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Influence of Methotrexate and Azathioprine on Radiologic Progression in Rheumatoid Arthritis: A Randomized, Double-Blind Study

Maurice E. C. Jeurissen, MD; Agnes M. Th. Boerbooms, MD, PhD; Levinus B. A. van de Putte, MD, PhD; Wim H. Doesburg, MSc; and Albert M. Lemmens, MD, PhD
[+] Article, Author, and Disclosure Information

Grant Support: By a grant from the Dutch League against Rheumatism. The trial medication was supplied by Wellcome and Lederle.

Requests for Reprints: Maurice E. C. Jeurissen, MD, Department of Rheumatology, University Hospital Nijmegen, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.

Current Author Addresses: Drs. Jeurissen, Boerbooms, Lemmens, Prof. Dr. van de Putte, and Mr. Doesburg: University Hospital, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.

©1991 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1991;114(12):999-1004. doi:10.7326/0003-4819-114-12-999
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Objective: To compare the effects of azathioprine and methotrexate on progression of radiologic damage in patients with rheumatoid arthritis.

Design: Double-blind, randomized 48-week trial.

Patients: Sixty-four patients with active rheumatoid arthritis who either have not responded to or who have reacted with side effects to at least parenteral gold and D-penicillamine.

Interventions: Either azathioprine, 100 mg daily, or methotrexate, 7.5 mg weekly, was administered orally. Depending on the clinical effect after 8 weeks, the dosage was increased to either azathioprine, 150 mg, or methotrexate, 15 mg. The dosages for nonsteroidal anti-inflammatory drugs and prednisone were held stable.

Measurements: Clinical and laboratory assessments were done by the same physician every 4 weeks for the first 24 weeks and every 8 weeks thereafter. Radiographs of hands, wrists, and feet obtained at baseline and after 24 and 48 weeks were scored by one rheumatologist blinded to medication and clinical findings.

Main Results: Initial radiologic scores were comparable in both groups and correlated with disease duration (r = 0.38). An intention-to-treat analysis after 24 and 48 weeks showed significantly fewer new erosions in the methotrexate group compared with the azathioprine group (difference, 2.0 [95% CI, 0.2 to 3.9] and 3.5 [CI, 1.3 to 5.8], respectively). The change in total joint score was also significantly less pronounced in the methotrexate group compared with the azathioprine group after 24 weeks (difference, 2.8 [CI, 0.2 to 5.2]) and after 48 weeks (difference, 3.9 [CI, 0.3 to 7.4]). Radiologic stabilization after 48 weeks was present in 10% of the azathioprine group compared with 29% of the methotrexate group.

Conclusions: Patients with rheumatoid arthritis treated with low-dose methotrexate showed significantly less radiologic progression than patients treated with azathioprine. This result suggests that methotrexate therapy is clinically superior in these patients.





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