Skin involvement as a relevant outcome measure in clinical trials of systemic sclerosis

Current Opinion in Rheumatology

Volumn 9, Issue 6, 1997, Pages 571-575

  Seibold, James R ^a   McCloskey, Deborah A ^a  

^a ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COST EFFECTIVENESS ANALYSIS; HUMAN; PATHOLOGY; PRIORITY JOURNAL; QUALITY OF LIFE; REPRODUCIBILITY; RHEUMATOID ARTHRITIS; SCLERODERMA; SCORING SYSTEM; SHORT SURVEY; SKIN DISEASE; SYSTEMIC SCLEROSIS; TREATMENT OUTCOME;

EID: 0030786759     PISSN: 10408711     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002281-199711000-00014     Document Type: Short Survey

References (17)

1. Seibold JR: Systemic sclerosis. In Textbook of Rheumatology, edn 5. Edited by Kelley WN, Harris ED, Ruddy S, Sledge CD. Philadelphia: WB Saunders; 1997:1133-1162.
2. Varga J, Jimenez SA: Pathogenesis of scleroderma: cellular aspects. In Systemic Sclerosis, edn 1. Edited by Furst DE, Clements PJ. Baltimore: Williams & Wilkins; 1995:123-152.
3. Clements PJ, Furst DE, Seibold JR, Lachenbruch PA: Controlled trials: trial design issues. In Systemic Sclerosis, edn 1. Edited by Furst DE, Clements PJ. Baltimore: Williams & Wilkins; 1995:515-533.
4. Steen VD, Medsger TA, Osial TA, Ziegler GL, Shapiro AP, Rodnan GP: Factors predicting development of renal Involvement in progressive systemic sclerosis. Am J Med 1984, 76:779-786.
5. Medsger TA, Steen VD: Classification, prognosis. In Systemic Sclerosis, edn 1. Edited by Furst DE, Clements PJ. Baltimore: Williams & Wilkins; 1995:51-64.
6. Seibold JR, Clements PJ, Furst DE: Treatment of systemic sclerosis by disease modifying agents. In Systemic Sclerosis, edn 1. Edited by Furst DE, Clements PJ. Baltimore: Williams & Wilkins; 1995:535-548. A comprehensive review of currently available scleroderma outcome measures and an analysis of their impact on sample size requirements and study design.
7. White B, Bauer EA, Goldsmith LA, et al.: Guidelines for clinical trials in systemic sclerosis (scleroderma): I. disease-modifying interventions. Arthritis Rheum 1995, 38:351-360. A multidisciplinary committee of rheumatologists, dermatologists, and representatives of the National Institutes of Health and FDA define the "gold standard" of disease modification as improved survival.
8. Seibold JR, Furst DE, Clements PJ: Why everything (or nothing) seems to work in the treatment of scleroderma. J Rheumatol 1992, 19:673-676.
9. Rook AH, Freundlich B, Jagesothy BV, Perez MI, Barr WG, Jimenez SA, Rietschel RL, Wintroub B, Kahaleh MB, Varga J, et al.: Treatment of systemic sclerosis with extracorporeal photochemotherapy: results of a multicenter trial. Arch Dermatol 1992, 128:337-346.
10. Rodnan GP, Lipinski E, Luksick J: Skin thickness and collagen content in progressive systemic sclerosis (scleroderma) and localized scleroderma. Arthritis Rheum 1979, 22:130-140.
11. Fries JF, Seibold JR, Medsger TA: Photopheresis for scleroderma? Nol J Rheumatol 1992, 19:1011-1013.
12. Clements PJ, Lachenbruch PA, Seibold JR, White B, Weiner S, Martin RW, Weinstein A, Weisman M, Mayes M, Collier DH, et al.: Inter and intraobserver variability of total skin thickness score (modified-Rodnan TSS) in systemic sclerosis. J Rheumatol 1995, 22:1281-1285.
13. Clements PJ, Lachenbruch PA, Seibold JR, Zee B, Steen VD, Brennan P, Silman AJ, Allegar N, Varga J, Massa M, et al.: Skin score: an assessment of inter-observer variability in three independent studies. J Rheumatol 1993, 20:1892-1896. Skin scoring is comparably reproducible and accurate in three independent surveys. Rheumatologists are better at skin scoring than at performing joint counts.
14. Furst DE, Seibold JR, Steen VD, Medsger TA, Masi AT, D'Angelo WA, Lachenbruch PA, Clements PJ: The modified Rodnan skin score (SKSC) is an accurate reflection of skin thickness in systemic sclerosis (SSc). J Rheumatol, in press.
15. Seibold JR, McCloskey DA, Clements PJ, Mayes MD, Rocco SE, Harkonen WS, Sanders ME: Six month pilot trial of recombinant human relaxin (rhRlx) in diffuse scleroderma (DS). Br J Rheumatol 1997, 36(suppl1):29.
16. Seibold JR, Korn J, Simms R, Clements PJ, Moreland L, Mayes MD, Furst DE, Rothfield N, Steen V, Weisman M, et al.: Controlled trial of recombinant human relaxin (rhRlxn) in diffuse scleroderma (DS). Arthritis Rheum, in press. A pregnancy-related hormone with antifibrotic effects, relaxin is studied for its potential to reverse established fibrosis.
17. Clements PJ, Wong WK, Furst DE, Seibold JR, and the Scleroderma Clinical Trials Consortium: High-dose (HI-DPA) vs low-dose (LO-DPA) penicillamine in early diffuse systemic sclerosis (SSc) trial: preliminary analysis. Arthritis Rheum, in press. The long-awaited results of the high-dose versus low-dose prospective trial of D-penicillamine. Outcome measures included skin scores, renal involvement, and survival.