| Summary: | <h4>Background</h4> <p>Baricitinib is an oral, reversible, JAK1/JAK2 inhibitor that may have therapeutic value in patients with rheumatoid arthritis.</p> <h4>Methods</h4> <p>In this 52-week, phase 3, double-blind, placebo and active-controlled study, 1307 patients with active rheumatoid arthritis receiving background methotrexate were randomized 3:3:2 to placebo (switched to baricitinib after 24 weeks), baricitinib 4-mg once daily, or anti-tumor necrosis factor α monoclonal antibody, adalimumab, 40-mg every other week. Endpoint measures controlled for multiplicity included American College of Rheumatology 20% response (ACR20, primary endpoint), 28-joint Disease Activity Scores (DAS28), Health Assessment Questionnaire-Disability Index (HAQ-DI), and Simplified Disease Activity Index (SDAI) at Week 12, and progressive radiographic joint damage as measured by van der Heijde modified Total Sharp score (mTSS) at Week 24.</p> <h4>Results</h4> <p>More patients achieved an ACR20 response at Week 12 with baricitinib than placebo (primary objective, 70% vs. 40%, P≤0.001). All major secondary objectives were met, including inhibition of progressive radiographic joint damage (mTSS, range 0 to 448, with higher scores indicating greater damage) at Week 24 for baricitinib vs. placebo (mean change from baseline 0.41 vs.0.90, P≤0.001) and increased ACR20 response rate at Week 12 for baricitinib vs. adalimumab (70% vs. 61%, P=0.014). Adverse events, including infections, were more frequent through Week 24 for baricitinib and adalimumab compared to placebo. Malignancies were reported in 5 patients (2 baricitinib, 3 placebo). Baricitinib was associated with reductions in neutrophils and increases in creatinine and low-density lipoprotein cholesterol.</p> <h4>Conclusions</h4> <p> In patients with rheumatoid arthritis with inadequate response to methotrexate, baricitinib was associated with significant clinical improvements compared to placebo and adalimumab </p>
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