Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus

SPRING HOUSE, PA, USA I June 26, 2020 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE.

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.

"Lupus patients are waiting for better treatments, which makes this outcome disappointing," said Alyssa Johnsen, M.D., Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. "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. Janssen continues to be strongly committed to research and development of novel therapies for lupus."

The decision to discontinue the LOTUS study does not impact any other ongoing studies with ustekinumab or current indications.

About the LOTUS Program
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.  

A second Phase 3 study, LOTUS-C, to be conducted in China was planned but will not start given this decision.

About STELARA® (ustekinumab)
STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

SOURCE: Janssen

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