Step-down approach using either cyclosporin A or MTX as maintenance therapy in early RA

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Online ISSN: 1529-0131 Print ISSN: 0004-3591

Arthritis Care & Research

Volume 47, Issue 1, 2002. Pages: 59-66

Published Online: 7 Feb 2002

Copyright © 2002 by the American College of Rheumatology

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Original Article

Step-down approach using either cyclosporin A or methotrexate as

maintenance therapy in early rheumatoid arthritis

Marchesoni 1 *, Norma Battafarano 1, Marco Arreghini 1, Raffaele

Pellerito 2, Cagnoli 1, Porziana Prudente 1, Alfonso Cerase 3,

Francesco Priolo 4, Tosi 1

1G. Pini Orthopaedic Institute, Milan, Italy

2Mauriziano Hospital, Turin, Italy

3Le e Hospital, Siena, Italy

4Catholic University, Rome, Italy

email: Marchesoni (marchesoni@...)

*Correspondence to Marchesoni, Rheumatology Department, G. Pini

Orthopaedic Institute, Via G. Pini 9, Milano 20122, Italy

Keywords

Rheumatoid arthritis; Cyclosporine; Methotrexate; Step-down; Combination

therapy

Abstract

Objective

To evaluate the feasibility and outcome of the step-down approach using

either cyclosporin A (CSA) or methotrexate (MTX) as maintenance therapy

following 6 months treatment with these 2 agents in combination in

early, nonerosive rheumatoid arthritis (RA).

Methods

Fifty-seven patients younger than 65 years with early, nonerosive RA

were first treated with CSA and MTX in combination for 6 months. They

were then randomly stepped down to single-agent maintenance treatment

for another 18 months. Safety, clinical efficacy, survival on treatment,

and radiographic progression were evaluated.

Results

When being treated with combination therapy, 7 of the 57 patients

(12.3%) withdrew because of adverse events. Of the remaining 50

patients, 42 (84.0%) were American College of Rheumatology (ACR) 20%

responders, 30 (60.0%) were ACR 50% responders, and 23 (46.0%) were ACR

70% responders. At month 6, 22 patients were randomized to CSA and 27 to

MTX. During this trial period, the treatment was discontinued by 16

patients taking CSA (mainly because of loss of efficacy) and by 4 taking

MTX. At month 24, the probability (± SEM) of survival on treatment was

0.273 ± 0.09 for CSA and 0.852 ± 0.07 for MTX. Of the 6 CSA patients who

completed the trial, 4 (66.7%) were ACR 20% responders, and 3 (50%) were

both ACR 50% and ACR 70% responders. Of the 23 completers in the MTX

arm, 21 (91.3%) were ACR 20% responders, 18 (78.3%) were ACR 50%, and 10

(43.5%) were ACR 70% responders. The treatment was not responsible for

severe adverse events. Radiography showed a slow progression in the

damage score and number of eroded joints in both treatment groups.

Conclusion

Stepping down to single agent maintenance therapy following 6 months of

combination treatment with CSA and MTX in early RA was only successful

with MTX. Because this treatment did not prevent some radiographic

progression, other approaches (e.g., step-up approach) may be more

appropriate in early RA.

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Received: 23 March 2001; Accepted: 7 September 2001