Rinvoq meets endpoints in phase 3 atopic dermatitis trial

Rinvoq monotherapy has met its primary and secondary endpoints in a phase 3 study for the treatment of moderate to severe atopic dermatitis, according to a press release from AbbVie.

The multicenter, randomized, double-blind, parallel-group Measure Up 2 study, the second phase 3 trial to evaluate Rinvoq (upadacitinib 15 mg and 30 mg), compared the active drug with placebo after 16 weeks of treatment.

The study’s primary endpoint, a 75% improvement in Eczema Area Severity Index scores, was achieved in 60% of patients receiving upadacitinib 15 mg and 73% of those receiving upadacitinib 30 mg compared with 13% in the placebo group (P < .001).

A validated Investigator’s Global Assessment of Atopic Dermatitis score of 0/1 (clear or almost clear), the other primary endpoint, was achieved in 39% and 52% of the upadacitinib 15 mg and 30 mg cohorts, respectively. This compared with 5% in the placebo group (P < .001).

“We are encouraged by these results that reaffirm the data from Measure Up 1 and underscore the potential impact Rinvoq could have for individuals struggling to control their atopic dermatitis,” Michael Severino, MD, vice chairman and president, AbbVie, said in the release. “We are committed to delivering on the needs of people living with atopic dermatitis, many of whom continue to endure relentless itch and skin symptoms that can interfere with daily activities.”

Clinically meaningful reductions in itch, defined as improvement in Worst Pruritus Numerical Rating Scale 4, was achieved in 42% and 60% of those on upadacitinib 15 mg and 30 mg, respectively, compared with 9% of those on placebo (P < .001).

Serious adverse events occurred in 1.8% of patients in the 15 mg treatment group and 2.5% in the 30 mg group compared with 2.9% in the placebo group. The most common adverse events included acne, headache and upper respiratory tract infection.