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
- P H de Jong1,
- J M Hazes1,
- H K Han2,
- M Huisman3,
- D van Zeben3,
- P A van der Lubbe4,
- A H Gerards4,
- B van Schaeybroeck5,
- P B de Sonnaville6,
- M V van Krugten6,
- J J Luime1,
- A E Weel1,2
- 1Department of Rheumatology, University Medical Center, Rotterdam, The Netherlands
- 2Department of Rheumatology, Maasstad Hospital, Rotterdam, The Netherlands
- 3Department of Rheumatology, Sint Francicus Gasthuis Hospital, Rotterdam, The Netherlands
- 4Department of Rheumatology, Vlietland Hospital, Schiedam, The Netherlands
- 5Department of Rheumatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands
- 6Department of Rheumatology, Admiraal de Ruyter Hospital, Goes & Vlissingen, The Netherlands
- Correspondence to Dr Pascal Hendrik Pieter de Jong, Department of Rheumatology, University Medical Center, Erasmus MC, Room Na850, Postbus 2040, Rotterdam 3000 CA, The Netherlands;
- Received 21 October 2013
- Revised 14 April 2014
- Accepted 16 April 2014
- Published Online First 1 May 2014
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.
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