Safety Profile in Patients With Psoriatic Arthritis Treated With Risankizumab Similar to That in Patients With Plaque Psoriasis
More patients with psoriatic arthritis (PsA) discontinue treatment with risankizumab due to adverse events (AEs) than do patients with plaque psoriasis (PsO), according to a pooled analysis of more than 20 clinical trials.
The rate was 2.3 events leading to discontinuation per 100 patient years (E/100PY) among patients with PsA, compared with 1.9 among patients with PsO. These data are being presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting.
The researchers presented “the longest safety reporting for risankizumab to date, supporting the safety of risankizumab for…long-term treatment,” wrote lead author Kenneth Gordon, MD, Medical College of Wisconsin, and colleagues.
The scientists analyzed data from 17 phase 1–3 clinical trials in PsO and 4 phase 2/3 trials in PsA, and presented safety data up to March 25, 2021 for 3197 patients with PsO (median treatment duration, 3.7 years [1 day–6.9 years]) and 1542 patients with PsA (1 year [84 days–2 years]).
The rates of treatment-emergent AEs (158.3 and 160.8 events (E)/100PY) were similar between patients with both conditions. But not only did those with PsA experience a higher rate of discontinuation due to adverse events, but they experienced more serious AEs: 8.4 E/100PY compared with 7.6.
The most common infections were nasopharyngitis (PsO: 14.5 E/100PY; PsA: 7.9 E/100PY) and upper respiratory infection (PsO: 7.8 E/100PY; PsA: 5.6 E/100PY). The most common serious infections among patients with PsO were sepsis and pneumonia; in those with PsA, COVID-19 was the most common serious infection (0.4 E/100PY). It was noted that the PsA trials were conducted during the COVID-19 pandemic. -John Otrompke
Reference
Gordon K, Blauvelt A, Bachelez H, et al. 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. Poster presented at: AAD Annual Meeting; March 25-29, 2022; Boston, MA.