P250 Effect of secukinumab on radiographic progression through 2 years in patients with active PsA: end-of-study results from a Phase 3 study

Abstract

Background: Secukinumab demonstrated sustained efficacy, inhibition of radiographic progression and a stable safety profile over 52 weeks in patients with psoriatic arthritis (PsA) in FUTURE 5. We report the end-of-study (2-year) results on the effect of secukinumab on radiographic progression in PsA patients in FUTURE 5. Methods: Adults (N=996) with active PsA were randomised to subcutaneous secukinumab 300mg load, 150mg load, 150mg no load or placebo at baseline, Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. The secukinumab dose could be escalated from 150 to 300mg from Week 52 onwards, based on physician judgement. Radiographic progression (mean change in vdH-mTSS) was based on hand/wrist/foot radiographs obtained at baseline, and Weeks 16 (nonresponders), 24, 52 and 104, assessed by two blinded readers (plus an adjudicator if required). Radiographic data were analysed using a linear mixed-effects model (random intercept, random slopes) at Weeks 24 and 52, and as observed at Week 104. Data are presented for patients originally randomised to secukinumab (300 and 150 mg); the 150mg groups also included patients who had dose escalation to 300 mg. Analyses by prior TNF inhibitor (TNFi) status (naive vs inadequate response) were also performed. Results: Overall, 85% (300 mg), 82% (150 mg) and 75% (150mg no load) of patients completed 2 years of treatment. A total of 86 (39%) and 92 (41%) patients had their dose escalated to 300mg in the 150mg and 150mg no load groups, respectively. In the overall population, the proportions of patients with no radiographic progression (change from baseline in vdH-mTSS≤0.5) with secukinumab were 89.5% (300 mg), 82.3% (150 mg) and 81.1% (150mg no load) at 2 years; the corresponding proportions of patients with changes from baseline in vdH-mTSS≤0.0 were: 81.2%, 69.1% and 73.4%, respectively. Radiographic progression was low in secukinumab-treated patients in the overall population and by prior TNFi use over 2 years (Table 1). Clinical responses were sustained through 2 years of secukinumab treatment. Conclusion: Low radiographic progression was observed over 2 years of treatment with secukinumab 300 and 150mg in PsA patients.