Abstract
We conducted a post hoc analysis to assess the potential impact of GAP (gender, age, physiology) stage on the treatment effect of nintedanib in patients with idiopathic pulmonary fibrosis.
Outcomes were compared in patients at GAP stage I versus II/III at baseline in the INPULSIS® trials.
At baseline, 500 patients were at GAP stage I (nintedanib 304, placebo 196), 489 were at GAP stage II (nintedanib 296, placebo 193) and 71 were at GAP stage III (nintedanib 38, placebo 33). In nintedanib-treated patients, the annual rate of decline in forced vital capacity (FVC) was similar in patients at GAP stage I and GAP stage II/III at baseline (−110.1 and −116.6 mL·year−1, respectively), and in both subgroups was lower than in placebo-treated patients (−218.5 and −227.6 mL·year−1, respectively) (treatment-by-time-by-subgroup interaction p=0.92). In the nintedanib group, the number of deaths was 43.8% of those predicted based on GAP stage (35 versus 79.9). In the placebo group, the number of deaths was 59.8% of those predicted based on GAP stage (33 versus 55.2).
In conclusion, data from the INPULSIS® trials suggest that nintedanib has a similar beneficial effect on the rate of FVC decline in patients at GAP stage I versus II/III at baseline.
Abstract
Nintedanib provides a similar benefit versus placebo on the rate of decline in forced vital capacity in patients with idiopathic pulmonary fibrosis irrespective of GAP stage at baseline http://ow.ly/HfJ730nNkRT
Footnotes
This article has supplementary material available from openres.ersjournals.com.
The INPULSIS trials are registered at www.clinicaltrials.gov with identifier numbers NCT01335464 and NCT01335477. Data are available upon request. A request can be submitted at https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html.
Conflict of interest: C.J. Ryerson reports grants and personal fees from Boehringer Ingelheim and Hoffmann-La Roche, outside the submitted work.
Conflict of interest: M. Kolb reports research funding from the Canadian Pulmonary Fibrosis Foundation and the Canadian Institute for Health Research, acting as a site principal investigator in industry-sponsored clinical trials for Roche, Sanofi and Boehringer Ingelheim, grants from and service on an advisory board for the Pulmonary Fibrosis Foundation, advisory board fees from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Vertex, Genoa, Gilead and Alkermes, and grants and advisory board fees from Roche Canada and Janssen, personal fees from Prometic, outside the submitted work.
Conflict of interest: L. Richeldi reports grants and personal fees from Boehringer Ingelheim during the conduct of the study; and grants and personal fees from InterMune, and personal fees from Medimmune, Biogen-Idec, Sanofi-Aventis Roche, Takeda, ImmuneWorks and Shionogi, outside the submitted work.
Conflict of interest: J. Lee reports grants from the NIH, and personal fees from Genentech and Celgene, outside the submitted work.
Conflict of interest: D. Wachtlin is an employee of Boehringer Ingelheim
Conflict of interest: S. Stowasser is an employee of Boehringer Ingelheim.
Conflict of interest: V. Poletti reports personal fees from Boehringer Ingelheim during the conduct of the study.
Support statement: The INPULSIS trials were funded by Boehringer Ingelheim. Funding information for this article has been deposited in the Crossref Funder Registry.
- Received August 3, 2018.
- Accepted February 8, 2019.
- Copyright ©ERS 2019
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