Evidence map›Paper›PMID 27926986›Full record

Observational studyAllergy2017

Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice.

A Zanichelli, M Maurer, W Aberer, T Caballero, H J Longhurst, L Bouillet, V Fabien, I Andresen, IOS Study Group

Erratum issued Registry-linked trialOpen access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Allergy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04978051 (Randomized, Open, Multicenter Phase II Clinical Trial, Proof of Concept, to Evaluate Efficacy and Safety of Icatibant in Hospitalized Patients With SARS-COV-2), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-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.

NCT04978051 phase2completednot on this mapstarted 2021, after this paper: background citation

Randomized, Open, Multicenter Phase II Clinical Trial, Proof of Concept, to Evaluate Efficacy and Safety of Icatibant in Hospitalized Patients With SARS-COV-2 (COVID-19) Without Assisted Ventilation Compared With Standard Care

TypeinterventionalSponsorSebastian VidelaRan2021 to 2022Enrolled73ConditionsCOVID-19 PneumoniaArmsFirazyr, SoC
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Three-Day Icatibant on Top of Standard Care in Patients With Coronavirus Disease 2019 Pneumonia: A Randomized, Open-Label, Phase 2, Proof-of-Concept Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. A hypothesized role for dysregulated bradykinin signaling in COVID-19 respiratory complications.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2020
    Article
  7. Observational
  8. Article
  9. Multiple doses of icatibant used during pregnancy.Allergy & rhinology (Providence, R.I.) · 2017
    Article
  10. Observational
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 7 countries.

A ZanichelliDepartment of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, ASST Fatebenefratelli Sacco, Milan, Italy.
M MaurerDepartment of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
W AbererDepartment of Dermatology and Venerology, Medical University of Graz, Graz, Austria.
T CaballeroDepartment of Allergy, Hospital La Paz Institute for Health Research (IdiPaz), Biomedical Research Network on Rare Diseases (CIBERER, U754), Madrid, Spain.
H J LonghurstDepartment of Immunology, Barts Health NHS Trust, London, UK.
L BouilletNational Reference Centre for Angioedema, Internal Medicine Department, Grenoble University Hospital, Grenoble, France.
V FabienShire, Zug, Switzerland at time of data analysis; now with Vifor Pharma, Glattbrugg, Switzerland.
I AndresenShire, Zug, Switzerland.
IOS Study Group
Barts Health NHS Trust · GBCentre for Biomedical Network Research on Rare Diseases · ESCentre Hospitalier Universitaire de Grenoble · FRCharité - Universitätsmedizin Berlin · DEMedical University of Graz · ATUniversity of Milan · ITVifor Pharma (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real-world setting. We analyzed safety data from 3025 icatibant-treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off-label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on-label vs off-label icatibant users.

Indexed as

AdolescentAngioedemaAnti-Inflammatory Agents, Non-SteroidalBradykininCardiovascular DiseasesFemaleGastrointestinal DiseasesHumansMaleOff-Label UseTime FactorsTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalBradykininicatibantangioedemaicatibantreal-worldsafety

Identifiers

PMID27926986
PMCPMC5434903
OpenAlexW2560528382

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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.