The British Journal of Rheumatology, Vol 36, 1082-1088, Copyright © 1997 by British Society for Rheumatology
CJ Haagsma, PL van Riel, AJ de Jong and LB van de Putte
To compare the efficacy of sulphasalazine, methotrexate, and the
combination of both in patients with early rheumatoid arthritis (RA), not
treated with disease-modifying anti-rheumatic drugs previously, we
conducted a double-blind, double-dummy, controlled, clinical trial. One
hundred and five patients with active, early RA, rheumatoid factor and/or
HLA DR1/4 positive were randomized between sulphasalazine (SSZ) 2000
(maximum 3000) mg daily, or methotrexate (MTX) 7.5 (maximum 15) mg weekly,
or the combination (COMBI) of both, and were followed up by a single
observer for 52 weeks. The mean change over time per patient, including all
visits, in Disease Activity Score (DAS) was: SSZ: -1.6 (95% CI -2.0 to
-1.2); MTX: -1.7 (-2.0 to -1.4); COMBI: -1.9 (-2.2 to - 1.6); the
difference week 0-week 52 (SSZ, MTX, COMBI respectively); DAS: -1.8, -2.0,
-2.3, Ritchie articular index: -9.2, -9.5, -10.6, swollen joints: -9.2,
-12.4, -14.3, erythrocyte sedimentation rate: - 17, -21, -28. Nausea
occurred significantly more in the COMBI group. The numbers of drop-outs
due to toxicity were SSZ 9, MTX 2, COMBI 5. In conclusion, there were no
significant differences in efficacy between combination and single therapy,
only a modest trend favouring COMBI. The results of MTX and SSZ were very
comparable. Nausea occurred more often in the COMBI group: the number of
withdrawals due to adverse events did not differ significantly.
ORIGINAL PAPERS
Combination of sulphasalazine and methotrexate versus the single components in early rheumatoid arthritis: a randomized, controlled, double-blind, 52 week clinical trial
Department of Rheumatology, University Hospital Nijmegen, The Netherlands.
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