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Pfizer Says Study Supports Use Of Xeljanz Alone In Rheumatoid Arthritis

Pfizer Inc. (PFE) said that results of ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis, provided important information on the use of Xeljanz XR as monotherapy after methotrexate withdrawal, which is significant as some people living with rheumatoid arthritis are unable or unwilling to use methotrexate.

The company noted that the study demonstrated non-inferiority of MTX withdrawal with XELJANZ XR 11 mg QD compared to XELJANZ XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48.

The primary analysis showed that XELJANZ XR 11 mg QD monotherapy was non-inferior to XELJANZ XR 11 mg QD with MTX at week 48.

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