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Rinvoq, a JAK inhibitor, is still under review at the FDA as a treatment of atopic dermatitis.
While AbbVie waits for word from the FDA on its application for Rinvoq (upadacitinib) to treat atopic dermatitis, the company recently presented new analyses from phase 3 trials at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
One analysis showed a greater proportion of patients treated with 15 mg or 30 mg of Rinvoq once daily with or without topical corticosteroids achieved 75% improvement in the Eczema Area Severity Index (EASI 75) at week 16 compared with placebo. Investigators presented results from three studies — Measure Up 1, Measure Up 2 and AD Up — of efficacy data based on age, weight, sex, disease severity, race/ethnicity and previous treatment history. More than half of all patients for all subgroups achieved EASI 75 for Rinvoq 15 mg regardless of patient characteristics.
Additionally, an analysis from the Heads Up trial showed more patients treated with Rinvoq 30 mg achieved EASI 75 at week 16 compared with Regeneron’s Dupixant (dupilumab). In another presentation, investigators presented interim data from an open-label extension trial that followed the Heads Up trial with 245 patients initially randomized to Dupixant who were candidates for continued treatment with Rinvoq. At 16 weeks after the switch to Rinvoq, treatment with Rinvoq resulted in high rates of skin clearance and itch improvement.
Atopic dermatitis is a common, chronic skin condition with persistent or relapsing lesions. It occurs in 7.3% of adults in the United States, and the prevalence is increasing. Of those affected with the disease, about 40% have moderate or severe symptoms. Many patients also suffer from asthma and allergic rhinitis along with intense itching and skin infection.
Rinvoq is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. The therapy is currently under review by the FDA. Although the European Commission in August 2021 approved Rinvoq to treat adults and adolescents with atopic dermatitis, the FDA extended the review period as it reviews safety data for this class of therapies.
This review was undertaken as a result of data released by Pfizer of a postmarketing study of a cardiovascular safety trial of its JAK inhibitor Xeljanz (tofacitinib). Investigators found that the use of JAK inhibitors appears to be associated with major cardiovascular adverse events and malignancies.
As a result of an extended review, the FDA required warnings on the JAK inhibitors approved to treat arthritis and ulcerative colitis about the increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death.
The only systemic biologic therapy on the market to treat atopic dermatitis is Dupixent, a monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13).
Rinvoq is approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate-to-severe atopic dermatitis. Rinvoq 15 mg is also approved in the EU for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis.
Phase 3 trials of Rinvoq in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondylarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.