Analysis of pooled data from three international, randomized, and placebo-controlled clinical trails — the Phase 2 TOMORROW trial and two Phase 3 INPULSIS trials — showed that nintedanib (Ofev) is an efficient and safe drug for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
The study, “Nintedanib in patients with idiopathic pulmonary fibrosis: Combined evidence from the TOMORROW and INPULSIS® trials,” was published in the journal Respiratory Medicine.
IPF is characterized by worsening dyspnea (difficult breathing), decline in forced vital capacity (FVC), and deterioration in patients’ health-related quality of life (HRQL). Ultimately fatal, the disease follows different patterns, with some patients displaying a rapid decline in lung function, while other exhibit a slower progression.
The Phase 2 TOMORROW clinical trial and the Phase 3 INPULSIS trials investigated the safety and efficacy of nintedanib, an intracellular inhibitor of tyrosine kinases approved as a drug treatment for IPF.
The research team pooled the trials’ results to understand the treatment’s efficiency, administered in two daily doses of nintedanib at a concentration of 150 mg. The parameters analyzed included annual rate of decline in FVC, time to first acute exacerbation, alterations from baseline in St George’s Respiratory Questionnaire (SGRQ) total score, and mortality over the treatment course (52 weeks).
In total, the team collected data from 1,231 patients, with 723 receiving nintedanib treatment and 508 a placebo (control group). Researchers observed that, in general, nintedanib treatment led to a consistent delay in disease progression, evidenced by a significant reduction of the annual rate of decline in FVC when compared to the control group.
Moreover, nintedanib showed a significant effect, across all pooled analysis, on the time for occurrence of first acute exacerbation, and change from baseline in SGRQ score at week 52 (2.92 with nintedanib and 4.97 with placebo). Nintedanib treatment was also associated with a reduction in the risk of all-cause and respiratory mortality, accompanied by a significant reduction in the risk of on-treatment mortality. Diarrhea was the most frequent adverse event in the nintedanib group.
In conclusion, the pooled data from the TOMORROW and INPULSIS trials supported the idea that nintedanib has a beneficial effect in slowing disease progression in patients with IPF.