Secukinumab improves signs and symptoms of non-radiographic axial spondyloarthritis: primary results of a randomized controlled phase III study.

OBJECTIVE: To report the primary (1-year) results from PREVENT, the first phase III study evaluating secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

METHODS: A total of 555 patients were randomized (1:1:1) to subcutaneous secukinumab 150 mg with loading (LD), without loading (NL), or placebo weekly and then every 4 weeks starting at Week 4. NL group received placebo at Weeks 1, 2, and 3 to maintain blinding. Switch to open-label secukinumab (OL) or standard of care (SoC) was permitted after Week 20. The study had 2 independent analysis plans per EU and non-US (Plan A: Week 16) and US (Plan B: Week 52) regulatory requirements. Primary endpoint was ASAS40 at Week 16 (LD) and at Week 52 (NL) in tumor necrosis factor inhibitor (TNFi)-naïve patients. Safety analyses included all patients who received ≥1 dose of study treatment.

RESULTS: Overall, 481 patients completed 52 weeks treatment: 84.3% (156/185) LD, 89.7% (165/184) NL, and 86.0% (160/186) placebo. Proportion of patients who switched to OL or SoC between Weeks 20 and 48 was 50.8% LD, 47.3% NL, and 64.0% placebo. Both primary and all secondary endpoints were met at Week 16. ASAS40 in TNFi-naïve patients was significantly higher for LD (41.5%) at Week 16 and NL (39.8%) at Week 52 versus placebo (29.2% at Week 16 and 19.9% at Week 52; both P <0.05). No new safety findings were reported.

CONCLUSIONS: Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr-axSpA through 52 weeks. Safety was consistent with previous reports.