged it is time consuming, and may not work for people who live far away from a clinic or who have other time commitments, making an alternative format necessary.

In terms of improving patient adherence to a doctor’s recommendations regarding chronic skin disease, “we cannot change our patients, we cannot change the disease, but we can strongly influence the treatment that we choose and how we interact as physicians with our patients,” said Dr. Wollenberg.

“Therapeutic patient education is virtually free of side effects, but evidence based. Have a look [at] it and adapt it to your own practice,” he added.

Dr. Wollenberg is a consultant, speaker and receives fees from numerous pharmaceutical companies.

Therapeutic patient education is an important, effective, and well-defined intervention for patients with atopic dermatitis (AD), Andreas Wollenberg, MD, said at the Revolutionizing Atopic Dermatitis symposium.

A major goal of patient education is increasing medication adherence, noted Dr. Wollenberg, professor in the department of dermatology and allergy at Ludwig Maximilian University of Munich. Quoting former U.S. Surgeon General C. Everett Koop, MD, he said, “drugs don’t work in patients who don’t take them.”

While this is a simple message, it is important, Dr. Wollenberg said, noting that there can be a gap between a physician’s well-intentioned message and how it is interpreted by the patient. “Our messages may not be heard, not understood, not accepted, and even if they are put into place, how long will they last?” he asked. “We need to find a way [to] place sticky messages in the brains of our patients who are sitting and interacting with us.”

One way to improve treatment adherence is through patient education, such as using a written action plan or graphics; simplifying treatment regimens; minimizing treatment costs; setting up reminder programs, early follow-up visits, and short-term treatment goals; and minimizing nocebo effects. “This is more than providing just leaflets to patients. It is a complete program. It is a holistic approach. It should be structured and should be interdisciplinary, and it should contain a psychological component,” Dr. Wollenberg said.

Therapeutic patient education is recommended at baseline for children and adults with moderate to severe AD in the 2020 European Task Force on Atopic Dermatitis (ETFAD) and European Academy of Dermatology and Venereology (EADV) position paper on the diagnosis and treatment of AD in adults and children, alongside other interventions, such as emollients, bath oils, and avoidance of clinically relevant allergens, noted Dr. Wollenberg, the first author . “Therapeutic patient education is an extremely helpful tool to address patient beliefs and questions regarding disease and treatment,” he and his coauthors wrote in the paper.

When considering a therapeutic patient education program for AD, content is key, but just as important is consideration of legal and cultural conditions in the local area, Dr. Wollenberg explained. Every country will need some degree of standardization of content, he noted. Clinicians interested in adopting a patient education program need to consider who will pay for it – patients, foundations, or insurance companies – as well as the time commitment needed.

Dr. Wollenberg said that his team uses an evidence-based education program for AD in Germany that works across patients with different personalities, with a multidisciplinary team that includes a dermatologist, a specialist nurse, a nutrition expert, and a psychologist. “Sometimes we replace the specialized nurse with the dermatology resident because, in Germany, it’s difficult to find any type of specialized nurse,” although this is not an issue in many other countries, he said.

The model for children involves six 90-minute sessions, which cover topics that include emollients and basic care, food allergies and diet, medical treatment, and psychology of itch. The program for adults involves six 2-hour sessions, which cover topics that include psychology, skin care/nutrition, and medical treatment.

While this education program improves adherence in patients with AD, he acknowledged it is time consuming, and may not work for people who live far away from a clinic or who have other time commitments, making an alternative format necessary.

In terms of improving patient adherence to a doctor’s recommendations regarding chronic skin disease, “we cannot change our patients, we cannot change the disease, but we can strongly influence the treatment that we choose and how we interact as physicians with our patients,” said Dr. Wollenberg.

“Therapeutic patient education is virtually free of side effects, but evidence based. Have a look [at] it and adapt it to your own practice,” he added.

Dr. Wollenberg is a consultant, speaker and receives fees from numerous pharmaceutical companies.

The Food and Drug Administration has approved dupilumab as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The approval, announced on June 7, 2022, makes dupilumab (Dupixent), an interleukin-4 receptor alpha antagonist, the first biologic available in the United States to treat uncontrolled moderate to severe atopic dermatitis in this age group. In this age group, it is administered subcutaneously every 4 weeks. Dupilumab remains the only biologic treatment approved for patients aged 6 years and older for this indication.

