Impact of lanadelumab on health-related quality of life in patients with hereditary angioedema in the HELP study.

Abstract

BACKGROUND:

An 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).

METHODS:

Patients 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.

RESULTS:

Compared 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.

CONCLUSION:

Patients with HAE-1/2 experienced significant and clinically meaningful improvements in HRQoL measured by AE-QoL following lanadelumab treatment in the HELP Study.

• Authors: William R Lumry, Karsten Weller, Markus Magerl, Aleena Banerji, Hilary J Longhurst, Marc A Riedl, Hannah B Lewis, Peng Lu, Giovanna Devercelli, Gagan Jain, Marcus Maurer, HELP Study Investigators
• Journal: Allergy (Allergy) Vol. 76 Issue 4 Pg. 1188-1198 (04 2021) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 33258114 (Publication Type: Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 Takeda Pharmaceuticals Company Limited. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Chemical References

• Antibodies, Monoclonal, Humanized
• lanadelumab

Topics

• Angioedemas, Hereditary (drug therapy)
• Antibodies, Monoclonal, Humanized
• Humans
• Quality of Life
• Surveys and Questionnaires