The Janssen Pharmaceuticals has announced today that it had decided to discontinue the Phase 3 LOTUS study of Stelara (ustekinumab) for patients suffering from Systemic Lupus Erythematosus (SLE). The company said that Stelara lacks efficacy in SLE.
The company announced that the decision is based on pre-planned interim efficacy analysis. Interim safety profile was like earlier indications, however the product lacked efficacy.
LOTUS is a randomized, double-blind, placebo-controlled, parallel group Phase 3 trials. The study included 516 patients; the primary endpoint is SRI-4 (Systemic Lupus Responder Index) response at Week 52.
Stelara is in development for other diseases. The drug is in Phase 3 trials for dermatomyositis, polymyositis, and Spondylarthritis. The drug is in Phase 2 trials for atopic dermatitis.
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Prior to the discontinuation for lupus erythematosus, the drug development was discontinued for other indications including rheumatoid arthritis, multiple sclerosis, primary biliary cirrhosis.