Janssen Pharmaceuticals announced the phase 3 LOTUS study, evaluating Stelara (ustekinumab) in patients with Systemic Lupus Erythematosus (SLE) will be discontinued due to lack of efficacy. The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of Stelara, and no new safety signals were identified. Investigators, study participants and health authorities have been informed of the decision. The company intends to thoroughly analyze the totality of the study data and publish findings.
LOTUS is a global, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of ustekinumab in individuals with active Systemic Lupus Erythematosus. It enrolled 516 patients, including representation from minority populations who are disproportionately impacted by lupus. The Primary Endpoint is the proportion of participants with a composite measure of SRI-4 (Systemic Lupus Responder Index) response at Week 52.
About Stelara (ustekinumab)
Stelara (ustekinumab) is a human IL-12 and IL-23 antagonist. It has been approved in the United States for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and with moderately to severely active ulcerative colitis.