Kinase Inhibitor Ofev Slows Progression of Idiopathic Pulmonary ibrosis Interview with –
Professor Luca Richeldi
University Hospital, Southampton
Southampton, UK What is the background for this study? What are the main findings?

Prof. Richeldi: The pooled analysis published in Respiratory Medicine is based on Ofev (nintedanib) data from the Phase II TOMORROW trial and the two Phase III INPULSIS studies, and a total of 1,231 patients with idiopathic pulmonary fibrosis (IPF), 723 of whom were treated with Ofev. The results of this analysis confirm that Ofev significantly slows disease progression by approximately 50%, as measured by decline in forced vital capacity (FVC) across a range of patient types in the clinical trial program. In addition, the analysis confirms that Ofev reduces the risk of acute exacerbations by approximately 50% and has a favorable effect across mortality outcomes with a trend in lower all-cause mortality and a significant lower on-treatment-mortality. What should clinicians and patients take away from your report?

Prof. Richeldi: Clinicians and their patients with  idiopathic pulmonary fibrosis need to recognize the importance of reducing the rate of progression and the risk of exacerbations as treatment goals in the management of this disease.  Acute exacerbations are unpredictable and have a devastating impact on the course of the disease.

It is important to note for clinicians that these results are based on exacerbations as reported by the investigators. In a previously-reported pooled analysis from the Phase III INPULSIS studies, the reduction in acute exacerbations was 68% as it was based on adjudicated exacerbations. In the two INPULSIS trials, a panel of IPF specialists reviewed all the investigator-reported acute exacerbations to determine whether or not the results reported were “truly” acute exacerbations. In the phase III INPULSIS trials, a process was in place to adjudicate exacerbations reported by investigators, as these events are difficult to detect and to define, and the pre-planned adjudicated exacerbations also yielded a significant result. What recommendations do you have for future research as a result of this study?

Prof. Richeldi: Ongoing research is imperative for helping physicians better manage patients with IPF, and to address the global burden of this progressive and life-threatening disease. There are a number of ongoing or planned global trials, including studies examining the efficacy and safety of combination therapies as well as the potential role of diagnostic biomarkers so that the physician community can detect  idiopathic pulmonary fibrosis at an earlier phase of the disease and, consequently, treat patients earlier. I believe these types of research will provide further scientific evidence needed to guide therapeutic decisions for IPF in the future


Respir Med. 2016 Apr;113:74-9. doi: 10.1016/j.rmed.2016.02.001. Epub 2016 Feb 3.

Nintedanib in patients with idiopathic pulmonary fibrosis: Combined evidence from the TOMORROW and INPULSIS(®) trials.

Richeldi L1, Cottin V2, du Bois RM3, Selman M4, Kimura T5, Bailes Z6, Schlenker-Herceg R7, Stowasser S8, Brown KK9.

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Professor Luca Richeldi (2016). Kinase Inhibitor Ofev Slows Progression of Idiopathic Pulmonary ibrosis

Last Updated on April 1, 2016 by Marie Benz MD FAAD