Combination therapy with sulfasalazine and methotrexate is more effective than either drug alone in patients with rheumatoid arthritis with a suboptimal response to sulfasalazine: results from the double-blind placebo-controlled MASCOT study

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 prev...

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Bibliographic Details
Published in:	Annals of the rheumatic diseases Vol. 66; no. 2; pp. 235 - 241
Main Authors:	Capell, Hilary A, Madhok, Rajan, Porter, Duncan R, Munro, Robin A L, McInnes, Iain B, Hunter, John A, Steven, Malcolm, Zoma, Asad, Morrison, Elaine, Sambrook, Martin, Wui Poon, Fat, Hampson, Rosemary, McDonald, Fiona, Tierney, Ann, Henderson, Neil, Ford, Ian
Format:	Journal Article
Language:	English
Published:	London BMJ Publishing Group Ltd and European League Against Rheumatism 01-02-2007 BMJ BMJ Publishing Group LTD BMJ Group
Subjects:	Adolescent Adult Aged Aged, 80 and over Antirheumatic Agents - administration & dosage Antirheumatic Agents - adverse effects Antirheumatic Agents - therapeutic use Arthritis, Rheumatoid - diagnostic imaging Arthritis, Rheumatoid - drug therapy Arthrography Biological and medical sciences Bones, joints and connective tissue. Antiinflammatory agents DAS disease activity score disease-modifying antirheumatic drug Diseases of the osteoarticular system DMARD Double-Blind Method Drug Administration Schedule Drug dosages Drug Therapy, Combination erythrocyte sedimentation rate ESR EULAR European League Against Rheumatism Extended Report Female HCQ Humans hydroxychloroquine Inflammatory joint diseases Male Medical sciences Methotrexate Methotrexate - administration & dosage Methotrexate - adverse effects Methotrexate - therapeutic use Middle Aged Mortality MTX Pharmacology. Drug treatments Rheumatism Rheumatoid arthritis SASP Scotland Studies sulfasalazine Sulfasalazine - administration & dosage Sulfasalazine - adverse effects Sulfasalazine - therapeutic use TICORA tight control in rheumatoid arthritis TNF Treatment Outcome Tumor necrosis factor-TNF tumour necrosis factor Sulfanilamide derivatives Antineoplastic agent Human Immunopathology Drug combination Diseases of the osteoarticular system Antiinflammatory agent Autoimmune disease Inflammatory joint disease Antifolate Chronic Antimetabolic Rheumatoid arthritis Double blind study Sulfasalazine Combined treatment Salicylates Methotrexate Arm
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Summary:	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.
Bibliography:	local:0660235 Correspondence to:  Professor H A Capell  Centre for Rheumatic Diseases, Glasgow Royal Infirmary, 84 Castle Street, Glasgow G4 0SF, UK; hilary.capell@northglasgow.scot.nhs.uk istex:E8D949A51F9177E86A977C3E3821A5503FAE0734 PMID:16926184 ark:/67375/NVC-LT8D82KF-1 href:annrheumdis-66-235.pdf
ISSN:	0003-4967 1468-2060
DOI:	10.1136/ard.2006.057133