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Cyclosporin/Methotrexate Combo Has Varied Effects In Early Rheumatoid Arthritis
A DGReview of :"Cyclosporin A monotherapy versus cyclosporin A and methotrexate combination therapy in patients with early rheumatoid arthritis: a double blind randomised placebo controlled trial"
Annals of the Rheumatic Diseases (ARD Online)
03/21/2003
By Harvey McConnell
Neither cyclosporin A (CsA) monotherapy, nor combination therapy with methotrexate (MTX), appear to be very effective in inducing clinical remission in early rheumatoid arthritis, say researchers.
The combination therapy is, however, better at improving clinical disease activity and at slowing down radiological progress.
Clinicians in university hospitals in Amsterdam, Maastricht, Leeuwarden, and Nijmegen, the Netherlands, undertook a double-blind, randomised, placebo controlled trial to compare cyclosporin A monotherapy with combined cyclosporin A/methotrexate therapy among a cohort of 120 patients.
All patients had active rheumatoid arthritis (RA): rheumatoid factor positive and/or erosive. Sixty were randomly allocated to receive the CsA with MTX combination and 60 were allocated to receive CsA with placebo.
Initial treatment with CsA at 2.5 mg/kg/day was given to all patients, and increased to a maximum of 5 mg/kg/day in 16 weeks. MTX was started at 7.5 mg/week and increased to a maximum dose of 15 mg/week at week 16. Primary outcomes were clinical remission (Pinals criteria) and radiological damage (Larsen score), at week 48.
Treatment was stopped prematurely for 27 patients in the monotherapy group and 26 in the combination therapy group. There was a tendency towards more toxicity in the combination therapy group.
At week 48, clinical remission was achieved in four patients in the monotherapy group and in six patients in the combination therapy group (p=0.5). The median Larsen score increased to 10 (25th, 75th centiles: 3.5; 13.3) points in the monotherapy group and to 4 (1.0; 10.5) points in the combination therapy group.
Twenty-eight out of 60 patients (47%) in the monotherapy group, and 34 patients of 60 patients (57%) in the combination therapy group had reached an American College of Rheumatology 20% (ACR20) response at week 48. In addition, 15 patients (25%) in the monotherapy group and 29 patients (48%) in the combination therapy group had reached an ACR50 response, and another 7 patients (12%) and 12 patients (20%) respectively reached an ACR70 response.
Ann Rheum Dis 2003 Apr;62:4:291-6.
"Cyclosporin A monotherapy versus cyclosporin A and methotrexate combination therapy in patients with early rheumatoid arthritis: a double blind randomised placebo controlled trial"
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