Approval was based on data from a 16-week pivotal phase 3 trial that evaluated the efficacy and safety of dupilumab added to standard of care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis. The trial’s principal investigator, Amy S. Paller, MD, professor and chair of dermatology at Northwestern University, Chicago, and colleagues, found that, at 16 weeks, 28% of patients who were treated with dupilumab, added to low-potency TCS, met the primary endpoint of clear or almost clear skin, compared with 4% of those who received low-potency TCS alone (P < .0001).

In addition, patients who received the combined treatment experienced a 70% average improvement in disease severity from baseline, compared with a 20% improvement among those in the TCS-only group (P < .0001). They also experienced a 49% improvement in itch, compared with a 2% improvement among their counterparts in the TCS-only group (P < .0001).

Outside of the United States, the study’s coprimary endpoint was achievement of 75% or greater improvement in overall disease severity. More than half of the patients who received combined treatment (53%) met this endpoint, compared with 11% in the TCS-only group (P < .0001), according to the company.

Safety results were generally consistent with the safety profile of dupilumab in atopic dermatitis for patients aged 6 years and older. The most common adverse events that were more commonly observed with dupilumab included conjunctivitis (5% vs 0% in the placebo group) and herpes viral infections (6% vs. 5% in the placebo group). Among those on dupilumab, ages 6 months to 5 years, hand,foot, and mouth disease was reported in 5% and skin papilloma were reported in 2%, but these cases did not lead to discontinuation of treatment, according to the company release.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved dupilumab as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The approval, announced on June 7, 2022, makes dupilumab (Dupixent), an interleukin-4 receptor alpha antagonist, the first biologic available in the United States to treat uncontrolled moderate to severe atopic dermatitis in this age group. In this age group, it is administered subcutaneously every 4 weeks. Dupilumab remains the only biologic treatment approved for patients aged 6 years and older for this indication.

Approval was based on data from a 16-week pivotal phase 3 trial that evaluated the efficacy and safety of dupilumab added to standard of care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis. The trial’s principal investigator, Amy S. Paller, MD, professor and chair of dermatology at Northwestern University, Chicago, and colleagues, found that, at 16 weeks, 28% of patients who were treated with dupilumab, added to low-potency TCS, met the primary endpoint of clear or almost clear skin, compared with 4% of those who received low-potency TCS alone (P < .0001).

In addition, patients who received the combined treatment experienced a 70% average improvement in disease severity from baseline, compared with a 20% improvement among those in the TCS-only group (P < .0001). They also experienced a 49% improvement in itch, compared with a 2% improvement among their counterparts in the TCS-only group (P < .0001).

Outside of the United States, the study’s coprimary endpoint was achievement of 75% or greater improvement in overall disease severity. More than half of the patients who received combined treatment (53%) met this endpoint, compared with 11% in the TCS-only group (P < .0001), according to the company.

Safety results were generally consistent with the safety profile of dupilumab in atopic dermatitis for patients aged 6 years and older. The most common adverse events that were more commonly observed with dupilumab included conjunctivitis (5% vs 0% in the placebo group) and herpes viral infections (6% vs. 5% in the placebo group). Among those on dupilumab, ages 6 months to 5 years, hand,foot, and mouth disease was reported in 5% and skin papilloma were reported in 2%, but these cases did not lead to discontinuation of treatment, according to the company release.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved dupilumab as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The approval, announced on June 7, 2022, makes dupilumab (Dupixent), an interleukin-4 receptor alpha antagonist, the first biologic available in the United States to treat uncontrolled moderate to severe atopic dermatitis in this age group. In this age group, it is administered subcutaneously every 4 weeks. Dupilumab remains the only biologic treatment approved for patients aged 6 years and older for this indication.

Approval was based on data from a 16-week pivotal phase 3 trial that evaluated the efficacy and safety of dupilumab added to standard of care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis. The trial’s principal investigator, Amy S. Paller, MD, professor and chair of dermatology at Northwestern University, Chicago, and colleagues, found that, at 16 weeks, 28% of patients who were treated with dupilumab, added to low-potency TCS, met the primary endpoint of clear or almost clear skin, compared with 4% of those who received low-potency TCS alone (P < .0001).

