Risankizumab has a favorable safety profile for short- and long-term treatment in patients with moderate to severe psoriasis, according to study findings published in the British Journal of Dermatology.
Investigators analyzed the long-term safety data of risankizumab, a selective interleukin-23 inhibitor, in 17 phase 1 to 3 trials in patients with moderate to severe plaque psoriasis, as well as the short-term safety data through week 16 from the placebo-controlled, double-blinded period of 5 of these trials. The cutoff for the ongoing trials in the long-term analysis set was March 25, 2020.
A total of 3,072 patients who received risankizumab (median age, 48 years; 69.3% men; 78.3% White) were included in the long-term analysis set, with 7,929.2 cumulative patient years of risankizumab exposure. Their median treatment duration was 2.9 years. The short-term analysis included 1,306 patients (median age, 48 years; 69.5% men; 78.1% White) who received risankizumab, with 402.2 patient years of exposure.
A total of 1,279 adverse events (AEs) occurred in the short-term group vs 13,548 AEs in the long-term group. The exposure-adjusted event rate (EAER) in the long-term analysis group was 170.9 events/100 patient years, compared with 318.0 events/100 patient years for the short-term analyses. EAERs were similar in risankizumab and placebo groups in the short-term analysis and were consistent with those in the long-term analysis group. The EAER for serious events was 7.8/100 patients years in the long-term analysis and 9.9/100 patient years in the short-term analysis.
Regarding specific AEs in the long-term analysis, the EAER for serious infection was 1.2/100 patient years, the rate for both nonmelanoma skin cancer (NMSC) and depression was 0.7/100 patient years, and the rate for malignant tumors excluding NMSC was 0.5/100 patient years.
A post-hoc subanalysis of patients aged 65 years and older (11.7% of the analysis population) found that EAERs were consistent with or lower than those that occurred in the entire cohort, with the exception of malignancies excluding NMSC and deaths.
Study limitations include the lack of long-term comparators, the possible inclusion of healthier patients in clinical trials in general, and EAER estimations were not adjusted for heterogeneity among the trials.
“These data do not identify any new potential safety signals for risankizumab,” concluded the researchers. “These reassuring results should inform decisions that practitioners make regarding long-term treatment options for their patients with moderate to severe psoriasis.”
Disclosure: The study was sponsored by AbbVie. Several of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Gordon KB, Lebwohl M, Papp KA, et al. Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. Published online October 15, 2021. doi: 10.1111/bjd.20818