Nintedanib: New indication for systemic sclerosis-associated interstitial lung disease.

Abstract:

:Nintedanib (Ofev™), an oral triple kinase inhibitor targeting pro-fibrotic pathways, has been used for treatment of idiopathic pulmonary fibrosis (IPF). Based on positive results from phase III, placebo-controlled, randomized comparative clinical trial conducted in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib received marketing approval in the United States and Japan for the treatment of SSc-ILD. Nintedanib significantly reduced the annual rate of decline in forced vital capacity over 52 weeks compared with placebo. The safety profiles observed in this trial were consistent with those reported in IPF patients, and the most common adverse events were gastrointestinal disorders, including diarrhea, nausea, and vomiting, which sometimes lead to discontinuation or permanent dose reduction of nintedanib. In contrast, serious adverse events were infrequent and were related mostly to worsening of cardiopulmonary involvement of SSc. This review summarizes the milestones in development of nintedanib leading to the approval for the treatment of SSc-ILD, and covers mechanisms of action, efficacy results and safety profiles, and future perspectives of nintedanib.

journal_name

Mod Rheumatol

journal_title

Modern rheumatology

authors

Kuwana M,Azuma A

doi

10.1080/14397595.2019.1696505

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

225-231

issue

2

eissn

1439-7595

issn

1439-7609

journal_volume

30

pub_type

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