Key clinical point: Ixekizumab demonstrated an overall consistent safety and tolerability profile with no unexpected/new adverse events (AE) in patients with psoriatic arthritis (PsA) and up to 3 years of exposure to ixekizumab.
Major finding: Treatment-emergent (mostly mild/moderate) and serious AE occurred in 80.7% and 9.6% of patients, respectively. The most common infections were nasopharyngitis, upper respiratory tract infection, bronchitis, and sinusitis, with frequency for serious events being ≤2%. The exposure-adjusted incidence rate for treatment-emergent AE reduced from 87 in the first year to 67.3 in the third year of ixekizumab exposure and was <2 for malignancies, inflammatory bowel disease, depression, and major adverse cerebrocardiovascular events.
Study details: This integrated safety analysis of four phase 3 trials included 1401 patients with active PsA and a cumulative ixekizumab exposure of 2247.7 patient-years.
Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.
Source: Deodhar AA et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 (Apr 7). Doi: 10.1136/annrheumdis-2021-222027