Systemic sclerosis - Continuing progress in developing clinical measures of response

Journal of Rheumatology

Volumn 34, Issue 5, 2007, Pages 1194-1200

  Furst, Daniel ^a,l   Khanna, Dinesh ^b   Matucci Cerinic, Marco ^c   Clements, Philip ^a   Steen, Virginia ^d   Pope, Janet ^e   Merkel, Peter ^f   Foeldvari, Ivan ^g   Seibold, James ^h   Pittrow, David ⁱ   Polisson, Richard ^j   Strand, Vibeke ^k  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c UNIVERSITY OF FLORENCE   (Italy)

^d GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF WESTERN ONTARIO   (Canada)

^f BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g Department of Pediatric Rheumatology   (Germany)

^h UNIVERSITY OF MICHIGAN   (United States)

ⁱ DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^j MASSACHUSETTS GENERAL HOSPITAL   (United States)

^k STANFORD UNIVERSITY   (United States)

^l UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

Cardiovascular; Combined response; Lung; Omeract; Renal; Systemic sclerosis

Indexed keywords

ALPHA INTERFERON; BOSENTAN; COLLAGEN TYPE 1; CYCLOPHOSPHAMIDE; ILOPROST; METHOTREXATE; PENICILLAMINE; PENTETATE TECHNETIUM TC 99M; PLACEBO; RELAXIN; TRANSFORMING GROWTH FACTOR BETA ANTIBODY;

CARDIOPULMONARY FUNCTION; CLINICAL TRIAL; CONFERENCE PAPER; EXERCISE TEST; GASTROINTESTINAL DISEASE; HIGH RESOLUTION COMPUTER TOMOGRAPHY; HUMAN; KIDNEY DISEASE; LUNG FUNCTION TEST; OUTCOME ASSESSMENT; PHYSICAL ACTIVITY; PRIORITY JOURNAL; PULMONARY HYPERTENSION; QUALITY OF LIFE; RAYNAUD PHENOMENON; SKIN MANIFESTATION; SYSTEMIC SCLEROSIS; TREATMENT RESPONSE;

CONSENSUS; DELPHI TECHNIQUE; ENDPOINT DETERMINATION; HEALTH STATUS; HUMANS; META-ANALYSIS; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS; SCLERODERMA, SYSTEMIC; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 34248643458     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (48)

