AbbVie Announces Rinvoq (Upadacitinib) Achieves Primary Endpoints in Phase 3 Trial for Moderate-to-Severe Atopic Dermatitis

Today, AbbVie announced that its JAK inhibitor Rinvoq (upadacitinib), as a monotherapy, met the co-primary endpoints in pivotal Phase 3 clinical trials for patients with moderate-to-severe atopic dermatitis, significantly reducing skin symptoms.

Atopic dermatitis is a common, chronic, relapsing, inflammatory skin disease characterized by recurrent cycles of itching and scratching, leading to skin pain and fissuring. 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 was approved by 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 the Phase 3 clinical trial named Measure Up 1, patients receiving Rinvoq monotherapy at doses of 15 mg or 30 mg showed significant improvement in skin symptom clearance. At Week 16 of treatment, 70% and 80% of patients, respectively, achieved EASI 75 (at least a 75% improvement in the Eczema Area and Severity Index), compared to 16% in the placebo group (p<0.001).

Using the vIGA score, 48% and 62% of patients treated with Rinvoq (15/30 mg) achieved scores of 0 (complete clearance of skin symptoms) or 1 (almost complete clearance of skin symptoms), respectively, compared to 8% in the placebo group (p<0.001).

“Patients with atopic dermatitis often struggle with skin and pruritus symptoms, and there remains a significant unmet need,” said Michael Severino, M.D., President of AbbVie Inc. “We are very excited about these results, which demonstrate the potential therapeutic benefit of Rinvoq for patients with atopic dermatitis.”

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