The manufacturer of baricitinib announced it is discontinuing the phase 3 development program for the treatment of patients with active systemic lupus erythematosus, based on efficacy results from two trials. 

Baricitinib is approved for patients with moderate-to-severe atopic dermatitis who have an inadequate response to topical treatments in the European Union and Japan.

Baricitinib was previously being evaluated as a treatment for lupus in the phase 3 SLE-BRAVE-1 and SLE-BRAVE-II trials, including more than 1,500 patients. In the SLE-BRAVE-1 trial, baricitinib met the primary endpoint showing a significant reduction in disease activity, defined by patients achieving an SRI-4 response at week 52 compared to placebo. However, baricitinib did not meet the same primary endpoint in the SLE-BRAVE-2 trial. In addition, secondary endpoints were not met in either study.

The release noted that safety findings for both studies were consistent with what was already known about baricitinib and were not a factor in the program’s discontinuation. 

“We are disappointed for the millions of people who suffer from these complex and hard-to-treat autoimmune diseases and are in need of more treatment options, and we remain committed to pursuing treatment advances in immunology that can make life better for people around the world,” Lotus Mallbris, MD, PhD, vice president of global immunology development and medical affairs at Lilly, said in the release. “These decisions do not affect Lilly’s other efforts for [baricitinib] or its approved indications. We are confident in [baricitinib] for approved indications in the US and globally as [baricitinib] has one of the largest and longest sets of available safety data in the JAK inhibitor class, including 9 years across the clinical development program.” 

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