Evidence map›Paper›PMID 41830315›Full record

ArticleAllergy2026

Switching Long-Term Prophylaxis to Donidalorsen for Hereditary Angioedema: 1-Year OASISplus Results.

Marc A Riedl, Jonathan A Bernstein, Joshua S Jacobs, Timothy Craig, William R Lumry, H James Wedner, Aleena Banerji, Selina Gierer, Andrew Smith, Michael E Manning and 7 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Allergy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05392114 (An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema), 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
–field-weighted citation impact
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.

NCT05392114 phase3active not recruitingnot on this map

An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

TypeinterventionalSponsorIonis Pharmaceuticals, Inc.Ran2022 to 2027Enrolled154ConditionsHereditary AngioedemaArmsDonidalorsen
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

17 authors.

Marc A RiedlDivision of Allergy and Immunology, University of California at San Diego, La Jolla, California, USA.ORCID https://orcid.org/0000-0003-3460-1544
Jonathan A BernsteinDivision of Rheumatology, Allergy, and Immunology, Department of Internal Medicine, University of Cincinnati College of Medicine, Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, USA.ORCID https://orcid.org/0000-0002-3476-1196
Joshua S JacobsAllergy and Asthma Clinical Research, Inc., Walnut Creek, California, USA.
Timothy CraigDepartment of Medicine, Pediatrics, MFM, and Biomedical Sciences, Penn State University, Allergy, Asthma, and Immunology, Hershey, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-7774-4855
William R LumryAsthma and Allergy Research Associates, Dallas, Texas, USA.
H James WednerDivision of Allergy and Immunology, Washington University, St. Louis, Missouri, USA.
Aleena BanerjiDivision of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Selina GiererDivision of Allergy, Clinical Immunology & Rheumatology, University of Kansas Medical Center, Kansas City, Kansas, USA.
Andrew SmithAllergy Associates of Utah, Sandy, Utah, USA.
Michael E ManningMedical Research of Arizona, Scottsdale, Arizona, USA.
Francesca PeregoDepartment of Internal Medicine, Istituti Clinici Scientifici Maugeri IRCCS, Milan, Italy.
Laura BordoneIonis, Carlsbad, California, USA.
Sabrina TreadwellIonis, Carlsbad, California, USA.
Tao LinIonis, Carlsbad, California, USA.
Kenneth B NewmanIonis, Carlsbad, California, USA.
Aaron YarlasIonis, Carlsbad, California, USA.
Danny M CohnDepartment of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID https://orcid.org/0000-0002-9036-3723

Funding

Ionis Pharmaceuticals, Inc.
6 · The paper itself

Abstract

backgroundDonidalorsen is an antisense oligonucleotide designed to reduce plasma prekallikrein in patients with hereditary angioedema (HAE). The Switch cohort of the OASISplus study (NCT05392114) evaluated the long-term safety and efficacy of donidalorsen in patients who switched from a long-term prophylactic treatment (LTP) to donidalorsen with 1-year outcomes.

methodsThis study enrolled patients with HAE aged ≥ 12 years previously on stable doses of an LTP (lanadelumab, berotralstat, C1 inhibitor). Patients directly switched from an LTP to donidalorsen 80 mg administered subcutaneously once every 4 weeks. Endpoints included incidence and severity of treatment-emergent adverse events (TEAEs; primary endpoint), monthly HAE attack rate, Angioedema Quality of Life (AE-QoL), and Angioedema Control Test (AECT) measured at baseline and Week 52.

resultsSixty-five patients enrolled, and 54 (83.1%) completed 1 year. Eleven (16.9%) patients discontinued treatment during the first year, and one discontinued treatment after 1 year. Donidalorsen reduced HAE attack rates from baseline on the prior LTP by 67.6% over 52 weeks. Fifty-six of 64 (87.5%) dosed patients experienced a TEAE; most reported mild to moderate events. The most common treatment-related TEAEs were injection-site erythema (10.9%) and injection-site pruritus (10.9%). One patient had a serious adverse event that was not treatment-related. AE-QoL total score improved by 12.2 points (clinically meaningful ≥ 6 points) from baseline to Week 52, and 90.4% of patients had well-controlled disease (AECT ≥ 10) at Week 52.

conclusionIn patients who switched from another LTP, donidalorsen was well tolerated and improved long-term HAE attack rates, quality of life, and disease control.

Indexed as

Angioedemas, HereditaryOligonucleotidesOligonucleotides, AntisenseAdolescentAdultAgedFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeYoung AdultdonidalorsenOligonucleotidesOligonucleotides, Antisenseangioedemaclinical immunologyinflammationquality‐of‐life

Identifiers

PMID41830315
PMCPMC13466153

What OpenQuestion holds

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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.