Real-Life Safety of Japanese Cedar Pollen Sublingual Immunotherapy Tablets: A Post-Marketing Survey
Fuente:
PubMed "pollen"
Clin Transl Allergy. 2026 Feb;16(2):e70157. doi: 10.1002/clt2.70157.ABSTRACTBACKGROUND: Japanese cedar (JC) pollen sublingual immunotherapy (SLIT)-tablets (5000 Japanese allergy units [JAU]) are licensed for the treatment of JC-pollinosis with no age restriction on the basis of the results of a 5-year clinical trial. However, there have been no large-scale surveys of 5000 JAU in an actual clinical setting.METHODS: This was a multicenter observational prospective study. We assessed the safety and effectiveness of the long-term use of 5000 JAU in patients with JC-pollinosis, with an observation period of two seasons of JC pollen dispersal, at clinical sites in Japan.RESULTS: Our safety analysis included 516 patients and the effectiveness analysis included 469 patients. Adverse drug reactions (ADRs) occurred in 68 patients (13.18%) and mainly comprised administration site-related events that occurred during the early phase of administration. Treatment discontinuation due to ADRs occurred in 18 patients (3.49%). No deaths, anaphylactic shock, or serious ADRs occurred. Regarding effectiveness, the severity of JC-pollinosis was rated as "almost asymptomatic + mild" in 82.19% of patients in Season 1 and 92.58% in Season 2. Quality of life was rated as "score 0 (Fine) + 1" in 75.83% of patients in Season 1 and 86.09% in Season 2. Overall improvement was rated as "improved + slightly improved" in 95.68% of patients in Season 1 and 96.38% in Season 2 following the initiation of JC pollen SLIT-tablets. Nasal and ocular symptom scores also decreased with increasing treatment duration. Treatment continuation rates were 89.53% in Season 1 and 78.29% in Season 2.CONCLUSION: The JC pollen SLIT-tablets appear to be safe and effective in an actual clinical setting during two seasons. No new safety or effectiveness issues were identified, and no additional safety or effectiveness precautions were required.PMID:41688412 | PMC:PMC12904777 | DOI:10.1002/clt2.70157
Al elegir "Aceptar todas las cookies", acepta el uso de cookies para ayudarnos a brindarle una mejor experiencia de usuario y analizar el uso del sitio web. Al hacer clic en "Ajuste sus preferencias" puede elegir qué cookies permitir. Solo las cookies esenciales son necesarias para el correcto funcionamiento de nuestro sitio web y no pueden ser rechazadas
Configuración de cookies
Nuestro sitio web almacena cuatro tipos de cookies. En cualquier momento puede elegir qué cookies acepta y cuáles rechaza. Puede obtener más información sobre qué son las cookies y qué tipos de cookies almacenamos en nuestra Política de cookies.
Son necesarios por razones técnicas. Sin ellos, es posible que este sitio web no funcione correctamente.
Son necesarios para una funcionalidad específica en el sitio web. Sin ellos, algunas funciones pueden estar deshabilitadas.
Nos permite analizar el uso del sitio web y mejorar la experiencia del visitante
Permítanos personalizar su experiencia y enviarle contenido y ofertas relevantes, en este sitio web y en otros sitios web