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      Evaluation of Time to Onset and Outcome of Lung Adverse Events Related to Pembrolizumab Using Marketing Surveillance

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          Abstract

          Background: Pembrolizumab has been widely used in patients since its release, but detailed information on lung-specific adverse events (AEs) from post-marketing monitoring has not been reported. Objectives: This study was undertaken to determine the risk of pembrolizumab-induced lung AEs, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. Method: We analyzed data for the period between April 2004 and March 2022. Data on lung AEs were extracted and the relative risks of AEs were estimated using reporting odds ratios. Results: We analyzed 2,021,907 reports and identified 15,306 reports of AEs caused by pembrolizumab, including 3,004 lung AEs. Signals were detected for 14 lung AEs. Interstitial lung disease was the most frequently reported (62.3%) and included fatal cases. A histogram of median time to onset showed occurrence ranging from 2 to 73 days, but some cases of interstitial lung disease occurred after 2 years of administration. The AEs showing the highest fatality rates were interstitial lung disease, respiratory failure, and pneumonia aspiration. Conclusions: This study focused on lung AEs caused by pembrolizumab as post-marketing AEs. Some cases could potentially involve serious outcomes, so patients should be monitored for signs of AE onset not only at the start of administration but also over an extended period, especially for interstitial lung disease.

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          Author and article information

          Journal
          OCL
          Oncology
          10.1159/issn.0030-2414
          Oncology
          Oncology
          S. Karger AG
          0030-2414
          1423-0232
          2023
          December 2023
          17 August 2023
          : 101
          : 12
          : 817-821
          Affiliations
          [_a] aDepartment of Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
          [_b] bDepartment of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women’s College of Liberal Arts, Kyotanabe, Japan
          [_c] cSchool of Pharmacy, Hyogo Medical University, Kobe, Japan
          Article
          533302 Oncology 2023;101:817–821
          10.1159/000533302
          37591211
          478c0341-53cc-4dde-a0cc-56c917efc633
          © 2023 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.

          History
          : 28 January 2023
          : 24 July 2023
          Page count
          Figures: 2, Tables: 2, Pages: 5
          Funding
          The authors have not disclosed any funding.
          Categories
          Clinical Trial Note

          Medicine
          Outcome,Time to onset,Pembrolizumab,Lung adverse events,Japanese Adverse Drug Event Report database

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