-
Something wrong with this record ?
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....
Language English Country Great Britain
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 1939-01-01 to 6 months ago
Health & Medicine (ProQuest)
from 1939-01-01 to 6 months ago
Family Health Database (ProQuest)
from 1939-01-01 to 6 months ago
ROAD: Directory of Open Access Scholarly Resources
- MeSH
- Enzyme Activators administration & dosage MeSH
- Scleroderma, Diffuse drug therapy pathology MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Risk Assessment MeSH
- Immunohistochemistry MeSH
- Internationality MeSH
- Biopsy, Needle MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Treatment Failure MeSH
- Pyrazoles administration & dosage MeSH
- Pyrimidines administration & dosage MeSH
- Respiratory Function Tests MeSH
- Drug Administration Schedule MeSH
- Severity of Illness Index MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial 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
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc20025034
- 003
- CZ-PrNML
- 005
- 20201222153644.0
- 007
- ta
- 008
- 201125s2020 xxk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1136/annrheumdis-2019-216823 $2 doi
- 035 __
- $a (PubMed)32299845
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxk
- 100 1_
- $a Khanna, Dinesh $u Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA khannad@med.umich.edu oliver.distler@usz.ch.
- 245 10
- $a Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial / $c 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. Stevens, G. Szücs, ME. Truchetet, M. Wosnitza, K. Laapas, J. de Oliveira Pena, Z. Yao, F. Kramer, O. Distler,
- 520 9_
- $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.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a jehlová biopsie $7 D001707
- 650 _2
- $a vztah mezi dávkou a účinkem léčiva $7 D004305
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 _2
- $a rozvrh dávkování léků $7 D004334
- 650 _2
- $a aktivátory enzymů $x aplikace a dávkování $7 D020536
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a následné studie $7 D005500
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a imunohistochemie $7 D007150
- 650 _2
- $a internacionalita $7 D038622
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a pyrazoly $x aplikace a dávkování $7 D011720
- 650 _2
- $a pyrimidiny $x aplikace a dávkování $7 D011743
- 650 _2
- $a respirační funkční testy $7 D012129
- 650 _2
- $a hodnocení rizik $7 D018570
- 650 _2
- $a difuzní sklerodermie $x farmakoterapie $x patologie $7 D045743
- 650 _2
- $a stupeň závažnosti nemoci $7 D012720
- 650 _2
- $a neúspěšná terapie $7 D017211
- 655 _2
- $a klinické zkoušky, fáze II $7 D017427
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Allanore, Yannick $u Rheumatology A department, Cochin Hospital, APHP, Paris Descartes University, Paris, France.
- 700 1_
- $a Denton, Christopher P $u Division of Medicine, Centre for Rheumatology, University College London, London, UK.
- 700 1_
- $a Kuwana, Masataka $u Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
- 700 1_
- $a Matucci-Cerinic, Marco $u Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy.
- 700 1_
- $a Pope, Janet E $u Schulich School of Medicine, Division of Rheumatology, The University of Western Ontario, London, Ontario, Canada.
- 700 1_
- $a Atsumi, Tatsuya $u Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
- 700 1_
- $a Bečvář, Radim $u Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.
- 700 1_
- $a Czirják, László $u Department of Rheumatology and Immunology, University of Pécs, Pécs, Hungary.
- 700 1_
- $a Hachulla, Eric $u Department of Internal Medicine and Clinical Immunology, Claude Huriez Hospital, Lille University School of Medicine, Lille, France.
- 700 1_
- $a Ishii, Tomonori $u Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.
- 700 1_
- $a Ishikawa, Osamu $u Department of Dermatology, Gunma University Postgraduate School of Medicine, Maebashi, Japan.
- 700 1_
- $a Johnson, Sindhu R $u Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University Health Network, Mount Sinai Hospital, University of Toronto, Toronto Scleroderma Research Program, Toronto, Ontario, Canada.
- 700 1_
- $a De Langhe, Ellen $u Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
- 700 1_
- $a Stagnaro, Chiara $u Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
- 700 1_
- $a Riccieri, Valeria $u Department of Clinical Medicine and Therapy, University of Rome La Sapienza, Rome, Italy.
- 700 1_
- $a Schiopu, Elena $u Division of Rheumatology, Department of Internal Medicine, Michigan Medicine University Hospitals, Ann Arbor, Michigan, USA.
- 700 1_
- $a Silver, Richard M $u Division of Rheumatology and Immunology, Medical University of South Carolina, Charleston, South Carolina, USA.
- 700 1_
- $a Smith, Vanessa $u Department of Rheumatology and Internal Medicine, Ghent University Hospital, Ghent, Belgium.
- 700 1_
- $a Steen, Virginia $u Division of Rheumatology, Georgetown University Medical Center, Washington, DC, USA.
- 700 1_
- $a Stevens, Wendy $u Department of Rheumatology, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
- 700 1_
- $a Szücs, Gabriella $u Division of Rheumatology, Department of Internal Medicine, University of Debrecen, Debrecen, Hungary.
- 700 1_
- $a Truchetet, Marie-Elise $u Department of Rheumatology, CHU Bordeaux, Bordeaux, France.
- 700 1_
- $a Wosnitza, Melanie $u Research & Development, Bayer AG, Wuppertal, Germany.
- 700 1_
- $a Laapas, Kaisa $u StatFinn Oy, Espoo, Finland.
- 700 1_
- $a de Oliveira Pena, Janethe $u Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey, USA.
- 700 1_
- $a Yao, Zhen $u Bayer Healthcare, Beijing, China.
- 700 1_
- $a Kramer, Frank $u Research & Development, Bayer AG, Wuppertal, Germany.
- 700 1_
- $a Distler, Oliver $u Department of Rheumatology, University Hospital, Zurich, Switzerland khannad@med.umich.edu oliver.distler@usz.ch.
- 773 0_
- $w MED00000444 $t Annals of the rheumatic diseases $x 1468-2060 $g Roč. 79, č. 5 (2020), s. 618-625
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/32299845 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20201125 $b ABA008
- 991 __
- $a 20201222153640 $b ABA008
- 999 __
- $a ok $b bmc $g 1599179 $s 1115720
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2020 $b 79 $c 5 $d 618-625 $e - $i 1468-2060 $m Annals of the rheumatic diseases $n Ann Rheum Dis $x MED00000444
- LZP __
- $a Pubmed-20201125
