OP0266 EFFICACY OF NINTEDANIB IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD) AND INTERNAL ORGAN INVOLVEMENT: DATA FROM THE SENSCIS TRIAL
نویسندگان
چکیده
Background: SSc is a heterogeneous autoimmune disease characterised by fibrosis of the skin and internal organs. In most patients with SSc-ILD, organs other than lungs are also affected. SENSCIS trial in nintedanib reduced rate decline forced vital capacity (FVC) (mL/year) over 52 weeks 44% versus placebo. Objectives: We investigated extent organ involvement related to at baseline effect placebo on FVC subgroups involvement. Methods: The enrolled SSc-ILD first non-Raynaud symptom ≤7 years before screening, fibrotic ILD ≥10% high-resolution computed tomography (HRCT) ≥40% predicted. Patients clinically significant pulmonary hypertension were excluded. randomised receive or until last patient reached week but for ≤100 weeks. post-hoc analyses, we analysed without different types SSc-related (upper gastrointestinal; lower cardiovascular [CV]; peripheral vascular; muscular; joint). These defined based patients’ medical history as reported case report form. A random slope intercept model was used assess an interaction test applied potential heterogeneity treatment between subgroups. Results: Of 576 patients, 96.9% had vascular involvement, 75.5% upper gastrointestinal 39.8% 45.7% CV 40.6% joint 27.1% muscular baseline. group, numerically greater (Figure). exploratory p-values did not indicate reducing (p>0.05 all treatment-by-time-by-subgroup interactions) Conclusion: diverse complications SSc. There no evidence differential gastrointestinal, CV, joint, Acknowledgements: funded Boehringer Ingelheim. Medical writing support provided FleishmanHillard Fishburn, London, UK. authors meet criteria authorship recommended International Committee Journal Editors (ICMJE). Disclosure Interests: Yannick Allanore Consultant of: Ingelheim, Medsenic, Menarini Sanofi, Grant/research from: Alpine Pharmaceuticals, Anna-Maria Hoffmann-Vold Speakers bureau: Actelion, Lilly, MSD Roche, ARXX, Bayer, Medscape, Maureen Mayes Paid consultant member Advisory Board/Steering Eicos, Galapagos Mitsubishi Tanabe Pharma, Clinical research from Corbus, Eicos Galapagos, Madelon Vonk GlaxoSmithKline, Janssen Ingelheim Janssen, Ferrer, Corinna Miede Employee Currently employee mainanalytics GmbH, contracted Margarida Alves Gabriela Riemekasten Cellgene, Novartis
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ژورنال
عنوان ژورنال: Annals of the Rheumatic Diseases
سال: 2021
ISSN: ['1468-2060', '0003-4967']
DOI: https://doi.org/10.1136/annrheumdis-2021-eular.1067