PMID- 32239475
OWN - NLM
STAT- MEDLINE
DCOM- 20210616
LR  - 20210616
IS  - 1720-8386 (Electronic)
IS  - 0391-4097 (Linking)
VI  - 43
IP  - 10
DP  - 2020 Oct
TI  - Immune checkpoint inhibitor-associated pituitary adverse events: an 
      observational, retrospective, disproportionality study.
PG  - 1473-1483
LID - 10.1007/s40618-020-01226-4 [doi]
AB  - PURPOSE: The aim of this study was to identify and characterize immune checkpoint 
      inhibitors (ICIs)-associated pituitary adverse events (AEs). METHODS: This is a 
      retrospective disproportionality study based on VigiBase, the World Health 
      Organization (WHO) global database of individual case safety reports (ICSRs), 
      with a study period from January 1, 2011 to March 6, 2019. Information component 
      (IC) and reporting odds ratio (ROR) are measures of disproportionate analysis. IC 
      was used to evaluate the association between ICIs and pituitary AEs, while ROR 
      was used to evaluate the differences in reporting of pituitary AEs between 
      different ICI subgroups. RESULTS: The following ICI-associated pituitary diseases 
      have been increasingly reported: hypophysitis (835 reports; information component 
      6.74 [95% CI 6.63-6.83]), hypopituitarism (268; 6.12 [95% CI 5.92-6.27]), 
      pituitary enlargement (28; 5.19 [95% CI 4.57-5.63]). The anti-CTLA-4 subgroup had 
      a stronger association with hypophysitis/hypopituitarism than the 
      anti-PD (anti-PD-1 or anti-PD-L1) subgroup (ROR 8.0 [95% CI 6.7-9.6]). Among 
      ICI-associated hypophysitis/hypopituitarism cases, the proportion of male was 
      higher than female (630 [63.9%] vs 356 [36.1%]). Anti-CTLA-4 subgroup and ICI 
      combination (nivolumab plus ipilimumab) subgroup both had a significantly earlier 
      onset time than anti-PD subgroup (67 days [IQR 48-87]; 90 [IQR 34-155]; 140 [IQR 
      62-218], both p < 0.05). Other endocrinopathies that co-occurred with 
      hypophysitis/hypopituitarism were adrenal insufficiency, thyroid dysfunction, 
      diabetes mellitus and diabetes insipidus. Gastrointestinal disorder was the most 
      common concurrent disease except for endocrinopathies. CONCLUSIONS: 
      ICI-associated pituitary adverse events have significantly increased, and their 
      clinical characteristics should be kept in mind by oncologists and 
      endocrinologists who manage patients treated by immunotherapy.
FAU - Bai, X
AU  - Bai X
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
FAU - Chen, X
AU  - Chen X
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
FAU - Wu, X
AU  - Wu X
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
FAU - Huang, Y
AU  - Huang Y
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
FAU - Zhuang, Y
AU  - Zhuang Y
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
FAU - Chen, Y
AU  - Chen Y
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
FAU - Feng, C
AU  - Feng C
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
FAU - Lin, Xiahong
AU  - Lin X
AUID- ORCID: 0000-0002-5515-730X
AD  - Department of Endocrinology, Second Affiliated Hospital of Fujian Medical 
      University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China. 
      linxiahongdr@fjmu.edu.cn.
AD  - Department of Medical Administration, Second Affiliated Hospital of Fujian 
      Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China. 
      linxiahongdr@fjmu.edu.cn.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20200401
PL  - Italy
TA  - J Endocrinol Invest
JT  - Journal of endocrinological investigation
JID - 7806594
RN  - 0 (Immune Checkpoint Inhibitors)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Endocrine System Diseases/chemically induced/epidemiology
MH  - Female
MH  - Humans
MH  - Immune Checkpoint Inhibitors/administration & dosage/*adverse effects
MH  - Immunotherapy/adverse effects
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Pharmacovigilance
MH  - Pituitary Diseases/*chemically induced/*epidemiology
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Adverse events
OT  - Hypophysitis
OT  - Hypopituitarism
OT  - Immune checkpoint inhibitor
OT  - Pituitary enlargement
EDAT- 2020/04/03 06:00
MHDA- 2021/06/17 06:00
CRDT- 2020/04/03 06:00
PHST- 2019/10/23 00:00 [received]
PHST- 2020/03/16 00:00 [accepted]
PHST- 2020/04/03 06:00 [pubmed]
PHST- 2021/06/17 06:00 [medline]
PHST- 2020/04/03 06:00 [entrez]
AID - 10.1007/s40618-020-01226-4 [pii]
AID - 10.1007/s40618-020-01226-4 [doi]
PST - ppublish
SO  - J Endocrinol Invest. 2020 Oct;43(10):1473-1483. doi: 10.1007/s40618-020-01226-4. 
      Epub 2020 Apr 1.