Low-dose cyclosporin versus placebo in patients with rheumatoid arthritis.
144 patients with severe rheumatoid arthritis from six centres were randomised to receive oral cyclosporin or placebo for 6 months. The initial daily dose of cyclosporin was 2.5 mg/kg, which was increased cautiously with monitoring of serum cyclosporin levels and creatinine; the mean stabilisation dose was 3.8 mg/kg. There were significant improvements in the cyclosporin-treated patients compared with the controls in the major outcomes of reduction of active joints (23% improvement), pain (24%), and functional status (16%); global improvement was 27%. In the cyclosporin group serum creatinine increased by a mean of 15.6 mumols/l and mean arterial blood pressure by 6.27 mmHg; these increases were controlled in all but 2 patients by dose adjustment without withdrawal from the study.
Tugwell
P
P
Division of Rheumatology, Chedoke-McMaster Hospital, Hamilton, Ontario, Canada.
Bombardier
C
C
Gent
M
M
Bennett
K J
KJ
Bensen
W G
WG
Carette
S
S
Chalmers
A
A
Esdaile
J M
JM
Klinkhoff
A V
AV
Kraag
G R
GR
D000203:Activities of Daily Living; D000284:Administration, Oral; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D001794:Blood Pressure / Q000187:drug effects; D003404:Creatinine / Q000097:blood / Q000652:urine; D003524:Cyclosporins / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index
D003524:Cyclosporins; D010919:Placebos; D003404:Creatinine