Pfizer’s Xeljanz RA safety alert prompts physician caution in 10mg BID dose in risky UC group, with potential dose avoidance and schedule changes

14 Mar 2019

Pfizer’s (NYSE:PFE) Xeljanz (tofacitinib) safety alert in rheumatoid arthritis (RA) patients could lead to exclusion of riskier ulcerative colitis (UC) patients from receiving the 10mg BID dose, some experts said, while others noted the need for more data to influence treatment decisions.

On 19 February Pfizer announced a Data Safety Monitoring Board (DSMB) notification of a safety signal in the 10mg Xeljanz BID treatment arm in a 4,400-patient Phase IIIb/IV (NCT02092467) study. The safety study compares Xeljanz safety to AbbVie’s (NYSE:ABBV) Humira (adalimumab) or Pfizer’s Enbrel (etanercept) in terms of major cardiovascular (CV) adverse events and malignancies. This announcement was followed by a 25 February FDA alert detailing the increased risk for blood clots and death associated with that 10mg BID dose.

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