Safety of Infliximab Treatment in Patients with Rheumatoid Arthritis in a Real-world Clinical Setting: Description and Evaluation of Infusion Reactions

The Journal of Rheumatology, 05/18/2012

Kelsall J et al. – The clinical data from 200 patients treated with infliximab (IFX) demonstrate that acute and delayed infusion reactions occur infrequently and are mostly mild to moderate in presentation.


  • The authors conducted a retrospective chart review of patients treated with IFX at the Mary Pack Arthritis Centre between 2000 and 2008.
  • The primary outcome was the occurrence of acute infusion reactions during infusions or 1–2 hours after each infusion, and secondary outcome was the occurrence of delayed infusion reactions 1–14 days after an infusion.
  • Descriptive analyses were conducted to summarize study outcomes and identify trends over followup.


  • Since 2000, 376 patients were referred to the Mary Pack IFX clinic and 200 received 4399 IFX infusions over a mean 140 ± 132 weeks of followup.
  • Of these, 135 were patients with RA who received 2977 IFX infusions over mean followup of 138 ± 132 weeks.
  • In total 258 episodes of acute reactions were observed for an overall acute reaction rate of 5.8%.
  • Acute infusion reactions were mostly mild (42.6%) and moderate (43.8%) and commonly affected sites were head and neck (31.5%) and cutaneous (21.1%).
  • A total of 37 delayed infusion reaction episodes were observed (0.9% rate); reactions were also mostly mild (16.2%) and moderate (64.9%).

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