Interstitial lung disease associated with ALK inhibitors and risk factors: an updated comparative pharmacovigilance analysis.

ABSTRACT:

Background

Inhibitors of the anaplastic lymphoma kinase (ALK) gene mutation are first-line treatments in patients with ALK-positive lung cancer. The FDA label warns of the risk of interstitial lung disease (ILD) in patients receiving ALK TKIs. However, ILD associated with ALK TKIs is not fully understood. The aim of this study was to characterize the features of ALK TKI-related ILD and to explore risk factors for ALK TKI-related ILD.

Methods

FDA's Adverse Event Reporting System (FAERS) reports from 2011 Q1 to 2023 Q2 were extracted and combined. Standardized MedDRA queries (SMQs) were used to search for AEs at the preferred term (PT) level. Four algorithms were employed to quantify the signals of ILD associated with ALK TKIs. The risk of ILD was further analyzed using logist

SUBMITTER: Dong J 

PROVIDER: S-EPMC11466793 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature