Long-term prevention of hereditary angioedema attacks with lanadelumab: The HELP OLE Study.

Abstract

BACKGROUND:

The aim was to evaluate long-term effectiveness and safety of lanadelumab in patients ≥12 y old with hereditary angioedema (HAE) 1/2 (NCT02741596).

METHODS:

Rollover patients completing the HELP Study and continuing into HELP OLE received one lanadelumab 300 mg dose until first attack (dose-and-wait period), then 300 mg q2wks (regular dosing stage). Nonrollovers (newly enrolled) received lanadelumab 300 mg q2wks from day 0. Baseline attack rate for rollovers: ≥1 attack/4 weeks (based on run-in period attack rate during HELP Study); for nonrollovers: historical attack rate ≥1 attack/12 weeks. The planned treatment period was 33 months.

RESULTS:

212 patients participated (109 rollovers, 103 nonrollovers); 81.6% completed ≥30 months on study (mean [SD], 29.6 [8.2] months). Lanadelumab markedly reduced mean HAE attack rate (reduction vs baseline: 87.4% overall). Patients were attack free for a mean of 97.7% of days during treatment; 81.8% and 68.9% of patients were attack free for ≥6 and ≥12 months, respectively. Angioedema Quality-of-Life total and domain scores improved from day 0 to end of study. Treatment-emergent adverse events (TEAEs) (excluding HAE attacks) were reported by 97.2% of patients; most commonly injection site pain (47.2%) and viral upper respiratory tract infection (42.0%). Treatment-related TEAEs were reported by 54.7% of patients. Most injection site reactions resolved within 1 hour (70.2%) or 1 day (92.6%). Six (2.8%) patients discontinued due to TEAEs. No treatment-related serious TEAEs or deaths were reported. Eleven treatment-related TEAEs of special interest were reported by seven (3.3%) patients.

CONCLUSION:

Lanadelumab demonstrated sustained efficacy and acceptable tolerability with long-term use in HAE patients.

• Authors: Aleena Banerji, Jonathan A Bernstein, Douglas T Johnston, William R Lumry, Markus Magerl, Marcus Maurer, Inmaculada Martinez-Saguer, Andrea Zanichelli, James Hao, Neil Inhaber, Ming Yu, Marc A Riedl, HELP OLE Investigators
• Journal: Allergy (Allergy) Vol. 77 Issue 3 Pg. 979-990 (03 2022) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 34287942 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 Takeda Development Center Americas, Inc. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Chemical References

• Antibodies, Monoclonal, Humanized
• Complement C1 Inhibitor Protein
• lanadelumab

Topics

• Angioedemas, Hereditary (drug therapy, prevention & control)
• Antibodies, Monoclonal, Humanized (adverse effects)
• Complement C1 Inhibitor Protein (therapeutic use)
• Humans
• Quality of Life
• Treatment Outcome