Résumé
Depemokimab, the first ultra-long-acting respiratory biologic, is under investigation for diseases with underlying type 2 (T2) inflammation. Subcutaneous depemokimab 100 mg was efficacious in patients with T2 asthma characterized by blood eosinophil count and in chronic rhinosinusitis with nasal polyps (CRSwNP) when administered twice-yearly in four Phase III randomized, double-blind, placebo-controlled studies (SWIFT-1/-2 and ANCHOR-1/-2, respectively). This pooled analysis examined the safety and tolerability of subcutaneous depemokimab 100 mg versus placebo in patients with T2 asthma and in CRSwNP.
Adverse event (AE) frequency, severity, time-to-onset, duration, and relative risk (RR) were evaluated for depemokimab 100 mg and placebo administered subcutaneously every 26 weeks for 52 weeks using pooled SWIFT-1/-2 and ANCHOR-1/-2 data. The impact of immunogenicity on safety was also evaluated.
Overall, 1290 patients from the four studies were included in the safety analysis population (773 [60%] received depemokimab; 517 [40%] received placebo). On-treatment AEs were reported by 73% and 78% of patients in the depemokimab and placebo groups, respectively; the majority were mild or moderate in intensity and transient, with similar durations between treatment groups. Serious AEs (SAEs; 5% and 10%, with depemokimab and placebo, respectively), and discontinuations due to AEs (< 1% and 1%, respectively) were infrequent. No fatal AEs or treatment-related SAEs (per investigator assessment) were reported. RRs (vs. placebo) were similar for all common on-treatment AEs except asthma and back pain, which occurred less frequently in the depemokimab group compared with the placebo group. Antidrug antibodies and neutralizing antibodies occurred infrequently, and no association between antidrug antibody status and depemokimab efficacy was identified.
In these studies, twice-yearly depemokimab 100 mg was generally well tolerated by patients with T2 asthma or CRSwNP over the 52-week treatment period, supporting the safety of the first ultra-long-acting biologic for these diseases.
NCT04719832/NCT04718103/NCT05274750/NCT05281523.