A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. Oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease

Arthritis and Rheumatism

Volumn 58, Issue 6, 2008, Pages 1810-1822

  Postlethwaite, Arnold E ^a   Weng, Kee Wong ^b   Clements, Philip ^b   Chatterjee, Soumya ^c   Fessler, Barri J ^d   Kang, Andrew H ^a   Korn, Joseph ^o   Mayes, Maureen ^f   Merkel, Peter A ^e   Molitor, Jerry A ^g,h   Moreland, Larry ^d   Rothfield, Naomi ⁱ   Simms, Robert W ^b   Smith, Edwin A ^j   Spiera, Robert ^k   Steen, Virginia ^l   Warrington, Kenneth ^a   White, Barbara ^m   Wigley, Frederick ⁿ   Furst, Daniel E ^b  

^a UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF TEXAS   (United States)

^g BENAROYA RESEARCH INSTITUTE   (United States)

^h UNIVERSITY OF MINNESOTA   (United States)

ⁱ UNIVERSITY OF CONNECTICUT HEALTH CENTER   (United States)

^j MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^k BETH ISRAEL MEDICAL CENTER   (United States)

^l GEORGETOWN UNIVERSITY   (United States)

^m UNIVERSITY OF MARYLAND   (United States)

ⁿ JOHNS HOPKINS UNIVERSITY   (United States)

^o NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

COLLAGEN TYPE 1; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; IMMUNOLOGICAL PARAMETERS; KIDNEY FAILURE; LEUKOCYTE COUNT; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MEDICAL PARAMETERS; MULTICENTER STUDY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SCLERODERMA; SIDE EFFECT; SKINFOLD THICKNESS; SYSTEMIC SCLEROSIS; THROMBOCYTOPENIA; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANIMALS; CATTLE; COLLAGEN TYPE I; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; SCLERODERMA, DIFFUSE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 45349109299     PISSN: 00043591     EISSN: None     Source Type: Journal    
DOI: 10.1002/art.23501     Document Type: Article

References (38)

