Risankizumab clears psoriasis in half of patients in 2 studies
The humanized IgG1 monoclonal antibody risankizumab cleared plaque psoriasis better than ustekinumab and placebo in two phase III head-to-head studies. Risankizumab also appeared to be superior to ustekinumab or placebo in many endpoints.
“In looking at a medication that gets 56 percent of patients in a clinical trial clear at 1 year – that’s a tremendous change in how we think about treating patients,” said Dr Kenneth Gordon from the Medical College of Wisconsin in Milwaukee, US, who presented the findings at the AAD 2018 meeting. Getting many patients with psoriasis clear could represent a fundamental change in patient care, he added.
Both the ultIMMa-1 and -2 trials met the co-primary endpoints of 90 percent improvement from baseline of the Psoriasis Area and Severity Index (PASI 90) score and achievement of the Static Physicians Global Assessment (sPGA) score of 0/1 (clear to almost clear skin) well as the ranked secondary endpoints (p<0.001), representing a high level of evidence for the efficacy of risankizumab, said Gordon. [AAD 2018, abstract 6495]
At 16 weeks, 75 percent of patients treated with risankizumab in the ultIMMa-1 trial achieved PASI 90 response vs 42 percent and 4.9 percent of those treated with ustekinumab and placebo, respectively. The same results were seen in the ultIMMa-2 trial. At 52 weeks, patients on risankizumab achieved significantly higher response rates vs those on ustekinumab.
The sPGA 0/1 response was comparable to the PASI 90 response, with risankizumab showing superiority to ustekinumab at both 16 and 52 weeks.
Rates of treatment-emergent adverse events (TEAEs) were also similar across the three groups throughout the duration of the studies, with upper respiratory tract infection as the most frequently reported TEAE.
PASI 100 (complete clearance) responses for risankizumab at week 16 were 36 percent in the ultIMMa-1 and 51 percent in the ultIMMa-2 trial vs 12 and 24 percent for ustekinumab and 0 and 2 percent for placebo. “The differences in the two studies pretty much even out when you take it out through the year as up to 56.3 percent and 59 percent of patients treated for a year with risankizumab reached PASI 100.”
Patients in the ultIMMa-1 trial were ≥18 years at screening, with stable moderate-to-severe chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months, body surface area (BSA) ≥ 10 percent, PASI score ≥12, sPGA score ≥3, and candidates for phototherapy or systemic therapy.
They were stratified by weight and prior TNF inhibitor exposure and randomized to an injection of risankizumab 150 mg, ustekinumab 45 or 90 mg, or a matching placebo at baseline, and followed by another injection after 4 weeks. At 16 weeks, patients in the placebo group crossed over to risankizumab and received injections which were repeated at 28 and 40 weeks.
At 16 and 52 weeks, risankizumab was superior to ustekinumab on both primary endpoints. In both studies, there were no new signals with risankizumab. The safety profile of risankizumab was consistent with previously reported phase 3 studies, said the researchers.