Pfizer has announced top-line results from its Phase 3B/4 study comparing treatment with Xeljanz (tofacitinib citrate) to adalimumab in patients with moderate to severe rheumatoid arthritis.

Xeljanz, a JAK inhibitor, has been approved in the U.S. since 2012 for treating moderate to severe rheumatoid arthritis (RA). The ORAL Strategy Phase 3B/4 trial compared Xeljanz as a monotherapy or in combination with methotrexate (MTX) vs. adalimumab plus MTX, in MTX inadequate responders. 

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The trial lasted 12 months and included 1,152 patients randomized to a regimen of either Xeljanz 5mg twice daily as monotherapy (n-386), Xeljanz 5mg twice daily in combination with a weekly dose of MTX (15–25mg; n=378), or adalimumab 40mg every other week via subcutaneous injection in combination with a weekly dose of MTX (15–25mg; n=388).

Results showed that Xeljanz plus MTX demonstrated non-inferiority vs. adalimumab plus MTX. However, Xeljanz monotherapy did not meet its primary endpoint for non-inferiority vs.adalimumab plus MTX, or vs. Xeljanz plus MTX.

“We are pleased that we demonstrated non-inferiority of Xeljanz plus MTX versus [adalimumab] plus MTX, reinforcing the efficacy of XELJANZ combination therapy,” said Michael Corbo, Chief Development Officer at Pfizer. “We will continue to analyze the monotherapy data from this study and look forward to sharing the full results of ORAL Strategy at an upcoming scientific forum.”

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