Evidence map›Paper›PMID 34287942›Full record

Trial reportAllergy2022

Long-term prevention of hereditary angioedema attacks with lanadelumab: The HELP OLE Study.

Aleena Banerji, Jonathan A Bernstein, Douglas T Johnston, William R Lumry, Markus Magerl, Marcus Maurer, Inmaculada Martinez-Saguer, Andrea Zanichelli, James Hao, Neil Inhaber and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Allergy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02741596 (HELP Study ExtensionTM), which is not on this map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT02741596 phase3completednot on this map

HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE)

TypeinterventionalSponsorShireRan2016 to 2019Enrolled212ConditionsHereditary Angioedema (HAE)ArmsDX-2930
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Effective long-term prophylaxis with lanadelumab in adolescents with hereditary angioedema: EMPOWER/ENABLE.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025
    Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Optimizing conversations on treatment management in hereditary angioedema: healthcare professional and patient perspectives on long-term prophylaxis and shared decision-making.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026
    Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. The International/Canadian hereditary angioedema guideline.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026
    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

13 authors at 8 institutions in 3 countries.

Aleena BanerjiDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Jonathan A BernsteinDivision of Immunology/Allergy Section, Department of Internal Medicine, University of Cincinnati, and Bernstein Clinical Research Center, Cincinnati, Ohio, USA.ORCID 0000-0002-3476-1196
Douglas T JohnstonAsthma & Allergy Specialists, Charlotte, North Carolina, USA.
William R LumryAllergy and Asthma Research Associates, Dallas, Texas, USA.
Markus MagerlDermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Marcus MaurerDermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-4121-481X
Inmaculada Martinez-SaguerHaemophilia Centre Rhine Main, Mörfelden-Walldorf, Germany.
Andrea ZanichelliDepartment of Internal Medicine, ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco-University of Milan, Milan, Italy.
James HaoTakeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Neil InhaberTakeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Ming YuTakeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Marc A RiedlDivision of Rheumatology, Allergy and Immunology, University of California San Diego, La Jolla, California, USA.ORCID 0000-0003-3460-1544
HELP OLE Investigators
Takeda (United States) · USCharité - Universitätsmedizin Berlin · DEAllergy Associates Research Center · USAsthma and Allergy Specialists · USBernstein Clinical Research Center · USHarvard University · USUniversity of California San Diego · USUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim was to evaluate long-term effectiveness and safety of lanadelumab in patients ≥12 y old with hereditary angioedema (HAE) 1/2 (NCT02741596).

methodsRollover patients completing the HELP Study and continuing into HELP OLE received one lanadelumab 300 mg dose until first attack (dose-and-wait period), then 300 mg q2wks (regular dosing stage). Nonrollovers (newly enrolled) received lanadelumab 300 mg q2wks from day 0. Baseline attack rate for rollovers: ≥1 attack/4 weeks (based on run-in period attack rate during HELP Study); for nonrollovers: historical attack rate ≥1 attack/12 weeks. The planned treatment period was 33 months.

results212 patients participated (109 rollovers, 103 nonrollovers); 81.6% completed ≥30 months on study (mean [SD], 29.6 [8.2] months). Lanadelumab markedly reduced mean HAE attack rate (reduction vs baseline: 87.4% overall). Patients were attack free for a mean of 97.7% of days during treatment; 81.8% and 68.9% of patients were attack free for ≥6 and ≥12 months, respectively. Angioedema Quality-of-Life total and domain scores improved from day 0 to end of study. Treatment-emergent adverse events (TEAEs) (excluding HAE attacks) were reported by 97.2% of patients; most commonly injection site pain (47.2%) and viral upper respiratory tract infection (42.0%). Treatment-related TEAEs were reported by 54.7% of patients. Most injection site reactions resolved within 1 hour (70.2%) or 1 day (92.6%). Six (2.8%) patients discontinued due to TEAEs. No treatment-related serious TEAEs or deaths were reported. Eleven treatment-related TEAEs of special interest were reported by seven (3.3%) patients.

conclusionLanadelumab demonstrated sustained efficacy and acceptable tolerability with long-term use in HAE patients.

Indexed as

Angioedemas, HereditaryAntibodies, Monoclonal, HumanizedComplement C1 Inhibitor ProteinHumansQuality of LifeTreatment OutcomeAntibodies, Monoclonal, HumanizedComplement C1 Inhibitor ProteinlanadelumabHAEHAE attacksHELP OLEhereditary angioedemalanadelumablong-term prophylaxis

Identifiers

PMID34287942
PMCPMC9292251
OpenAlexW3185247302

What OpenQuestion holds

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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.