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Proposal to establish a register for the long term surveillance of adverse events in patients with rheumatic diseases exposed to biological agents: the EULAR Surveillance Register for Biological Compounds
  1. ALAN SILMAN
  1. LARS KLARESKOG
  1. FERDINAND BREEDVELD
  1. BARRY BRESNIHAN
  1. RAVINDER MAINI
  1. PIET VAN RIEL
  1. DEBORAH SYMMONS
  1. Manchester
  2. Stockholm, Joint Chairmen
  3. Leiden
  4. Dublin
  5. London
  6. Nijmegen
  7. Manchester

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All pharmacological interventions, including the use of disease suppressive agents in rheumatology, are associated with adverse side effects in a proportion of patients treated. Adverse events, often occurring early during treatment, will be ascertained during clinical trials and by surveillance studies after marketing. Longer term complications, such as malignancy, and indeed all rare events, are unlikely to be detected until large numbers of patients have been treated. Thus observation needs to be continued beyond the treatment period. Immunosuppressive treatment is considered to be a potential risk factor for both malignancy and life threatening infection. The use of treatments such as azathioprine is associated with an increased risk of lymphoproliferative malignancies in patients with rheumatoid arthritis.1-3 Immunosuppressed patients are also at risk of serious infections—for example, fromMycobacterium tuberculosis, pneumocystis, and even from fungi.4 In current clinical practice these small risks are accepted if the potential benefit for the patient is proportionately greater. Informed prescribing of new agents therefore requires knowledge of the risk of such longer term adverse events.

Long term hazards from new biological agents

It is likely that in the near future a large number of new, so called biological agents will become available for disease suppressive treatment in rheumatoid and related inflammatory arthropathies. Currently, the most notable are those designed to block the action of tunour necrosis factor (TNF)—etanercept and infliximab, which are currently available on prescription in several countries, with release in further countries likely soon. …

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Footnotes

  • On behalf of an ad hoc EULAR working group on the long term toxicity from new biological agents.