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EXTENDED REPORT |
1 Centre for Rheumatic Diseases, Glasgow Royal Infirmary, Glasgow, UK
2 Gartnavel General Hospital, Glasgow, UK
3 Monklands & Wishaw General Hospital, Lanarkshire, UK
4 Raigmore Hospital, Inverness, UK
5 Hairmyres Hospital, East Kilbride, Lanarkshire, UK
6 Southern General Hospital, Glasgow, UK
7 Radiology Department, Glasgow Royal Infirmary, Glasgow, UK
8 Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
Correspondence to:
Correspondence to:
Professor H A Capell
Centre for Rheumatic Diseases, Glasgow Royal Infirmary, 84 Castle Street, Glasgow G4 0SF, UK; hilary.capell{at}northglasgow.scot.nhs.uk
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.
Abbreviations: 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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