FRI0272 SECUKINUMAB DEMONSTRATES A CONSISTENT SAFETY PROFILE IN PATIENTS WITH PSORIASIS, PSORIATIC ARTHRITIS AND ANKYLOSING SPONDYLITIS OVER LONG TERM: UPDATED POOLED SAFETY ANALYSES

Abstract

Background: Pooled safety data has been reported with secukinumab (SEC) in patients (pts) with Psoriatic arthritis (PsA), Ankylosing Spondylitis (AS) and Psoriasis (PsO).1 Objectives: To report longer‐term safety data of SEC treatment in PsA, AS, PsO pts up to 5 years. Methods: The integrated clinical trial safety dataset included data pooled from 28 randomised controlled clinical trials of SEC 300 or 150 or 75 mg in PsO (11 Phase 3 and 8 Phase 4 trials), PsA (5 Phase 3 trials), and AS (4 Phase 3 trials), along with post‐marketing safety surveillance data with a cut‐off date of 25 December 2018. Adverse events (AEs) were reported as exposure‐adjusted incident rates (EAIRs) per 100 pt‐years. Analyses included all pts who received ≥1 dose of SEC. Results: A total of 12637 pts (8819, 2678 and 1140 pts with PsO, PsA and AS, with an exposure of 15063.1, 5984.6 and 3527.2 pt‐years, respectively) were included. The most frequent AE was upper respiratory tract infection and EAIR per 100 pt‐years for IBD, malignancies and MACE remained low. The EAIR per 100 pt‐years for adverse events (AEs) of special interest are reported in Table 1. The cumulative post‐marketing exposure to SEC was estimated to be ~285,811 pt‐years across the approved indications. Safety data from post‐marketing surveillance are reported in Table 2. (Table Presented) Conclusion: In this long‐term analysis across clinical trials and post‐marketing surveillance, of pts with PsO, PsA and AS, SEC was well tolerated, with a safety profile consistent with previous reports.