Dr. Spiera has received consultancy fees, speaking fees, and/or honoraria (less than $10,000 each) from Genentech and Roche.
Assessment of health-related quality of life as an outcome measure in granulomatosis with polyangiitis (Wegener's)†
Article first published online: 25 JAN 2012
Copyright © 2012 by the American College of Rheumatology
Arthritis Care & Research
Volume 64, Issue 2, pages 273–279, February 2012
How to Cite
Tomasson, G., Boers, M., Walsh, M., LaValley, M., Cuthbertson, D., Carette, S., Davis, J. C., Hoffman, G. S., Khalidi, N. A., Langford, C. A., Mcalear, C. A., McCune, W. J., Monach, P. A., Seo, P., Specks, U., Spiera, R., St. Clair, E. W., Stone, J. H., Ytterberg, S. R. and Merkel, P. A. (2012), Assessment of health-related quality of life as an outcome measure in granulomatosis with polyangiitis (Wegener's). Arthritis Care Res, 64: 273–279. doi: 10.1002/acr.20649
ClinicalTrials.gov identifier: NCT00315393.
- Issue published online: 25 JAN 2012
- Article first published online: 25 JAN 2012
- Accepted manuscript online: 27 SEP 2011 10:30AM EST
- Manuscript Accepted: 13 SEP 2011
- Manuscript Received: 12 FEB 2011
- Vasculitis Clinical Research Consortium
- National Institute of Arthritis and Musculoskeletal and Skin Diseases. Grant Numbers: U54-AR-057319, RC1-AR-058303, U01-AR-51874, K23-AR-052820, K24-AR-02126, K24-AR-049185, K24-AR-2224
- National Center for Research Resources. Grant Number: U54-RR-019497
- Office of Rare Diseases Research
- The Vasculitis Clinical Research Consortium is also supported by a Clinical and Translational Science Award from the National Center for Research Resources to Boston University. Grant Number: RR-025771
- Mayo Clinic. Grant Number: RR-024150-01
- Johns Hopkins University. Grant Number: RR-025005
- The Wegener's Granulomatosis Etanercept Trial was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Grant Number: N01-AR-92240
- FDA Office of Orphan Products. Grant Number: FD-R-001652
- General Clinical Research Center Grants to Boston University. Grant Number: M01-RRO-00533
- University of Michigan. Grant Number: M01-RRO-0042
- Duke University. Grant Number: MO1-RR-30
- Johns Hopkins University School of Medicine. Grant Number: M01-RRO-2719
- National Center for Research Resources/NIH
- Canadian Institutes of Health Research Randomized Controlled Trial Mentoring Award
- Arthritis Foundation Investigator Award
To assess a generic measure of health-related quality of life (HRQOL) as an outcome measure in granulomatosis with polyangiitis (Wegener's) (GPA).
Subjects were participants in the Wegener's Granulomatosis Etanercept Trial (WGET) or the Vasculitis Clinical Research Consortium Longitudinal Study (VCRC-LS). HRQOL was assessed with the Short Form 36 (SF-36) health survey that includes physical and mental component summary scores (PCS and MCS, respectively). Disease activity was assessed with the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG).
The data from 180 subjects in the WGET (median followup 2.3 years, mean number of visits 10) and 237 subjects in the VCRC-LS (median followup 2.0 years, mean number of visits 8) were analyzed. A 1 unit increase in the BVAS/WG corresponded to a 1.15 unit (95% confidence interval [95% CI] 1.02, 1.29) decrease for the PCS and a 0.93 (95% CI 0.78, 1.07) decrease for the MCS in the WGET, and to a 1.16 unit decrease for the PCS (95% CI 0.94, 1.39) and a 0.79 unit decrease for the MCS (95% CI 0.51, 1.39) in the VCRC-LS. In both arms of the WGET study, SF-36 measures improved rapidly during the first 6 weeks of treatment followed by gradual improvement among patients achieving sustained remission (0.5 improvement in PCS per 3 months), but worsened slightly (0.03 decrease in PCS every 3 months) among patients not achieving sustained remission (P = 0.005).
HRQOL, as measured by the SF-36, is reduced among patients with GPA. SF-36 measures are modestly associated with other disease outcomes and discriminate between disease states of importance in GPA.