Vunakizumab shows early efficacy in plaque psoriasis
Vunakizumab showed efficacy in treating moderate to severe plaque psoriasis at all dose levels, with a 240 mg dose showing the best clinical response, according to a phase 2 trial.
“Vunakizumab (SHR-1314) is a novel humanized monoclonal immunoglobulin (IgG1 kappa isotype) targeting IL-17A,” Chunlei Zhang, PhD, of Peking University Third Hospital in Beijing, and colleagues wrote.
This 36-week multicenter, randomized, double-blind, dose ranging phase 2 study included 187 psoriasis patients randomly assigned to receive 40 mg, 80 mg, 160 mg or 240 mg of vunakizumab or placebo. Subjects received subcutaneous injections at week 0, 4, 8 and 12. After week 12 patients in the vunakizumab groups received doses at week 16 and week 20, while those in the placebo group received standard of care. Follow-up continued for an additional 16 weeks.
A 75% or greater improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12 was the study’s main endpoint.
Significantly greater proportions of the four treatment groups achieved PASI 75 compared with the placebo group, with 56.8% of the 40 mg group, 65.8% of the 80 mg group, 81.6% of the 160 mg group and 86.5% of the 240 mg group, compared with 5.4% of the placebo group (P < .001 for all).
Physician Global Assessment scores of 0 or 1 (clear or almost clear) were recorded in 45.9%, 47.4%, 60.5% and 73% of the treatment groups, respectively, compared with 8.1% of the placebo group at week 12.
In addition, Dermatology Life Quality Index scores of 0 or 1 were 28.9% to 63.2% in the treatment groups, compared with 5.4% of the placebo group.
Adverse events were reported in 108 (72%) of the 150 patients treated with vunakizumab and 24 (64.9%) of the 37 placebo-treated patients, with treatment-related adverse events in 65 patients (43.3%) receiving vunakizumab and 11 patients (29.7%) receiving placebo. The most frequent adverse events were upper respiratory infections (16.7% of vunakizumab group and 16.2% of the placebo group), hepatic enzyme abnormalities (8.1% and 8.7%), hyperuricemia (7.3% and 8.1%) and injection site reaction (6% and 8.1%).
One patient discontinued treatment due to adverse events.
“Vunakizumab showed promising efficacy for moderate to severe plaque psoriasis, with good tolerability in this phase 2 trial,” the authors wrote. “Larger and longer studies are needed to better assess the overall efficacy and safety profile of vunakizumab.”