Evidence map›Paper›PMID 32239475›Full record

Observational studyJournal of endocrinological investigation2020

Immune checkpoint inhibitor-associated pituitary adverse events: an observational, retrospective, disproportionality study.

X Bai, X Chen, X Wu, Y Huang, Y Zhuang, Y Chen, C Feng, Xiahong Lin

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of endocrinological investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

X BaiDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
X ChenDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
X WuDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
Y HuangDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
Y ZhuangDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
Y ChenDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
C FengDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China.
Xiahong LinDepartment of Endocrinology, Second Affiliated Hospital of Fujian Medical University, No. 950 Donghai Street, Fengze, Quanzhou, Fujian, China. linxiahongdr@fjmu.edu.cn.ORCID http://orcid.org/0000-0002-5515-730X
Fujian Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this study was to identify and characterize immune checkpoint inhibitors (ICIs)-associated pituitary adverse events (AEs).

methodsThis 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.

resultsThe 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.

conclusionsICI-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.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDatabases, FactualDrug-Related Side Effects and Adverse ReactionsEndocrine System DiseasesFemaleHumansImmune Checkpoint InhibitorsImmunotherapyIncidenceMaleMiddle AgedPharmacovigilancePituitary DiseasesImmune Checkpoint InhibitorsAdverse eventsHypophysitisHypopituitarismImmune checkpoint inhibitorPituitary enlargement

Identifiers

PMID32239475
OpenAlexW3014248176

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.