Pfizer announces new head to head study of Xeljanz with or without MTX vs Humira/MTX

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• Pfizer has announced ORAL STRATEGY [link], a new efficacy and safety study comparing Xeljanz with or without MTX and Humira/MTX

• The Phase 4 study is large, aiming to enroll 1080 MTX-IR patients across the three treatment arms

• The primary endpoint is ACR50

• The study is intended to provide new answers to two questions:  1) What impact does MTX have on the response to Xeljanz and; 2) How does the safety/efficacy of Xeljanz monotherapy compare to Humira/MTX

Comments:  We believe this to be an important study, and as indicated by title it should provide valuable information on the strategic use of Xeljanz.  Firstly, in MTX-IR patients can MTX be withdrawn with the introduction of Xeljanz without losing efficacy?  This would be attractive to patients and physicians, reducing monitoring and avoiding AEs/tolerability issues associated with MTX.  Secondly, with regards to selection of Xeljanz vs Humira, the two options have already been compared head to head in ORAL Standard.  The two strategies produced similar efficacy when administered on a background of MTX.  ORAL STRATEGY will provide information on whether Xeljanz produces similar efficacy even in the absence of MTX.  If use of Xeljanz monotherapy does not come at the expense of a loss of efficacy vs Humira/MTX, the rational for switching MTR-IRs to Xeljanz monotherapy rather than to Humira/MTX will be strengthened.  There will still be the open question of whether MTX-IR patients should be better switched to (Ro)Actemra