Extended reports
Limited effect of sulphasalazine treatment in reactive arthritis.
A randomised double blind placebo controlled trial
a Department of Rheumatology, Copenhagen Municipal
Hospital, Copenhagen and GentofteUniversity Hospital, Hellerup, Denmark
, b Department of Rheumatology,
Herlev University Hospital, Herlev, Denmark , c Department of Rheumatology, King Christian X Rheumatism
Hospital, Graasten, Denmark , d Department of Rheumatology, Odense University
Hospital, Denmark , e Department of Rheumatology, Hjørring Hospital, Denmark
, f Department of Rheumatology,
University Hospital Maastricht, The Netherlands
Correspondence to: Charlotte Egsmose, Department of Rheumatology B4, Slagelse County Hospital, DK-4200 Slagelse, Denmark.
Accepted for publication 4 September
1996
OBJECTIVE
To assess the efficacy and safety of
sulphasalazine in reactive arthritis.
METHODSDouble blind placebo controlled trial of
six months duration comparing sulphasalazine 2-3 g per day (n = 37)
with matching placebo (n = 42) in adults with active reactive arthritis
(age 19-57 years, median 34). Treatment response was evaluated once a
month by changes in erythrocyte sedimentation rate (ESR), pain, peripheral arthritis, tender iliosacral joints, entesopathy,
extra-articular manifestations, and working ability.
RESULTS15 patients in the sulphasalazine group
and eight in the placebo group withdrew from the study prematurely.
Adverse events, primarily gastrointestinal, were the main reason
for withdrawal in the actively treated group. Intention-to-treat
analyses showed significant improvements over time in both groups in
ESR, pain, and number of swollen joints (P < 0.01). Number of days on
sick leave decreased significantly in the sulphasalazine group only (P < 0.01). No significant differences between the two groups were
present after six months. Among the patients completing the trial
according to protocol, persistent complete remission had occurred
within two months in five (23%) of the actively treated, but in no
placebo treated patients (P = 0.013).
CONCLUSIONSSulphasalazine seemed to improve only
the very short term outcome of reactive arthritis. The possible
beneficial effect of the drug should also be weighed against the
risk of adverse events. Although these were mainly mild, almost 25% of
the patients in the actively treated group gave up treatment for this reason.
© 1997 by Annals of the Rheumatic Diseases
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