Dr. Clements has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Gilead.
Course of dermal ulcers and musculoskeletal involvement in systemic sclerosis patients in the scleroderma lung study
Version of Record online: 30 NOV 2010
Copyright © 2010 by the American College of Rheumatology
Arthritis Care & Research
Volume 62, Issue 12, pages 1772–1778, December 2010
How to Cite
Au, K., Mayes, M. D., Maranian, P., Clements, P. J., Khanna, D., Steen, V. D., Tashkin, D., Roth, M. D., Elashoff, R. and Furst, D. E. (2010), Course of dermal ulcers and musculoskeletal involvement in systemic sclerosis patients in the scleroderma lung study. Arthritis Care Res, 62: 1772–1778. doi: 10.1002/acr.20320
- Issue online: 30 NOV 2010
- Version of Record online: 30 NOV 2010
- Accepted manuscript online: 25 AUG 2010 03:02PM EST
- Manuscript Accepted: 27 JUL 2010
- Manuscript Received: 11 MAR 2010
- American College of Rheumatology
- Scleroderma Foundation
- Cure Scleroderma Foundation
- NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases Award). Grant Number: K23-AR053858-03
- Scleroderma Foundation (New Investigator Award)
To evaluate changes in vascular and musculoskeletal involvement in subjects in the Scleroderma Lung Study, a multicenter, double-blind, randomized, controlled trial comparing placebo treatment with oral cyclophosphamide (CYC) for 1 year in systemic sclerosis patients with interstitial lung disease. Subjects were then followed off the study agent for an additional 12 months.
The following parameters were noted at baseline and every 6 months for each patient: digital tip ulcers, other dermal ulcers, joint swelling, joint tenderness, large joint contractures, muscle tenderness, muscle weakness, oral aperture, hand extension, and fist closure.
A total of 158 patients were enrolled from 13 centers in the US; 79 were randomized to the CYC group and 79 to the placebo group. There were no differences in dermal ulcer and musculoskeletal measures between the CYC and placebo groups at baseline and 12 and 24 months. Improvement in percent predicted forced vital capacity was associated with improvement in the Rodnan skin thickness score (P < 0.05) at 12 and 24 months, and with increased mean oral aperture at 24 months (P = 0.005).
These data document the frequency and course of these vascular and musculoskeletal features over time, therefore providing essential information for sample size calculations and magnitude of effect in future clinical trials. There was no treatment effect of CYC on the vascular and musculoskeletal features described.