Radiographic progression in early rheumatoid arthritis: a 12-month randomized controlled study comparing the combination of cyclosporin and methotrexate with methotrexate alone
British Journal of Rheumatology
Objective. To determine whether patients with early rheumatoid arthritis (RA) treated with cyclosporin A (CsA) and methotrexate (MTX) in combination for 12 months show a lower rate of radiographic deterioration than those treated with MTX alone. Methods. In this controlled and randomized single-blind trial, 61 consecutive patients with untreated RA of less than 2 yr duration were treated with either CsA þ MTX combination therapy (n ¼ 30) or MTX alone (n ¼ 31). The primary end-point was
... -point was radiographic progression after 12 months, measured using the damage score (DS) of the Sharp and van der Heijde method. Results. Although there was a significant difference between the mean baseline and 12-month DS in both treatment groups (MTX/CsA, 1.93 ± 0.90; MTX, 7.47 ± 2.03), it was significantly less in the combination arm (P ¼ 0.018). Of the 30 evaluable CsA þ MTX patients, 16 (53%) were ACR20 responders, 15 (50%) ACR50 and 14 (47%) ACR70; the corresponding figures in the MTX arm were 19 (61%), 13 (44%) and 6 (19%). Toxicity was acceptable in both groups. Conclusions. In patients with early RA, CsA þ MTX combination therapy led to a significantly lower rate of 12-month radiographic progression, was effective on inflammatory articular symptoms, and was well tolerated.