Black cloud hangs over JAK blockers after safety study miss

28 January 2021
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A post-marketing safety study of Pfizer’s (NYSE: PFE) Xeljanz (tofacitinib) has missed both primary endpoints, threatening to undermine the drug’s competitiveness among rival options.

Required by the US Food and Drug Administration, the study was designed to evaluate the safety of two doses of the JAK blocker, in comparison with a TNF inhibitor, for people with rheumatoid arthritis.

The results showed 98 cardiovascular events among the test group, compared with 37 for the TNF inhibitor group. For those taking Xeljanz, 122 developed cancers, versus 42.

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