© 2002 by Annals of the Rheumatic Diseases
LEADER
Rheumatoid arthritis
Follow up studies in rheumatoid arthritis
University Hospital, Department of Internal Medicine/Rheumatology, Maastricht, The Netherlands
Correspondence to:
Correspondence to:
Dr R B M Landewé, Department of Rheumatology, University Hospital, PO Box 5800, 6202 AZ Maastricht, The Netherlands;
rlan@sint.azm.nl
Do we really need follow up studies of randomised clinical trials in RA?
Keywords: rheumatoid arthritis; cyclosporin; gold; clinical trial
In rheumatology we have been told for years that the results of randomised controlled trials may not be extrapolated to the long term, and that a gain in the beginning may not necessarily mean a gain in what we solemnly call the "final outcome". In almost every review on disease modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA), long term efficacy and long term toxicity are always considered. The importance of long term data is repeatedly stated, without, however, explaining what information is really necessary. And regulatory authorities nowadays require long term studies before approving drugs which claim, for example, to preserve function.
Probably as a consequence of this, we are now facing an increasing number of published follow up reports of clinical trials—for example, references 1–6a.1–6a The conclusion is always that some drug is still as effective and as toxic as its comparator, x years after the
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