Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial

P. Verschueren, D. de Cock, L. Corluy, R. Joos, C. Langenaken, V. Taelman, F. Raeman, I. Ravelingien, K. Vandevyvere, J. Lenaerts, E. Geens, P. Geusens, J. Vanhoof, A. Durnez, J. Remans, B. vander Cruyssen, E. van Essche, A. Sileghem, G. de Brabanter, J. JolyS. Meyfroidt, K. van der Elst, R. Westhovens

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objectives To compare the efficacy and safety of intensive combination strategies with glucocorticoids (GCs) in the first 16 weeks (W) of early rheumatoid arthritis (eRA) treatment, focusing on high-risk patients, in the Care in early RA trial.

Methods 400 disease-modifying antirheumatic drugs (DMARD)-naive patients with eRA were recruited and stratified into high risk or low risk according to classical prognostic markers. High-risk patients (n=290) were randomised to 1/3 treatment strategies: combination therapy for early rheumatoid arthritis (COBRA) Classic (methotrexate (MTX)+ sulfasalazine+60 mg prednisone tapered to 7.5 mg daily from W7), COBRA Slim (MTX + 30 mg prednisone tapered to 5 mg from W6) and COBRA Avant-Garde (MTX+leflunomide+30 mg prednisone tapered to 5 mg from W6). Treatment modifications to target low-disease activity were mandatory from W8, if desirable and feasible according to the rheumatologist. The primary outcome was remission (28 joint disease activity score calculated with C-reactive protein

Results Data from 98 Classic, 98 Slim and 94 Avant-Garde patients were analysed. At W16, remission was reached in 70.4% Classic, 73.6% Slim and 68.1% Avant-Garde patients (p=0.713). Likewise, no significant differences were shown in other secondary endpoints. However, therapy-related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006).

Conclusions For high-risk eRA, MTX associated with a moderate step-down dose of GCs was as effective in inducing remission at W16 as DMARD combination therapies with moderate or high step-down GC doses and it showed a more favourable short-term safety profile.

Original languageEnglish
Pages (from-to)27-34
Number of pages8
JournalAnnals of the Rheumatic Diseases
Volume74
Issue number1
DOIs
Publication statusPublished - 1 Jan 2015

Keywords

  • MODIFYING ANTIRHEUMATIC DRUGS
  • PLACEBO-CONTROLLED TRIAL
  • EARLY RA PATIENTS
  • DOUBLE-BLIND
  • RANDOMIZED-TRIAL
  • TIGHT CONTROL
  • RADIOGRAPHIC PROGRESSION
  • TREATMENT STRATEGIES
  • TARGET STRATEGY
  • BIOLOGIC AGENTS

Cite this

Verschueren, P., de Cock, D., Corluy, L., Joos, R., Langenaken, C., Taelman, V., Raeman, F., Ravelingien, I., Vandevyvere, K., Lenaerts, J., Geens, E., Geusens, P., Vanhoof, J., Durnez, A., Remans, J., vander Cruyssen, B., van Essche, E., Sileghem, A., de Brabanter, G., ... Westhovens, R. (2015). Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial. Annals of the Rheumatic Diseases, 74(1), 27-34. https://doi.org/10.1136/annrheumdis-2014-205489