The new descriptive analyses on long-term treatment with nintedanib* in the Phase II TOMORROW trial (NCT01170065; abstract A1019)3 was presented at the conference. Following the placebo-controlled 52 week treatment phase of the trial (period 1), patients were given the option to continue blinded treatment (period 2) until the last patients had finalized the 52 week treatment period.
Overall, the analyses across both periods showed:
- Average observed change in decline in forced vital capacity (FVC) or the amount of air that can be exhaled after maximum inhalation (a measure of IPF disease progression), was consistently lower in the nintedanib* 150 mg bid group than in the comparator group (-3.1% vs. -6.3% from baseline to week 76)
- A lower proportion of patients in the nintedanib* 150 mg bid group versus the comparator group had at least 1 acute IPF exacerbation (a sudden and severe worsening of IPF) (4.7% vs. 19.5 % of patients)
- The safety and tolerability of nintedanib 150 mg bid was similar between periods 1 and 2.
Worldwide, IPF affects as many as 14–43 people per 100,0004,5 , most commonly over the age of 50.6
Dr Martin Kolb, Director, Division of Respiratory, Department of Medicine, McMaster University, Canada added: “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.”
In a post-hoc analysis of the INPULSIS® trials (NCT01335464 and NCT01335477; abstract A1021),7 nintedanib* showed a consistent effect on reducing the annual rate of FVC decline, a measure of disease progression, whether patients had varying degrees of lung function impairment (i.e. FVC of > 90% predicted or ≤ 90% predicted.). Patients with early disease benefited in a similar way from treatment with nintedanib* compared to patients with more advanced disease.
The abstracts presented at the conference can be downloaded here by searching for the abstract numbers listed.
Two further abstracts were presented at the conference including:
- An analysis of the open-label extension of the Phase III INPULSIS® trials – INPULSIS®-ON (NCT01619085; abstract A1020)8 that confirmed the manageable safety and tolerability profile of nintedanib* in patients exposed to nintedanib* up to 33 months
- A post-hoc analysis of the INPULSIS trials (NCT01335464 and NCT01335477; abstract A1022),9 that showed the consistent effect of nintedanib* on reducing the annual rate of FVC decline, a measure of disease progression, in patients with different radiologic patterns at baseline, provided that they met the IPF diagnostic criteria required for trial participation.
*Nintedanib is approved under the brand name OFEV® in the US and EU for use in patients with IPF. Nintedanib is under regulatory review by health authorities in other countries.
‡Adjudicated exacerbations was a pre-specified sensitivity analysis in the pooled data set. Time to first investigator-reported exacerbation was a secondary endpoint which was met in TOMORROW and INPULSIS®-2 but not in INPULSIS®-1.
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Please click on the link below for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/18_may_2015_ofev.html
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