1. Pope JE, Bellamy N. Outcome measurement in scleroderma clinical trials. Semin Arthritis Rheum 1993;23:22-33.
2. Merkel PA, Clements PJ, Reveille JD, Suarez-Almazor ME, Valentini G, Furst DE. Current status of outcome measure development for clinical trials in systemic sclerosis. Report from OMERACT 6. J Rheumatol 2003;30:1630-47.
3. Furst DE, Khanna D, Mattucci-Cerinic M, Silman AJ, Merkel PA, Foeldvari I; OMERACT 7 Special Interest Group. Scleroderma - developing measures of response. J Rheumatol 2005;32:2477-80.
4. Demedts M, Behr J, Buhl R, et al. High-dose acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med 2005;353:2229-42.
5. Fujita J, Yoshinouchi T, Ohtsuki Y, et al. Non-specific interstitial pneumonia as pulmonary involvement of systemic sclerosis. Ann Rheum Dis 2001;60:281-3.
6. Flaherty KR, Toews GB, Travis WD, et al. Clinical significance of histological classification of idiopathic interstitial pneumonia. Eur Respir J 2002;19:275-83.
7. Bonnefoy O, Ferretti G, Calaque O, et al. Serial chest CT findings in interstitial lung disease associated with polymyositis-dermatomyositis. Eur J Radiol 2004;49:235-44.
8. Clements PJ, Goldin JG, Kleerup EC, et al. Regional differences in bronchoalveolar lavage and thoracic high-resolution computed tomography results in dyspneic patients with systemic sclerosis. Arthritis Rheum 2004;50:1909-17.
9. Strand V, Crawford B. Improvements in health related quality of life in patients with systemic lupus erythematosus following sustained reductions in anti-dsDNA antibodies. Expert Rev Pharmacoeconomics Outcomes Res 2005;5:317-26.
10. Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol 2000;27:2635-41.
11. Koldingsnes W, Jacobsen EA, Sildnes T, Hjalmarsen A, Nossent HC. Pulmonary function and high-resolution CT findings five years after disease onset in patients with Wegener's granulomatosis. Scand J Rheumatol 2005;34:220-8.
12. Komocsi A, Reuter M, Heller M, Murakozi H, Gross WL, Schnabel A. Active disease and residual damage in treated Wegener's granulomatosis: an observational study using pulmonary high-resolution computed tomography. Eur Radiol 2003;13:36-42.
13. Diot P, Palmer LB, Smaldone A, DeCelie-Germana J, Grimson R, Smaldone GC. RhDNase I aerosol deposition and related factors in cystic fibrosis. Am J Respir Crit Care Med 1997;156:1662-8.
14. Ziora D, Jastrzebski D, Lubina M, Wojdala A, Kozielski J. High-resolution computed tomography in hypersensitivity pneumonitis - correlation with pulmonary function. Ann Agric Environ Med 2005;12:31-4.
15. Pignone A, Matucci-Cerinic M, Lombardi A, et al. High resolution computed tomography in systemic sclerosis. Real diagnostic utilities in the assessment of pulmonary involvement and comparison with other modalities of lung investigation. Clin Rheumatol 1992;11:465-72.
16. Morelli S, Barbieri C, Sgreccia A, et al. Relationship between cutaneous and pulmonary involvement in systemic sclerosis. J Rheumatol 1997;24:81-5.
17. Zaporozhan J, Ley S, Gast KK, et al. Functional analysis in single-lung transplant recipients: a comparative study of high-resolution CT, 3He-MRI, and pulmonary function tests. Chest 2004;125:173-81.
18. Altin R, Ozdolap S, Savranlar A, et al. Comparison of early and late pleuropulmonary findings of ankylosing spondylitis by high-resolution computed tomography and effects on patients' daily life. Clin Rheumatol 2005;24:22-8. Epub 2004 Jul 20.
19. El Maghraoui A, Chaouir S, Abid A, et al. Lung findings on thoracic high-resolution computed tomography in patients with ankylosing spondylitis. Correlations with disease duration, clinical findings and pulmonary function testing. Clin Rheumatol 2004;23:123-8.
20. Magkanas E, Voloudaki A, Bouros D, et al. Pulmonary sarcoidosis. Correlation of expiratory high-resolution CT findings with inspiratory patterns and pulmonary function tests. Acta Radiol 2001;42:494-501.
21. Devenyi K, Czirjak L. High resolution computed tomography for the evaluation of lung involvement in 101 patients with scleroderma. Clin Rheumatol 1995;14:633-40.
22. Griffiths B, Miles S, Moss H, Robertson R, Veale D, Emery P. Systemic sclerosis and interstitial lung disease: a pilot study using pulse intravenous methylprednisolone and cyclophosphamide to assess the effect on high resolution computed tomography scan and lung function. J Rheumatol 2002;29:2371-8.
23. Badesch DB, Tapson VF, McGoon MD, et al. Continuous intravenous epoprostenol for pulmonary hypertension due to the scleroderma spectrum of disease. A randomized, controlled trial. Ann Intern Med 2000;132:425-34.
24. Kowal-Bielecka O, Kowal K, Rojewska J, et al. Cyclophosphamide reduces neutrophilic alveolitis in patients with scleroderma lung disease: a retrospective analysis of serial bronchoalveolar lavage investigations. Ann Rheum Dis 2005;64:1343-6.
25. Lynch DA, David Godwin J, Safrin S, et al. High-resolution computed tomography in idiopathic pulmonary fibrosis: diagnosis and prognosis. Am J Respir Crit Care Med 2005;172:488-93.
