Daily practice effectiveness of a step-down treatment in comparison with a tight step-up for early rheumatoid arthritis.
OBJECTIVE
To study prospectively the daily practice effectiveness of a step-down early rheumatoid arthritis (RA) treatment strategy.


METHODS
Patients with severe RA and no contra-indications were proposed step-down therapy, the others step-up. Step-down patients received a modified combination therapy in early RA (COBRA) regimen: sulphasalazine (SPS), 2 g daily, and methotrexate (MTX), 15 mg weekly, combined with step-down oral prednisolone (start 60 mg daily, fast tapering to 7.5 mg over 6 weeks, discontinuation from week 28). At week 40, patients were randomized to maintenance therapy with either SPS or MTX if disease activity score-28 (DAS28) was acceptably low. The step-up group started disease-modifying anti-rheumatic drug (DMARD) monotherapy. In both groups, treatment was adjusted at follow-up, based on DAS28. DAS28, functionality Health Assessment Questionnaire (HAQ), adverse events, DMARD changes and steroid use were registered 4-monthly for 2 yrs.


RESULTS
Nineteen patients received step-down and 52 step-up treatment. More patients completed the first year without unplanned DMARD changes and without dosage adjustment and fewer had DMARD changes due to side effects or inefficacy in the step-down group compared with step-up, whereas the number of adverse events was comparable. MTX proved to be the most effective maintenance therapy after step-down. The DAS response, proportion of patients in remission, HAQ response and proportion of patients without disability at 4 months was higher in the step-down group.


CONCLUSIONS
In daily practice, a step-down treatment strategy for early RA is more effective than a step-up approach.
Department of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. patrick.verschueren@uz.kuleuven.ac.be
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Verschueren
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Esselens
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R
Westhovens
D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006304:Health Status; D006801:Humans; D007223:Infant; D007596:Joints / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage; D011446:Prospective Studies; D012219:Rheumatology / Q000379:methods*; D012720:Severity of Illness Index; D012460:Sulfasalazine / Q000008:administration & dosage; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D012460:Sulfasalazine; D011239:Prednisolone; D008727:Methotrexate