Janssen Pharmaceutical has decided to suspend the Phase III LOTUS clinical trial of Stelara (ustekinumab) in systemic lupus erythematosus (SLE) patients over efficacy data.
Results from a pre-planned interim efficacy analysis showed that the drug lacked efficacy in this indication. The interim safety profile was observed to be consistent with the known profile of the drug, without any new safety signals.
The company informed investigators, study participants, and health authorities regarding its decision to discontinue the LOTUS trial. Janssen noted that the decision will not be applicable to other ustekinumab studies or current indications.
Janssen Research & Development rheumatology disease area leader Alyssa Johnsen said: “Lupus patients are waiting for better treatments, which makes this outcome disappointing.
“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.”
Stelara is a human IL-12 and IL-23 antagonist indicated in the US to treat certain patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.
The global, randomised, double-blind, placebo-controlled, parallel-group LOTUS trial assessed the drug in 516 patients with active SLE. The primary endpoint was a composite measure of Systemic Lupus Responder Index (SRI-4) response at week 52.
Janssen said that a second Phase III LOTUS-C trial, planned to be performed in China, will not launch in the wake of this decision.
In February this year, Janssen reported interim results from the Phase IIIb STARDUST trial, where the drug led to clinical remission in moderately to severely active Crohn’s disease (CD) patients.
According to the study data, 79% of participants experienced clinical response and 67% were in clinical remission at week 16.