Baricitinib Shows Positive Results for Systemic Lupus Erythematosus in Phase 2 Study

SLE on woman's leg
SLE on woman’s leg
Baricitinib 4 mg was safe and effective in patients with systemic lupus erythematosus.
The following article is part of conference coverage from the European League Against Rheumatism (EULAR) Congress 2018 in Amsterdam, The Netherlands. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from EULAR 2018.

Once-daily oral baricitinib 4 mg was associated with significant clinical improvements compared with placebo in patients with systemic lupus erythematosus (SLE) receiving standard background therapy, according to data presented at the European League Against Rheumatism (EULAR) Congress held in Amsterdam, June 13 to 16, 2018.

Investigators conducted a 24-week, phase 2, double-blind, placebo-controlled study of baricitinib, an oral selective Janus kinase (JAK) 1 and JAK 2 inhibitor, in patients with SLE receiving standard therapy. Participants were randomly assigned to receive either placebo, baricitinib 2 mg, or baricitinib 4 mg once daily. The primary end point was resolution of arthritis or rash, measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K), at 24 weeks. Of the 314 participants who were randomly assigned to treatment, 79%, 82%, and 83% completed 24 weeks of treatment with placebo, baricitinib 2 mg, and baricitinib 4 mg, respectively.

A significantly greater percentage of patients in the baricitinib 4 mg group achieved resolution of SLEDAI-2K arthritis or rash (67% vs 53%; P <.05) and SLE Responder Index-4 response (64% vs 48%; P <.05) at 24 weeks compared with placebo. In addition, the percentage of patients achieving flare reduction, Lupus Low Disease Activity State, and tender joint count change from baseline were also more improved in the baricitinib 4 mg group compared with placebo.

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The investigators noted that there were no significant differences between the baricitinib 2 mg group and placebo for any of the end points. The rate of adverse events leading to treatment discontinuation and serious adverse events were higher for patients receiving baricitinib 2 mg or 4 mg compared with placebo.

“These findings support further study of [baricitinib 4 mg] as a potential therapy for patients with SLE,” the authors concluded.

Please see abstract for a full list of author disclosures.

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Wallace DJ, Furie RA, Tanaka Y, et al. Baricitinib in systemic lupus erythematosus (SLE): results from a phase 2, randomized, double-blind, placebo-controlled study. Presented at: European League Against Rheumatism (EULAR) Congress 2018; June 13-16, 2018; Amsterdam, The Netherlands. Abstract OP0019.