Secukinumab In Selune: Phase III Lupus Nephritis Readout

Key Takeaways

• Complete renal response at week 52 was lower with secukinumab than with placebo.
• No differences were seen across secondary endpoints, and treatment-emergent adverse events were similar between groups.
• A planned futility analysis led to early termination, and the extension was not interpretable because only 31 patients were analyzed.

In adults with active lupus nephritis, secukinumab plus background standard-of-care therapy did not improve the prespecified primary endpoint of complete renal response at week 52 versus placebo. Complete renal response at week 52 occurred in 24.2% of patients receiving secukinumab and 36.3% receiving placebo, leaving secukinumab without superior efficacy in the randomized core study.

The SELUNE phase III trial was a randomized, placebo-controlled, double-blind study in adults with active lupus nephritis. Patients received secukinumab 300 mg plus standard of care or placebo plus standard of care for the first 4 weeks, followed by monthly maintenance dosing. The core study was planned to continue for 104 weeks, with an open-label extension of up to 260 weeks for patients who completed the core phase. The prespecified primary endpoint was complete renal response at week 52.

Both studies were terminated early after a planned futility analysis in the core study showed no clinically meaningful benefit of secukinumab over placebo. No differences were seen in any secondary endpoints from the core study. Treatment-emergent adverse events were comparable between groups, and secukinumab was well tolerated. No new or unexpected safety signals were identified during the study period. The open-label extension was not interpretable because only 31 patients were included in the analysis.