Phase 3 Study of Tofacitinib for Rheumatoid Arthritis

Pfizer announced results from its Phase 3 study of tofacitinib, formerly known as tasocitinib, for the treatment of patients with rheumatoid arthritis (RA). The ORAL Scan, an ongoing two-year study, randomized 800 patients with moderate-to-severe active RA who had an inadequate response to methotrexate (MTX) to receive tofacitinib 5mg or 10mg twice daily or placebo. Data from a planned analysis at one year showed that the study met all primary endpoints of the 10mg twice-daily dose. The tofacitinib group showed statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months. It also reduced the progression of structural damage and improved physical function. As for the 5mg twice-daily dose, the study only demonstrated statistically significant improvements versus placebo in ACR20 response rates at six months, but no differences elsewhere.

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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