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Cyclosporin A in Severe, Treatment-Refractory Rheumatoid Arthritis: A Randomized Study

David E. Yocum, MD; John H. Klippel, MD; Ronald L. Wilder, MD, PhD; Naomi L. Gerber, MD; Howard A. Austin III, MD; Sharon M. Wahl, PhD; Lawrence Lesko, PhD; James R. Minor, PharmD; Harry G. Preuss, MD; Cheryl Yarboro, RN; Carole Berkebile, RN; and Suanne Dougherty, BS
[+] Article, Author, and Disclosure Information

This article was presented in part on 11 June 1987 at the annual meeting of the American Rheumatism Association, Washington, D.C.

Requests for Reprints: David E. Yocum, MD, Department of Internal Medicine, Division of Rheumatology, Allergy, and Immunology, College of Medicine, Tucson, AZ 85724.

Current Author Addresses: Dr. Yocum: Department of Internal Medicine, Division of Rheumatology, Allergy, and Immunology, College of Medicine, Tucson, AZ 85724.

Drs. Klippel and Wilder and Ms. Yarboro and Berkebile: Arthritis and Rheumatism Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases; Dr. Wahl and Ms. Dougherty: Cellular Immunology Section, Laboratory of Microbiology and Immunology, National Institute of Dental Research; Dr. Austin: Kidney Disease Section, National Institute of Diabetes, Digestive, and Kidney Diseases; Dr. Gerber: Department of Rehabilitation Medicine, and Dr. Minor, Pharmacy Department, Clinical Center; National Institutes of Health, Bethesda, MD 20892.

Dr. Preuss: Department of Medicine, Nephrology Division, Georgetown University Medical Center, Washington, D. C. 20007.

Dr. Lesko: Pharmacokinetic Laboratories, Baltimore, MD 21201.

Ann Intern Med. 1988;109(11):863-869. doi:10.7326/0003-4819-109-11-863
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Study objective: To assess the efficacy and toxicity of cyclosporin A in patients with severe, treatment-refractory rheumatoid arthritis.

Design: Prospective randomized, double-blind 6-month trial.

Patients: Thirty-one patients who had classic seropositive rheumatoid arthritis with active synovitis unresponsive to conventional therapy.

Interventions: Patients were randomly assigned to high-dose (10 mg/kg body weight · d) or low-dose (1 mg/kg · d) cyclosporin A therapy. A reduction in the dose was permitted for adverse side effects. After 6 months of therapy, patients who showed clinically relevant improvement, defined as a 40% or greater reduction in their total joint activity score, were given the option to continue receiving the therapy for an additional 6 months.

Measurements and Main Results: At 6 months, clinically relevant improvement occurred in 10 of 15 patients (95% CI, 38 to 88) receiving high-dose therapy and in 4 of 16 patients (CI, 7 to 52) receiving low-dose therapy (P = 0. 02). Statistically significant improvements in individual measures were shown only in the high-dose group. Improvements were noted in the number of tender joints (-18.8; CI, -24.5 to -13.1) and swollen joints (-12.1; CI, -15.4 to -8.6), as well as in physician's global scores (-1.5; CI, -2.1 to -0.9) and patient's global scores (-1.1; CI, -1.9 to -0.5). Improvement in disease activity was maintained through 12 months in the high-dose group. The clinical responses to cyclosporin A were most evident in patients with depressed in-vitro proliferative responses of peripheral blood mononuclear lymphocytes to soluble recall antigens. Toxicities, such as fatigue, gastrointestinal and neurologic complaints, and hypertrichosis were frequent but often reversible with a reduction in the dose. Nephrotoxicity, with a 20% increase in the serum creatinine level, was seen in 27 of 31 patients (CI, 71 to 97).

Conclusions: Cyclosporin A is an effective therapy for severe, treatment-refractory rheumatoid arthritis. Side effects, particularly nephrotoxicity, are common.





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