Background: Optimal use of disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis is vital if progression of disease is to be reduced. Methotrexate (MTX) and sulfasalazine (SASP) are widely used inexpensive DMARDs, recently often combined despite no firm evidence of benefit from previous studies.
Aim: To establish whether a combination of SASP and MTX is superior to either drug alone in patients with rheumatoid arthritis with a suboptimal response to 6 months of SASP.
Methods: A randomised controlled study of step-up DMARD treatment in early rheumatoid arthritis. In phase I, 687 patients received SASP for 6 months. Those with a disease activity score (DAS) ⩾2.4 were offered additional treatment in phase II (SASP alone, MTX alone or a combination of the two). The primary outcome measure was change in DAS.
Results: At 6 months, 191 (28%) patients had a DAS <2.4, 123 (18%) were eligible but did not wish to enter phase II, 130 (19%) stopped SASP because of reversible adverse events and 165 (24%) entered phase II. DAS at 18 months was significantly lower in those who received combination treatment compared with those who received either SASP or MTX: monotherapy arms did not differ. Improvement in European League Against Rheumatism and American College of Rheumatology 20, 50 and 70 scores favoured combination therapy.
Conclusions: In this “true-to-life” study, an inexpensive combination of DMARDs proved more effective than monotherapy in patients with rheumatoid arthritis with a suboptimal response to SASP. There was no increase in toxicity. These results provide an evidence base for the use of this combination as a component of tight control strategies.
- DAS, disease activity score
- DMARD, disease-modifying antirheumatic drug
- ESR, erythrocyte sedimentation rate
- EULAR, European League Against Rheumatism
- HCQ, hydroxychloroquine
- MTX, methotrexate
- SASP, sulfasalazine
- TICORA, tight control in rheumatoid arthritis
- TNF, tumour necrosis factor
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Published Online First 22 August 2006
Funding: This study was funded by the Arthritis Research Campaign. Wyeth Pharmaceuticals supplied methotrexate and matching placebo. Pharmacia supplied sulpfasalazine and matching placebo.
Competing interests: None declared.
The study was funded by the Arthritis Research Campaign, which had no role in data collection, data analysis, data interpretation, writing of the report, or in the decision to submit the paper for publication. Wyeth (Maidenhead, UK) and Pharmacia (Milton Keynes, UK) provided drugs and placebo, but had no role in the conduct or analysis of the study.
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