|The following article is part of conference coverage from the 2018 American Academy of Dermatology Annual Meeting in San Diego, California. Dermatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in dermatology. Check back for the latest news from AAD 2018.|
Treatment with risankizumab for moderate to severe plaque psoriasis is superior to ustekinumab and placebo, according to data from 2 phase 3 trials presented at the 2018 American Academy of Dermatology Annual Meeting, February 16-20, 2018 in San Diego, California.
Risankizumab was evaluated in the UltIMMa-1 (ClinicalTrials.gov Identifier: NCT02684370) and UltIMMa-2 (ClinicalTrials.gov Identifier: NCT02684357) replicate trials, which evaluated the safety and efficacy of risankizumab in adults with moderate to severe plaque psoriasis.
Participants were stratified by weight and prior tumor necrosis factor inhibitor exposure and randomly assigned to receive either 150 mg risankizumab, 45/90 mg ustekinumab (weight-based as per approved labeling), or placebo.
Dosing occurred at weeks 0, 4, 16, 28, and 40, with crossover to risankizumab occurring at week 16. Primary endpoints were Psoriasis Area and Severity Index (PASI) 90 and Static Physicians Global Assessment (sPGA) 0/1 at 16 weeks vs placebo, with additional comparisons between risankizumab and ustekinumab.
Overall, all primary and secondary endpoints were met (P <.001). At week 16, patients treated with risankizumab in both trials had a significantly higher PASI 90 (75.3%/ 74.8%) and sPGA (87.8%/ 83.7%) response rate compared with those who received placebo (4.9%/ 2.0%; 7.8%/ 5.1%) or ustekinumab (42.0%/ 47.5%; 63.0%/ 61.6%).
At 53 weeks, response rate was significantly greater in patients treated with risankizumab vs ustekinumab.
The most common adverse event was upper respiratory tract infection, with events comparable across all treatment groups.
Overall, risankizumab was found to be superior for the treatment of moderate to severe plaque psoriasis.
Disclosures: Both clinical trials were sponsored by AbbVie, with additional support from Boehringer Ingelheim.
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Gordon K, etal. Efficacy and safety of risankizumab: results from two double-blind, placebo- and ustekinumab-controlled, phase 3 trials in moderate-to-severe plaque psoriasis. Presented at: 2018 American Academy of Dermatology Annual Meeting. February 16-20, 2017; San Diego, CA. Abstract 6495.