AbbVie has reported positive results from the Phase III Measure Up 2 clinical trial of Rinvoq (upadacitinib) as a monotherapy in patients with moderate to severe atopic dermatitis.
The trial compared the safety and efficacy of two doses of upadacitinib to placebo in adolescent and adult patients eligible for systemic therapy.
According to the data, the trial met all primary and secondary endpoints.
The co-primary endpoints were at least a 75% improvement in the Eczema Area Severity Index (EASI 75) and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1, which indicates clear or almost clear, at week 16.
AbbVie said that a higher proportion of patients on either dose of upadacitinib experienced improvement in skin clearance and a decrease in itch versus placebo at week 16.
Compared to 13% in the placebo arm, 60% and 73% of patients treated with upadacitinib 15mg or 30mg reached EASI 75, respectively.
Furthermore, 39% and 52% of patients on upadacitinib 15mg or 30mg achieved vIGA-AD 0/1, respectively, compared to 5% with placebo.
AbbVie vice-chairman and president Michael Severino said: “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.
“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.”
At week 16, 42% or 60% of patients on a 15mg or 30mg dose of the drug showed clinically meaningful reductions in itch, respectively, versus 9% on placebo. The company said that an early reduction in itch was observed with both doses and was maintained until week 16.
Investigators did not report any new safety risks compared to the safety profile in rheumatoid arthritis and psoriatic arthritis patients treated with Rinvoq.
The most common adverse events of the drug were acne, headache, and upper respiratory tract infection.
In February this year, AbbVie reported that the Phase III SELECT-PsA 1 study of Rinvoq met its primary endpoint in adults with active psoriatic arthritis.