LONG-TERM SAFETY of RISANKIZUMAB in PATIENTS with PSORIATIC DISEASE: FINDINGS from INTEGRATED ANALYSES of 17 CLINICAL TRIALS in PSORIASIS and 4 in PSORIATIC ARTHRITIS

ABSTRACT

Background: Risankizumab, an interleukin-23 inhibitor, was efficacious and well tolerated in phase 2 and 3 clinical studies in patients with psoriatic disease. Objectives: To report long-term risankizumab safety in patients with psoriatic disease. Methods: Risankizumab safety data to March 25, 2021 were pooled from 17 phase 1-3 clinical trials in plaque psoriasis (PsO) and 4 phase 2/3 trials in pso-riatic arthritis (PsA). Adverse events (AEs) of safety interest were reported for patients receiving ≥1 dose risankizumab. Results: Among 3197 patients with PsO (9982.6 patient years' [PY] exposure;median (range) treatment duration, 3.7 years [1 day-6.9 years]) and 1542 patients with PsA (1594.9 PY;1. 0 year [84 days-2.0 years]), rates of treatment-emergent AEs (158.3 and 160.8 events (E)/100PY), serious AEs (7.6 and 8.4 E/100PY) and AEs leading to discontinuation (1.9 and 2.3 E/100PY) were similar. Nasopharyn-gitis (PsO 14.5 E/100PY, PsA 7. 9 E/100PY) and upper respiratory infection (PsO 7. 8 E/100PY, PsA 5.6 E/100PY) were the most common infections;sepsis and pneumonia for PsO (0.1 E/100PY each) and COVID-19 for PsA (0.4 E/100PY) were the most common serious infections. Rates of opportunistic fungal infections were <0.1 and 0.1 E/100PY in PsO/PsA patients. Rates of non-melanoma skin cancer (NMSC) were 0.7 and 0.4 E/100PY, and malignant tumors excluding NMSC were 0.6 and 0.3 E/100PY in PsO/PsA patients. Rates of major adverse cardiovascular events were 0.5 and 0.4 E/100PY in PsO/PsA patients. Conclusion: Rates of AEs of safety interest remained low in this largest and longest safety reporting for risankizumab to date, supporting the safety of risankizumab for the long-term treatment of patients with psoriatic disease.