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Pfizer’s Blockbuster Arthritis Drug Falls Short in Postmarket Study

February 1, 2021

Pfizer has announced that its blockbuster rheumatoid arthritis drug Xeljanz (tofacitinib) failed to meet its primary endpoints in a postmarket safety study.

The study evaluated the drug’s safety at two doses — 5 mg twice-daily and 10 mg twice-daily — in 4,362 patients with rheumatoid arthritis age 50 and up with at least one additional cardiovascular risk factor, compared to a tumor necrosis factor inhibitor (TNFi).

The study was designed to show Xeljanz’s noninferiority compared with a TNFi in reducing major adverse cardiovascular events and cancer, excluding nonmelanoma skin cancer. Patients taking the Pfizer drug who experienced one of these adverse events most frequently had heart attacks or developed lung cancer.

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