Article Text

Extended report
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
  1. P H de Jong1,
  2. J M Hazes1,
  3. H K Han2,
  4. M Huisman3,
  5. D van Zeben3,
  6. P A van der Lubbe4,
  7. A H Gerards4,
  8. B van Schaeybroeck5,
  9. P B de Sonnaville6,
  10. M V van Krugten6,
  11. J J Luime1,
  12. A E Weel1,2
  1. 1Department of Rheumatology, University Medical Center, Rotterdam, The Netherlands
  2. 2Department of Rheumatology, Maasstad Hospital, Rotterdam, The Netherlands
  3. 3Department of Rheumatology, Sint Francicus Gasthuis Hospital, Rotterdam, The Netherlands
  4. 4Department of Rheumatology, Vlietland Hospital, Schiedam, The Netherlands
  5. 5Department of Rheumatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands
  6. 6Department of Rheumatology, Admiraal de Ruyter Hospital, Goes & Vlissingen, The Netherlands
  1. 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; p.h.p.dejong{at}erasmusmc.nl

Abstract

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.

  • Rheumatoid Arthritis
  • DMARDs (synthetic)
  • Early Rheumatoid Arthritis
  • Treatment

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

View Full Text

Statistics from Altmetric.com

Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Files in this Data Supplement:

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.