Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study.

OBJECTIVE

The objective of this study was to evaluate the efficacy and safety of s.c. secukinumab 300 mg combined with standard of care (SoC) in adult patients with active LN.

METHODS

The core study was a phase III randomized, placebo-controlled, double-blind study (planned duration: 104 weeks) of patients with active LN. Eligible patients were randomized to receive secukinumab 300 mg or placebo for the first 4 weeks, followed by a monthly maintenance dose, with all patients receiving a SoC background regimen. Patients completing the 104-week treatment of the core study were eligible for an open-label extension study (planned duration: up to 260 weeks) to receive secukinumab 300 mg every 4 weeks. The primary end point of the core study was the proportion of patients achieving complete renal response (CRR) at week 52.

RESULTS

Both studies were terminated early, following a planned futility analysis in the core study that showed no clinically meaningful benefit of secukinumab over placebo. In the core study, the proportion of patients achieving CRR at week 52 was lower after receiving secukinumab (24.2%) than after receiving the placebo (36.3%). No differences were observed between the secukinumab and placebo groups in any of the secondary end points of the core study. The incidence of treatment-emergent adverse events was comparable between the secukinumab and placebo groups. In the extension study, the results were not interpretable, owing to the low patient number included in the data analysis (n = 31).

CONCLUSION

Secukinumab did not demonstrate superior efficacy over placebo in patients with active LN. Secukinumab was well-tolerated with no new or unexpected safety signals detected.

TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04181762, NCT04181762 (Novartis study code: CAIN457Q12301). https://www.clinicaltrials.gov/study/NCT05232864, NCT05232864 (Novartis study code: CAIN457Q12301E1).