POS0900 SECUKINUMAB 150 MG PROVIDES SUSTAINED IMPROVEMENT IN SIGNS AND SYMPTOMS OF NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS: 2-YEAR RESULTS FROM THE PREVENT STUDY

Abstract

Background:Axial spondyloarthritis (axSpA) is an inflammatory disease characterised by chronic back pain, and it comprises radiographic axSpA and non-radiographic axSpA (nr-axSpA).1 Secukinumab (SEC) 150 mg, with (LD) or without loading (NL), dose significantly improved the signs and symptoms of patients with nr-axSpA in the PREVENT (NCT02696031) study through Week 52.2Objectives:To report the long-term clinical efficacy and safety of secukinumab from the PREVENT study through 2 years.Methods:A detailed study design, key primary and secondary endpoints have been reported previously.2 In total, 555 patients fulfilling ASAS criteria for axSpA plus abnormal C-reactive protein (CRP) and/or MRI, without evidence of radiographic changes in sacroiliac (SI) joints according to modified New York Criteria for AS were randomised (1:1:1) to receive SEC 150 mg with LD, NL, or placebo (PBO) at baseline. LD patients received SEC 150 mg at Weeks 1, 2, 3, and 4, and then every 4 weeks (q4wk) starting at Week 4. NL patients received SEC 150 mg at baseline and PBO at weeks 1, 2, and 3, and then 150 mg q4wk. 90% patients were anti-tumour necrosis factor (anti-TNF) naïve, 57% had elevated CRP and 73% had evidence of SI joint inflammation on MRI. All images were assessed centrally before inclusion. All patients continued to receive open-label SEC 150 mg treatment after Week 52. Efficacy assessments through Week 104 included ASAS40 in anti-TNF-naïve patients, ASAS40, BASDAI change from baseline, BASDAI50, ASAS partial remission, and ASDAS-CRP inactive disease in the overall population. The safety analyses included all patients who received ≥1 dose of study treatment for the entire treatment period up to Week 104. Data are presented as observed.Results:Overall, 438 patients completed 104 weeks of study: 78.9% (146/185; LD), 77.7% (143/184; NL) and 80.1% (149/186; PBO). Efficacy results at Week 52 were sustained through Week 104 and are reported in the Table 1. The safety profile was consistent with the previous reports with no deaths reported during the entire treatment period up to Week 104.2Conclusion:Secukinumab 150 mg demonstrated sustained improvement in the signs and symptoms of patients with nr-axSpA through 2 years. Secukinumab was well tolerated with no new or unexpected safety signals.