Evidence map›Paper›PMID 35654647›Full record

Observational studyAnais brasileiros de dermatologia

Icatibant use in Brazilian patients with hereditary angioedema (HAE) type 1 or 2 and HAE with normal C1-INH levels: findings from the Icatibant Outcome Survey Registry Study.

Anete S Grumach, Marina T Henriques, Maine L D Bardou, Daniele A Pontarolli, Jaco Botha, Mariangela Correa, IOS Brazil Study Group

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Anais brasileiros de dermatologia. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01034969 (Icatibant Outcome Survey), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

NCT01034969 completednot on this map

Icatibant Outcome Survey (IOS) Registry

TypeobservationalSponsorShireRan2009 to 2024Enrolled1,761ConditionsHereditary Angioedema (HAE)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Global frequency, diagnosis, and treatment of hereditary angioedema with normal C1 inhibitor.The journal of allergy and clinical immunology. Global · 2025
    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

7 authors at 3 institutions in 3 countries.

Anete S GrumachClinical Immunology, Faculdade de Medicina, Centro Universitario Saúde ABC, Santo André, SP, Brazil. Electronic address: anete.grumach@fmabc.net.
Marina T HenriquesClinical Immunology, Faculdade de Medicina, Centro Universitario Saúde ABC, Santo André, SP, Brazil.
Maine L D BardouClinical Immunology, Faculdade de Medicina, Centro Universitario Saúde ABC, Santo André, SP, Brazil.
Daniele A PontarolliClinical Immunology, Faculdade de Medicina, Centro Universitario Saúde ABC, Santo André, SP, Brazil.
Jaco BothaTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Mariangela CorreaTakeda Distribuidora Ltda, São Paulo, SP, Brazil.
IOS Brazil Study Group
Faculdade de Medicina do ABC · BRTakeda (Japan) · JPTakeda (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHereditary angioedema can be caused by C1-Inhibitor (C1-INH) deficiency and/or dysfunction (HAE-1/2) or can occur in patients with normal C1-INH (HAE nC1-INH).

methodsThe Icatibant Outcome Survey (IOS; NCT01034969) registry monitors the safety and effectiveness of icatibant for treating acute angioedema.

objectivePresent findings from Brazilian patients with HAE-1/2 and HAE nC1-INH participating in IOS.

results42 patients were enrolled (HAE-1/2, n = 26; HAE nC1-INH, n = 16). Median age at symptom onset was significantly lower with HAE-1/2 vs. HAE nC1-INH (10.0 vs. 16.5y, respectively; p = 0.0105), whereas median age at diagnosis (31.1 vs. 40.9y; p = 0.1276) and the median time between symptom onset and diagnosis (15.0 vs. 23.8y; p = 0.6680) were numerically lower vs. HAE nC1-INH, respectively. One icatibant dose was used for > 95% of HAE attacks. Median (range) time-to-event outcomes were shorter for patients with HAE nC1-INH vs. HAE-1/2, including time to first administration (0.5 [0-96.0] vs. 1.0 [0-94.0]h, respectively), time from first administration to complete resolution (1.0 [0-88.0] vs. 5.5 [0-96.0]h, respectively), and total attack duration (7.0 [0.3-99.0] vs. 18.5 [0.1-100.0]h, respectively). Mean (SD) time from attack onset to resolution was significantly shorter for patients with HAE nC1-INH vs. HAE-1/2 (9.8 [18.7] vs. 19.6 [24.0]h, respectively; p = 0.0174). 83 adverse events (AEs) in 42 patients were reported; most were mild (66.3%) or moderate (13.3%) and non-serious (75.9%). The most common icatibant-related AE was injection site erythema (HAE-1/2, 34.6%; HAE nC1-INH, 18.8%). STUDY LIMITATIONS: This was an observational study without a treatment comparator and that relied on patient recall.

conclusionsFindings demonstrate effectiveness and tolerability of icatibant in Brazilian HAE patients.

Indexed as

Angioedemas, HereditaryBradykininBrazilComplement C1 Inhibitor ProteinHumansRegistriesTreatment OutcomeBradykininComplement C1 Inhibitor ProteinicatibantBradykininBradykinin receptorBrazilHereditary angioedema

Identifiers

PMID35654647
PMCPMC9263662
OpenAlexW4281733587

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.