Can nintedanib be taken long-term?

Nintedanib (Nintedanib) is an inhibitor of multiple tyrosine kinases and is a drug approved to treatidiopathic pulmonary fibrosis (IPF). This drug is one of a variety of targeted therapies that slow the progression of the disease by inhibiting signaling by a variety of cytokines and receptors. The efficacy and safety of nintedanib 150 mg twice daily (bd) for the treatment of IPF patients for 52 weeks was demonstrated in the Phase III INPULSIS trial. In both trials, nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) compared with placebo. Based on pooled data from the two trials, the annual rate of decline in FVC in patients treated with nintedanib was 113.6 mL/year.

The long-term efficacy and safety of nintedanib were confirmed in INPULSIS-ON, an open-label extension of the INPULSIS trial, which showed that the effect of nintedanib in slowing disease progression was sustained over 4 years and that the safety and tolerability of nintedanib in the long-term were consistent with results observed in the short-term study. The adverse event profile of nintedanib was primarily gastrointestinal, particularly diarrhea. These side effects may have a cumulative risk with long-term use. Therefore, doctors typically evaluate a patient's condition and potential benefits and risks before deciding to take nintedanib long-term.

Even though nintedanib can improve symptoms and slow progression of the disease in the short term, it does not cure pulmonary fibrosis. Therefore, long-term use of nintedanib does not mean that the disease will completely disappear or be cured, but it is intended to help control the disease and maintain stability. If a patient requires treatment with this medication, their doctor will evaluate the potential benefits and risks based on their specific situation and provide guidance about long-term use of the medication.