%0 Journal Article %A Luca Richeldi %A Sophie Fletcher %A Huzaifa Adamali %A Nazia Chaudhuri %A Sabrina Wiebe %A Sven Wind %A Kathrin Hohl %A Andrew Baker %A Rozsa Schlenker-Herceg %A Susanne Stowasser %A Toby M. Maher %T No relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone %D 2018 %R 10.1183/13993003.01060-2018 %J European Respiratory Journal %P 1801060 %X 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.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Richeldi reports grants and personal fees from InterMune, personal fees from Sanofi-Aventis, personal fees from Roche, personal fees from ImmuneWorks, personal fees from Shionogi, personal fees from Boehringer Ingelheim, personal fees from Celgene, personal fees from Nitto, personal fees from Fibrogen, personal fees from Promedior, personal fees from Bristol Myers Squibb, personal fees from DynaMed, outside the submitted work.Conflict of interest: Dr. Fletcher has nothing to disclose.Conflict of interest: Dr. Adamali has nothing to disclose.Conflict of interest: Dr. Chaudhuri reports grants from Boehringer Ingelheim, personal fees from Boehringer Ingelheim, other from Roche, other from Boehringer Ingelheim, personal fees from Roche, outside the submitted work.Conflict of interest: Ms. Wiebe reports she is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG.Conflict of interest: Dr. Wind reports to be employee of Boehringer Ingelheim Pharma GmbH & Co KG.Conflict of interest: Dr. Hohl has nothing to disclose.Conflict of interest: Mr. Baker reports and Employee of the Sponsor, Boehringer Ingelheim.Conflict of interest: Dr. Schlenker-Herceg has nothing to disclose.Conflict of interest: Dr. Stowasser reports that she is an employee of Boehringer Ingelheim International GmbH.Conflict of interest: TMM has, via his institution, received industry-academic funding from GlaxoSmithKline R&D and UCB and has received consultancy or speakers fees from Apellis, Astra Zeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Cipla, GlaxoSmithKline R&D, ProMetic, Roche, Sanumed and UCB. %U https://erj.ersjournals.com/content/erj/early/2018/11/01/13993003.01060-2018.full.pdf