Phase IIIB/IV study of Xeljanz (tofacitinib citrate) plus meets primary endpoint in rheumatoid arthritis- Pfizer
Pfizer announced today top-line results from ORAL Strategy, a Phase IIIB/IV study of Xeljanz (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint.
There were three comparisons,which found Xeljanz 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX. Xeljanz 5mg monotherapy did not meet its primary endpoint of non-inferiority versus Humira plus MTX or versus Xeljanz plus MTX. The safety findings were consistent with the known adverse events and serious adverse events profile for Xeljanz.
Comment: Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
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