Ami Schattner, MD
What is the safety of biologic agents in patients with medical conditions other than HIV or AIDS?
Included studies compared biologic agents (etanercept, infliximab, rituximab, adalimumab, golimumab, certolizumab pegol, abatacept, anakinra, or tocilizumab), alone or combined with other therapies, with placebo or other therapies in patients ≥ 16 years of age with medical conditions other than HIV or AIDS. Major outcomes included serious adverse events (SAEs), total AEs (TAEs), serious infections, and AE-related withdrawals.
Cochrane Database of Systematic Reviews, Health Technology Assessment Database, and Database of Abstracts of Reviews of Effects (all Cochrane Library, 2010, Issue 1) were searched for systematic reviews; relevant studies were identified. MEDLINE (2005 to Jan 2010), EMBASE/Excerpta Medica (2006 to 2010, wk 5), and CENTRAL (Cochrane Library, 2010, Issue 1) were searched for randomized controlled trials (RCTs), controlled clinical trials (CCTs), and open-label RCT extension studies published after the most recent systematic review. 156 RCTs and 4 CCTs (n = 48 676, mean age 50 y, 59% women, median study duration 6 mo) met inclusion criteria; 46 open-label extension studies (n = 11 954) were included in the review but are not discussed in this abstract. 39 trials evaluated etanercept, 39 infliximab, 29 rituximab, 22 adalimumab, 8 golimumab, 6 certolizumab pegol, 6 abatacept, 5 anakinra, 5 tocilizumab, and 1 evaluated both infliximab and abatacept. Data were pooled in Bayesian network meta-analyses using a mixed treatment comparison approach, which allows for combination of direct and indirect treatment comparisons.
Network meta-analysis showed that biologic agents were associated with higher rates of TAEs, AE-related withdrawals, and serious infections than control treatment; groups did not differ for SAEs.
In patients with conditions other than HIV or AIDS, biologic agents increase short-term risk for some adverse outcomes more than other therapies.
Biologic agents vs control in patients with medical conditions other than HIV or AIDS*
*AE = adverse event; CrI = credible interval; OR = odds ratio; other abbreviations defined in Glossary. Quality of evidence (assessed using Grading of Recommendations Assessment, Development and Evaluation methodology) was high (total AEs) or moderate (all other outcomes).
†Biologic agent risk was calculated using the meta-analysis OR (Schünemann HJ, Oxman AD, Higgins JP, et al. Presenting results and “Summary of findings” tables. In Higgins JP, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated Mar 2011]. The Cochrane Collaboration, 2011. www.cochrane-handbook.org) (accessed 27 Mar 2012). Control risk was calculated based on the number of events in included studies.
‡Bayesian network mixed treatment comparison meta-analyses of standard dose equivalent treatment groups vs control. Credible intervals in Bayesian meta-analysis are conceptually similar to confidence intervals in standard meta-analysis.
Ami Schattner. Review: Biologic agents increase short-term risk for some adverse events in conditions other than HIV or AIDS. Ann Intern Med. 2012;156:JC5–9. doi: 10.7326/0003-4819-156-10-201205150-02009
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Published: Ann Intern Med. 2012;156(10):JC5-9.
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