26. Miyamoto S, Nagaya N, Satoh T, et al. Clinical correlates and prognostic significance of six-minute walk test in patients with primary pulmonary hypertension. Comparison with cardiopulmonary exercise testing. Am J Respir Crit Care Med 2000;161 (2 Pt 1):487-92.
27. Olsson LG, Swedberg K, Ducharme A, et al. Atrial fibrillation and risk of clinical events in chronic heart failure with and without left ventricular systolic dysfunction: results from the Candesartan in Heart failure-Assessment of Reduction in Mortality and morbidity (CHARM) program. J Am Coll Cardiol 2006;47:1997-2004. Epub 2006 Apr 27.
28. Kennedy DM, Stratford PW, Hanna SE, Wessel J, Gollish JD. Modeling early recovery of physical function following hip and knee arthroplasty. BMC Musculoskelet Disord 2006;7:100.
29. McLaughlin VV, Hill N, Tapson VF, et al. Sitaxsentan improves 6MW in patients with pulmonary arterial hypertension related to connective tissue diseases [abstract]. Arthritis Rheum 2004;50 Suppl:S692.
30. Thumboo J, Fong KY, Ng TP, et al. Validation of the MOS SF-36 for quality of life assessment of patients with systemic lupus erythematosus in Singapore. J Rheumatol 1999;26:97-102.
31. Khanna D, Furst DE, Clements PJ, et al. Responsiveness of the SF-36 and the Health Assessment Questionnaire Disability Index in a systemic sclerosis clinical trial. J Rheumatol 2005;32:832-40.
32. Khanna D, Clements PJ, Furst DE, et al. Correlation of the degree of dyspnea with health-related quality of life, functional abilities, and diffusing capacity for carbon monoxide in patients with systemic sclerosis and active alveolitis: results from the Scleroderma Lung Study. Arthritis Rheum 2005;52:592-600.
33. Khanna D, Furst DE, Hays RD, et al. Minimally important difference in diffuse systemic sclerosis: Results from the D-Penicillamine Study. Ann Rheum Dis 2006;65:1325-9. Epub 2006 Mar 15.
34. Kingdon EJ, Knight CJ, Dustan K, et al. Calculated glomerular filtration rate is a useful screening tool to identify scleroderma patients with renal impairment. Rheumatology Oxford 2003;42:26-33.
35. Clements PJ, Wong WK, Hurwitz EL, et al. The Disability Index of the Health Assessment Questionnaire is a predictor and correlate of outcome in the High-dose Versus Low-dose Penicillamine in Systemic Sclerosis Trial. Arthritis Rheum 2001;44:653-61.
36. Latsi PI, Wells AU. Evaulation and management of alveolitis and interstitial lung disease in scleroderma. Curr Opin Rheumatol 2003;15:748-55.
37. Kazerooni EA, Martinez FJ, Flint A, et al. Thin-section CT obtained at 10-mm increments versus limited three-level thin-section CT for idiopathic pulmonary fibrosis: Correlation with pathologic scoring. AJR Am J Roentgenol 1997;169:977-83.
38. Tashkin DP, Clements P, Furst DE, et al, for SLS Investigators. The Scleroderma Lung Study (SLS) shows the beneficial effects of cyclophosphamide (CYC) over placebo (PL) in systemic sclerosis (SSc) patients with active alveolitis [abstract]. New Engl J Med 2006;52:S624.
39. Goldin J, Lynch D, Strollo R, et al, and the SLS Research Group. CT detection of alveolitis: is there inter-reader agreement? Am J Respir Crit Care Med 2007; (in press).
40. Seibold JR, Black CM, Denton CP, et al. Bosentan versus placebo in interstitial lung disease secondary to systemic sclerosis (SSc): The Build 2 Study. Proc Am Thorac Soc 2006;3:A243.
41. van den Hoogen FH, Boerbooms AM, Swaak AJ, Rasker JJ, van Lier HJ, van de Putte LB. Comparison of methotrexate with placebo in the treatment of systemic sclerosis: a 24 week randomized double-blind trial, followed by a 24 week observational trial. Br J Rheumatol 1996;35:364-72.
42. Pope JE, Bellamy N, Seibold JR, et al. A randomized, controlled trial of methotrexate versus placebo in early diffuse scleroderma. Arthritis Rheum 2001;44:1351-8.
43. Black CM, Silman AJ, Herrick AI, et al. Interferon-alpha does not improve outcome at one year in patients with diffuse cutaneous scleroderma: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 1999;42:299-305.
44. Denton CP, Merkel PA, Furst DE, et al. Cat-192 Study Group; Scleroderma Clinical Trials Consortium. Recombinant human antitransforming growth factor beta 1 antibody therapy in systemic sclerosis: a multicenter, randomized, placebo-controlled phase I/II trial of CAT-192. Arthritis Rheum 2007;56:323-33.
45. Black CM, Halkier-Sorensen L, Belch JJ, et al. Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis: a multicentre, placebo-controlled, dose-comparison study. Br J Rheumatol 1998;37:952-60.
46. Korn JH, Mayes M, Matucci Cerinic M, et al. Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. Arthritis Rheum 2004;50:3985-93.
47. Seibold JR, Denton CP, Furst DE, et al. Bosentan prevents occurrence but does not speed healing of digital ulcers in patients with systemic sclerosis (SSc) (abstract). Arthritis Rheum 2005;52 Suppl:4057.
48. Postlethwait AE, Wong W, Ingles J, et al. Maximal T cell reactivity to type I collagen (CI) is present during the first 3 years of diffuse systemic sclerosis (SSc) (abstract). Arthritis Rheum 2005;52 Suppl:1209.