Trial reportAllergy2021
Impact of lanadelumab on health-related quality of life in patients with hereditary angioedema in the HELP study.
Trial report in Allergy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.
- Interventions for the long-term prevention of hereditary angioedema attacks.The Cochrane database of systematic reviews · 2022Pooled it
- Impact of Oral Sebetralstat on Anxiety Associated With Hereditary Angioedema Attacks.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026Trial
- Patient-Reported Outcomes in the Phase III OASIS-HAE Study of Donidalorsen for Hereditary Angioedema.Allergy · 2025Trial
- Lanadelumab for prevention of attacks of non-histaminergic normal C1 inhibitor angioedema: results from the randomized, double-blind CASPIAN Study and CASPIAN open-label extension.Frontiers in immunology · 2025Trial
- Long-term prevention of hereditary angioedema attacks with lanadelumab: The HELP OLE Study.Allergy · 2022Trial
- Lanadelumab Use for Hereditary Angioedema Long-Term Prophylaxis Over the Last 7 Years: A Narrative Review of Clinical and Real-World Data.Clinical reviews in allergy & immunology · 2026Review
- Sustained Effectiveness of Lanadelumab in Preventing Hereditary Angioedema Attacks: The ENABLE Study.Clinical and translational allergy · 2026Article
- Psychometric validation of the Angioedema Quality of Life Questionnaire (AE-QoL) for hereditary angioedema.Journal of patient-reported outcomes · 2026Article
- The 2025 WAO Guidelines for the classification, diagnosis, and treatment of hereditary angioedema, with consideration of worldwide disparities.The World Allergy Organization journal · 2026Article
- Quality of Life and Socioeconomic Situation of Patients with Hereditary Angioedema in Slovakia.Medicina (Kaunas, Lithuania) · 2026Article
- Burden of disease in adult patients with hereditary angioedema: results from a multinational survey.Orphanet journal of rare diseases · 2026Article
- Is hereditary angioedema associated with deficits in emotion regulation? A quantitative study in adult patients.Orphanet journal of rare diseases · 2026Article
- The patient experience of hereditary angioedema: findings from a racially diverse sample of adult patients.Orphanet journal of rare diseases · 2026Article
- The International/Canadian hereditary angioedema guideline.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026Review
- Physiological evaluation of the emotional regulation of patients with hereditary angioedema.BioPsychoSocial medicine · 2026Article
- Content validation of the Angioedema Quality of Life Questionnaire (AE-QoL) in a population of adult and adolescent patients with hereditary angioedema (HAE).Journal of patient-reported outcomes · 2025Article
- Quality of life in patients with hereditary angioedema correlates with angioedema control: Our experience at Chandigarh, India.Asia Pacific allergy · 2025Article
- The adolescent experience of hereditary angioedema: a qualitative study of disease burden and treatment experience.Orphanet journal of rare diseases · 2025Article
- Disease control and disease activity in hereditary angioedema: two sides of the same coin?Frontiers in immunology · 2025Article
- One-year real-life outcomes of lanadelumab therapy in Romanian patients with hereditary angioedema due to C1-inhibitor deficiency.Frontiers in allergy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAn objective of the phase 3 HELP Study was to investigate the effect of lanadelumab on health-related quality of life (HRQoL) in patients with hereditary angioedema (HAE).
methodsPatients with HAE-1/2 received either lanadelumab 150 mg every 4 weeks (q4wks; n = 28), 300 mg q4wks (n = 29), 300 mg every 2 weeks (q2wks; n = 27), or placebo (n = 41) for 26 weeks (days 0-182). The Angioedema Quality of Life Questionnaire (AE-QoL) was administered monthly, consisting of four domain (functioning, fatigue/mood, fears/shame, nutrition) and total scores. The generic EQ-5D-5L questionnaire was administered on days 0, 98, and 182. Comparisons were made between placebo and (a) all lanadelumab-treated patients and (b) individual lanadelumab groups for changes in scores (day 0-182) and proportions achieving the minimal clinically important difference (MCID, -6) in AE-QoL total score.
resultsCompared with the placebo group, the lanadelumab total group demonstrated significantly greater improvements in AE-QoL total and domain scores (mean change, -13.0 to -29.3; p < 0.05 for all); the largest improvement was in functioning. A significantly greater proportion of the lanadelumab total group achieved the MCID (70% vs 37%; p = 0.001). The lanadelumab 300 mg q2wks group had the highest proportion (81%; p = 0.001) and was 7.2 times more likely to achieve the MCID than the placebo group. Mean EQ-5D-5L scores at day 0 were high in all groups, indicating low impairment, with no significant changes at day 182.
conclusionPatients with HAE-1/2 experienced significant and clinically meaningful improvements in HRQoL measured by AE-QoL following lanadelumab treatment in the HELP Study.
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