Low-dose cyclosporin versus placebo in patients with rheumatoid arthritis

Lancet. 1990 May 5;335(8697):1051-5. doi: 10.1016/0140-6736(90)92630-z.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Administration, Oral
  • Arthritis, Rheumatoid / blood
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / urine
  • Blood Pressure / drug effects
  • Creatinine / blood
  • Creatinine / urine
  • Cyclosporins / administration & dosage*
  • Cyclosporins / adverse effects
  • Cyclosporins / blood
  • Cyclosporins / therapeutic use
  • Drug Administration Schedule
  • Drug Evaluation
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Placebos
  • Randomized Controlled Trials as Topic
  • Severity of Illness Index

Substances

  • Cyclosporins
  • Placebos
  • Creatinine