In addition, patients who received the combined treatment experienced a 70% average improvement in disease severity from baseline, compared with a 20% improvement among those in the TCS-only group (P < .0001). They also experienced a 49% improvement in itch, compared with a 2% improvement among their counterparts in the TCS-only group (P < .0001).

Outside of the United States, the study’s coprimary endpoint was achievement of 75% or greater improvement in overall disease severity. More than half of the patients who received combined treatment (53%) met this endpoint, compared with 11% in the TCS-only group (P < .0001), according to the company.

Safety results were generally consistent with the safety profile of dupilumab in atopic dermatitis for patients aged 6 years and older. The most common adverse events that were more commonly observed with dupilumab included conjunctivitis (5% vs 0% in the placebo group) and herpes viral infections (6% vs. 5% in the placebo group). Among those on dupilumab, ages 6 months to 5 years, hand,foot, and mouth disease was reported in 5% and skin papilloma were reported in 2%, but these cases did not lead to discontinuation of treatment, according to the company release.

A version of this article first appeared on Medscape.com.

Clinicians everywhere are excited to have more options, but they are also reeling from trying to keep up with the enormous amount of data. We are fortunate to have a lot of information for these therapies published in the past month, which provides important insight into how to best use them.

Let's start with some new data on dupilumab, which has emerged as a first-line systemic therapy for moderate to severe AD in the US. Patients who were enrolled in the phase 1-3 randomized clinical trials for dupilumab were allowed to enroll in a long-term open-label extension study where they received 300 mg dupilumab weekly. Beck and colleagues published the interim analysis of the ongoing international, multicenter, long-term extension study of 2677 adults with up to 4 years of dupilumab exposure. They found no major increases in adverse event rates, with high durable efficacy and high rates of drug persistence over time. It is important to note that this was an open-label study without a control group — that is, patients knew exactly what treatment they were receiving. In addition, the analysis presented efficacy among those patients who remained in the study over time, which may not adequately account for loss of efficacy over time in patients who dropped out of the study. Nevertheless, the results suggest that dupilumab can be a good long-term treatment option for patients with chronic AD, with no new major safety concerns.

There is now a large body of evidence generated by phase 4 studies showing the real-world effectiveness of dupilumab. Stingeni and colleagues published the results of a prospective study of 139 adolescents (aged 12-17 years) with moderate-to-severe AD who received dupilumab for 16 weeks. They found significant improvement in AD signs and quality of life overall and across different clinical phenotypes of AD, with robust endpoints achieved most in the diffuse eczema subtype. Despite the previously demonstrated heterogeneity of AD,^1,2 these results suggest that dupilumab can be effective across a variety of patient subtypes.

The JAK inhibitors are new additions to our therapeutic armamentarium for AD. Given how new they are to dermatology, we are always craving more data to inform clinical decision-making. Several recent studies provide additional insights into how we can use the JAK inhibitors in clinical practice.

One major question is how well they work in patients in whom dupilumab previously failed. Shi and colleagues published the results of an interesting and clinically relevant phase 3 study (JADE EXTEND), which included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg once-daily abrocitinib after previously receiving dupilumab for 14 weeks in the JADE COMPARE study. They found that at week 12, the majority of dupilumab nonresponders had high Eczema Area and Severity Index (EASI-75) responses with both doses of abrocitinib. Patients who previously had a good clinical response with dupilumab had even higher treatment responses on abrocitinib than those who were dupilumab nonresponders. These data provide important information to support the use of abrocitinib, and perhaps by extension other JAK inhibitors, in patients who previously had inadequate response to dupilumab.

Another major question is how to differentiate the JAK inhibitors from biologics in AD. One consideration is that patients taking JAK inhibitors may achieve more robust clinical responses compared with those on biologics. Stander and colleagues performed a post hoc analysis of pooled phase 2B/3 studies of abrocitinib (942 patients). They found that, at week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib achieved more robust endpoints, such as EASI-90 and EASI-100 scores, compared with placebo recipients. Of note, these data did not include any comparison data with dupilumab. However, on the basis of cross-study comparison, it would seem that abrocitinib, particularly at the higher 200 mg dose, may lead to more robust clinical responses than dupilumab. However, it is very important to acknowledge that this study focused on 12-week data and maximal efficacy with dupilumab may take longer to achieve.

