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Correspondence to: Dr M Dougados, Institut de Rhumatologie, Hardy B, Hôpital Cochin, 27 rue du Fg Saint-Jacques, 75014 Paris, France.
Accepted for publication 4 November 1998
OBJECTIVES
To
investigate the potential clinical benefit of a combination therapy.
METHODS205 patients
fulfilling the ACR criteria for rheumatoid arthritis (RA), not treated
with disease modifying anti-rheumatoid drugs previously, with an early
(
1 year duration), active (Disease Activity Score (DAS) > 3.0),
rheumatoid factor and/or HLA DR 1/4 positive disease were randomised
between sulphasalazine (SASP) 2000 (maximum 3000) mg daily (n = 68), or
methotrexate (MTX) 7.5 (maximum 15) mg weekly (n = 69) or the
combination (SASP + MTX) of both (n = 68).
RESULTSThe mean
changes in the DAS during the one year follow up of the study was
1.15, 0.87, 1.26 in the SASP, MTX, and SASP + MTX group
respectively (p = 0.019). However, there was no statistically significant difference in terms of either EULAR good responders 34%,
38%, 38% or ACR criteria responders 59%, 59%, 65% in the SASP,
MTX, and SASP + MTX group respectively. Radiological progression evaluated by the modified Sharp score was very modest in the three groups: mean changes in erosion score: +2.4, +2.4, +1.9, in narrowing score: +2.3, +2.1, +1.6 and in total damage score: +4.6, +4.5, +3.5, in
the SASP, MTX, and SASP + MTX groups respectively. Adverse events
occurred more frequently in the SASP + MTX group 91% versus 75% in
the SASP and MTX group (p = 0.025). Nausea was the most frequent side
effect: 32%, 23%, 49% in the SASP, MTX, and SASP + MTX groups
respectively (p = 0.007).
CONCLUSIONThis study
suggests that an early initiation therapy of disease modifying drug
seems to be of benefit. However, this study was unable to demonstrate a
clinically relevant superiority of the combination therapy although
several outcomes were in favour of this observation. The tolerability
of the three treatment modalities seems acceptable.
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