Delphi Consensus Recommendations on Management of Dosing, Adverse Events, and Comorbidities in the Treatment of Idiopathic Pulmonary Fibrosis with Nintedanib

Franck Rahaghi, John A. Belperio, John Fitzgerald, Mridu Gulati, Robert Hallowell, Kristin B. Highland, Tristan J. Huie, Hyun J. Kim, Martin Kolb, Joseph A. Lasky, Brian D. Southern, Jeffrey J. Swigris, Joao A. de Andrade

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Nintedanib is an approved treatment for idiopathic pulmonary fibrosis (IPF), which slows disease progression. Management of patients with IPF receiving nintedanib can be complicated by tolerability issues, comorbidities, and concomitant medications. We developed consensus recommendations on the management of dosing, adverse events and comorbidities in patients with IPF treated with nintedanib. Methods: A modified Delphi process using 3 questionnaires was used to survey 14 pulmonologists experienced in using nintedanib. Panelists rated their agreement with statements on a Likert scale from −5 (strongly disagree) to +5 (strongly agree). Consensus was predefined as a mean score of ⩽−2.5 or ⩾+2.5 with a standard deviation not crossing zero. Results: The panelists’ recommendations were largely aligned with clinical trial data, real-world evidence, and the prescribing information, and provided additional guidance regarding minimizing gastrointestinal effects, periodic monitoring for liver dysfunction, caution with respect to concomitant administration of cytochrome P450 3A4 and P-glycoprotein 1 inhibitors and inducers and anticoagulants, and management of comorbidities. The panelists unanimously agreed that adverse event management should be individualized, based on careful consideration of the risks and benefits of each possible intervention and discussion with the patient. Conclusions: These consensus recommendations provide additional guidance on the appropriate management of IPF with nintedanib, for use alongside evidence-based literature and the prescribing information.

Bibliographical note

Funding Information:
This Delphi study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). The authors did not receive payment for development of this article. Writing support was provided by Edward K. Baldwin, PhD, of AXON Communications, and Melanie Stephens, PhD, from Fleishman-Hillard, which were contracted and funded by BIPI. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. The authors thank Dr. Howard M. Lazarus, then an employee of BIPI, for his assistance with this project. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This Delphi study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). The authors did not receive payment for development of this article.

Publisher Copyright:
© The Author(s) 2021.

Keywords

  • Comorbidity
  • drug interactions
  • interstitial lung disease
  • safety
  • tyrosine kinase

PubMed: MeSH publication types

  • Journal Article

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