Background/Purpose: Secukinumab has demonstrated a consistent and reliable safety profile in three Phase 3 studies in ankylosing spondylitis (AS): MEASURE 1 (NCT01358175), MEASURE 2 (NCT01649375), and MEASURE 3 (NCT02008916).^1–4 Here, we report long-term (up to 3 years) pooled safety and tolerability data for secukinumab from these three studies (data cut-off: June 25, 2016).

Methods: Overall, 371, 219, and 226 patients with active AS were randomized in MEASURE 1, MEASURE 2, and MEASURE 3, respectively. Study design, efficacy, and safety results of these studies have been reported elsewhere.^4,5 Secukinumab doses differed in the studies and included intravenous 10 mg/kg or subcutaneous (s.c.; 75–300 mg) multi-dose loading, followed by s.c. maintenance dosing (75, 150, or 300 mg). Data collected up to the last patient performing the Week (Wk) 156 visit in MEASURE 1, the Wk 104 visit in MEASURE 2, and the Wk 52 visit in MEASURE 3 were pooled at the individual patient level. Exposure-adjusted incidence rates were calculated to account for differences in treatment exposure, and safety analyses included all patients who received ≥1 dose of secukinumab.

Results: A total of 794 patients were included in the analysis (representing 1706.3 patient-years of exposure). The exposure-adjusted incidence rates of adverse events (AEs) and serious AEs with secukinumab across the entire safety period were 146.8 and 6.2 per 100 patient-years, respectively. Nasopharyngitis, diarrhea, headache and upper respiratory tract infections were the most frequently reported AEs (Table). The incidences of serious infections, Candida infections, uveitis, and inflammatory bowel disease were low and consistent with previous reports over shorter exposure periods¹ (Table). No cases of suicidal ideation or depression were reported.

Conclusion: Secukinumab was well tolerated during long term treatment (representing 1706.3 patient-years of exposure) in patients with AS, with a favorable safety profile consistent with previous reports, with no new safety signals.

References: 1. Braun J, et al. Ann Rheum Dis. 2017;76:1070-7; 2. Baraliakos X, et al. Clin Exp Rheumatol. 2017; 3. Marzo-Ortega H, et al. Arthritis Care Res (Hoboken). 2017;doi: 10.1002/acr.23233; 4. Kivitz A, et al. XIX PANLAR 2016, Panamá City, Panama. Poster No. P-081; 5. Baeten D, et al. N Engl J Med 2015;373:2534–48.