1. White B. Immunopathogenesis of systemic sclerosis. Rheum Dis Clin North Am 1996;22:695-708.
2. Prescott RJ, Freemont AJ, Jones CJ, Hoyland J, Fielding P. Sequential dermal microvascular and perivascular changes in the development of scleroderma. J Pathol 1992;166:255-63.
3. Roumm AD, Whiteside TL, Medsger TA Jr, Rodnan GP. Lymphocytes in the skin of patients with progressive systemic sclerosis: quantification, subtyping, and clinical correlations. Arthritis Rheum 1984;27:645-53.
4. Wells AU, Lorimer S, Majumdar S, Harrison NK, Corrin B, Black CM, et al. Fibrosing alveolitis in systemic sclerosis: increase in memory T-cells in lung interstitium. Eur Respir J 1995;8:266-71.
5. Fleischmajer R, Perlish JS, Reeves JR. Cellular infiltrates in scleroderma skin. Arthritis Rheum 1977;20:975-84.
6. Sakkas LI, Xu B, Artlett CM, Lu S, Jimenez SA, Platsoucas CD. Oligoclonal T cell expansion in the skin of patients with systemic sclerosis. J Immunol 2002;168:3649-59.
7. Claman HN. Mast cell changes in a case of rapidly progressive scleroderma-ultrastructural analysis. J Invest Dermatol 1989;92:290-5.
8. Atamas SP, Yurovsky VV, Wise R, Wigley FM, Goter Robinson CJ, Henry P, et al. Production of type 2 cytokines by CD8+ lung cells is associated with greater decline in pulmonary function in patients with systemic sclerosis. Arthritis Rheum 1999;42:1168-78.
9. Atamas SP, White B. Interleukin 4 in systemic sclerosis: not just an increase. Clin Diagn Lab Immunol 1999;6:658-9.
10. Atamas SP, White B. Cytokine regulation of pulmonary fibrosis in scleroderma. Cytokine Growth Factor Rev 2003;14:537-50.
11. Molteni M, Della Bella S, Mascagni B, Bazzi S, Zulian C, Compasso S, et al. Increased interferon-γ (IFN-γ) levels produced in vitro by alloactivated T lymphocytes in systemic sclerosis and Raynaud's phenomenon. Clin Exp Immunol 1999;11:164-8.
12. Stuart JM, Postlethwaite AE, Kang AH. Evidence for cell-mediated immunity to collagen in progressive systemic sclerosis. J Lab Clin Med 1976;88:601-7.
13. McKown KM, Carbone LD, Bustillo J, Seyer JM, Kang AH, Postlethwaite AE. Induction of immune tolerance to human type I collagen in patients with systemic sclerosis by oral administration of bovine type I collagen. Arthritis Rheum 2000;43:1054-61.
14. Gurram M, Pahwa S, Frieri M. Augmented interleukin-6 secretion in collagen-stimulated peripheral blood mononuclear cells from patients with systemic sclerosis. Ann Allergy 1994;73:493-6.
15. Hawrylko E, Spertus A, Mele CA, Oster N, Frieri M. Increased interleukin-2 production in response to human type I collagen stimulation in patients with systemic sclerosis. Arthritis Rheum 1991;34:580-7.
16. Huffstutter JE, DeLustro FA, LeRoy EC. Cellular immunity to collagen and laminin in scleroderma. Arthritis Rheum 1985;28:775-80.
17. Miller EJ. Chemistry of the collagens and their distribution. In: Piez KA, Reddi AH, editors. Extracellular matrix biochemistry. New York: Elsevier; 1984. p. 41-82.
18. Weiner HL, Mackin GA, Matsui M, Orav EJ, Khoury SJ, Dawson DM, et al. Double-blind pilot trial of oral tolerization with myelin antigens in multiple sclerosis. Science 1993;259:1321-4.
19. Nussenblatt RB, Whitcup SM, Smet MD, Caspi RR, Kozhieh AT, Weiner HL, et al. Intraocular inflammatory disease (uveitis) and the use of oral tolerance: a status report. Ann N Y Acad Sci 1996;778:325-37.
20. Myers LK, Higgins GC, Finkel TH, Reed AM, Thompson JW, Walton RC, et al. Juvenile arthritis and autoimmunity to type II collagen. Arthritis Rheum 2001;44:1775-81.
21. McKown KM, Carbone LD, Kaplan SB, Aelion JA, Lohr KM, Cremer MA, et al. Lack of efficacy of oral bovine type II collagen added to existing therapy in rheumatoid arthritis. Arthritis Rheum 1999;42:1204-8.
22. Barnett ML, Combitchi D, Trentham DE. A pilot trial of oral type II collagen in the treatment of juvenile rheumatoid arthritis. Arthritis Rheum 1996;39:623-8.
23. Trentham DE, Dynesius-Trentham RA, Orav EJ, Combitchi D, Lorenzo C, Sewell KL, et al. Effects of oral administration of type II collagen on rheumatoid arthritis. Science 1993;261:1727-30.
24. Sieper J, Kary S, Sorensen H, Alten R, Eggens U, Huge W, et al. Oral type II collagen treatment in early rheumatoid arthritis: a double-blind, placebo-controlled, randomized trial. Arthritis Rheum 1996;39:41-51.
25. Subcommittee for Scleroderma Criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee. Preliminary criteria for the classification of systemic sclerosis (scleroderma). Arthritis Rheum 1980;23:581-90.
26. Wolfe F, Kleinheksel SM, Cathey MA, Hawley DJ, Spitz PW, Fries JF. The clinical value of the Stanford Health Assessment Questionnaire functional disability index in patients with rheumatoid arthritis. J Rheumatol 1988;15:1480-8.
27. Clements PJ, Furst DE, Wong WK, Mayes M, White B, Wigley F, et al. High-dose versus low-dose D-penicillamine in early diffuse systemic sclerosis: analysis of a two-year, double-blind, randomized, controlled clinical trial. Arthritis Rheum 1999;42:1194-203.
28. Ware JE, Kosinski M. Interpreting SF-36 summary health measures: a response. Qual Life Res 2001;10:405-13.
29. Clements PJ, Lachenbruch PA, Seibold JR, Zee B, Steen VD, Brennan P, et al. Skin thickness score in systemic sclerosis: an assessment of interobserver variability in 3 independent studies. J Rheumatol 1993;20:1892-6.
30. Clements P, Lachenbruch P, Siebold J, White B, Weiner S, Martin R, et al. Inter and intraobserver variability of total skin thickness score (modified Rodnan TSS) in systemic sclerosis. J Rheumatol 1995;22:1281-5,
31. American Thoracic Society. Single-breath carbon monoxide diffusing capacity (transfer factor). Recommendations for a standard technique: 1995 update. Am J Respir Crit Care Med 1995;152(6 Pt 1):2185-98.
32. American Thoracic Society. Lung function testing: selection of reference values and interpretative strategies. American Thoracic Society. Am Rev Respir Dis 1991;144:1202-18.
33. Strand V, Tugwell P, Bombardier C, Maetzel A, Crawford B, Dorrier C, et al, on behalf of the Leflunomide Rheumatoid Arthritis Investigators Group. Function and health-related quality of life: results from a randomized controlled trial of leflunomide versus methotrexate or placebo in patients with active rheumatoid arthritis. Arthritis Rheum 1999;42:1870-8.
34. Takeda K, Hatamochi A, Ueki H, Nakata M, Oishi Y. Decreased collagenase expression in cultured systemic sclerosis fibroblasts. J Invest Dermatol 1994;103:359-63.
35. Hasty KA, Kanangat S, Postlethwaite AE. Collagenase expression is inhibited in fibroblasts from fibrotic, but not non-fibrotic, scleroderma skin: the role of intracellular interleukin 1 receptor antagonist [abstract]. Arthritis Rheum 2007;56 Suppl 9:S77.
36. Clements PJ, Hurwitz EL, Wong WK, Seibold JR, Mayes M, White B, et al. Skin thickness score as a predictor and correlate of outcome in systemic sclerosis: high-dose versus low-dose penicillamine trial. Arthritis Rheum 2000;43:2445-54.
37. Steen VD, Medsger TA Jr. Improvement in skin thickening in systemic sclerosis associated with improved survival. Arthritis Rheum 2001;44:2828-35.
38. Shand L, Lunt M, Nihtyanova S, Hoseini M, Silman A, Black CM, et al. Relationship between change in skin score and disease outcome in diffuse cutaneous systemic sclerosis: application of a latent linear trajectory model. Arthritis Rheum 2007;56:2422-31.