The journal of allergy and clinical immunology. In practice · 2026
Efficacy of Epinephrine Nasal Spray in the Treatment of Urticaria.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Bernstein David I, Talreja Neetu, Casale Thomas B, Li H Henry, Kaliner Michael A, Lowenthal Richard, Tanimoto Sarina
Аннотация
BACKGROUND: Although current treatment options for acute exacerbations of antihistamine refractory chronic spontaneous urticaria (CSU) are generally considered safe and effective, patients have breakthrough symptoms necessitating treatment. Epinephrine injections were once used for the treatment for acute urticaria or acute exacerbations of chronic urticaria or angioedema, but their use has declined. The development of an intranasal epinephrine spray (ARS-2) offers a needle-free alternative for the treatment of CSU exacerbations.
OBJECTIVE: To assess the efficacy and safety of ARS-2 for the treatment of exacerbations of CSU.
METHODS: This was a phase 2, single-dose, randomized, placebo-controlled crossover efficacy study in which adult patients (n = 21) experiencing an acute flare or exacerbation of urticaria symptoms were treated with ARS-2 (1 or 2 mg) or placebo. Urticaria symptoms and severity were assessed based on both patient-reported and investigator-rated assessments.
RESULTS: Relative to placebo, both 1- and 2-mg doses of ARS-2 resulted in lower patient-reported hive and pruritus scores (P < .05) and a lower investigator-reported extent of urticaria and erythema scores (P < .05). Additionally, a greater percentage of patients receiving ARS-2 were considered by investigators to have been effectively treated. Patient-reported satisfaction scores were also significantly higher for both doses of ARS-2 relative to placebo. Only minor adverse events were reported.
CONCLUSION: ARS-2 may offer a safe and effective treatment option for urticaria exacerbations.
OBJECTIVE: To assess the efficacy and safety of ARS-2 for the treatment of exacerbations of CSU.
METHODS: This was a phase 2, single-dose, randomized, placebo-controlled crossover efficacy study in which adult patients (n = 21) experiencing an acute flare or exacerbation of urticaria symptoms were treated with ARS-2 (1 or 2 mg) or placebo. Urticaria symptoms and severity were assessed based on both patient-reported and investigator-rated assessments.
RESULTS: Relative to placebo, both 1- and 2-mg doses of ARS-2 resulted in lower patient-reported hive and pruritus scores (P < .05) and a lower investigator-reported extent of urticaria and erythema scores (P < .05). Additionally, a greater percentage of patients receiving ARS-2 were considered by investigators to have been effectively treated. Patient-reported satisfaction scores were also significantly higher for both doses of ARS-2 relative to placebo. Only minor adverse events were reported.
CONCLUSION: ARS-2 may offer a safe and effective treatment option for urticaria exacerbations.