Efficacy and Safety of Nintedanib in Advanced IPF

Efficacy and Safety of Nintedanib in Advanced IPF

1 (0.2) 2 (1.5) Data are n (%) of patients with ≥1 such event. In INPULSIS, events with onset between the first dose of trial drug and day 195 (or between the first dose and 28 days after the last dose for patients who discontinued trial drug before week 24) were included. In INSTAGE, events with onset between the first dose and up to 28 days after the last dose of trial drug were included. a Events that resulted in death, were life-threatening, resulted in hospitalisation or prolonged hospitalisation, resulted in persistent or clinically significant disability or incapacity, were a congenital anomaly or birth defect, or were deemed serious for any other reason. b Reported in ≥1.5% of patients in any of the groups shown, based on MedDRA preferred terms. c Corresponds to MedDRA term 'IPF', which included disease worsening and acute exacerbations References Authors and Disclosures Authors and Disclosures Luca Richeldi 1 *, Martin Kolb 2 , Stéphane Jouneau 3 , Wim A. Wuyts 4 , Birgit Schinzel 5 , Susanne Stowasser 5 , Manuel Quaresma 5 and Ganesh Raghu 6 1 Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. 2 McMaster University and St. Joseph's Healthcare, Hamilton, Ontario, Canada. 3 Hôpital Pontchaillou - CHU de Rennes, IRSET UMR 1085, Université de Rennes 1, Rennes, France. 4 Unit for Interstitial Lung Diseases, Department of Respiratory Medicine, University Hospitals Leuven, Leuven, Belgium. 5 Boehringer Ingelheim International GmbH, Ingelheim, Germany. 6 University of Washington, Seattle, USA. *Correspondence Authors' contributions LR, MK, BS, SS, MQ and GR contributed to the design of the study. LR, MK, SJ, WAW and GR contributed to the acquisition of the data. All authors contributed to the interpretation of the data. All authors critically revised the manuscript and approved the final version for submission. Competing interests LR reports grants and personal fees from Boehringer Ingelheim and Roche; and personal fees from Asahi Kasei, Biogen, Bristol-Myers Squibb, Celgene, CSL Behring, FibroGen, ImmuneWorks, Nitto, Pliant Therapeutics, Promedior, Respivant, and Toray. MK reports grants and personal fees from Boehringer Ingelheim, Gilead, GlaxoSmithKline, Prometic, and Roche; grants from Actelion, Alkermes, Pharmaxis, and RespiVert; and personal fees from Genoa, Indalo, and Third Pole. SJ has received fees, funding, or reimbursement for participation at meetings from Actelion, AIRB, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Gilead, GlaxoSmithKline, LVL, Mundipharma, Novartis, Pfizer, Roche, and Savara-Serendex. WAW reports grants to his institution from Boehringer Ingelheim and Roche and personal fees from Boehringer Ingelheim. BS, SS and MQ are employees of Boehringer Ingelheim, which funded the INPULSIS and INSTAGE trials; BS, SS and MQ were involved in the design of these trials, in the interpretation of the data and in writing the manuscript. BS was involved in analysing the data. GR has acted as a consultant for Bellerophon, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, FibroGen, Gilead, Nitto, Patara, Promedior, Sanofi, and Veracyte; has received a grant from the US National Institute of Health; and is a principal investigator and steering committee member for IPFnet studies.



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