EULAR news
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
| The first 150 words of the full text of this article appear below. |
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, from
Mycobacterium tuberculosis, pneumocystis,
and even from fungi.4 In current clinical practice these
small risks are accepted if the potential benefit for the patient
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