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Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension
  1. Luca Richeldi1,
  2. Michael Kreuter2,
  3. Moisés Selman3,
  4. Bruno Crestani4,
  5. Anne-Marie Kirsten5,
  6. Wim A Wuyts6,
  7. Zuojun Xu7,
  8. Katell Bernois8,
  9. Susanne Stowasser9,
  10. Manuel Quaresma2,9,
  11. Ulrich Costabel10
  1. 1National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK
  2. 2Center for Interstitial and Rare Lung Diseases, Department of Pneumology, Thoraxklinik, University of Heidelberg, and Translational Lung Research Center Heidelberg, German Center for Lung Research Germany, Heidelberg, Germany
  3. 3Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
  4. 4Hôpital Bichat, Pneumologie, Paris, France
  5. 5Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
  6. 6Department of Respiratory Medicine, University Hospitals Leuven, Leuven, Belgium
  7. 7Peking Union Medical College Hospital, Beijing, China
  8. 8Boehringer Ingelheim France S.A.S., Paris, France
  9. 9Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
  10. 10Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany
  1. Correspondence to Professor Luca Richeldi, National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton SO17 1BJ, UK; luca.richeldi{at}me.com

Abstract

The TOMORROW trial of nintedanib comprised a randomised, placebo-controlled, 52-week period followed by a further blinded treatment period and an open-label extension. We assessed outcomes across these periods in patients randomised to nintedanib 150 mg twice daily or placebo at the start of TOMORROW. The annual rate of decline in FVC was −125.4 mL/year (95% CI −168.1 to −82.7) in the nintedanib group and −189.7 mL/year (95% CI −229.8 to −149.6) in the comparator group. The adverse event profile of nintedanib remained consistent throughout the studies. These results support a benefit of nintedanib on slowing progression of idiopathic pulmonary fibrosis beyond 52 weeks.

  • idiopathic pulmonary fibrosis

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Footnotes

  • Contributors LR, MS and UC contributed to the design of the TOMORROW trial. KB contributed to the analysis of data. All the authors were involved in the interpretation of data and in writing or revising the manuscript. LR takes responsibility for the integrity of the work in this manuscript and is the guarantor of the manuscript.

  • Funding The TOMORROW trial and its open-label extension trial were funded by Boehringer Ingelheim.

  • Competing interests LR reports receipt of personal fees from Boehringer Ingelheim for being a coprincipal investigator and member of the steering committee for the INPULSIS trials; grants and personal fees for being an advisory board member from InterMune; personal fees from MedImmune, Roche and Takeda for being an advisory board member; consulting fees from Biogen Idec, Celgene, ImmuneWorks, Pliant Therapeutics and Sanofi-Aventis; speaker honoraria from Shionogi. MK reports receipt of grants and personal fees from Boehringer Ingelheim, InterMune and Roche. MS reports receipt of personal fees from Boehringer Ingelheim for being a member of the INPULSIS steering committee. BC reports receipt of grants, personal fees and non-financial support from Boehringer Ingelheim and InterMune; personal fees and non-financial support from Sanofi; grants from Cardif and MedImmune; and personal fees from AstraZeneca. A-MK reports receipt of grants (paid to her institution) and lecture fees from Boehringer Ingelheim. WAW reports receipt of grants (paid to his institution) from InterMune and travel costs for congresses from Boehringer Ingelheim, Roche and Bayer. ZX reports no competing interests. KB, SSt and MQ are employees of Boehringer Ingelheim. UC reports receipt of grants (paid to his institution); personal fees for consulting and lecture fees from Boehringer Ingelheim, InterMune and Bayer; and personal fees for consulting from AstraZeneca, Biogen, Centocor, FibroGen, Gilead, GlaxoSmithKline, Roche and UCB Celltech.

  • Patient consent Obtained.

  • Ethics approval The study was approved by an IRB at every site.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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