|The following article is part of conference coverage from the 2018 American Academy of Dermatology Annual Meeting in San Diego, California. Dermatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in dermatology. Check back for the latest news from AAD 2018.|
Upadacitinib 30 mg, a selective JAK-1 inhibitor, is safe and effective for the treatment of moderate to severe atopic dermatitis (AD), according to results of a phase 2b trial (ClinicalTrials.gov Identifier: NCT02925117) presented at the 2018 American Academy of Dermatology Annual Meeting, February 16-20, 2018 in San Diego, California.
In the first 16 weeks of an 88-week, dose-ranging trial, 166 patients with moderate to severe AD (Eczema Area and Severity Index (EASI) score ≥16) were randomly assigned to receive once-daily upadacitinib monotherapy at either 7.5 mg, 15 mg, or 30 mg (n=42), or placebo (n=40).
All participants had an inadequate response to topical treatment, or topical treatment was deemed not medically advisable.
The mean percentage improvement in EASI from baseline to week 16 for the upadacitinib 7.5 mg, 15 mg, and 30 mg group groups was 39.4%, 61.7%, and 74.4%, respectively, compared with 23.0% in the placebo group (P <.001 for 30 mg). A score of 90 on EASI was achieved at week 16 by 14.3%, 26.2%, and 50.0% of patients in the 7.5 mg, 15 mg, and 30 mg treatment groups, respectively, compared with 2.4% in the placebo group (P <.001 for 30 mg). The mean percentage improvement in pruritus from baseline to week 16 for the treatment group was 14.3%, 26.2%, and 50.0% vs 9.7% in the placebo group.
The most common adverse events in both arms were upper respiratory tract infection and AD exacerbation. No patients in the 30 mg treatment group reported serious adverse events.
Overall, the positive response and generally safe profile of upadacitinib for the treatment of atopic dermatitis supports advancing to a phase 3 trial.
Disclosures: This trial was sponsored by AbbVie.
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Guttman E, et al. Primary results from a phase 2b, randomized, placebo-controlled trial of upadacitinib for patients with atopic dermatitis. Presented at: 2018 American Academy of Dermatology Annual Meeting. February 16-20, 2018; San Diego, CA. Abstract 6533.