OBJECTIVE: To determine whether patients with early rheumatoid arthritis (RA) treated withcyclosporin 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 + MTX combination therapy (n = 30) or MTX alone (n = 31). The primary end-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 = 0.018). Of the 30 evaluable CsA + 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 + MTX combination therapy led to a significantly lower rate of 12-month radiographic progression, was effective on inflammatory articular symptoms, and was well tolerated.
RCT Entities:
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 + MTX combination therapy (n = 30) or MTX alone (n = 31). The primary end-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 = 0.018). Of the 30 evaluable CsA + MTXpatients, 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 + MTX combination therapy led to a significantly lower rate of 12-month radiographic progression, was effective on inflammatory articular symptoms, and was well tolerated.
Authors: B Combe; R Landewe; C Lukas; H D Bolosiu; F Breedveld; M Dougados; P Emery; G Ferraccioli; J M W Hazes; L Klareskog; K Machold; E Martin-Mola; H Nielsen; A Silman; J Smolen; H Yazici Journal: Ann Rheum Dis Date: 2006-01-05 Impact factor: 19.103
Authors: Yvonne P M Goekoop-Ruiterman; Jeska K de Vries-Bouwstra; Cornelia F Allaart; Pit J S M Kerstens; Bernard A M Grillet; Mike H de Jager; K Huub Han; Irene Speyer; Peter A H M van der Lubbe; Patrick E H Seys; Ferdinand C Breedveld; Ben A C Dijkmans Journal: Ann Rheum Dis Date: 2007-04-03 Impact factor: 19.103
Authors: K Visser; W Katchamart; E Loza; J A Martinez-Lopez; C Salliot; J Trudeau; C Bombardier; L Carmona; D van der Heijde; J W J Bijlsma; D T Boumpas; H Canhao; C J Edwards; V Hamuryudan; T K Kvien; B F Leeb; E M Martín-Mola; H Mielants; U Müller-Ladner; G Murphy; M Østergaard; I A Pereira; C Ramos-Remus; G Valentini; J Zochling; M Dougados Journal: Ann Rheum Dis Date: 2008-11-25 Impact factor: 19.103