Phase 3 Trial Update of Tofacitinib for Rheumatoid Arthritis

Pfizer announced top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib in the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

ORAL Start, an ongoing two-year study that randomized 958 methotrexate (MTX)-naïve patients with moderate-to-severe active RA to receive tofacitinib 5mg or 10mg twice-daily (BID) as monotherapy or MTX, met its primary endpoints at both the 5mg and 10mg BID doses. Tofacitinib was found to be superior to MTX with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Sharp Score (mTSS), and in reducing signs and symptoms of RA, as measured by ACR70 response rates. Both primary endpoints assessed tofacitinib vs. MTX at six months. The data reported are from a planned analysis at one year.

Tofacitinib is an oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. It targets the intracellular signaling pathways that operate as hubs in the inflammatory cytokine network. 

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