WEDNESDAY, Sept. 21 (HealthDay News) -- In patients with idiopathic pulmonary fibrosis, treatment with 150 mg of the tyrosine kinase inhibitor BIBF 1120 twice daily is safe, reduces lung function decline with fewer acute exacerbations, and preserves quality of life, according to a study published in the Sept. 22 issue of the New England Journal of Medicine.
Luca Richeldi, M.D., Ph.D., from the Policlinico Hospital in Modena, Italy, and colleagues compared the relative efficacy and safety of four doses of BIBF 1120 (50 mg once a day, and 50, 100, and 150 mg twice a day) and placebo in 432 patients with idiopathic pulmonary fibrosis. The annual decline rate of forced vital capacity (FVC) was the primary end point, and acute exacerbations, quality of life (measured with the St. George's Respiratory Questionnaire [SGRQ]), and total lung capacity were the secondary end points.
The investigators found that the decline in FVC in the group receiving 150 mg BIBF 1120 twice daily was 0.06 liters versus 0.19 liters per year in the placebo group, corresponding to a 68.4 percent reduction in the rate of loss with BIBF 1120. This dose group had lower incidence of acute exacerbations than placebo (2.4 versus 15.7 per 100 patient-years) and a small decrease in the SGRQ score versus an increase with placebo (−0.66 versus 5.46). Patients treated with 150 mg twice a day had more frequent gastrointestinal symptoms leading to discontinuation, and increased levels of liver aminotransferases than placebo.
"The results of this phase 2 study showed an acceptable safety profile and potential clinical benefits of treatment with 150 mg of BIBF 1120 twice a day," the authors write.
The study was supported by Boehringer Ingelheim; several authors disclosed financial relationships with pharmaceutical and biotechnology companies, including Boehringer Ingelheim.
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