ArticleFrontiers in pharmacology2024
Interstitial lung disease associated with ALK inhibitors and risk factors: an updated comparative pharmacovigilance analysis.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.
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Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Target-specific cardiotoxicity of tyrosine kinase inhibitors: a Systematic Review and meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Clinical features, diagnosis, and outcome of anaplastic lymphoma kinase tyrosine kinase inhibitors associated interstitial lung disease.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2026Article
- Drug-related pulmonary fibrosis: A real-world pharmacovigilance study of the FDA Adverse Event Reporting System.Medicine · 2026Article
- Paradoxical Efficacy With Rare Adverse Events: Sequential ALK Inhibitor Therapy in Lung Adenocarcinoma.Clinical case reports · 2026Article
- Pharmacovigilance study and genetic target prediction analysis of FDA adverse event reporting system for anticancer drug-associated interstitial lung disease.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Article
- Is Immunotherapy a Contraindication for Treating Lung Cancer Patients with Interstitial Lung Diseases? A Review of the Literature.Journal of clinical medicine · 2026Review
- Safety recommendations for ALK tyrosine kinase inhibitors in non-small cell lung cancer: evidence from FAERS and CVARDD real-world databases.Frontiers in oncology · 2026Article
- Targeted Therapy-Induced Interstitial Lung Disease in NSCLC: Mechanisms, Clinical Signatures, and a Precision Medicine Roadmap.Drug design, development and therapy · 2026Review
- Article
- Differential risk of adverse drug reactions with baricitinib across age groups: integrating real-world pharmacovigilance and genetic causal inference.Therapeutic advances in drug safety · 2025Article
- Case Report: Severe brigatinib-induced pneumonitis in a patient with EML4-ALK+ metastatic non-small cell lung adenocarcinoma.Frontiers in oncology · 2025Article
- Proteins Combined Score Prediction Based on Improved Gene Expression Programming Algorithm and Protein-Protein Interaction Network Characterization.IET systems biologyArticle
- Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
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 logistic regression. Results: A total of 20,064 reports of ALK TKIs and 640 (3.2%) reports of ILD AEs were extracted. Significant disproportionality was detected in all five ALK TKIs. Interstitial lung disease and pneumonitis were the most common lung toxicities induced by ALK TKIs. Results of further analyses revealed a different spectrum of lung toxicity among the various TKIs. The median time to onset of ILD related to ALK TKIs was 53 days (Q1:12, Q3:209), and more than 70% of AEs occurred within the first 2 months. Logistic regression analysis and risk prediction model both showed that different ALK TKIs and their combination with PPIs, amlodipine, and magnesium oxide were independent risk factors for ILD ( Conclusion: ALK TKIs have different safety profiles regarding lung toxicity, which normally occurs within the first 2 months. Administration in combination with PPIs, amlodipine, and magnesium oxide significantly increases the risk of ILD. These results provide risk prediction for ILD related to ALK TKIs and support pharmacovigilance to promote safe prescribing in oncology.
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