The British journal of dermatology | 2021
Long-Term Safety of Risankizumab From 17 Clinical Trials in Patients With Moderate-to-Severe Plaque Psoriasis.
Abstract
BACKGROUND\nRisankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.\n\n\nOBJECTIVES\nWe evaluated safety data from risankizumab psoriasis phase 1-3 clinical trials.\n\n\nMETHODS\nShort-term safety (through week 16) was analyzed using integrated data from five phase 2 and 3 clinical trials; long-term safety was evaluated using integrated data from 17 phase 1-3 completed and ongoing trials.\n\n\nRESULTS\nShort-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: 7927.2 PY); median (range, excluding 4 outliers) treatment duration was 2.9 years (2 days-5.9 years). Exposure-adjusted adverse event (AE) rates did not increase with long-term treatment (318.0 vs 170.9 events/100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious AEs were 7.8/100 PY, serious infections, 1.2/100 PY, non-melanoma skin cancer (NMSC), 0.7/100 PY, malignant tumors excluding NMSC, 0.5/100 PY, and adjudicated major adverse cardiovascular events, 0.3/100 PY, with no important identified risks. Limitations include that study inclusion/exclusion criteria varied and three studies enrolled ≤50 patients.\n\n\nCONCLUSIONS\nRisankizumab demonstrated a favorable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.