Study: Investigational Psoriasis Therapy Superior to Ustekinumab
At this year’s American Academy of Dermatology annual meeting, Kenneth Gordon, MD, and colleagues presented results from 2 phase 3 trials that showed risankizumab was superior to ustekinumab (Stelara) for treating patients with moderate to severe plaque psoriasis.
“Not only do these data show significant rates of clear skin, but because we know the burden of psoriasis extends beyond the skin, we are encouraged by the patient-reported improvement in quality of life after 1 year of treatment,” said Kenneth B. Gordon, MD, chair of the Department of Dermatology at the Medical College of Wisconsin and principal investigator of the ultIMMa-1 study.
The ultIMMa-1 and ultIMMa-2 replicate clinical trials assessed the safety and efficacy of risankizumab compared with ustekinumab and placebo. In ultIMMa-1, 304 participants were randomly assigned to receive 150 mg of risankizumab and 100 participants were randomly assigned to receive 45 mg or 90 mg of ustekinumab based on their weight. ultIMMa-2 included 294 participants randomly assigned to receive 150 mg of risankizumab and 99 participants randomly assigned to receive 45 or 90 mg of ustekinumab.
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Primary endpoints included the achievement of at least a 90% improvement in Psoriasis Area and Severity Index (PASI 90) score at week 16 and achievement of a static Physician Global Assessment (sPGA) score of 0 or 0/1 (clear or almost clear skin) at week 16 compared with placebo. In addition, PASI 90, sPGA score of 0, sPGA score of 0/1, and Dermatology Life Quality Index score of 0 or 1 were compared between risankizumab and ustekinumab at week 16 and week 52.
After 16 weeks of treatment, 37% and 51% of participants who received risankizumab in ultIMMa-1 and ultIMMa-2, respectively, achieved sPGA 0 compared with those who received ustekinumab (ultIMMa-1: 14%; ultIMMa-2: 25%). Clear skin was achieved by 58% of participants in ultIMMa-1 and 60% of participants in ultIMMa-2 after 1 year of treatment with risankizumab compared with ustekinumab (ultIMMa-1: 54%; ultIMMa-2: 55%).
In addition, 66% and 67% of participants who received risankizumab in ultIMMa-1 and ultIMMa-2, respectively, reported DLQI of 0 or 1 at week 16 compared with those who received ustekinumab (43% and 47%, respectively). At 52 weeks, 75% and 71% of participants who received risankizumab in ultIMMa-1 and ultIMMa-2, respectively, reported DLQI of 0 or 1 compared with 47% and 44% among those who received ustekinumab in ultIMMa-1 and ultIMMa-2, respectively.
The most frequently reported treatment-emergent adverse event in both trials was upper respiratory tract infection among participants who received risankizumab, with 1 participant presenting with latent tuberculosis.
Gordon KB, et al. 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: American Academy of Dermatology Annual Meeting; February 16-20, 2018; San Diego, CA. Abstract 6945.