Evidence map›Paper›PMID 37963438›Full record

ArticleORL; journal for oto-rhino-laryngology and its related specialties2023

Characterizing Adverse Events of Biologic Treatment of T2 Disease: A Disproportionality Analysis of the FDA Adverse Event Reporting System.

Taylor J Stack, Sulgi Kim, Meredith M Lamb, Ibtisam Mohammad, Abdullah Zeatoun, Erin Lopez, Cristine Klatt-Cromwell, Brian D Thorp, Charles S Ebert, Brent A Senior and 2 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ORL; journal for oto-rhino-laryngology and its related specialties, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
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

12 authors at 1 institution in 1 country.

Taylor J StackDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Sulgi KimDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Meredith M LambDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Ibtisam MohammadDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Abdullah ZeatounDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Erin LopezDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Cristine Klatt-CromwellDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Brian D ThorpDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Charles S EbertDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Brent A SeniorDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Adam J KimpleDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
Daniel AliceaDepartment of Otolaryngology, Head and Neck Surgery at the University of North Carolina, Chapel Hill, North Carolina, USA.
University of North Carolina at Chapel Hill · US

Funding

North Carolina Translational and Clinical Science Institute (NC TraCS) KL2KL2TR002490 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WEINBERGER, MORRIS · 2018 to 2022
$11.0M
NCATS NIH HHS KL2 TR002490NCATS NIH HHS KL2TR002490
6 · The paper itself

Abstract

introductionOver the last 3 years, the FDA has approved dupilumab, omalizumab, and mepolizumab for the treatment of CRSwNP; however, adverse events of these biologics have not been described in post-marketing surveillance trials. By utilizing the FDA Adverse Event Reporting System (FAERS), this study describes and compares biologic-associated adverse events in T2 disease.

methodsThis case-non-case study assessed disproportionate reporting rates using reporting odds ratios (RORs). RORs and p values for biologic-associated AEs were categorized and compared among dupilumab, omalizumab, and mepolizumab. This analysis included AEs associated with all treatment indications. Relative AE rates and outcomes were calculated.

resultsThere were a total of 112,560, 24,428, and 18,741 unique AE reports associated with dupilumab, omalizumab, and mepolizumab, respectively. Omalizumab had the strongest association with anaphylaxis (ROR = 20.80, 95% confidence interval [CI]: 18.58, 23.29). Dupilumab had large relative proportions and positive signals in the ophthalmologic category (7.76%, ROR = 6.20, 95% CI: 6.06, 6.35), such as with blurry vision (ROR = 3.80, CI: 3.52, 4.12) and visual impairment (ROR = 1.98, CI: 1.80, 2.19). Dupilumab was the only biologic associated with injection-site reactions (7.98%, ROR = 8.17, 95% CI: 7.98, 8.37). DISCUSSION/

conclusionThis is the first large-scale comparative analysis of the AE profiles of dupilumab, omalizumab, and mepolizumab. Our data suggest possible relations between dupilumab and ophthalmologic and injection-site AEs. Omalizumab was the only biologic with a positive anaphylaxis signal. This FAERS investigation suggests important AE differences among these biologics.

Indexed as

AnaphylaxisBiological ProductsAdverse Drug Reaction Reporting SystemsHumansOmalizumabUnited StatesUnited States Food and Drug AdministrationBiological ProductsOmalizumabChronic rhinosinusitisChronic sinusitisRhinology

Identifiers

PMID37963438
PMCPMC10842062
OpenAlexW4388661909

What OpenQuestion holds

Textmetadata
LicenceTDM
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.