Additional References

1.         Chovatiya R, Silverberg JI. The heterogeneity of atopic dermatitis. J Drugs Dermatol. 2022;21(2):172-176. Doi:  10.36849/JDD.6408

2.         Yew YW, Thyssen JP, Silverberg JI. A systematic review and meta-analysis of the regional and age-related differences in atopic dermatitis clinical characteristics. J Amer Acad Dermatol. 2019;80(2):390-401. Doi: 10.1016/j.jaad.2018.09.035

Clinicians everywhere are excited to have more options, but they are also reeling from trying to keep up with the enormous amount of data. We are fortunate to have a lot of information for these therapies published in the past month, which provides important insight into how to best use them.

Let's start with some new data on dupilumab, which has emerged as a first-line systemic therapy for moderate to severe AD in the US. Patients who were enrolled in the phase 1-3 randomized clinical trials for dupilumab were allowed to enroll in a long-term open-label extension study where they received 300 mg dupilumab weekly. Beck and colleagues published the interim analysis of the ongoing international, multicenter, long-term extension study of 2677 adults with up to 4 years of dupilumab exposure. They found no major increases in adverse event rates, with high durable efficacy and high rates of drug persistence over time. It is important to note that this was an open-label study without a control group — that is, patients knew exactly what treatment they were receiving. In addition, the analysis presented efficacy among those patients who remained in the study over time, which may not adequately account for loss of efficacy over time in patients who dropped out of the study. Nevertheless, the results suggest that dupilumab can be a good long-term treatment option for patients with chronic AD, with no new major safety concerns.

There is now a large body of evidence generated by phase 4 studies showing the real-world effectiveness of dupilumab. Stingeni and colleagues published the results of a prospective study of 139 adolescents (aged 12-17 years) with moderate-to-severe AD who received dupilumab for 16 weeks. They found significant improvement in AD signs and quality of life overall and across different clinical phenotypes of AD, with robust endpoints achieved most in the diffuse eczema subtype. Despite the previously demonstrated heterogeneity of AD,^1,2 these results suggest that dupilumab can be effective across a variety of patient subtypes.

The JAK inhibitors are new additions to our therapeutic armamentarium for AD. Given how new they are to dermatology, we are always craving more data to inform clinical decision-making. Several recent studies provide additional insights into how we can use the JAK inhibitors in clinical practice.

One major question is how well they work in patients in whom dupilumab previously failed. Shi and colleagues published the results of an interesting and clinically relevant phase 3 study (JADE EXTEND), which included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg once-daily abrocitinib after previously receiving dupilumab for 14 weeks in the JADE COMPARE study. They found that at week 12, the majority of dupilumab nonresponders had high Eczema Area and Severity Index (EASI-75) responses with both doses of abrocitinib. Patients who previously had a good clinical response with dupilumab had even higher treatment responses on abrocitinib than those who were dupilumab nonresponders. These data provide important information to support the use of abrocitinib, and perhaps by extension other JAK inhibitors, in patients who previously had inadequate response to dupilumab.

Another major question is how to differentiate the JAK inhibitors from biologics in AD. One consideration is that patients taking JAK inhibitors may achieve more robust clinical responses compared with those on biologics. Stander and colleagues performed a post hoc analysis of pooled phase 2B/3 studies of abrocitinib (942 patients). They found that, at week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib achieved more robust endpoints, such as EASI-90 and EASI-100 scores, compared with placebo recipients. Of note, these data did not include any comparison data with dupilumab. However, on the basis of cross-study comparison, it would seem that abrocitinib, particularly at the higher 200 mg dose, may lead to more robust clinical responses than dupilumab. However, it is very important to acknowledge that this study focused on 12-week data and maximal efficacy with dupilumab may take longer to achieve.

