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ABSTRACT
Introduction: Five anti-tumor necrosis factor (anti-TNF) agents have received regulatory approval for use in rheumatology: adalimumab, golimumab, infliximab, certolizumab, and etanercept. Apart from their well-documented therapeutic value, it is still uncertain to what extent they are associated with an increased risk of infectious adverse events.
Areas covered: We conducted a systematic review and meta-analysis of published randomized studies to determine the effect of anti-TNF drugs on the occurrence of infectious adverse events (serious infections; tuberculosis; opportunistic infections; any infection). We searched Medline, Embase, and the Cochrane Library up to May 2014 to identify eligible studies in adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis that evaluated anti-TNF drugs compared with placebo or no treatment.
Expert opinion: Our study encompassed data from 71 randomized controlled trials involving 22,760 participants (range of follow-up: 1–36 months) and seven open label extension studies with 2,236 participants (range of follow-up: 6–48 months). Quantitative synthesis of the available data found statistically significant increases in the occurrence of any infections (20%), serious infections (40%), and tuberculosis (250%) associated with anti-TNF drug use, while the data for opportunistic infections were scarce. The quality of synthesized evidence was judged as moderate. Further evidence from registries and long-term epidemiological studies are needed to better define the relationship between anti-TNF agents and infection complications.
Acknowledgments
We are grateful to Dr Antonio Spadaro who participated in the early phase of this study. Unfortunately, he passed away before seeing the completion of the review.
Article highlights
The association between anti-TNF drug use and infectious adverse events (AEs) is unclear.
The authors conducted a systematic review and meta-analysis of published trials involving patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis to determine the effect of anti-TNF agents on the risk of infectious AEs (serious infections, tuberculosis, opportunistic infections, or any infection).
71 RCTs with 22,760 patients, and seven OLE studies with 2,236 patients, met eligibility criteria and reported the occurrence of infectious AEs.
Synthesis of the evidence supports the hypothesis that the use of anti-TNF drugs significantly increases the risk of infectious AEs. The meta-analysis showed an increase in the occurrence of any infections (20%), serious infections (40%), and tuberculosis (250%) associated with anti-TNF drug use, while the data for opportunistic infections were scarce.
Given the increasing use of TNF inhibitors in adult patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, it is important to continue monitoring their safety profiles through complementary sources (e.g., registries, and long-term epidemiological studies).
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Declaration of interest
Valentina Marino is an employee of Pfizer Italia. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Supplemental data
Supplemental data for this article can be accessed here.