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# Xeljanz Study Does Not Meet Co-Primary Endpoints
- URL: https://www.fdaweb.com/xeljanz-study-does-not-meet-co-primary-endpoints/
- Published: 2021-01-27T12:00:00.000Z
- Updated: 2026-09-14T16:44:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148538

Pfizer says its Xeljanz (tofacitinib) failed to meet the co-primary endpoints in the recently completed post-marketing required ORAL Surveillance safety study. The study evaluated Xeljanz safety at two doses versus a TNF inhibitor (TNFi) in subjects with rheumatoid arthritis who were age 50 or older and had at least one additional cardiovascular risk factor.

The co-primary endpoints were the non-inferiority of Xeljanz compared to TNFi in regard to major adverse cardiovascular events and specified malignancies. The pre-specified non-inferiority criteria were not met for primary or secondary comparisons, Pfizer says.