Pfizer Inc. recently released top-line results for ORAL Strategy, a Phase 3B/4 study of XELJANZ (tofacitinib citrate) 5mg twice daily in the treatment of moderate to severe rheumatoid arthritis (RA).
The study is the first to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) vs. adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint.
According to Pfizer, the study found that XELJANZ 5mg plus MTX demonstrated non-inferiority vs. Humira plus MTX. On the other hand, XELJANZ 5mg monotherapy failed to show non-inferiority vs. Humira plus MTX or versus XELJANZ plus MTX.
“ORAL Strategy is representative of the type of innovative and clinically meaningful trials that Pfizer Inflammation & Immunology believes are important to help advance patient care and the science of JAK inhibition,” Michael Corbo, chief development officer for Inflammation & Immunology and Global Product Development, said in a statement. “We are pleased that we demonstrated non-inferiority of XELJANZ plus MTX versus Humira plus MTX, reinforcing the efficacy of XELJANZ combination therapy. 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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