Baricitinib in Patients with Refractory Rheumatoid Arthritis

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Just published in the N Engl J Med Baricitinib a new jak inhibitor improved outcomes in RA patients who failed to biologics

Genovese M es al. N Engl J Med 2016;374:1243-1252

BACKGROUND

In phase 2 studies, baricitinib, an oral Janus kinase 1 and 2 inhibitor, reduced disease activity in patients with rheumatoid arthritis who had not previously received treatment with biologic disease-modifying antirheumatic drugs (DMARDs).
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METHODS
In this phase 3 study involving 527 patients with an inadequate response to or unacceptable side effects associated with one or more tumor necrosis factor inhibitors, other biologic DMARDs, or both, we randomly assigned the patients in a 1:1:1 ratio to baricitinib at a dose of 2 or 4 mg daily or placebo for 24 weeks. End points, tested hierarchically at week 12 to control type 1 error, were the American College of Rheumatology 20% (ACR20) response (primary end point), the Health Assessment Questionnaire–Disability Index (HAQ-DI) score, the 28-joint Disease Activity Score based on C-reactive protein level (DAS28-CRP), and a Simplified Disease Activity Index (SDAI) score of 3.3 or less (on a scale of 0.1 to 86.0, with a score of 3.3 or less indicating remission). Comparisons with placebo were made first with the 4-mg dose of baricitinib and then with the 2-mg dose

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RA Drug Tested & FDA Orders Drug-Interaction Studies for Kayexalate

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November 11, 2015 • By

The Rheumatologist

GENERIC_Drugs_500x270Barcitinib Promising in Phase 3 Trials
Baricitinib, a once-daily oral selective JAK1 and JAK2 inhibitor, has shown positive results in the Phase 3 RA-BEAM study.1,2 This is the fourth successful Phase 3 study of this agent for treating adults with moderate to severe activerheumatoid arthritis (RA). This study enrolled more than 1,300 adults with active RA despite use of methotrexate (MTX). The safety and efficacy of baricitinib was compared with placebo for 24 weeks or adalimumab for 52 weeks. Patients receiving MTX were randomized to receive either 4 mg barcitinib once daily, 40 mg subcutaneous adalimumab every other week or placebo

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