Background Cyclosporin-A (CsA) added to low dose methotrexate (MTX) in patients with advanced rheumatoid arthritis (RA) is clinically superior to MTX alone.1 The potential of CsA and MTX to inhibit radiological progression has not been established yet.
Objectives To assess in patients with early, active and potentially aggressive RA whether the combination of CsA and MTX results in less radiological progression as compared to 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, 95% rheumatoid factor positive, 49% erosions and/or joint space narrowing. Patients received CsA and MTX or CsA and placebo. MTX was started at 7.5 mg/week, and was increased to 15 mg/week after 16 weeks. CsA was started at 2.5 mg/kg/day, and was increased to a maximum of 5 mg/kg/day. Plain X-rays of hands and feet were obtained at week 0 and week 48 and were read in chronological order by two independent observers, blind for the study medication, using the Larsen-modified Larsen score.2
Results The Table 1 summarises the Larsen Score of patients in which 2 sets of films were available.
Conclusion CsA and MTX significantly retards radiological progression in comparison with CsA alone in patients with early, active and potentially aggressive RA.
Tugwell. NEJM 1995;333:137–41
Larsen. J Rheum. 1995;22(10):1974–5
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