199 Baricitinib in patients with systemic lupus erythematosus: results from a phase 2, randomized, double-blind, placebo-controlled study

Background Baricitinib (Bari), an oral selective inhibitor of Janus kinase (JAK)1 and JAK2, has been approved for the treatment of rheumatoid arthritis (RA) in over 50 countries including the United States, European countries, and Japan. The purpose of this study was to report results from a 24 week global, Phase 2, double-blind, placebo (PBO)-controlled study of Bari in patients with systemic lupus erythematosus (SLE) receiving standard therapy. Methods Patients with SLE (positive antinuclear antibody [ANA] or anti-double stranded DNA [anti-dsDNA], clinical SLE Disease Activity Index 2000 [SLEDAI-2K] 4, arthritis or rash required) receiving stable background SLE therapy were randomized 1:1:1 to PBO or Bari (2- or 4 mg) once-daily. The primary endpoint was resolution of arthritis or rash as defined by the SLEDAI-2K at Week 24. Results Of 314 patients randomized, 79%, 82%, and 83% completed 24 weeks of treatment in the PBO, Bari 2 mg, and Bari 4 mg groups, respectively. At Week 24, a significantly greater proportion of patients in the Bari 4 mg group compared to PBO achieved resolution of arthritis or rash (67% vs 53%, p Conclusions In patients with SLE receiving standard background therapy, once-daily oral Bari 4 mg was associated with significant clinical improvements compared to PBO and an acceptable benefit/risk profile. These findings support further study of Bari as a potential therapy for patients with SLE. Funding Source(s): This study was funded by Eli Lilly and Company.