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FRI0031 Cyclosporin-a plus methotrexate combination therapy is as safe as cyclosporin-a alone in patients with early rheumatoid arthritis
  1. AH Gerards1,
  2. RB Landewé2,
  3. AP Prins1,
  4. GA Bruijn3,
  5. HS Goei The2,
  6. BA Dijkmans1
  1. 1Rheumatology, Vrije Universiteit Medical Centre, Amsterdam
  2. 2Rheumatology, University Hospital, Maastricht
  3. 3Rheumatology, Medisch Centrum, Leeuwarden, The Netherlands


Background Combination therapy with cyclosporin-A (CsA) and methotrexate (MTX) has shown to be advantageous in early RA. A major concern is still the possibility of synergistically increased toxicity.

Objectives To assess whether long-term combination therapy wit CsA and MTX results in more renal and hepatic toxicity than CsA alone.

Design A randomised double blind placebo controlled trial of 48 weeks duration.

Methods 120 patients with active RA: mean age 52 yrs, mean disease duration 3 months. Patients received CsA and MTX or CsA and placebo. MTX was started at 7.5 mg/week, and was increased to 15 mg/wk after 16 weeks. CsA was started at 2.5 mg/kg/day, and was increased to a maximum of 5 mg/kg/day. Additionally, all patients used folic acid 1 mg/d. Patients who did not have an ACR 20 response at week 24 were withdrawn.

Results The mean CsA dosage at 48 weeks was 2.8 mg/kg/day in the CsA and placebo group and 3.0 mg/kg/day in the CsA and MTX group. After 48 weeks of treatment mean creatinine rose significantly 19μmol/L (+25%) in the CsA and placebo group, and 21μmol/L (+28%) in the CsA and MTX group (p = 0.28 between groups). Changes in blood pressure and liver enzymes were not significant and clinically different between the two groups.

Table 1: premature discontinuations due to:

Abstract FRI0031 Table 1

Conclusion Therapy with CsA and MTX in early RA does on average not result in more clinically relevant renal or hepatic toxicity than CsA alone, but a trend towards more discontinuations due to renal toxicity and hypertension was observed

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