Long‐term safety of risankizumab from 17 clinical trials in patients with moderate‐to‐severe plaque psoriasis. (24th November 2021)

• Record Type: Journal Article
• Authors: Gordon, K.B.; Lebwohl, M.; Papp, K.A.; Bachelez, H.; Wu, J.J.; Langley, R.G.; Blauvelt, A.; Kaplan, B.; Shah, M.; Zhao, Y.; Sinvhal, R.; Reich, K.
• Is Part Of: British journal of dermatology. Volume 186:Number 3(2022)
• Page Start: 466
• Page End: 475
• Publication Date: 2021-11-24
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.20818
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Risankizumab has demonstrated efficacy and safety in patients with moderate‐to‐severe plaque psoriasis in randomized clinical trials. Objectives: To evaluate safety data from risankizumab psoriasis phase I–III clinical trials. Methods: Short‐term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long‐term safety was evaluated using integrated data from 17 phase I–III completed and ongoing trials. Results: Short‐term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient‐years (PY) of exposure, respectively]. Long‐term analyses included 3072 risankizumab‐treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure‐adjusted adverse event rates did not increase with long‐term treatment (318 vs. 171 events per 100 PY for short‐ and long‐term analyses). With long‐term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients. Conclusions: Risankizumab demonstrated a favourable safety profile over short‐ and long‐term treatment in patients with moderate‐to‐severe psoriasis. Abstract : What is already known about this topic? In clinical trials of patients with moderate‐to‐severe plaque psoriasis, risankizumab, a selective interleukin‐23 inhibitor, was well tolerated and efficacious. What does this study add? In this comprehensive evaluation of risankizumab safety in patients with moderate‐to‐severe psoriasis, adverse event rates were comparable between risankizumab ( n = 1306, 402 patient‐years) and placebo ( n = 300, 92 patient‐years) in the short‐term (16‐week) analysis set, and were consistent with those in the long‐term analysis ( n = 3072, 7927 patient‐years of risankizumab exposure). These findings are consistent with the known safety profile of risankizumab and support its long‐term use in moderate‐to‐severe psoriasis. Linked Comment: S. Mirali et al. Br J Dermatol 2022; 186 :394–395 . Plain language summary available online