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Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): open-label, long-term extension of a phase 2b, randomised, placebo-controlled trial.
Distler, Oliver; Allanore, Yannick; Denton, Christopher P; Kuwana, Masataka; Matucci-Cerinic, Marco; Pope, Janet E; Atsumi, Tatsuya; Becvár, Radim; Czirják, László; Hachulla, Eric; Ishii, Tomonori; Ishikawa, Osamu; Johnson, Sindhu R; De Langhe, Ellen; Stagnaro, Chiara; Riccieri, Valeria; Schiopu, Elena; Silver, Richard M; Smith, Vanessa; Steen, Virginia; Stevens, Wendy; Szücs, Gabriella; Truchetet, Marie-Elise; Wosnitza, Melanie; Laapas, Kaisa; Kramer, Frank; Khanna, Dinesh.
Afiliación
  • Distler O; Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. Electronic address: oliver.distler@usz.ch.
  • Allanore Y; Rheumatology A Department, Cochin Hospital, APHP, Paris Descartes University, Paris, France.
  • Denton CP; Division of Medicine, Centre for Rheumatology, UCL, London, UK.
  • Kuwana M; Department of Allergy and Rheumatology, Nippon Medical School, Tokyo, Japan.
  • Matucci-Cerinic M; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Hospital, Milan, Italy.
  • Pope JE; Schulich School of Medicine, Division of Rheumatology, University of Western Ontario, London, ON, Canada.
  • Atsumi T; Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
  • Becvár R; Institute of Rheumatology, Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic.
  • Czirják L; Department of Rheumatology and Immunology, Medical School, University of Pécs, Pécs, Hungary.
  • Hachulla E; Department of Internal Medicine and Clinical Immunology, Referral Centre for Rare Systemic Autoimmune Diseases North and North-West of France (CeRAINO), Centre Hospitalier Universitaire Lille, University of Lille, Inserm, U1286 - INFINITE - Institute for Translational Research in Inflammation, Lille
  • Ishii T; Clinical Research, Innovation and Education Center, Tohuko University, Sendai, Japan.
  • Ishikawa O; Ishii Hospital, Division of Dermatology, Isezaki, Gunma, Japan.
  • Johnson SR; Toronto Scleroderma Program, Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University Health Network, Mount Sinai Hospital and University of Toronto, Toronto, ON, Canada.
  • De Langhe E; Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Division of Rheumatology, University Hospitals, Leuven, Belgium.
  • Stagnaro C; Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
  • Riccieri V; Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.
  • Schiopu E; Medical College of Georgia at Augusta University, Augusta, GA, USA.
  • Silver RM; Division of Rheumatology and Immunology, Medical University of South Carolina, Charleston, SC, USA.
  • Smith V; Department of Rheumatology, Ghent University Hospital, Ghent, Belgium; Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium; Unit for Molecular Immunology and Inflammation, VIB Inflammation Research Center (IRC), Ghent, Belgium.
  • Steen V; Division of Rheumatology, Georgetown University, Washington, DC, USA.
  • Stevens W; Department of Rheumatology, St Vincent's Hospital, Melbourne, VIC, Australia.
  • Szücs G; Department of Rheumatology, University of Debrecen, Debrecen, Hungary.
  • Truchetet ME; Department of Rheumatology, CHU, Bordeaux University Hospital, Bordeaux, France.
  • Wosnitza M; Research & Development, Bayer, Wuppertal, Germany.
  • Laapas K; StatFinn, Espoo, Finland; Bayer, Espoo, Finland.
  • Kramer F; Research & Development, Bayer, Wuppertal, Germany.
  • Khanna D; Division of Rheumatology, Department of Internal Medicine, Michigan Medicine University Hospital, Ann Arbor, MI, USA; University of Michigan Scleroderma Program, Ann Arbor, MI, USA. Electronic address: khannad@med.umich.edu.
Lancet Rheumatol ; 5(11): e660-e669, 2023 Nov.
Article en En | MEDLINE | ID: mdl-38251533
ABSTRACT

BACKGROUND:

The phase 2b Riociguat Safety and Efficacy in Patients with Diffuse Cutaneous Systemic Sclerosis (RISE-SSc) trial investigated riociguat versus placebo in early diffuse cutaneous systemic sclerosis. The long-term extension evaluated safety and exploratory treatment effects for an additional year.

METHODS:

Patients were enrolled to RISE-SSc between Jan 15, 2015, and Dec 8, 2016. Those who completed the 52-week, randomised, parallel-group, placebo-controlled, double-blind phase were eligible for the long-term extension. Patients originally assigned to riociguat continued therapy (riociguat-riociguat group). Those originally assigned to placebo were switched to riociguat (placebo-riociguat group), adjusted up to 2·5 mg three times daily in a 10-week, double-blind dose-adjustment phase, followed by an open-label phase. Statistical analyses were descriptive. Safety including adverse events and serious adverse events was assessed in the long-term safety analysis set (all patients randomly assigned and treated with study medication in the double-blind phase who continued study medication in the long-term extension). The RISE-SSc trial is registered with ClinicalTrials.gov, NCT02283762.

FINDINGS:

In total, 87 (72%) of 121 patients in the main RISE-SSc study entered the long-term extension (riociguat-riociguat, n=42; placebo-riociguat, n=45). 65 (75%) of 87 patients were women, 22 (25%) were men, and 62 (71%) were White. Overall, 82 (94%) of 87 patients in the long-term extension had an adverse event; most (66 [76%] of 87) were of mild to moderate severity, with no increase in pulmonary-related serious adverse events in patients with interstitial lung disease.

INTERPRETATION:

No new safety signals were observed with long-term riociguat in patients with early diffuse cutaneous systemic sclerosis. Study limitations include the absence of a comparator group in this open-label extension study.

FUNDING:

Bayer and Merck Sharp & Dohme.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirimidinas / Esclerodermia Difusa Tipo de estudio: Clinical_trials Límite: Female / Humans / Male Idioma: En Revista: Lancet Rheumatol Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirimidinas / Esclerodermia Difusa Tipo de estudio: Clinical_trials Límite: Female / Humans / Male Idioma: En Revista: Lancet Rheumatol Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido