title: An open, randomized comparison study of cyclosporine A, cyclosporine A + methotrexate and cyclosporine A + hydroxychloroquine in the treatment of early severe rheumatoid arthritis.
abstract: 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.
authors.affiliation: Unità Operativa di Reumatologia, University Hospital L. Sacco, Via G. B. Grassi 74, 20157 Milan, Italy. Sarzi@tiscali.it
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.forename: Enzo
authors.initials: E
authors.lastname: D'Ingianna
authors.forename: Mario
authors.initials: M
authors.lastname: Fumagalli
authors.forename: Magda
authors.initials: M
authors.lastname: Scarpellini
authors.forename: Tania
authors.initials: T
authors.lastname: Fiorini
authors.forename: Enrico Luigi
authors.initials: EL
authors.lastname: Chérié-Lignière
authors.forename: Benedetta
authors.initials: B
authors.lastname: Panni
authors.forename: Franco
authors.initials: F
authors.lastname: Fiorentini
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Corbelli
authors.forename: Nebiat Belai
authors.initials: NB
authors.lastname: Beyene
authors.forename: Claudio
authors.initials: C
authors.lastname: Mastaglio
authors.forename: Carlo
authors.initials: C
authors.lastname: Severi
authors.forename: Maurizio
authors.initials: M
authors.lastname: Locati
authors.forename: Marco
authors.initials: M
authors.lastname: Cazzola
authors.forename: Guido
authors.initials: G
authors.lastname: Menozzi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Monti
authors.forename: Francesco
authors.initials: F
authors.lastname: Saccardo
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Alfieri
authors.forename: Fabiola
authors.initials: F
authors.lastname: Atzeni
mesh_terms: 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
chemical_list: D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents; D006886:Hydroxychloroquine; D016572:Cyclosporine; D008727:Methotrexate