American journal of otolaryngology · 2025
Stapokibart (CM310): A review in seasonal allergic rhinitis.
СтатьяОбзорНазвание и аннотация: Перевод в очереди
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Xue Ping, Yan Jing, Li Jianwei
Аннотация
BACKGROUND: Stapokibart (CM310), a humanized anti-IL-4Rα monoclonal antibody, blocks IL-4/IL-13 signaling for type 2 inflammatory diseases like seasonal allergic rhinitis (SAR), where standard of care often fails.
OBJECTIVE: Assess stapokibart's efficacy on the primary endpoint (reflective Total Nasal Symptom Score, rTNSS) and safety as add-on therapy in SoC-inadequate moderate-to-severe SAR.
METHODS: Data from a Phase II trial (MERAK, n = 92) and the pivotal Phase III PHECDA trial (n = 108; enriched for blood eosinophils ≥300 cells/μL) were reviewed. Patients received subcutaneous stapokibart (600 mg loading, then 300 mg Q2W) or placebo + SoC for 4 weeks.
RESULTS: In MERAK, stapokibart Q2W showed a trend for rTNSS improvement (LSMD -1.0 vs placebo, p = 0.065). In PHECDA, stapokibart significantly improved rTNSS at Week 4 (LSMD -1.7, 95 % CI: -2.5, -0.8; p = 0.0002). Treatment-emergent adverse event rates were comparable to placebo in both trials (e.g.
, PHECDA: 52.0 % vs 46.6 %), mostly mild/moderate.
CONCLUSION: Add-on stapokibart is a valuable therapeutic option for adults with SoC-inadequate moderate-to-severe SAR and elevated eosinophils, providing statistically significant improvements in nasal symptoms and quality of life, with an acceptable safety profile.
OBJECTIVE: Assess stapokibart's efficacy on the primary endpoint (reflective Total Nasal Symptom Score, rTNSS) and safety as add-on therapy in SoC-inadequate moderate-to-severe SAR.
METHODS: Data from a Phase II trial (MERAK, n = 92) and the pivotal Phase III PHECDA trial (n = 108; enriched for blood eosinophils ≥300 cells/μL) were reviewed. Patients received subcutaneous stapokibart (600 mg loading, then 300 mg Q2W) or placebo + SoC for 4 weeks.
RESULTS: In MERAK, stapokibart Q2W showed a trend for rTNSS improvement (LSMD -1.0 vs placebo, p = 0.065). In PHECDA, stapokibart significantly improved rTNSS at Week 4 (LSMD -1.7, 95 % CI: -2.5, -0.8; p = 0.0002). Treatment-emergent adverse event rates were comparable to placebo in both trials (e.g.
, PHECDA: 52.0 % vs 46.6 %), mostly mild/moderate.
CONCLUSION: Add-on stapokibart is a valuable therapeutic option for adults with SoC-inadequate moderate-to-severe SAR and elevated eosinophils, providing statistically significant improvements in nasal symptoms and quality of life, with an acceptable safety profile.