Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial
| Autor: | P. B. J. de Sonnaville, J.M. Hazes, P H de Jong, H K Han, Angelique E. A. M. Weel, B van Schaeybroeck, Jolanda J. Luime, Andreas H. Gerards, M V van Krugten, D. Van Zeben, P. A. van der Lubbe, M. Huisman |
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| Přispěvatelé: | Rheumatology |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Immunology Administration Oral Rheumatoid Arthritis Injections Intramuscular General Biochemistry Genetics and Molecular Biology Arthritis Rheumatoid Rheumatology Early Rheumatoid Arthritis Sulfasalazine Internal medicine Humans Immunology and Allergy Medicine Single-Blind Method Longitudinal Studies Adverse effect Glucocorticoids Aged business.industry Area under the curve Hydroxychloroquine Clinical and Epidemiological Research Middle Aged medicine.disease Surgery Treatment Radiography Clinical trial Methotrexate Treatment Outcome Antirheumatic Agents Area Under Curve Rheumatoid arthritis Disease Progression Drug Therapy Combination Female DMARDs (synthetic) business Intramuscular injection medicine.drug |
| Zdroj: | Annals of the Rheumatic Diseases, 73(7), 1331-1339. BMJ Publishing Group Annals of the Rheumatic Diseases |
| ISSN: | 1468-2060 0003-4967 |
| DOI: | 10.1136/annrheumdis-2013-204788 |
| Popis: | OBJECTIVES: To compare 1-year clinical efficacy of (1) initial triple disease-modifying antirheumatic drug therapy (iTDT) with initial methotrexate (MTX) monotherapy (iMM) and (2) different glucocorticoid (GC) bridging therapies: oral versus a single intramuscular injection in early rheumatoid arthritis.METHODS: In a single-blinded randomised clinical trial patients were randomised into three arms: (A) iTDT (methotrexate+sulfasalazine+hydroxychloroquine) with GCs intramuscularly; (B) iTDT with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Primary outcomes were (1) area under the curve (AUC) of Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) and (2) the proportion of patients with radiographic progression.RESULTS: 281 patients were randomly assigned to arms A (n=91), B (n=93) or C (n=97). The AUC DAS and HAQ were respectively -2.39 (95% CI -4.77 to -0.00) and -1.67 (95% CI -3.35 to 0.02) lower in patients receiving iTDT than in those receiving iMM. After 3 months, treatment failure occurred less often in the iTDT group, resulting in 40% fewer treatment intensifications. The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time. No differences were seen between the two GC bridging therapies. Respectively 21%, 24% and 23% of patients in arms A, B and C had radiographic progression after 1 year. Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM.CONCLUSIONS: Treatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM. However, no difference in radiographic progression is seen. Both GC bridging therapies are equally effective and, therefore, both can be used.TRIAL REGISTRATION NUMBER: ISRCTN26791028. |
| Databáze: | OpenAIRE |
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