ON-DEMAND TREATMENT OF LARYNGEAL HEREDITARY ANGIOEDEMA ATTACKS WITH SEBETRALSTAT: POOLED ANALYSIS FROM KONFIDENT AND KONFIDENT-S
In the phase 3 KONFIDENT trial, on-demand treatment of hereditary angioedema (HAE-C1INH) attacks with orally administered sebetralstat resulted in significantly faster beginning of symptom relief versus placebo; laryngeal attacks were not evaluable as a subgroup given the small number of events. Thi...
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Published in | Annals of allergy, asthma, & immunology Vol. 133; no. 6; p. S33 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Elsevier Inc
01.11.2024
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Online Access | Get full text |
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Summary: | In the phase 3 KONFIDENT trial, on-demand treatment of hereditary angioedema (HAE-C1INH) attacks with orally administered sebetralstat resulted in significantly faster beginning of symptom relief versus placebo; laryngeal attacks were not evaluable as a subgroup given the small number of events. This analysis pooled data from laryngeal attacks treated with sebetralstat 600mg in the phase 3 KONFIDENT (NCT05259917) and ongoing open-label KONFIDENT-S (NCT05505916) trials to evaluate the effectiveness of sebetralstat for laryngeal attacks.
Efficacy assessments for sebetralstat 600mg were time to beginning of symptom relief, defined as a rating of “A Little Better” on the Patient Global Impression of Change (PGI-C) scale at ≥2 consecutive time points within 12 hours; time to reduction in attack severity, defined as an improved rating on the Patient Global Impression of Severity (PGI-S) scale at ≥2 consecutive time points within 12 hours; and time to complete attack resolution, defined as a PGI-S rating of “None” within 24 hours.
As of January 31, 2024, 16 laryngeal attacks were treated with sebetralstat 600mg. The median time to oral treatment administration was 8 minutes (IQR: 1–30). In laryngeal attacks, the median time to beginning of symptom relief was 1.5 hours (0.7–6.1). The median time to reduction in severity was 1.7 hours (0.8–6.8) and median time to complete attack resolution was 9.7 hours (1.8–>24) (Table).
Sebetralstat was self-administered rapidly and its efficacy in treating laryngeal attacks was consistent with that observed across all attacks in both KONFIDENT and KONFIDENT-S. |
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ISSN: | 1081-1206 |
DOI: | 10.1016/j.anai.2024.08.128 |