Boehringer Ingelheim recently announced positive results regarding the safety, tolerability and efficacy of FDA-approved OFEV® (nintedanib*) in patients with idiopathic pulmonary fibrosis (IPF). The results were recently presented during the 2015 International Conference of the American Thoracic Society (ATS), which took place in Denver, and reveal continued long-term effectiveness in treating IPF patients.
IPF is a life-threating condition that causes progressive lung tissue damage, difficulty in breathing and irreversible lung function decline.
“As IPF is a life-threatening and progressive disease, patients will be on life-long treatment to manage their disease. It is important to assess and continue to monitor the efficacy and safety of OFEV® in these patients,” said Professor Bruno Crestani, Professor of Pneumology and Deputy Dean for Research at the Paris Diderot University School of Medicine in a recent news release. “These data strengthen the evidence supporting the efficacy, safety and tolerability of OFEV® and further our understanding of treating this complex disease.”
The results presented during the conference related to the TOMORROW phase II clinical trial, after a total of 52 weeks in the placebo-controlled period 1 of the treatment trials. All patients had the option to continue for a period 2 of blind treatment until they reached the 5 weeks of treatment.
Results showed that after the two treatment periods:
- There was a change in the decline of the forced vital capacity (FVC), which was lower in the group of patients under treatment with nintedanib* at a dosing of 150 mg in comparison with the control group of patients (-3.1% vs. -6.3% from baseline to week 76, respectively);
- A small proportion of patients in the group that received the nintedanib* at a dosing of 150 mg vs. the control patients group had at least one severe IPF exacerbation (4.7% vs. 19.5 % of patients, respectively);
- Results also showed that between that between groups the tolerability and safety of nintedanib 150 mg bid was similar both the study periods.
Dr. Martin Kolb, Director, Division of Respiratory, Department of Medicine, McMaster University, Canada added in the news release regarding the results: “The unique data from post-hoc subgroup analyses from the pooled INPULSIS® clinical trials demonstrate a consistent effect of OFEV® in patients with different degrees of lung function impairment and patients with different radiologic patterns in imaging tests at baseline (no honeycombing and no confirmation of diagnosis in lung biopsy vs. patients with honeycombing and/or biopsy confirmation of diagnosis). The results presented highlight the importance of early detection and timely treatment of patients with IPF. In addition, the data presented at the conference includes a wide range of patient types which are representative of patients seen in clinical practice.”
Results from other analyses of the INPULSIS® trials revealed that nintedanib reduced the annual rate of FVC decline. IPF patients in an early disease stage had similar benefits treatment with nintedanib in comparison with patients in advanced staged of the condition.