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An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Study Examines Tofacitinib’s Long-Term Cardiovascular Risk & More

  |  Issue: March 2021  |  

Pfizer continues to examine data for the rates of pulmonary embolism and other secondary endpoints points. The company is working with the FDA to review the study’s full results as more information becomes available.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

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References

  1. Pfizer Inc. News release: Pfizer shares co-primary endpoint results from post-marketing required safety study of Xeljanz (tofacitinib) in subjects with rheumatoid arthritis (RA). 2021 Jan 27.
  2. U.S. Food & Drug Administration. Center for drug evaluation and research application number: 203214 (Xeljanz) Orig1s000 approval letter. 2021 Nov 6
  3. U.S. Food & Drug Administration. Highlights of prescribing information: Xeljanz (tofacitinib). 2020 Nov.
  4. U.S. Food & Drug Administration. Supplement approval letter Xeljanz (tofacitinib). 2019 July 25.
  5. Pfizer Inc. Safety study of tofacitinib vs. tumor necrosis factor (TNF) inhibitor in subjects with rheumatoid arthritis (NCT02092467). Clinicaltrials.gov. 2021 Jan 28.

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