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Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease

Authors
Yannick Allanore,Dinesh Khanna
Vanessa Smith,Martin Aringer,Anna‐Maria Hoffmann‐Vold,Masataka Kuwana,Peter Merkel,Christian Stock,Steven Sambevski,Christopher Denton,Miguel Bergna,Gema Casado,Peter Walter,Susanna Proudman,Wendy Stevens,Vivek Thakkar,Lauren Troy,Judith Löffler‐Ragg,Horst Olschewski,Béatrice Andre,Benjamin Bondue,Frédéric Houssiau,V. Smith,Wim Wuyts,Valderílio Azevedo,Sindhu Johnson,EC Keystone,Nader Khalidi,Marc Levesque,R. Rozas,A. Orellana,Chengyu Huang,Jingyang Li,Zhi Jiang,Y Liu,Wei Xiao,Jing Xu,Xiaofeng Zeng,Yu Zheng,Hejian Zou,Radim Bečvář,Hanne Madsen,Klaus Søndergaard,Maritta Kilpeläinen,Marjukka Myllärniemi,C. Agard,Y Allanore,Arnaud Bourdin,V Cottin,B Crestani,Elizabeth Diot,S. Dominique,É. Hachulla,S. Jouneau,Sylvie Leroy,Hilario Nunès,Grégoire Prévôt,B. Wallaert,L Wemeau,Burkhard Bewig,Stefan Blaas,J. Distler,Jan Ehrchen,Ralf Ewert,Sven Gläser,Jöerg Henes,Nicolas Hunzelmann,Ramona König,Ina Kötter,Michael Kreuter,Antje Prasse,Hendrik Schulze‐Koops,Petros Sfikakis,Panayiotis Vlachoyiannopoulos,György Losonczy,Digambar Behera,H.J. Devi,Jugal Kadel,M Kawedia,Deepali Kumar,Umesh Kumar,Rahul Lokhande,Anand Malpani,Murali Mohan,A Nalawade,Ujjwal Parakh,Rajesh Swarnakar,Vineeta Shobha,Balamugesh Thangakunam,Zarir Udwadia,Michael Henry,K. O'Reilly,Alexandra Balbir‐Gurman,Mordechai Kramer,Irena Litinsky,Itzhak Rosner,Maurizio Cutolo,A Gabrielli,Leonardo Iaccarino,Alberto Pesci,Valeria Riccieri,S. Vettori,Yu Funakubo,Yoshikazu Inoue,Atsushi Kawakami,Yasushi Kawaguchi,Tomohiro Kawamura,Yasuhiro Kondoh,M Kuwana,Toshihiro Nanki,Yuko Nishioka,K Nozawa,Takashi Ogura,M Okamoto,Hajime Sano,Ryo Sasai,Noriko Sasaki,T. Suda,Hiroki Takahashi,Tohru Takeuchi,Shigeki Makino,Sumiaki Tanaka,Yoshioki Yamasaki,S. Ch’ng,Chan Cheah,Shinichi Kan,Rehab Mohamed,Moisés Selman,Jeska Vries-Bouwstra,L Toorn,Madelon Vonk,Alexandre Voskuyl,A. Hoffmann-Vold,M Seip,Iwona Dankiewicz-Fares,Ryszard Olesiejuk,Grażyna Pulka,Jacek Szepietowski,José Alves,Miguel Bernardes,Ana Cordeiro,J. Costa,Sabrina Neves,M Salvador,Juan‐Manuel Sancho,Patricia Delgado,Ivan Barranco,J.L. Martinez,Alfredo Castillo,Juan Ovalles,FJ López-Longo,Andrés Gallego,M Dapena,José Ivorra,A-K Ekwall,Britta Maurer,Cristina Mihai,R. Müller,Ajanee Mahakkanukrauh,Kanokrat Nantiruj,Boonjing Siripaitoon,C.P. Denton,A. Herrick,Rajan Madhok,Toby Maher,Alex West,Danielle Antin‐Ozerkis,Rebecca Bascom,Gerard Criner,Mary Csuka,J. D'Amico,Neil Ettinger,Aryeh Fischer,Aldo Gerbino,Alicia Gerke,Marilyn Glassberg,Craig Glazer,Jeffrey Golden,Ria Gripaldo,Nishant Gupta,Mark Hamblin,Kristin Highland,Lawrence Ho,John Huggins,Laura Hummers,Lisa Jones,M. Kahaleh,Ho Kim,Lisa Lancaster,Tracy Luckhardt,Maureen Mayes,F. Ballesteros,John Mooney,Paul Mohabir,Brian Morrissey,Teng Moua,María Padilla,Nina Patel,Ruperto Pérez,José Román,Milton Rossman,T. Russell,Lesley Saketkoo,Ami Shah,Oksana Shlobin,M Scholand,Robert Simms,Robert Spiera,Virginia Steen,Srihari Veeraraghavan
+208 authors
,S. Weigt
Published
Jun 9, 2023
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Abstract

Abstract Objectives To investigate the course of interstitial lung disease (ILD) and the effects of nintedanib in patients with limited cutaneous systemic sclerosis (lcSSc). Methods In the SENSCIS trial, patients with SSc-ILD were randomized to receive nintedanib or placebo. Patients who completed the SENSCIS trial were eligible to enter SENSCIS-ON, in which all patients received open-label nintedanib. Results Among 277 patients with lcSSc treated in the SENSCIS trial, the rate (s.e.) of decline in forced vital capacity (FVC; ml/year) over 52 weeks was −74.5 (19.2) in the placebo group and −49.1 (19.8) in the nintedanib group (difference: 25.3 [95% CI −28.9, 79.6]). Among 249 patients with data at week 52, mean (s.e.) change in FVC at week 52 was −86.4 (21.1) ml in the placebo group and −39.1 (22.2) ml in the nintedanib group. Among 183 patients with lcSSc who participated in SENSCIS-ON and had data at week 52, mean (s.e.) change in FVC from baseline to week 52 of SENSCIS-ON was −41.5 (24.0) ml in patients who took placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON and −45.1 (19.1) ml in patients who took nintedanib in the SENSCIS trial and continued it in SENSCIS-ON. Conclusion Patients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD. Trial registration ClinicalTrials.gov (https://clinicaltrials.gov), NCT02597933 and NCT03313180

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