Background: We systematically reviewed infliximab benefit in reducing hospitalizations and/or major surgery rates in patients with inflammatory bowel disease (IBD).
Methods: A literature search to May 2012 was performed to identify all studies (experimental and observational) evaluating patients with IBD treated with infliximab and providing data on hospitalizations and/or major surgery rates. Three reviewers independently performed studies' selection, quality assessment, and data extraction. Analyses were carried according to study design (randomized clinical trials [RCTs] and observational studies) and IBD type (Crohn's disease [CD] and ulcerative colitis [UC]). Random-effects meta-analysis was used to derive pooled and 95% confidence intervals (CIs) estimates of odds ratios (OR). Heterogeneity was assessed with I2 test.
Results: Twenty-seven eligible studies were included (9 RCTs and 18 observational studies). Infliximab reduced hospitalization risk, both in pooled RCTs (OR, 0.51; 95% CI 0.40–0.65; I2 = 0%) and results of observational studies (OR, 0.29, 95% CI, 0.19–0.43; I2 = 87%), without differences between CD and UC. Infliximab reduced surgery risk in pooled RCTs results, both in CD (OR, 0.31; 95% CI, 0.15–0.64; I2 = 0%) and UC (OR, 0.57; 95% CI, 0.37–0.88; I2 = 0%). Pooled estimate from observational studies favored infliximab for patients with CD (OR, 0.32; 95% CI, 0.21–0.49; I2 = 77%), but not for patients with UC.
Conclusions: The best evidence available points toward a reduction of the risk of hospitalization and major surgery requirement in patients with IBD treated with infliximab. This impact is clinically and economically relevant because hospitalization and surgery are considered to be markers of disease severity and significantly contribute to the total direct costs associated with IBD.
Article first published online 15 July 2013
*Evidence-Based Medicine Centre, and
†Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Portugal;
‡Portuguese Collaborating Centre of the Iberoamerican Cochrane Network;
§Institute of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal;
‖Department of Gastroenterology, São João University Hospital, Porto, Portugal; and
¶Institute for Molecular and Cell Biology, University of Porto, Porto, Portugal.
Reprints: Fernando Magro, MD, PhD, Instituto de Farmacologia e Terapêutica, Faculdade de Medicina, Universidade do Porto, Al. Prof. Hernâni Monteiro, Porto 4200-319, Portugal (e-mail: firstname.lastname@example.org).
This was an academic project without any direct funding. The initiative of the project is also of the entire responsibility of the Evidence Based Medicine (EBM) Centre at Lisbon School of Medicine, Portugal. In the last years, the Lisbon EBM center has undertaken several research projects, which were unrestricted funded by more than 20 different pharmaceutical companies. One of those is Merck Sharp & Dohme (MSD), which holds the marketing authorization for infliximab. Merck Sharp & Dohme has not directly or indirectly participated in any phase of this project.
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Received April 11, 2013
Accepted April 27, 2013