Additional References

1.         Chovatiya R, Silverberg JI. The heterogeneity of atopic dermatitis. J Drugs Dermatol. 2022;21(2):172-176. Doi:  10.36849/JDD.6408

2.         Yew YW, Thyssen JP, Silverberg JI. A systematic review and meta-analysis of the regional and age-related differences in atopic dermatitis clinical characteristics. J Amer Acad Dermatol. 2019;80(2):390-401. Doi: 10.1016/j.jaad.2018.09.035

Clinicians everywhere are excited to have more options, but they are also reeling from trying to keep up with the enormous amount of data. We are fortunate to have a lot of information for these therapies published in the past month, which provides important insight into how to best use them.

Let's start with some new data on dupilumab, which has emerged as a first-line systemic therapy for moderate to severe AD in the US. Patients who were enrolled in the phase 1-3 randomized clinical trials for dupilumab were allowed to enroll in a long-term open-label extension study where they received 300 mg dupilumab weekly. Beck and colleagues published the interim analysis of the ongoing international, multicenter, long-term extension study of 2677 adults with up to 4 years of dupilumab exposure. They found no major increases in adverse event rates, with high durable efficacy and high rates of drug persistence over time. It is important to note that this was an open-label study without a control group — that is, patients knew exactly what treatment they were receiving. In addition, the analysis presented efficacy among those patients who remained in the study over time, which may not adequately account for loss of efficacy over time in patients who dropped out of the study. Nevertheless, the results suggest that dupilumab can be a good long-term treatment option for patients with chronic AD, with no new major safety concerns.

There is now a large body of evidence generated by phase 4 studies showing the real-world effectiveness of dupilumab. Stingeni and colleagues published the results of a prospective study of 139 adolescents (aged 12-17 years) with moderate-to-severe AD who received dupilumab for 16 weeks. They found significant improvement in AD signs and quality of life overall and across different clinical phenotypes of AD, with robust endpoints achieved most in the diffuse eczema subtype. Despite the previously demonstrated heterogeneity of AD,^1,2 these results suggest that dupilumab can be effective across a variety of patient subtypes.

The JAK inhibitors are new additions to our therapeutic armamentarium for AD. Given how new they are to dermatology, we are always craving more data to inform clinical decision-making. Several recent studies provide additional insights into how we can use the JAK inhibitors in clinical practice.

One major question is how well they work in patients in whom dupilumab previously failed. Shi and colleagues published the results of an interesting and clinically relevant phase 3 study (JADE EXTEND), which included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg once-daily abrocitinib after previously receiving dupilumab for 14 weeks in the JADE COMPARE study. They found that at week 12, the majority of dupilumab nonresponders had high Eczema Area and Severity Index (EASI-75) responses with both doses of abrocitinib. Patients who previously had a good clinical response with dupilumab had even higher treatment responses on abrocitinib than those who were dupilumab nonresponders. These data provide important information to support the use of abrocitinib, and perhaps by extension other JAK inhibitors, in patients who previously had inadequate response to dupilumab.

Another major question is how to differentiate the JAK inhibitors from biologics in AD. One consideration is that patients taking JAK inhibitors may achieve more robust clinical responses compared with those on biologics. Stander and colleagues performed a post hoc analysis of pooled phase 2B/3 studies of abrocitinib (942 patients). They found that, at week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib achieved more robust endpoints, such as EASI-90 and EASI-100 scores, compared with placebo recipients. Of note, these data did not include any comparison data with dupilumab. However, on the basis of cross-study comparison, it would seem that abrocitinib, particularly at the higher 200 mg dose, may lead to more robust clinical responses than dupilumab. However, it is very important to acknowledge that this study focused on 12-week data and maximal efficacy with dupilumab may take longer to achieve.

Additional References

1.         Chovatiya R, Silverberg JI. The heterogeneity of atopic dermatitis. J Drugs Dermatol. 2022;21(2):172-176. Doi:  10.36849/JDD.6408

2.         Yew YW, Thyssen JP, Silverberg JI. A systematic review and meta-analysis of the regional and age-related differences in atopic dermatitis clinical characteristics. J Amer Acad Dermatol. 2019;80(2):390-401. Doi: 10.1016/j.jaad.2018.09.035