Evidence map›Paper›PMID 32452549›Full record

Trial reportAllergy2020

Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.

Marc A Riedl, Marcus Maurer, Jonathan A Bernstein, Aleena Banerji, Hilary J Longhurst, H Henry Li, Peng Lu, James Hao, Salomé Juethner, William R Lumry and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Allergy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% 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.

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

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Interventions for the long-term prevention of hereditary angioedema attacks.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Trial
  4. 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
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. The International/Canadian hereditary angioedema guideline.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026
    Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. Successful Use of Lanadelumab in an Older Patient With Type II Hereditary Angioedema.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2022
    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

11 authors at 8 institutions in 3 countries.

Marc A RiedlDivision of Rheumatology, Allergy and Immunology, University of California, San Diego, San Diego, CA, USA.ORCID 0000-0003-3460-1544
Marcus MaurerDermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-4121-481X
Jonathan A BernsteinDivision of Immunology/Allergy Section, Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA.ORCID 0000-0002-3476-1196
Aleena BanerjiDivision of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Hilary J LonghurstAddenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge and University College London Hospitals, London, UK.
H Henry LiInstitute for Asthma and Allergy, P.C., Chevy Chase, MD, USA.
Peng LuShire, a Takeda company, Lexington, MA, USA.
James HaoShire, a Takeda company, Lexington, MA, USA.
Salomé JuethnerShire, a Takeda company, Lexington, MA, USA.
William R LumryAllergy and Asthma Research Associates, Dallas, TX, USA.
HELP Investigators
Takeda (United States) · USAllergy Associates Research Center · USBernstein Clinical Research Center · USCambridge University Hospitals NHS Foundation Trust · GBCharité - Universitätsmedizin Berlin · DEHarvard University · USInstitute for Asthma and Allergy · USUniversity of California San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study.

objectiveTo assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.

methodsEligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints.

resultsOne hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤ .001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable-HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182.

conclusionProtection with lanadelumab started from the first dose and continued throughout the entire study period.

Indexed as

Angioedemas, HereditaryAntibodies, Monoclonal, HumanizedComplement C1 Inhibitor ProteinHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedComplement C1 Inhibitor Proteinlanadelumabdurable efficacyhereditary angioedemalong-term prophylaxisonset of action

Identifiers

PMID32452549
PMCPMC7689768
OpenAlexW3032400603

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.