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01.12.2011 | Commentary

Systemic sclerosis-associated pulmonary hypertension: why disease-specific composite endpoints are needed

verfasst von: Christopher P Denton, Jerome Avouac, Frank Behrens, Daniel E Furst, Ivan Foeldvari, Marc Humbert, Doerte Huscher, Otylia Kowal-Bielecka, Marco Matucci-Cerinic, Peter Nash, Christian F Opitz, David Pittrow, Lewis J Rubin, James R Seibold, Oliver Distler

Erschienen in: Arthritis Research & Therapy | Ausgabe 3/2011

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Abstract

Pulmonary arterial hypertension (PAH) is a serious complication of systemic sclerosis (SSc). In clinical trials PAH-SSc has been grouped with other forms, including idiopathic PAH. The primary endpoint for most pivotal studies was improvement in exercise capacity. However, composite clinical endpoints that better reflect long-term outcome may be more meaningful. We discuss potential endpoints and consider why the same measures may not be appropriate for both idiopathic PAH and PAH-SSc due to inherent differences in clinical outcome and management strategies of these two forms of PAH. Failure to take this into account may compromise progress in managing PAH in SSc.

Simonneau G, Galiè N, Rubin LJ, Langleben D, Seeger W, Domenighetti G, Gibbs S, Lebrec D, Speich R, Beghetti M, Rich S, Fishman A: Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004, 43 (12 Suppl S): 5S-12S.CrossRefPubMed

Simonneau G, Robbins IM, Beghetti M, Channick RN, Delcroix M, Denton CP, Elliott CG, Gaine SP, Gladwin MT, Jing ZC, Krowka MJ, Langleben D, Nakanishi N, Souza R: Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2009, 54 (1 Suppl): S43-54.CrossRefPubMed

Kabunga P, Coghlan G: Endothelin receptor antagonism: role in the treatment of pulmonary arterial hypertension related to scleroderma. Drugs. 2008, 68: 1635-1645. 10.2165/00003495-200868120-00003.CrossRefPubMed

Macchia A, Marchioli R, Marfi si R, Scarano M, Levantesi G, Tavazzi L, Tognoni G: A meta-analysis of trials of pulmonary hypertension: a clinical condition looking for drugs and research methodology. Am Heart J. 2007, 153: 1037-1047. 10.1016/j.ahj.2007.02.037.CrossRefPubMed

Furst D, Khanna D, Matucci-Cerinic M, Clements P, Steen V, Pope J, Merkel P, Foeldvari I, Seibold J, Pittrow D, Polisson R, Strand V: Systemic sclerosis - continuing progress in developing clinical measures of response. J Rheumatol. 2007, 34: 1194-1200.PubMed

Distler O, Behrens F, Pittrow D, Huscher D, Denton CP, Foeldvari I, Humbert M, Matucci-Cerinic M, Nash P, Opitz CF, Rubin LJ, Seibold JR, Furst DE, EPOSS-Omeract Group: Defining appropriate outcome measures in pulmonary arterial hypertension related to systemic sclerosis: a Delphi consensus study with cluster analysis. Arthritis Rheum. 2008, 59: 867-875. 10.1002/art.23718.CrossRefPubMed

Sánchez-Román J, Opitz CF, Kowal-Bielecka O, García-Hernández FJ, Castillo-Palma MJ, Pittrow D, EPOSS-OMERACT Group: Screening for PAH in patients with systemic sclerosis: focus on Doppler echocardiography. Rheumatology (Oxford). 2008, 47 (Suppl 5): v33-35.CrossRef

Huscher D, Pittrow D, Distler O, Denton CP, Foeldvari I, Humbert M, Matucci-Cerinic M, Kowal-Bielecka O, Avouac J, Behrens F, Nash P, Opitz CF, Rubin LJ, Seibold JR, Strand V, Furst DE, EPOSS-OMERACT Group: Interactions between rheumatologists and cardio-/pulmonologists in the assessment and use of outcome measures in pulmonary arterial hypertension related to systemic sclerosis. Clin Exp Rheumatol. 2010, 28 (2 Suppl 58): S47-52.PubMed

Avouac J, Kowal-Bielecka O, Pittrow D, Huscher D, Behrens F, Denton CP, Foeldvari I, Humbert M, Matucci-Cerinic M, Nash P, Opitz CF, Rubin LJ, Seibold JR, Distler O, Furst DE, EPOSS Group: Validation of the 6 min walk test according to the OMERACT filter: a systematic literature review by the EPOSS-OMERACT group. Ann Rheum Dis. 2010, 69: 1360-1363.CrossRefPubMed

10.

