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

被引:9
|
作者
Lumry, William R. [10 ]
Maurer, Marcus [1 ,2 ,3 ,4 ,5 ]
Weller, Karsten [2 ,3 ,4 ]
Riedl, Marc A. [6 ]
Watt, Maureen [7 ]
Yu, Ming [7 ]
Devercelli, Giovanna [7 ]
Meunier, Juliette [8 ]
机构
[1] Allergy & Asthma Res Associates, Dallas, TX USA
[2] Charite Univ Med Berlin, Inst Allergol, Berlin, Germany
[3] Free Univ Berlin, Berlin, Germany
[4] Humboldt Univ, Berlin, Germany
[5] Fraunhofer Inst Translat Med & Pharmacol ITMP, Allergol & Immunol, Berlin, Germany
[6] Univ Calif San Diego, Div Rheumatol Allergy & Immunol, La Jolla, CA 92037 USA
[7] Takeda Dev Ctr Amer Inc, Lexington, MA USA
[8] Modus Outcomes, Dept THREAD, Lyon, France
[9] Harvard Med Sch, Massachusetts Gen Hosp, Dept Med, Div Rheumatol Allergy & Immunol, Boston, MA USA
[10] AARA Res Ctr, 10100 N Cent Expressway,Suite 100, Dallas, TX 75231 USA
关键词
VALIDATION; BURDEN; QOL;
D O I
10.1016/j.anai.2023.03.028
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
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, Treat-ment Satisfaction Questionnaire for Medication, and Global Impression of Treatment Response were adminis-tered 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. Nonroll-overs (n = 81) reported a change of-19.5 (21.3). Controlled disease (Angioedema Control Test total score & GE;10) was reported by 90.2% of rollovers and 95.9% of nonrollovers at the end of the study. Excellent treat-ment response was reported by 78.7% of patients and 82.4% of investigators. Results from other PROs indi-cated 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 treat-ment, supporting the benefit of lanadelumab therapy associated with attack prevention. Trial Registration: ClinicalTrials.gov Identifiers: NCT02586805 (HELP Study) and NCT02741596 (HELP open -label extension). & COPY; 2023 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc.
引用
收藏
页码:101 / +
页数:11
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