Evidence map›Paper›PMID 42860370›Full record

ArticleClinical and translational allergy2026

Experiences From the First Year of Using Garadacimab to Treat Hereditary Angioedema and Acquired Angioedema.

Markus Magerl, Kathrin Schön, Janine Ruhe, Felix Aulenbacher, Leonie Shirin Herzog, Thomas Buttgereit

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Article in Clinical and translational allergy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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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

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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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

6 authors.

Markus MagerlAngioedema Center of Reference and Excellence (ACARE), Institute of Allergology, Charité - University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID https://orcid.org/0000-0001-9218-5468
Kathrin SchönAngioedema Center of Reference and Excellence (ACARE), Institute of Allergology, Charité - University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID https://orcid.org/0009-0008-6055-6787
Janine RuheAngioedema Center of Reference and Excellence (ACARE), Institute of Allergology, Charité - University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID https://orcid.org/0009-0002-6660-167X
Felix AulenbacherAngioedema Center of Reference and Excellence (ACARE), Institute of Allergology, Charité - University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID https://orcid.org/0009-0000-2105-6060
Leonie Shirin HerzogAngioedema Center of Reference and Excellence (ACARE), Institute of Allergology, Charité - University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID https://orcid.org/0000-0002-7691-0372
Thomas ButtgereitAngioedema Center of Reference and Excellence (ACARE), Institute of Allergology, Charité - University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID https://orcid.org/0000-0002-9389-1767

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGaradacimab, a first-in-class, recombinant monoclonal antibody targeting activated FXII, is available in Germany for long-term prophylaxis (LTP) of hereditary angioedema (HAE) since March 2025. We aimed to examine garadacimab real-life treatment outcomes at our Berlin Angioedema Center of Reference and Excellence (ACARE), the reasons for switching therapies, and approaches to tailoring treatment individually.

methodsIn total, 29 patients (27 patients with HAE and 2 patients with angioedema due to acquired C1 inhibitor deficiency) were treated in regular care with garadacimab; 3 patients discontinued garadacimab due to lack of efficacy after loading dose or second dose and were excluded from analysis due to insufficient follow up. Ultimately, 26 patients were monitored for 26 weeks (median) using the angioedema control test (AECT) and the angioedema quality of life questionnaire (AE-QoL). In seven patients, garadacimab from the open-label-VANGUARD study was continued in regular care. Patients who had previously participated in the study-provided they were symptom-free-were offered the option, upon transitioning to routine care, to extend the interval between injections by alternating between three and four days. Patients who were switched to garadacimab in routine care were offered the same option if they were completely symptom-free 2 months after starting the therapy.

resultsOverall, 16 patients switched from previous LTP to garadacimab mostly at the end of their individual treatment interval and due to the prospect of higher efficacy and convenience. The injection interval could be extended in most patients (median, 42 days, range 31-56). The mean AECT and AE-QoL improved clinically meaningfully, regardless of previous treatment (9.2-14.4 and 35.5-14.9 points, respectively), however, improvement in patients switched from previous LTP was less pronounced when compared to patients that switched from on-demand treatment (11.2-14.5 vs. 6.7-14.2 points and 29.4-14.3 vs. 43.1-15.7 points, respectively). No side effects were reported.

conclusionsGaradacimab showed high efficacy and safety and the gradual extension of injection intervals presented underline its potential for longer dosing intervals that may further reduce treatment burden.

Indexed as

C1 inhibitor deficiencydisease controlgaradacimabHAElong‐term prophylaxisnormalization of lifequality of life

Identifiers

PMID42860370
PMCPMC13654816

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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.