185 Secukinumab demonstrates consistent safety over long-term exposure in patients with psoriatic arthritis and moderate-to-severe plaque psoriasis: updated pooled safety analyses

Abstract

Background: Pooled safety data from secukinumab psoriasis and psoriatic arthritis (PsA) clinical trial programmes after ≥1 year of exposure have been reported previously. Here, we report on the updated longer-term safety data of secukinumab exposure from psoriasis and PsA studies Methods: The psoriasis data pool consisted of nine Phase 3 studies in moderate-to-severe plaque psoriasis and the PsA pool consisted of three Phase 3 studies in active PsA. Secukinumab doses differed in the studies and included intravenous (up to 10 mg/kg) or subcutaneous (s.c.; 75-300 mg) loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were re-randomised to secukinumab at 12-24 weeks, depending on the study design. Exposure-adjusted incident rates (EAIRs) were used to adjust for differences in treatment exposure and analyses included all patients who received -1 dose of secukinumab. Results: A total of 3,893 and 1,380 patients from psoriasis and PsA studies representing an exposure of 7,769.0 and 2,841.3 patient years, respectively, were included in this pooled safety analysis. In both psoriasis and PsA, the most frequently reported adverse events (AEs) with secukinumab were nasopharyngitis, headache, non-serious infections of the upper respiratory tract, and arthralgia (Table). The EAIRs of AEs of special interest with secukinumab including serious infections, Candida infections, inflammatory bowel disease, and major adverse cardiac events (Table) were similar in both psoriasis and PsA indications, and comparable to those reported previously. No cases of tuberculosis were reported. Conclusion: Secukinumab demonstrated a favourable safety profile during long-term treatment (up to 7,769 patient-years of exposure) in patients with moderate-to-severe plaque psoriasis or PsA consistent with previous reports, with no new safety signals. Safety was comparable across psoriasis and PsA patients supporting long-term use in these chronic conditions. (Table Presented).