SUSTAINED IMPROVEMENT IN HEALTH-RELATED QUALITY OF LIFE WITH CONTINUED LANADELUMAB TREATMENT IN HEREDITARY ANGIOEDEMA

Abstract

<h3>Introduction</h3> Lanadelumab is approved for the prevention of hereditary angioedema attacks. Reduced attack rate is associated with improved health-related quality of life (HRQoL). HRQoL was assessed in patients who completed the HELP Study (NCT02586805) and rolled into the HELP OLE Study (NCT02741596) using the Angioedema Quality of Life Questionnaire (AE-QoL). <h3>Methods</h3> Rollover patients completed 26 weeks' treatment in HELP, where they received placebo or lanadelumab (150mg every 4 weeks [Q4W], 300mg Q4W, or 300mg every 2 weeks [Q2W]), then continued into HELP OLE with lanadelumab 300mg Q2W for ≤33 months. A decrease in AE-QoL total score of ≥6 was considered clinical meaningful improvement. <h3>Results</h3> From the baseline of HELP to the end of study (EOS) visit in HELP OLE, rollovers (n=98) had a mean(SD) change in AE-QoL total score of -25.1(19.8). The reduction of total score in rollovers (n=97) during HELP OLE was -10.2(17.9). Among patients who received lanadelumab 300mg Q2W in HELP (n=24), total scores for patients with baseline attack rates of 1–<2 (n=7), 2–<3 (n=5), and ≥3 (n=12) attacks/month were reduced from 23.1(27.3), 15.3(9.5), and 24.4(22.0), respectively, at HELP OLE baseline, to 10.3(8.9) 18.0(12.9), and 20.4(20.6), respectively, at EOS. For rollovers treated with placebo in HELP (n=33), total scores for patients with baseline attack rates of 1–<2 (n=10), 2–<3 (n=7), and ≥3 (n=16) attacks/month were reduced from 37.8(20.0), 36.3(14.2), and 43.2(23.4), respectively, at HELP OLE baseline, to 17.5(15.3), 8.6(8.4), and 27.4(24.6), respectively, at EOS. <h3>Conclusion</h3> These data demonstrate sustained clinically meaningful improvement in HRQoL with continued lanadelumab treatment.