Daniele Piovani1,2, Silvio Danese1,2, Laurent Peyrin-Biroulet3, Georgios K Nikolopoulos4, Stefanos Bonovas1,2. 1. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 2. IBD Center, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. 3. Department of Gastroenterology, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France. 4. Medical School, University of Cyprus, Nicosia, Cyprus.
Abstract
BACKGROUND: Uncertainty exists concerning the risk of infection and cancer associated with biologic therapies in elderly patients with inflammatory bowel disease (IBD). AIMS: To identify, synthesise and critically appraise the available evidence on the topic. METHODS: We systematically searched Medline/PubMed, Embase and Scopus, through October 2019, and recent conference proceedings, to identify studies investigating the risk of serious infections, opportunistic infections, any infection and cancer in elderly IBD patients (>60 years) exposed to biologics as compared to those unexposed to biologics. Two reviewers independently extracted study data and assessed each study's risk of bias. We examined heterogeneity, and calculated summary effect estimates using fixed- and random effects models. Quality of evidence was determined with GRADE. RESULTS: We included 15 studies (one post hoc analysis of a randomised trial, nine cohort and five case-control studies). Elderly IBD patients treated with biologics were at increased risk of developing serious infections (random effects summary relative risk: 2.70, 95% CI: 1.56-4.66; seven studies; I2 = 57%) and opportunistic infections (3.16, 1.09-9.20; four studies; I2 = 73%). The occurrence of any infection (1.67, 0.51-5.43; five studies; I2 = 75%) and cancer (0.90, 0.64-1.26; nine studies; I2 = 0%) was not significantly affected. Nevertheless, our confidence in the effect estimates is rather limited; the quality of evidence is low to very low. CONCLUSIONS: Biologics are likely to increase the risk of serious and opportunistic infections in old IBD patients. Large prospective studies are needed to further assess the biologic treatments' long-term safety profile in this population.
BACKGROUND: Uncertainty exists concerning the risk of infection and cancer associated with biologic therapies in elderly patients with inflammatory bowel disease (IBD). AIMS: To identify, synthesise and critically appraise the available evidence on the topic. METHODS: We systematically searched Medline/PubMed, Embase and Scopus, through October 2019, and recent conference proceedings, to identify studies investigating the risk of serious infections, opportunistic infections, any infection and cancer in elderly IBDpatients (>60 years) exposed to biologics as compared to those unexposed to biologics. Two reviewers independently extracted study data and assessed each study's risk of bias. We examined heterogeneity, and calculated summary effect estimates using fixed- and random effects models. Quality of evidence was determined with GRADE. RESULTS: We included 15 studies (one post hoc analysis of a randomised trial, nine cohort and five case-control studies). Elderly IBDpatients treated with biologics were at increased risk of developing serious infections (random effects summary relative risk: 2.70, 95% CI: 1.56-4.66; seven studies; I2 = 57%) and opportunistic infections (3.16, 1.09-9.20; four studies; I2 = 73%). The occurrence of any infection (1.67, 0.51-5.43; five studies; I2 = 75%) and cancer (0.90, 0.64-1.26; nine studies; I2 = 0%) was not significantly affected. Nevertheless, our confidence in the effect estimates is rather limited; the quality of evidence is low to very low. CONCLUSIONS: Biologics are likely to increase the risk of serious and opportunistic infections in old IBDpatients. Large prospective studies are needed to further assess the biologic treatments' long-term safety profile in this population.
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