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Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial
D. Khanna, Y. Allanore, CP. Denton, M. Kuwana, M. Matucci-Cerinic, JE. Pope, T. Atsumi, R. Bečvář, L. Czirják, E. Hachulla, T. Ishii, O. Ishikawa, SR. Johnson, E. De Langhe, C. Stagnaro, V. Riccieri, E. Schiopu, RM. Silver, V. Smith, V. Steen, W....
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
NLK
ProQuest Central
od 1939-01-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 1939-01-01 do Před 6 měsíci
Family Health Database (ProQuest)
od 1939-01-01 do Před 6 měsíci
ROAD: Directory of Open Access Scholarly Resources
- MeSH
- aktivátory enzymů aplikace a dávkování MeSH
- difuzní sklerodermie farmakoterapie patologie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- hodnocení rizik MeSH
- imunohistochemie MeSH
- internacionalita MeSH
- jehlová biopsie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- neúspěšná terapie MeSH
- pyrazoly aplikace a dávkování MeSH
- pyrimidiny aplikace a dávkování MeSH
- respirační funkční testy MeSH
- rozvrh dávkování léků MeSH
- stupeň závažnosti nemoci MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
OBJECTIVES: Riociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression. METHODS: In this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52. RESULTS: At week 52, change from baseline in mRSS units was -2.09±5.66 (n=57) with riociguat and -0.77±8.24 (n=52) with placebo (difference of least squares means -2.34 (95% CI -4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths. CONCLUSIONS: Riociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.
Bayer Healthcare Beijing China
Bayer HealthCare Pharmaceuticals Inc Whippany New Jersey USA
Clinical Research Innovation and Education Center Tohoku University Hospital Sendai Japan
Department of Allergy and Rheumatology Nippon Medical School Graduate School of Medicine Tokyo Japan
Department of Clinical Medicine and Therapy University of Rome La Sapienza Rome Italy
Department of Dermatology Gunma University Postgraduate School of Medicine Maebashi Japan
Department of Experimental and Clinical Medicine University of Florence Firenze Italy
Department of Rheumatology and Immunology University of Pécs Pécs Hungary
Department of Rheumatology and Internal Medicine Ghent University Hospital Ghent Belgium
Department of Rheumatology CHU Bordeaux Bordeaux France
Department of Rheumatology St Vincent's Hospital Melbourne Melbourne Victoria Australia
Department of Rheumatology University Hospital Zurich Switzerland
Division of Medicine Centre for Rheumatology University College London London UK
Division of Rheumatology Department of Internal Medicine University of Debrecen Debrecen Hungary
Division of Rheumatology Georgetown University Medical Center Washington DC USA
Division of Rheumatology University of Michigan Ann Arbor Michigan USA
Research and Development Bayer AG Wuppertal Germany
Rheumatology A department Cochin Hospital APHP Paris Descartes University Paris France
Rheumatology Unit Department of Clinical and Experimental Medicine University of Pisa Pisa Italy
Citace poskytuje Crossref.org
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- $a Khanna, Dinesh $u Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA khannad@med.umich.edu oliver.distler@usz.ch.
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- $a OBJECTIVES: Riociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression. METHODS: In this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52. RESULTS: At week 52, change from baseline in mRSS units was -2.09±5.66 (n=57) with riociguat and -0.77±8.24 (n=52) with placebo (difference of least squares means -2.34 (95% CI -4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths. CONCLUSIONS: Riociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.
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