Treatment of early RA in clinical practice: a comparative study of two different DMARD/corticosteroid options

Clin Exp Rheumatol. 2003 May-Jun;21(3):327-32.


Objectives: To study the outcome in clinical practice of first DMARD and/or corticosteroid (CS) treatment in patients with recent onset rheumatoid arthritis (RA).

Patients: 245 patients with active RA, not previously treated with DMARDs or CS, were randomised to one of two treatment groups, T1 = 7.5-15 mg of prednisolone (PRE) daily for one to three months followed, if needed, by methotrexate (MTX) in a weekly dose of 5-15 mg in addition to the lowest possible dose of PRE or T2 = sulfasalazine (SAL), supplemented with lowest possible CS dose if needed.

Methods: The EULAR individual response criteria were applied and remission was defined as a final DAS28 < 2.6. Function was assessed by the HAQ and radiographic progression by Larsen scores. A patient who managed to remain on the allocated treatment for two years was described as a "completer".

Results: After 2 years of treatment, 70% of the patients in T1 and 63% in T2 were responders (30% and 33% "good responders", respectively). In T1 29% and in T2 19% were in remission. There was a significant functional improvement in both groups but radiographic progression occurred. The mean decrease in HAQ and increase in the Larsen score were similar in the two groups. One-third of the patients were non-completers, 19% from T1 and 47% from T2. Non-completers had, compared with completers, a significantly lower rate of individual response and remission. Completers and non-completers had similar functional improvement and similar radiological progression.

Conclusions: Individual response and remission was reduced in patients who did not complete their first DMARD/CS treatment option. Treatment failures were significantly more frequent in the sulfasalazine plus optional CS than in the CS plus optional methotrexate treatment group.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Arthritis, Rheumatoid / diagnosis
  • Arthritis, Rheumatoid / drug therapy*
  • Chi-Square Distribution
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Pain Measurement / drug effects
  • Patient Satisfaction
  • Prednisolone / adverse effects
  • Prednisolone / therapeutic use*
  • Range of Motion, Articular / physiology
  • Reference Values
  • Rheumatology / methods
  • Risk Assessment
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Sulfasalazine / adverse effects
  • Sulfasalazine / therapeutic use*
  • Treatment Outcome


  • Sulfasalazine
  • Prednisolone
  • Methotrexate