Tyrosine Kinase Inhibitor–Induced Pulmonary Arterial Hypertension

Preda, Mariana; Seferian, Andrei; Jutant, Étienne-Marie; Chaumais, Marie‐Camille; Savale, Laurent; Jaïs, Xavier; Weatherald, Jason; Sitbon, Olivier; Humbert, Marc; Montani, David

doi:10.21693/1933-088x-17.2.69

Cited by 3 publications

(3 citation statements)

References 48 publications

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“…Moreover, tyrosine kinase inhibitors used in the treatment of other malignancies have been associated with pulmonary arterial hypertension including dasatinib, lapatinib, and bosutinib. 50 Among ALK inhibitors, alectinib is the only agent for which the product label contains precautions to avoid photosensitivity. 51 However, our analysis of the FAERS databases found four significant signals for photosensitivity reactions associated with brigatinib, alectinib, crizotinib, and ceritinib.…”

Section: Discussionmentioning

confidence: 99%

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Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS)

Omar¹,

Soliman²,

Eshra³

et al. 2021

ESMO Open

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Background: Inhibitors of the anaplastic lymphoma kinase (ALK) gene mutation are highly effective treatments for ALKpositive lung cancer. We conducted this pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS). Patients and methods: FAERS files from 2012 to 2020 were used. Reports for crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib were filtered. We used the Medical Dictionary for Regulatory Activities (MedDRA version 22.1). Further, we searched for adverse events on the preferred term (PT) level based on case reports in the literature. After filtering duplicate reports, disproportionality analysis was used to detect safety signals by calculating proportional reporting ratios (PRRs), reporting odds ratios (RORs), empirical Bayesian geometric mean, and information component. Reports were considered statistically significant if the 95% confidence interval did not contain the null value. Results: Within the system organ classes, significant safety signals were found, including those for crizotinib [eye disorders (PRR 2.09, ROR 2.12)], ceritinib [gastrointestinal disorders (PRR 2.19, ROR 2.41), hepatobiliary disorders (PRR 4.4, ROR 4.52), respiratory disorders (PRR 1.96, ROR 2.08)], alectinib [hepatobiliary disorders (PRR 2.60, ROR 2.63)], brigatinib [respiratory disorders (PRR 2.15, ROR 2.31)], and lorlatinib [metabolism disorders (PRR 3.34, ROR 3.53)]. For adverse events on the PT level, we found several significant signals, including pneumothorax with crizotinib (

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS)

Omar¹,

Soliman²,

Eshra³

et al. 2021

ESMO Open

View full text Add to dashboard Cite

show abstract

“…The mechanism of PAH development is presumed to be endothelial cell toxicity through the production of mitochondrial reactive oxygen species. 12 The kinase inhibition profile of each TKI is likely to play a key role in determining the net pulmonary vascular response. Src inhibition mediates the development of PAH after treatment with dasatinib or ponatinib.…”

mentioning

confidence: 99%