International forum of allergy & rhinology · 2021
Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Cervin Anders, Rimmer Joanne, Wrobel Agnieszka, Abelak Yogen, Brayton Lindsay, Kuang Yina
Аннотация
BACKGROUND: Topical steroids are first-line treatment for chronic rhinosinusitis (CRS), but fail to provide adequate symptom control for all patients. Designed for medical treatment failures, LYR-210 is an implantable matrix that locally elutes mometasone furoate to inflamed sinonasal tissue for up to 24 weeks in CRS patients. In an open-label phase 1 study, LYR-210 demonstrated clinically relevant improvement in the 22-item Sino-Nasal Outcome Test (SNOT-22). Safety and efficacy of LYR-210 in CRS were evaluated in the LANTERN Phase 2 study.
METHODS: Sixty-seven surgically naive adult CRS patients who were inadequately controlled by previous medical management and seeking an alternative treatment enrolled in a multicenter, blinded, controlled, dose-ranging study. Patients had moderate-to-severe disease based on SNOT-22 and composite 7-day average scores of the 4 cardinal CRS symptoms (4CS), with diagnosis confirmed by nasal endoscopy and magnetic resonance imaging. Patients were randomized (1:1:1) to saline irrigation-only control or bilateral in-office administration of LYR-210 (2500 μg) or LYR-210 (7500 μg). Safety and efficacy were evaluated over 24 weeks.
RESULTS: Both LYR-210 doses were safe and well-tolerated over the 24-week treatment period. LYR-210 demonstrated rapid and durable dose-dependent symptom improvement based on 4CS and SNOT-22, with LYR-210 (7500 μg) achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control. LYR-210 (7500 μg) reduced rescue treatment use and radiographic ethmoid opacification at week 24.
CONCLUSIONS: LYR-210 is the first implantable sinonasal treatment to achieve up to 24 weeks of benefit from a single administration in surgically naive CRS patients with and without nasal polyps.
METHODS: Sixty-seven surgically naive adult CRS patients who were inadequately controlled by previous medical management and seeking an alternative treatment enrolled in a multicenter, blinded, controlled, dose-ranging study. Patients had moderate-to-severe disease based on SNOT-22 and composite 7-day average scores of the 4 cardinal CRS symptoms (4CS), with diagnosis confirmed by nasal endoscopy and magnetic resonance imaging. Patients were randomized (1:1:1) to saline irrigation-only control or bilateral in-office administration of LYR-210 (2500 μg) or LYR-210 (7500 μg). Safety and efficacy were evaluated over 24 weeks.
RESULTS: Both LYR-210 doses were safe and well-tolerated over the 24-week treatment period. LYR-210 demonstrated rapid and durable dose-dependent symptom improvement based on 4CS and SNOT-22, with LYR-210 (7500 μg) achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control. LYR-210 (7500 μg) reduced rescue treatment use and radiographic ethmoid opacification at week 24.
CONCLUSIONS: LYR-210 is the first implantable sinonasal treatment to achieve up to 24 weeks of benefit from a single administration in surgically naive CRS patients with and without nasal polyps.