Risk of infections using anti-TNF agents in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: a systematic review and meta-analysis

Silvia Minozzi, Stefanos Bonovas, Theodore Lytras, Valentina Pecoraro, Marien González-Lorenzo, Anan Judina Bastiampillai, Eugenia Maria Gabrielli, Carlo Andrea Lonati, Lorenzo Moja, Michela Cinquini, Anna Valentina De Marino, Andrea Matucci, Giuseppe Maria Milano, Giuliano Tocci, Raffaele Scarpa, Delia Goletti, Fabrizio Cantini

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)11-34
Number of pages24
JournalExpert Opinion on Drug Safety
Publication statusPublished - Dec 1 2016


  • Ankylosing spondylitis
  • anti-TNF drugs
  • drug safety
  • infections
  • meta-analysis
  • opportunistic infections
  • psoriatic arthritis
  • rheumatoid arthritis
  • serious infections
  • systematic review
  • tuberculosis

ASJC Scopus subject areas

  • Pharmacology (medical)


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