Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis

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 center dot 2 and 92 center dot 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 center dot 9 years (range 2 days to 5 center dot 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 center dot 8 per 100 PY, serious infections 1 center dot 2 per 100 PY, nonmelanoma skin cancer (NMSC) 0 center dot 7 per 100 PY, malignant tumours excluding NMSC 0 center dot 5 per 100 PY, and adjudicated major adverse cardiovascular events 0 center dot 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.