Two phase III trials show positive safety and efficacy of ABBV 066 in plaque psoriasis.- AbbVie.

AbbVie presented new positive results from the pivotal Phase III ultIMMa-1 and ultIMMa-2 replicate clinical trials that evaluated the safety and efficacy of ABBV 066 (risankizumab 150 mg) compared to placebo or ustekinumab (45 or 90 mg, based on patient weight) in adult patients with moderate to severe chronic plaque psoriasis. Results at week 16 and one year (52 weeks) demonstrated significantly higher rates of clear skin (sPGA 0), both ranked secondary endpoints, in patients treated with risankizumab, compared to ustekinumab patients in ultIMMa-1 and ultIMMa-2 (58% and 60% vs 21% and 30% respectively).

In an exploratory analysis at one year (52 weeks), more risankizumab patients also demonstrated clear or almost clear skin (sPGA 0/1), compared to ustekinumab patients in ultIMMa-1 and ultIMMa-2 (86% and 83% vs 54% and 55% respectively).In addition, more patients treated with risankizumab reported a DLQI score of 0 or 1 versus ustekinumab at 16 weeks, a ranked secondary endpoint, and one year (75% and 71% vs 47% and 44% at 52 weeks, respectively). DLQI is a measure of a patient's health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality. In both the ultIMMa-1 and ultIMMa-2 trials, the most frequently reported treatment-emergent adverse events in the risankizumab arms were upper respiratory tract infection. These results were featured during the "Late-breaking Research: Clinical Trials" session at the 2018 American Academy of Dermatology Annual Meeting in San Diego.

Comment: Risankizumab is an investigational interleukin-23 (IL-23) inhibitor being evaluated for the treatment of patients with moderate to severe plaque psoriasis. Risankizumab is not approved by regulatory authorities.