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Sepsis as a possible adverse drug reaction in patients with rheumatoid arthritis treated with TNFalpha antagonists

A Kling1, T Mjörndal, S Rantapää-Dahlqvist

  • 1Division of Clinical Pharmacology, Norrland University Hospital, Umeå, Sweden. anders.kling@pharm.umu.se

Journal of Clinical Rheumatology : Practical Reports on Rheumatic & Musculoskeletal Diseases
|October 18, 2006
PubMed
Abstract

Insights

Tumor necrosis factor-alpha (TNFalpha) antagonists may increase the risk of sepsis, a serious adverse drug reaction. Physicians should be aware of this risk, especially in patients with predisposing conditions.

Area of Science:

  • Rheumatology
  • Pharmacovigilance
  • Infectious Diseases

Background:

  • Rheumatoid arthritis (RA) treatment with TNFalpha antagonists is effective but uncommon adverse drug reactions (ADRs) are less understood.
  • Concerns exist regarding increased infection frequency with TNFalpha antagonists, with existing infections listed as contraindications.
  • This study investigates sepsis as a potential serious ADR associated with TNFalpha antagonist therapy.

Purpose of the Study:

  • To raise physician awareness of sepsis as a serious adverse drug reaction (ADR) during TNFalpha antagonist treatment.
  • To identify patient groups at higher risk for sepsis when using TNFalpha antagonists.
  • To contribute to the understanding of rare but severe adverse events associated with biologic therapies.

Main Methods:

  • Utilized Sweden's mandatory adverse drug reaction (ADR) reporting system to the Medical Product Agency (MPA).
  • Analyzed reported cases of sepsis suspected to be caused by drug therapy between January 1, 1999, and June 30, 2003.
  • Included preliminary causality assessment and data transfer to a central online database.

Main Results:

  • 29 cases of drug-associated sepsis were reported; 17 involved TNFalpha antagonists.
  • Three reports specifically linked etanercept, a TNFalpha antagonist, to septicemia in Northern Sweden.
  • Factors contributing to susceptibility and fatal outcomes in serious infections were considered.

Conclusions:

  • Physicians need increased awareness regarding sepsis as a potential serious adverse drug reaction (ADR) with TNFalpha antagonists.
  • Patients with predisposing conditions or those with infrequent rheumatologist visits may face elevated sepsis risk.
  • Further information is crucial for safe and effective management of patients on TNFalpha antagonist therapy.

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