PMID- 37258564
OWN - NLM
STAT- MEDLINE
DCOM- 20230602
LR  - 20230609
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 13
IP  - 1
DP  - 2023 May 31
TI  - Evaluation of lung adverse events with nivolumab using the spontaneous reporting 
      system in Japan.
PG  - 8819
LID - 10.1038/s41598-023-35602-w [doi]
LID - 8819
AB  - This study was conducted to examine times to onset, incidence rates, and outcomes 
      of nivolumab-induced lung adverse events (AEs), using the Japanese Adverse Drug 
      Event Report database. We analysed data for the period between April 2004 and 
      March 2021. Data on lung AEs were extracted, and relative risks of AEs were 
      estimated using the reporting odds ratio. We analysed 5,273,115 reports and found 
      18,721 reports of nivolumab-related AEs, including 3084 lung AEs. Signals were 
      detected for nine lung AEs: interstitial lung disease; pneumonitis; lung 
      disorder; organising pneumonia; pleural effusion; pneumonia aspiration; pneumonia 
      bacterial; radiation pneumonitis; and infectious pleural effusion. Among these, 
      interstitial lung disease was the most frequently reported (68.7%) and included 
      some fatal cases. A histogram of median times to onset showed AEs occurring from 
      34 to 79 days after the first dose, but some cases occurred even more than one 
      year after starting administration. In conclusion, we focused on lung AEs caused 
      by nivolumab as post-marketing AEs. Some cases could potentially involve serious 
      outcomes, particularly in interstitial lung disease. Patients should be monitored 
      for signs of the development of these AEs not only at the start of 
      administration, but also over an extended time.
CI  - (c) 2023. The Author(s).
FAU - Kanbayashi, Yuko
AU  - Kanbayashi Y
AD  - Department of Education and Research Center for Clinical Pharmacy, Faculty of 
      Pharmacy, Osaka Medical and Pharmaceutical University, 4-20-1 Nasahara, 
      Takatsuki, Osaka, 569-1094, Japan. yuko.kambayashi@ompu.ac.jp.
FAU - Shimizu, Tadashi
AU  - Shimizu T
AD  - School of Pharmacy, Hyogo Medical University, 1-3-6 Minatojima, Kobe, Hyogo, 
      650-8530, Japan.
FAU - Kojima, Asuka
AU  - Kojima A
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, 
      Kodominamihokotate, Kyotanabe-shi, Kyoto, 610-0395, 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, 97-1, 
      Kodominamihokotate, Kyotanabe-shi, Kyoto, 610-0395, Japan.
FAU - Kawai, Rika
AU  - Kawai R
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, 
      Kodominamihokotate, Kyotanabe-shi, Kyoto, 610-0395, 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, 97-1, 
      Kodominamihokotate, Kyotanabe-shi, Kyoto, 610-0395, Japan.
LA  - eng
PT  - Journal Article
DEP - 20230531
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Humans
MH  - Nivolumab/adverse effects
MH  - Japan/epidemiology
MH  - *Lung Diseases, Interstitial/chemically induced/epidemiology
MH  - Lung
MH  - *Pleural Effusion
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology
PMC - PMC10232428
COIS- The authors declare no competing interests.
EDAT- 2023/06/01 01:08
MHDA- 2023/06/02 06:42
PMCR- 2023/05/31
CRDT- 2023/05/31 23:19
PHST- 2023/01/26 00:00 [received]
PHST- 2023/05/20 00:00 [accepted]
PHST- 2023/06/02 06:42 [medline]
PHST- 2023/06/01 01:08 [pubmed]
PHST- 2023/05/31 23:19 [entrez]
PHST- 2023/05/31 00:00 [pmc-release]
AID - 10.1038/s41598-023-35602-w [pii]
AID - 35602 [pii]
AID - 10.1038/s41598-023-35602-w [doi]
PST - epublish
SO  - Sci Rep. 2023 May 31;13(1):8819. doi: 10.1038/s41598-023-35602-w.