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FRI0021 Combination therapy with cyclosporin-a and methotrexate in patients with early potentially aggressive rheumatoid arthritis, a randomised double blind placebo controlled trial
  1. AH Gerards1,
  2. RB Landewé2,
  3. AP Prins1,
  4. GA Bruijn3,
  5. HS Goei Thé2,
  6. BA Dijkmans1
  1. 1Rheumatology, Vrije Universiteit Medical Centre, Amsterdam
  2. 2Rheumatology, University Hospital Maastricht, Maastricht
  3. 3Rheumatology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands


Background Patients with advanced RA with a suboptimal response on low dose methotrexate (MTX) have shown to respond well after the addition of cyclosporin-A (CsA).1 The combination of CsA and MTX has never been tested in a parallel design in patients with early RA.

Objectives To assess in patients with early, and potentially aggressive RA whether combination therapy with CsA and MTX compared to CsA mono therapy, results in a higher number of clinical improvements.

Methods 120 RA-patients with active disease who were rheumatoid factor positive (95%) and/or had signs of radiological damage (49%) received CsA and MTX or CsA and placebo for 48 weeks. MTX was started ad a dose of 7.5 mg/week, and increased to 15 mg/wk at week 16. CsA was started at a dose of 2.5 mg/kg/day and increased to a maximum of 5 mg/kg/day. Patients who did not have an ACR20 response after 24 weeks were withdrawn. ACR responses at the 20%, 50% and 70% levels were calculated on basis of intention to treat with the last visit put forward in case of premature discontinuation.

Results Baseline demography was comparable between the two groups. 26 patients in the CsA and MTX group and 27 patients in the CsA and placebo group stopped study medication because of lack of efficacy (14 vs. 21, p = 0.23) or adverse events (12 vs. 6, p = 0.20).

Data from week 48 are shown in the Table 1.

Abstract FRI0021 Table 1

Conclusion In patients with early, potentially aggressive RA, CsA and MTX combination therapy, compared to CsA mono therapy, results in a higher number of major clinical improvements.


  1. Tugwell, et al. NEJM 1995;3333:137–41

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