PMID- 37591211
OWN - NLM
STAT- MEDLINE
DCOM- 20231216
LR  - 20231216
IS  - 1423-0232 (Electronic)
IS  - 0030-2414 (Linking)
VI  - 101
IP  - 12
DP  - 2023
TI  - Evaluation of Time to Onset and Outcome of Lung Adverse Events Related to 
      Pembrolizumab Using Marketing Surveillance.
PG  - 817-821
LID - 10.1159/000533302 [doi]
AB  - 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.
CI  - (c) 2023 S. Karger AG, Basel.
FAU - Kanbayashi, Yuko
AU  - Kanbayashi Y
AD  - Department of Education and Research Center for Clinical Pharmacy, Faculty of 
      Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
FAU - Kobayashi, Momoko
AU  - Kobayashi M
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, 
      Japan.
FAU - Anzai, Miku
AU  - Anzai M
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, 
      Japan.
FAU - Shimizu, Tadashi
AU  - Shimizu T
AD  - School of Pharmacy, Hyogo Medical University, Kobe, Japan.
FAU - Uchida, Mayako
AU  - Uchida M
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, 
      Japan.
LA  - eng
PT  - News
DEP - 20230817
PL  - Switzerland
TA  - Oncology
JT  - Oncology
JID - 0135054
RN  - DPT0O3T46P (pembrolizumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - Antibodies, Monoclonal, Humanized/adverse effects
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Lung
MH  - *Lung Diseases, Interstitial/chemically induced
OTO - NOTNLM
OT  - Japanese Adverse Drug Event Report database
OT  - Lung adverse events
OT  - Outcome
OT  - Pembrolizumab
OT  - Time to onset
EDAT- 2023/08/18 00:42
MHDA- 2023/12/17 09:44
CRDT- 2023/08/17 18:23
PHST- 2023/01/28 00:00 [received]
PHST- 2023/07/24 00:00 [accepted]
PHST- 2023/12/17 09:44 [medline]
PHST- 2023/08/18 00:42 [pubmed]
PHST- 2023/08/17 18:23 [entrez]
AID - 000533302 [pii]
AID - 10.1159/000533302 [doi]
PST - ppublish
SO  - Oncology. 2023;101(12):817-821. doi: 10.1159/000533302. Epub 2023 Aug 17.