Abstract
Nintedanib and pirfenidone are approved treatments for idiopathic pulmonary fibrosis (IPF). This open-label, two-group trial investigated the pharmacokinetic drug–drug interaction between these two drugs in patients with IPF.
Subjects not treated with antifibrotics at screening (group 1, n=20) received a single nintedanib dose (150 mg) followed by pirfenidone (titrated to 801 mg thrice daily) for 3 weeks, with a further single nintedanib dose (150 mg) on the last day (day 23). Subjects treated with pirfenidone at screening (group 2, n=17) continued to receive pirfenidone alone (801 mg thrice daily) for 7 days, then co-administered with nintedanib (150 mg twice daily) for a further 7 days, before single doses of both treatments on day 16.
In group 1, adjusted geometric mean (gMean) ratios (with/without pirfenidone) were 88.6% and 80.6% for nintedanib area under the plasma concentration–time curve (AUC) and maximum plasma concentration (Cmax), respectively. In group 2, gMean ratios (with/without nintedanib) were 97.2% and 99.5% for pirfenidone AUC and Cmax, respectively. For all parameters, the 90% confidence intervals included 100%, suggesting similar exposure for administration alone and when co-administered. Both treatments were well tolerated.
These data indicate there is no relevant pharmacokinetic drug–drug interaction between nintedanib and pirfenidone when co-administered in IPF patients.
Abstract
There is no pharmacokinetic interaction between nintedanib and pirfenidone in patients with IPF http://ow.ly/utJD30msHeU
Footnotes
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This study is registered at ClinicalTrials.gov with identifier number NCT02606877. Researchers can use the link http://trials.boehringer-ingelheim.com to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Conflict of interest: L. Richeldi reports grants and personal fees (member of an advisory board) from InterMune, personal fees for consultancy from Sanofi-Aventis, ImmuneWorks, Celgene, Nitto and Bristol Myers Squibb, personal fees as member of an advisory board from Roche, Fibrogen and Promedior, personal fees for speaking from Shionogi, personal fees as a member of a steering committee from Boehringer Ingelheim, personal fees for editorial activity from DynaMed, outside the submitted work.
Conflict of interest: S. Fletcher has nothing to disclose.
Conflict of interest: H. Adamali has nothing to disclose.
Conflict of interest: N. Chaudhuri reports grants (for a project) from Boehringer Ingelheim, personal fees (for speakers fees) from Boehringer Ingelheim, other funding for educational sponsorship from Roche and Boehringer Ingelheim, and personal fees (for advisory boards) from Roche, outside the submitted work.
Conflict of interest: S. Wiebe is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG.
Conflict of interest: S. Wind is an employee of Boehringer Ingelheim Pharma GmbH & Co KG.
Conflict of interest: K. Hohl has nothing to disclose.
Conflict of interest: A. Baker is an employee of Boehringer Ingelheim.
Conflict of interest: R. Schlenker-Herceg has nothing to disclose.
Conflict of interest: S. Stowasser is an employee of Boehringer Ingelheim International GmbH.
Conflict of interest: T.M. Maher has, via his institution, received industry-academic funding from GlaxoSmithKline R&D and UCB and has received consultancy or speakers fees from Apellis, AstraZeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Cipla, GlaxoSmithKline R&D, ProMetic, Roche, Sanumed and UCB.
Support statement: This study was supported by funding from Boehringer Ingelheim. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received March 1, 2018.
- Accepted October 28, 2018.
- Copyright ©ERS 2019