Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema

William R Lumry; Marcus Maurer; Karsten Weller; Marc A Riedl; Maureen Watt; Ming Yu; Giovanna Devercelli; Juliette Meunier; Aleena Banerji; HELP OLE Study Group

doi:10.1016/j.anai.2023.03.028

Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema

Ann Allergy Asthma Immunol. 2023 Jul;131(1):101-108.e3. doi: 10.1016/j.anai.2023.03.028. Epub 2023 Apr 5.

Authors

William R Lumry¹, Marcus Maurer², Karsten Weller², Marc A Riedl³, Maureen Watt⁴, Ming Yu⁴, Giovanna Devercelli⁴, Juliette Meunier⁵, Aleena Banerji⁶; HELP OLE Study Group

Affiliations

¹ Allergy and Asthma Research Associates, Dallas, Texas. Electronic address: LumryMD@AllergySpecialists.us.
² Institute of Allergology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP), Immunology, and Allergology, Berlin, Germany.
³ Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, California.
⁴ Takeda Development Center Americas, Inc, Lexington, Massachusetts.
⁵ Modus Outcomes, a department of THREAD, Lyon, France.
⁶ Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

PMID: 37028510
DOI: 10.1016/j.anai.2023.03.028

Abstract

Background: Hereditary angioedema (HAE) is associated with a substantial disease burden. Lanadelumab reduced the HAE attack rate during 132 weeks of follow-up in the HELP open-label extension (OLE) Study (NCT02741596).

Objective: To measure the impact of long-term lanadelumab treatment on patient-reported outcomes (PROs).

Methods: Rollover patients (completed the 26-week HELP study [NCT02586805]) and nonrollovers (newly enrolled) received lanadelumab 300 mg every 2 weeks. PROs (Angioedema Quality of Life Questionnaire [AE-QoL], Short Form Health Survey 12-item version 2, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment-General Health Questionnaire, and EQ-5D-5L questionnaire) were assessed at baseline (day 0 of HELP OLE) and various time points until the end-of-study visit. The Angioedema Control Test, Treatment Satisfaction Questionnaire for Medication, and Global Impression of Treatment Response were administered starting at week 52.

Results: The mean (SD) change in AE-QoL total score from baseline to end-of-study for rollovers (n = 90) was -10.2 (17.9), exhibiting further improvement from HELP in health-related quality of life (HRQoL); 48.9% of rollovers achieved the previously defined 6-point minimal clinically important difference. Nonrollovers (n = 81) reported a change of -19.5 (21.3). Controlled disease (Angioedema Control Test total score ≥10) was reported by 90.2% of rollovers and 95.9% of nonrollovers at the end of the study. Excellent treatment response was reported by 78.7% of patients and 82.4% of investigators. Results from other PROs indicated a slight improvement in anxiety, a high level of satisfaction with treatment, and increased work productivityor activity.

Conclusion: Clinically meaningful improvement in HRQoL was exhibited with long-term lanadelumab treatment, supporting the benefit of lanadelumab therapy associated with attack prevention.

Trial registration: ClinicalTrials.gov Identifiers: NCT02586805 (HELP Study) and NCT02741596 (HELP open-label extension).

Publication types

Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Angioedemas, Hereditary* / drug therapy
Antibodies, Monoclonal, Humanized / therapeutic use
Humans
Quality of Life
Surveys and Questionnaires

Substances

Antibodies, Monoclonal, Humanized
lanadelumab

Associated data

ClinicalTrials.gov/NCT02586805
ClinicalTrials.gov/NCT02741596
ClinicalTrials.gov/NCT02741596
ClinicalTrials.gov/NCT02586805