A randomized, double-blind, multicenter, controlled clinical trial of cyclosporine plus chloroquine vs. cyclosporine plus placebo in early-onset rheumatoid arthritis.
BACKGROUND
Our objective was to assess the efficacy and safety of cyclosporine-A (CsA) plus chloroquine (Clq) in early-onset rheumatoid arthritis (RA) compared to CsA plus placebo.


METHODS
We conducted a prospective, 12-month follow-up, multicenter, double-blind, placebo-controlled study of CsA (2.5-5 mg/kg/day[d]) plus Clq (150 mg/d) vs. CsA plus placebo in active RA of <2 years of evolution.


RESULTS
A total of 149 patients were included; 111 patients (74.4%) completed the 12-month follow-up period. Evaluation at 6 and 12 months showed improvement for all clinical disease parameters. In both groups there was a decrease in tender joint count, swollen joint count, pain, assessment of efficacy by both investigator and patient, functional assessment, and morning stiffness, all differences statistically significant. With an intention-to-treat analysis, there was 64% in the CsA plus Clq group (CsA/Clq) and 63% in the CsA plus placebo group (CsA/Plac) at 12 months in the American College of Rheumatology (ACR)-20 criteria of improvement. Response rate for ACR-50 was 48 and 47%, and for ACR-70 it was 29% in both groups; the difference was not statistically significant between study groups. Gastrointestinal complaints were common in both groups. Four patients in CsA/Clq group and five patients in CsA/placebo group increased creatinine levels; two patients in each group discontinued treatment due to this reason.


CONCLUSIONS
There was no advantage to adding chloroquine to cyclosporine in patients with RA.
Miranda
Juan M
JM
Departamento de Reumatología, Hospital de Especialidades, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico. jmmlimon@data.net.mx
Alvarez-Nemegyei
José
J
Saavedra
Miguel A
MA
Terán
Leobardo
L
Galván-Villegas
Federico
F
García-Figueroa
José
J
Jara
Luis J
LJ
Barile
Leonor
L
D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology; D002738:Chloroquine / Q000627:therapeutic use*; D016572:Cyclosporine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos
D018501:Antirheumatic Agents; D010919:Placebos; D016572:Cyclosporine; D002738:Chloroquine