A Serious Complication with Tocilizumab

Summary and Comment |
December 15, 2016

A Serious Complication with Tocilizumab

  1. Jonathan S. Coblyn, MD

This rheumatoid arthritis drug was associated with excess lower gastrointestinal perforations.

  1. Jonathan S. Coblyn, MD

In early trials of the biologic drug tocilizumab (Actemra; commonly prescribed for rheumatoid arthritis [RA]), lower gastrointestinal (GI) perforations occurred in 26 of 4000 patients who received the drug. To assess the postmarketing incidence of GI perforations among patients who received tocilizumab, researchers identified 167,000 patients who started one of four new biologic RA therapies (abatacept [Orencia], tocilizumab, tofacitinib [Xeljanz], or rituximab [Rituxan]) or tumor-necrosis factor (TNF) inhibitors between 2006 and 2014.

Lower GI tract perforations that required hospitalization were significantly more common among tocilizumab patients than among TNF-inhibitor patients (1.26 vs. 0.46 cases per 1000 patient-years). Two cases of lower GI perforation occurred in the tofacitinib group (0.86 cases/1000 patient-years). Overall risk for lower GI perforations with the first four agents above (1 case/1000 patient-years) was approximately double that with TNF inhibitors. Mortality among hospitalized patients with perforations was 16% (17 of 106).


This study confirms that a significant excess of lower GI perforations occur in tocilizumab-treated patients and possibly in tofacitinib-treated patients. Although the incidence of perforations is quite small, early awareness of this potential complication could be lifesaving, because perforation-associated mortality is high.

Editor Disclosures at Time of Publication

  • Disclosures for Jonathan S. Coblyn, MD at time of publication Consultant / Advisory board CVS Health (member, Pharmacy and Therapeutics Committee)


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