Adverse effects of biologics: a network meta‐analysis and Cochrane overview

JA Singh, GA Wells, R Christensen… - Cochrane database …, 2011 - cochranelibrary.com
JA Singh, GA Wells, R Christensen, ET Ghogomu, LJ Maxwell, JK MacDonald, G Filippini…
Cochrane database of systematic reviews, 2011cochranelibrary.com
Background Biologics are used for the treatment of rheumatoid arthritis and many other
conditions. While the efficacy of biologics has been established, there is uncertainty
regarding the adverse effects of this treatment. Since important risks such as lymphomas,
serious infections and tuberculosis (TB) reactivation may be more common to the biologics
but occur in small numbers across the various indications, we planned to combine the
results from biologics used in many conditions to obtain much needed risk estimates …
Background
Biologics are used for the treatment of rheumatoid arthritis and many other conditions. While the efficacy of biologics has been established, there is uncertainty regarding the adverse effects of this treatment. Since important risks such as lymphomas, serious infections and tuberculosis (TB) reactivation may be more common to the biologics but occur in small numbers across the various indications, we planned to combine the results from biologics used in many conditions to obtain much needed risk estimates.
Objectives
To compare the potential adverse effects of tumor necrosis factor inhibitor (adalimumab, certolizumab, etanercept, golimumab, infliximab), interleukin (IL)‐1 antagonist (anakinra), IL‐6 antagonist (tocilizumab), anti‐CD28 (abatacept), and anti‐B cell (rituximab) therapy in patients with any disease condition except human immunodeficiency disease (HIV/AIDS).
Methods
Randomized controlled trials (RCTs), controlled clinical trials (CCTs) and open‐label extension (OLE) studies that studied one of the nine biologics for use in any indication (with the exception of HIV/AIDS) and that reported our pre‐specified adverse outcomes (serious adverse events (SAEs), withdrawals due to adverse events (AEs), total AEs, serious infections; specific AEs, namely, tuberculosis (TB) reactivation, lymphoma and congestive heart failure) were considered for inclusion. We searched The Cochrane Library, MEDLINE, and EMBASE (to January 2010). Identifying search results and data extraction were performed independently and in duplicate. For the network meta‐analysis, we performed both Bayesian mixed‐treatment comparison models and arm‐based generalized linear mixed models.
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