Kowal-Bielecka O, Avouac J, Pittrow D, Huscher D, Behrens F, Denton CP, Foeldvari I, Humbert M, Matucci-Cerinic M, Nash P, Opitz CF, Rubin LJ, Seibold JR, Strand V, Furst DE, Distler O, EPOSS Group: Echocardiography as an outcome measure in scleroderma-related pulmonary arterial hypertension: a systematic literature analysis by the EPOSS group. J Rheumatol. 2010, 37: 105-115. 10.3899/jrheum.090661.CrossRefPubMed

11.

Khanna D, Distler O, Avouac J, Behrens F, Clements PJ, Denton C, Foeldvari I, Giannini E, Huscher D, Kowal-Bielecka O, Lovell D, Matucci-Cerinic M, Mayes M, Merkel PA, Nash P, Opitz CF, Pittrow D, Rubin L, Seibold JR, Steen V, Strand CV, Tugwell PS, Varga J, Zink A, Furst DE, CRISS; EPOSS: Measures of response in clinical trials of systemic sclerosis: the Combined Response Index for Systemic Sclerosis (CRISS) and Outcome Measures in Pulmonary Arterial Hypertension related to Systemic Sclerosis (EPOSS). J Rheumatol. 2009, 36: 2356-2361. 10.3899/jrheum.090372.CrossRefPubMed

12.

Pittrow D, Ghofrani HA, Opitz CF, Huscher D, Hoeper MM: International, prospective register for the documentation of first-line and maintenance therapy in patients with pulmonary hypertension (CompERA-XL)]. Dtsch Med Wochenschr. 2009, 134 (Suppl 5): S173-175.CrossRefPubMed

13.

Hachulla E, de Groote P, Gressin V, Sibilia J, Diot E, Carpentier P, Mouthon L, Hatron PY, Jego P, Allanore Y, Tiev KP, Agard C, Cosnes A, Cirstea D, Constans J, Farge D, Viallard JF, Harle JR, Patat F, Imbert B, Kahan A, Cabane J, Clerson P, Guillevin L, Humbert M: The three-year incidence of pulmonary arterial hypertension associated with systemic sclerosis in a multicenter nationwide longitudinal study in France. Arthritis Rheum. 2009, 60: 1831-1839. 10.1002/art.24525.CrossRefPubMed

14.

de Oliveira NC, dos Santos Sabbag LM, Ueno LM, de Souza RB, Borges CL, de Sá Pinto AL, Lima FR: Reduced exercise capacity in systemic sclerosis patients without pulmonary involvement. Scand J Rheumatol. 2007, 36: 458-4561. 10.1080/03009740701605889.CrossRefPubMed

15.

Buch MH, Denton CP, Furst DE, Guillevin L, Rubin LJ, Wells AU, Matucci-Cerinic M, Riemekasten G, Emery P, Chadha-Boreham H, Charef P, Roux S, Black CM, Seibold JR: Submaximal exercise testing in the assessment of interstitial lung disease secondary to systemic sclerosis: reproducibility and correlations of the 6-min walk test. Ann Rheum Dis. 2007, 66: 169-173.CrossRefPubMed

16.

McLaughlin VV, Badesch DB, Delcroix M, Fleming TR, Gaine SP, Galiè N, Gibbs JS, Kim NH, Oudiz RJ, Peacock A, Provencher S, Sitbon O, Tapson VF, Seeger W: End points and clinical trial design in pulmonary arterial hypertension. J Am Coll Cardiol. 2009, 54 (1 Suppl): S97-107.CrossRefPubMed

Titel: Systemic sclerosis-associated pulmonary hypertension: why disease-specific composite endpoints are needed
verfasst von: Christopher P Denton
Jerome Avouac
Frank Behrens
Daniel E Furst
Ivan Foeldvari
Marc Humbert
Doerte Huscher
Otylia Kowal-Bielecka
Marco Matucci-Cerinic
Peter Nash
Christian F Opitz
David Pittrow
Lewis J Rubin
James R Seibold
Oliver Distler
Publikationsdatum: 01.12.2011
Verlag: BioMed Central
Erschienen in: Arthritis Research & Therapy / Ausgabe 3/2011
Elektronische ISSN: 1478-6362
DOI: https://doi.org/10.1186/ar3346

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