Safety of Infliximab: Primum non nocere (original) (raw)

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Center for Inflammatory Bowel Disease, Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation

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Center for Inflammatory Bowel Disease, Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation

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The safety profile of infliximab in patients with Crohn's disease: the Mayo Clinic experience in 500 patients. Colombel JF, Loftus EV Jr, Tremaine WJ, et al. Gastroenterology. 2004;126:19–31.

In this large series, the investigators evaluated the short- and long-term safety of infliximab in patients with Crohn's disease. Using pharmacy records, 500 patients with Crohn's disease who were treated with infliximab at the Mayo Clinic between October 1998 and October 2002 were included. A total of 2211 infusions were given, and the likelihood of a causal relationship between infliximab therapy and each adverse event was rated on a 0 to 4 scale: 0, not related; 1, doubtful; 2, possible; 3, likely; and 4, definite. Likelihood scores ≥2 were considered to be related to infliximab. The median follow-up of the patients was 17 months (range, 0 to 48 months), with 298 patients (60%) having more than 1-year of follow-up.

Forty-three patients (8.6%) experienced a serious adverse event, of which 30 (6.0%) were considered to be related to infliximab therapy. These included 15 serious infections (4 fatal), 2 severe infusion reactions, 5 serum sickness-like reactions, 3 cases of drug-induced lupus, 2 cases of solid tumors (one with associated death), and one case each of non-Hodgkin's lymphoma, demyelination syndrome, and worsening heart failure. Acute infusion reactions occurred in 19 of 500 patients (3.8%), leading to discontinuation of the infusion in 9 of 19. Two of the infusion reactions were potentially life-threatening cardiopulmonary symptoms that required treatment with epinephrine. Serum sickness-like disease occurred in 19 of 500 patients and was considered at least possibly related to infliximab in 14 patients (2.8%). Three patients developed clinical symptoms consistent with drug-induced lupus after 5, 10, and 19 infusions. Forty-eight patients had an infectious event, of which 41 (8.2%) were considered to be related to infliximab. These included cases of sepsis, pneumonia, Candida infections, viral gastroenteritis, abdominal abscesses, cellulitis, and histoplasmosis. There were no cases of tuberculosis. A total of 10 deaths were observed, 5 of which (1.0%), were judged to be related to infliximab.

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