An open, randomized comparison study of cyclosporine A, cyclosporine A + methotrexate and cyclosporine A + hydroxychloroquine in the treatment of early severe rheumatoid arthritis.
OBJECTIVE
To determine whether a regimen of cyclosporine (CSA) and methotrexate (MTX), or CSA and hydroxychloroquine (HCQ) introduced in early rheumatoid arthritis (RA) can produce a significant improvement in clinical outcome and/or retard radiographic damage in comparison with standard monotherapy with CSA alone.


METHODS
One hundred five patients with active RA of less than 36 months duration, who had never previously been treated with immunosuppressive agents, were included in a 12-month, multi-center, open, randomized trial. Patients who fulfilled the criteria for early severe RA were randomized to receive either combination therapy (CSA + MTX n = 34, CSA + HCQ n = 35) or CSA alone (n = 36).


RESULTS
CSA + MTX was more effective than the other two treatment groups in controlling RA symptoms. CSA+MTX did not show a significant radiographic progression according to Larsen-Dale (0.90 +/- 3.89 compared to baseline values, P > 0.05); moreover, patients treated with CSA alone or CSA+HCQ showed a significant worsening of Larsen-Dale score (2.91 +/- 5.99 and 2.97 +/- 4.28 respectively vs baseline values, P < 0.05), although not significant when compared with the CSA + HCQ group (P = 0.56 and 0.39, respectively).


CONCLUSIONS
This trial indicated that CSA+MTX was more effective than the other two treatments in improving clinical data and inhibiting radiographic progression, although the differences were not significant in this relatively small study. However, the difference was significant in favor of CSA + MTX regarding ACR 50% response.
Sarzi-Puttini
Piercarlo
P
Unità Operativa di Reumatologia, University Hospital L. Sacco, Via G. B. Grassi 74, 20157 Milan, Italy. Sarzi@tiscali.it
D'Ingianna
Enzo
E
Fumagalli
Mario
M
Scarpellini
Magda
M
Fiorini
Tania
T
Chérié-Lignière
Enrico Luigi
EL
Panni
Benedetta
B
Fiorentini
Franco
F
Corbelli
Vincenzo
V
Beyene
Nebiat Belai
NB
Mastaglio
Claudio
C
Severi
Carlo
C
Locati
Maurizio
M
Cazzola
Marco
M
Menozzi
Guido
G
Monti
Giuseppe
G
Saccardo
Francesco
F
Alfieri
Giuseppina
G
Atzeni
Fabiola
F
D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D001175:Arthrography; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D010147:Pain Measurement; D012720:Severity of Illness Index; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents; D006886:Hydroxychloroquine; D016572:Cyclosporine; D008727:Methotrexate