D1.250 - Real-World Effectiveness and Safety of Icatibant for Hereditary Angioedema in China: An Interim Analysis of the EASTERN Study

Lanadelumab and icatibant have recently gained approval in China for prophylactic and on-demand hereditary angioedema (HAE) treatment, however real-world data in the Chinese population are limited. The EASTERN (NCT06346899) study evaluates the effectiveness and safety of lanadelumab and icatibant in Chinese patients (pts) with HAE. Here, we report interim results for icatibant.

This retrospective, multicenter, observational study included pts from 13 sites in China who received ≥1 dose of lanadelumab and/or icatibant between Dec 2, 2020 and July 17, 2024. Pts were categorized into 3 treatment groups: lanadelumab only (Group L), icatibant only (Group I), and lanadelumab+icatibant (Group B). Data was abstracted from medical records and patient HAE diaries. Primary endpoint: median time to complete HAE attack resolution for each icatibant-treated patient. Secondary endpoint: frequency of adverse events. Interim data collection ended on Jan 20, 2025.

Overall, 43 pts were included in icatibant safety analysis set (Group I: N=19, Group B: N=24) and 42 in effectiveness analysis set (Group I: N=19, Group B: N=23). Mean age was 39.1±11.4 years and 60.5% (26/43) were female. Overall, 100 attacks (N=42) with resolution time were reported. The most frequently involved body site in overall pts was the abdominal-gastrointestinal tract (54.0%; 54/100) and facial (32.0%; 32/100), differing from other geographical regions, where peripheral attacks may predominate. The overall median time to complete resolution after first icatibant injection was 180.0 mins (95% CI: 120.0, 420.0), with 120.0 mins for attacks (n=36) treated with icatibant within <4 hours and 480.0 mins for ≥4 hours (n=64). The shorter time to resolution compared to previous studies is likely multifaceted. A total of 34 (34%) attacks were self-administered. The proportions of mild, moderate, and severe treated attacks were 25.0%, 35.0%, and 40.0% respectively. Treatment emergent adverse events occurred in 30.2% (13/43) pts; injection site erythema and injection site pain (14.0%; 6/43 each), and injection site swelling (7.0%; 3/43) were most common. Most were grade 1; no grade 3 events occurred, and no events resulted in icatibant discontinuation. 

Acknowledging some limitations in collecting real-world data, icatibant showed favorable effectiveness and safety in Chinese pts with HAE by providing rapid attack resolution, particularly when administered early.