Janssen has decided to discontinue the phase 3 LOTUS study evaluating ustekinumab (Stelara®) for the treatment of systemic lupus erythematosus (SLE).
The global, randomized, double-blind, placebo-controlled study, which included 516 patients with SLE, was discontinued based on data from a pre-planned interim efficacy analysis. The primary end point of the trial was the proportion of patients with a composite measure of SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response at week 52.
No new safety signals were observed in the LOTUS study. The decision to discontinue the study does not impact the current FDA-approved indications for ustekinumab.
According to the Company, study findings will be published in the future following further analysis of the data. Additionally, based on the decision to discontinue the LOTUS program, a second phase 3 study in China (LOTUS-C) will not be initiated.
“Our hope is that by ultimately sharing these data with the scientific community we can help inform lupus research and therefore still have a positive impact on the lives of patients living with SLE,” said Alyssa Johnsen, MD, PhD, VP, Rheumatology Disease Area Leader, Janssen Research & Development, LLC.
Stelara, an interleukin-12 and interleukin-23 antagonist, is currently approved for the treatment of active psoriatic arthritis, moderately to severely active Crohn disease or ulcerative colitis, and moderate to severe plaque psoriasis.
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