Abrocitinib plus topical therapy effective in adolescents with atopic dermatitis
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Abrocitinib combined with a medicated topical therapy was effective, well tolerated and improved quality of life in adolescents with atopic dermatitis, according to phase 3 results from the JADE TEEN Study.
The study was presented at this year’s virtual American Academy of Allergy, Asthma and Immunology Annual Meeting.
“Abrocitinib, a novel oral janus kinase inhibitor developed for atopic dermatitis, has been studied both in the core phase 3 trials — called JADE Mono 1 and 2, as monotherapy — and in this study of 285 adolescents,” Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital and vice chair of the department of dermatology at the University of California, San Diego, told Healio Primary Care.
Efficacy, safety
Eichenfield and colleagues assessed the safety and efficacy of abrocitinib (Pfizer) in adolescents aged 12 to 17 years with moderate-to-severe atopic dermatitis who were receiving a background medicated topical therapy in the randomized, double-blind, placebo-controlled phase 3 JADE TEEN study.
Participants were randomly assigned to receive abrocitinib 200 mg daily, abrocitinib 100 mg daily or placebo in addition to medicated topical therapy for 12 weeks.
The researchers’ primary endpoints were Investigator’s Global Assessment (IGA) response of “clear” or “almost clear,” with at least a two-grade improvement, and a 75% or greater improvement on the Eczema Area and Severity Index (EASI-75) at the end of the study period. They also assessed Peak Pruritus Numerical Rating Scale (PP-NRS) responses — indicating itch — as a secondary endpoint.
A total of 285 adolescents (mean age, 14.9 years) were included in the study, with 94 participants assigned to receive abrocitinib 200 mg, 95 participants assigned to abrocitinib 100 mg, and 96 participants assigned to placebo.
Eichenfield and colleagues found that, at week 12, 46.2% of those who received 200 mg abrocitinib and 41.6% of those who received 100 mg abrocitinib achieved IGA responses, compared with 24.5% of those who received placebo.
Additionally, they found that 72% of those who received 200 mg abrocitinib and 68.5% of those who received 100 mg abrocitinib had a 75% or greater improvement on EASI-75, compared with 41.5% of those who received placebo.
For the PP-NRS, 55.4% of those who received 200 mg abrocitinib and 52.6% of those who received 100 mg abrocitinib had a four-point or greater improvement in score, compared with 29.8% of those who received placebo. The researchers observed large mean percentage reductions within 2 days of the start of treatment among those given abrocitinib compared with participants given placebo.
In addition, the researchers observed treatment-emergent adverse events in 62.8% of patients who received 200 mg abrocitinib, 56.8% of those who received 100 mg abrocitinib and 52.1% of those who received placebo. These adverse events led to discontinuation in 2.1% of those taking 200 mg abrocitinib, 1.1% of those taking 100 mg abrocitinib, and 2.1% of those taking placebo.
Eichenfield said these findings, combined with previous studies, show that “abrocitinib monotherapy or in combination with topical therapy appears effective and well tolerated in adolescents with moderate-to-severe atopic dermatitis.”
Patient-reported outcomes
In another presentation on the JADE TEEN Study, Amy McMichael, MD, a chair and professor of dermatology at Wake Forest School of Medicine, and colleagues evaluated patient-related outcomes in adolescents who received abrocitinib in addition to medicated topical therapy.
In their study, they assessed the 285 patients’ responses on the Patient Global Assessment (PtGA), Patients-Oriented Eczema Measure (POEM), Children’s Dermatology Life Quality Index (CDLQI) and the Dermatitis Family Impact (DFI).
They found that 36.6% of participants who received 200 mg abrocitinib and 30% of those who received 100 mg achieved PtGA responses of “clear” or “almost clear” and had at least a two-grade improvement in response from baseline, compared with 10.6% of those who received placebo.
McMichael and colleagues also found that 83.9% of those given 200 mg abrocitinib and 77% of those given 100 mg abrocitinib had an improvement of four points or greater from baseline on the POEM, compared with 60.2% of those who received placebo.
For the CDLQI, 78.5% of those who received 200 mg abrocitinib and 80.9% of those who received 100 mg abrocitinib had at least a 2.5-point improvement in score from baseline to week 12, compared with 67.7% of those who received placebo.
The researchers also found that, for DFI scores reported by caregivers, the least-square mean score reductions at week 12 were –7.3 (95% CI, –8.6 to –6.0) with 200 mg abrocitinib, –6.7 (95% CI, –7.9 to –5.4) with 100 mg abrocitinib and –5.2 (95% CI, –6.5 to –3.9) with placebo.
During the presentation, McMichael said that “among adolescents with moderate-to-severe atopic dermatitis, abrocitinib combined with medicated topical therapy substantially improved patient-reported signs and symptoms of their atopic dermatitis. It also improved quality of life of the adolescents and their caregivers, and reduced the loss due to the atopic dermatitis, and changes in all of these were detected as early as week 2.”
She added that longer-term studies are needed to assess “durability of the response.”
References:
- Eichenfield L, et al. Abstract 467. Presented at: AAAAI Annual Meeting; February 26-March 1, 2021. (Virtual)
- McMichael A, et al. Abstract 498. Presented at: AAAAI Annual Meeting; February 26-March 1, 2021. (Virtual)