AbbVie’s JAK Inhibitor Rinvoq Demonstrates Significant Efficacy in Phase 3 Trial for Atopic Dermatitis

Today, AbbVie announced that its JAK inhibitor Rinvoq (upadacitinib), in combination with topical corticosteroids (TCS), met both co-primary endpoints and all secondary endpoints in the pivotal Phase 3 AD Up clinical trial for atopic dermatitis. This marks the third pivotal Phase 3 study in which Rinvoq has demonstrated positive results for the treatment of atopic dermatitis.

Atopic dermatitis is a common, chronic, relapsing, inflammatory skin disease characterized by recurrent cycles of itching and scratching, leading to skin pain and fissures. It is estimated that 25% of adolescents and 10% of adults are affected by this condition at some point in their lives. Between 20% and 46% of adult patients with atopic dermatitis have moderate-to-severe disease. The condition imposes significant physical, psychological, and economic burdens on affected individuals.

Rinvoq, discovered and developed by AbbVie scientists, is an oral, once-daily, selective and reversible JAK inhibitor. In August 2019, it received approval from the U.S. FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

In this study, patients with moderate-to-severe atopic dermatitis received placebo, upadacitinib 15 mg, or upadacitinib 30 mg, with all patients concurrently receiving topical corticosteroids (TCS). Trial results demonstrated that, at Week 16, a greater proportion of patients in both upadacitinib + TCS groups achieved significant improvement in skin symptoms compared with the placebo + TCS group. Among patients treated with upadacitinib (15/30 mg) + TCS, 65% and 77%, respectively, achieved an EASI-75 response (≥75% improvement in the Eczema Area and Severity Index), versus 26% in the placebo group (p<0.001). Based on the vIGA-AD score, 40% and 59% of patients in the upadacitinib (15/30 mg) + TCS groups, respectively, achieved a score of 0 or 1 (clear or almost clear skin), compared with 11% in the placebo group (p<0.001).

▲Primary Results of the AD Up Clinical Trial at 16 Weeks (Image source: Reference [1], click to view full-size image)

In a prespecified supplementary analysis, upadacitinib treatment also resulted in an increased number of days without the use of topical corticosteroids (TCS) through Week 16 compared with placebo. Among patients receiving upadacitinib (15/30 mg), the mean number of TCS-free days while maintaining EASI 75 response was 34 and 47 days, respectively, compared with 8 days in the placebo group (p<0.001). Upadacitinib also significantly reduced the severity of pruritus in patients.

“These results are encouraging, including analyses showing that some patients in the upadacitinib treatment group were able to control their skin symptoms without topical corticosteroids,” said Dr. Kristian Reich, Head of the Clinical Trial from the University Medical Center Hamburg-Eppendorf in Germany. “Many current treatment regimens rely on patients self-managing their condition, often requiring multiple applications of topical medications. Patients can benefit from additional treatment options that help control symptoms without the need for frequent use of topical agents.”

References:

[1] Third Pivotal Phase 3 Study Shows RINVOQ™ (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients. Retrieved July 28, 2020, from https://www.prnewswire.com/news-releases/third-pivotal-phase-3-study-shows-rinvoq-upadacitinib-plus-topical-corticosteroids-improves-skin-and-itch-symptoms-in-atopic-dermatitis-patients-301100693.html

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