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RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis

Distler, O; Pope, J; Denton, C; Allanore, Y; Matucci-Cerinic, M; de Oliveira Pena, J; Khanna, D; (2017) RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis. Respiratory Medicine , 122 (Sup 1) S14-S17. 10.1016/j.rmed.2016.09.011. Green open access

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Abstract

RISE-SSc is a randomized, double-blind, placebo-controlled phase 2 study investigating the efficacy and safety of riociguat in patients with diffuse cutaneous systemic sclerosis (dcSSc). Based on positive results from riociguat trials in patients with pulmonary hypertension and chronic thromboembolic pulmonary hypertension in combination with the known antiproliferative and antifibrotic effects seen in animal models, patients with SSc may benefit from treatment with riociguat. Patients with SSc meeting the ACR/EULAR systemic sclerosis classification criteria with diffuse cutaneous SSc (dcSSc) subset per LeRoy criteria, and a disease duration of less than or equal to 18 months will be randomized to placebo or riociguat 0.5 mg (up-titrated to a maximum dose of 2.5 mg TID over 10 weeks) and maintained on therapy for a total of 52 weeks. During the first 10 weeks of the long-term extension phase, placebo subjects will be up-titrated on riociguat, and all patients will be followed for up to 6 years. The primary endpoint of change in modified Rodnan skin score (mRSS) from baseline will be assessed at 52 weeks, as will be secondary endpoints such as mRSS progression and regression rates, patient quality of life, digital ulcer burden, and change in forced vital capacity and carbon monoxide diffusing capacity. This review will further define the clinical rationale for the use of riociguat in the treatment of SSc and provide details on study protocol, design, and outcome reporting. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02283762.

Type: Article
Title: RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.rmed.2016.09.011
Publisher version: http://dx.doi.org/10.1016/j.rmed.2016.09.011
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Fibrosis, Riociguat, Soluble guanylate cyclase, Systemic sclerosis, Carbon Monoxide, Dose-Response Relationship, Drug, Double-Blind Method, Enzyme Activators, Female, Humans, Hypertension, Pulmonary, Male, Pulmonary Diffusing Capacity, Pulmonary Embolism, Pyrazoles, Pyrimidines, Quality of Life, Scleroderma, Diffuse, Scleroderma, Systemic, Skin, Skin Diseases, Soluble Guanylyl Cyclase, Treatment Outcome, Vital Capacity
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation
URI: https://discovery.ucl.ac.uk/id/eprint/10051537
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