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Eli Lilly and Incyte announced positive topline results of RA-BEAM, the fourth Phase 3 study of baricitinib for patients with moderately-to-severely active rheumatoid arthritis (RA).

Four Phase 3 clinical trials of baricitinib in the treatment of moderate-to-severe active rheumatoid arthritis enrolled patients who were methotrexate-naïve or had inadequate response to methotrexate, conventional disease-modifying antirheumatic drugs (DMARDs) or DMARDs with TNF inhibitors.

Taylor, Peter C. et al. “Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis”

Reduction in death seen at 28, 60 days for patients receiving invasive mechanical ventilation, extracorporeal membrane oxygenation

Adding baricitinib to topical corticosteroids significantly improved disease severity in adult patients with moderate to severe atopic dermatitis, according to top-line results from BREEZE-AD7 study. The phase 3 study included 300 patients who had been diagnosed with moderate to severe atopic dermatitis for at least 12 months and had an inadequate response to topical medications.…

The ACTT-2 study began on May 8 and included more than 1000 patients.

The update was based on data from the COV-BARRIER study.

The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.

Eli Lilly and Incyte announced that the New Drug Application (NDA) for once-daily oral baricitinib has been submitted to the Food and Drug Administration (FDA) for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

Data suggest that patients in remission with baricitinib 4 mg daily dose who have taken this medication for at least 1 year may be able to attempt baricitinib dose-tapering while continuing their methotrexate regimen.