Long‐term safety of risankizumab from 17 clinical trials in patients with moderate‐to‐severe plaque psoriasis
British Journal of Dermatology Oct 21, 2021
Gordon KB, Lebwohl M, Papp KA, et al. - Findings showed a favorable safety profile of risankizumab over short- and long-term treatment in patients suffering from moderate-to-severe psoriasis.
Short- and- long-term analyses were conducted using integrated data from five phase 2 and 3 clinical trials and using integrated data from 17 phase 1–3 completed and ongoing trials, respectively.
Risankizumab-treated patients were 1,306 and 3,072 in the short-term and long-term analyses, respectively.
Long-term therapy did not elevate the rates of exposure-adjusted adverse event (AE) rates.
Rates of serious AEs with long-term risankizumab were 7.8/100 patient-years [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 crucial identified risks.
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