Secukinumab Effective in Non-Radiographic Axial SpA Save

The PREVENT trial was a one year, phase III study that showed significant benefits when secukinumab (SEC) was given to patients with active non‐radiographic axial spondyloarthritis (nr‐axSpA) for 52 weeks.

To be enrolled patients had to have inflammatory low back pain and have either an elevated CRP or abnormal MRI of the SI joint. Patients were ~70% HLA-B27+ and 90% were TNF inhibitor naive and 10-15% continued on background methotrexate or sulfasalazine. 

This multicenter trial entered 555 nr-axSpA patients who 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.  Patients were allowed to switch to open‐label secukinumab (OL) or standard of care (SoC) after Week 20 for patient and investigator defined lack of response. The primary endpoint was ASAS40 at Week 16 (LD) and at Week 52 (NL) in tumor necrosis factor inhibitor (TNFi)‐naïve patients.

Roughly 85% (n 481) of patients completed 52 weeks treatment.

SEC was superior at primary and all secondary endpoints at Week 16.  The ASAS40 in TNFi‐naïve patients was significantly higher for SEC treated patients:

• SEC with LD = 41.5% at Week 16
• Placebo = 29.2% at Week 16
• SEC without (NL) = 39.8% at Week 52
• Placebo = 19.9% at Week 52; (both P <0.05).

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.

There were no new safety findings reported.

Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr‐axSpA through 52 weeks. While nearly half of the patients exited out of the study for open label therapy, those on blinded therapy did better w/ SEC than placebo. The higher than expected placebo response (29% at wk 16)  remains unexplained.