Parietaria sublingual allergoid immunotherapy with a co-seasonal treatment schedule

Background: Sublingual immunotherapy (SLIT) with monomeric allergoid, given according to the standard scheme, resulted effective and safe. However, the achievement of a clinical benefit requires a long time. We thus performed this study using an administration protocol starting in the co-seasonal period with a 3-day build-up phase and lasting only 6 months, in order to obtain the above benefit in a shorter time. Methods and results: The study, prospective, randomised and controlled versus drug therapy, was conducted on 65 rhinitic and/or asthmatic patients allergic to Parietaria with or without other sensitisations. Twenty-four were allocated to 1,000 AU/week, 21 to 3,000 AU/week and 21 to drug therapy. They were treated from April to September 2006. At baseline, 3 and 6 months a Visual Analogue Scale (VAS) was performed to assess the patients' well-being. Drug consumption was evaluated by means of monthly diary cards. Bronchial reactivity was investigated at baseline and 6 months by methacholine challenge test. There was a greater VAS improvement in both the SLIT groups than in the controls after 6 months (p < 0.05). In patients taking 3,000 AU/week this was already evident after 3 months. There was a significant reduction in rescue medication consumption between 3 and 6 months (p < 0.05) in all three groups. The bronchial reactivity was reduced only in the SLIT groups (p < 0.001). No adverse events were observed. Conclusions: At 6 months the allergoid SLIT showed itself to be effective and safe. In addition the subjective clinical benefit was obtained in a more rapid period, i.e. 3 instead of 6 months, when a higher maintenance dose was administered

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Clinical efficacy and safety of preseasonal sublingual immunotherapy with grass pollen carbamylated allergoid in rhinitic patients. A double-blind, placebo-controlled study / Eficacia clínica y seguridad de la inmunoterapia sublingual preestacional con polen de gramíneas con alergoide carbamilado en pacientes con rinitis alérgica. Estudio a doble ciego controlado por placebo

Background: The aim of this study was to confirm the clinical efficacy and safety of a preseasonal sublingual immunotherapy (SLIT) in a group of allergic patients with seasonal rhinoconjunctivitis with or without mild intermittent or mild persistent asthma. The immunotherapy was administered through the oral mucosa with a monomeric carbamylated allergoid (allergoid SLIT) for grass pollens. A secondary endpoint was to evaluate the effect of the allergoid SLIT on nasal reactivity. Methods and results: A single-center, randomized, double-blind, placebo-controlled study was performed. Patients were selected and randomly allocated to two groups: one group received active treatment (allergoid SLIT) for 2 years and the other received placebo. Both groups received the necessary drug treatment throughout the trial. Thirty-three outpatients (20 men and 13 women, mean age: 30 years; range: 19-43) attending our center were enrolled in the study. Symptoms and medications were scored on diary cards during the pollen season. An allergen nasal challenge was performed at baseline and after 2 years of SLIT to evaluate nasal reactivity. Because the clinical scores were non-normally distributed, the Mann-Whitney and the Chi-square tests for intergroup comparisons and the Wilcoxon test for intragroup comparisons were used. The results were evaluated after 1 and 2 years of treatment. Between the first and second years of treatment, no changes in the scores for the placebo group were found, while for the active vaccine group significant decreases were found in rhinorrhea (p < 0.03), sneezing (p < 0.03), and conjunctivitis (p < 0.02). Symptom scores after nasal challenge decreased (p < 0.03) after 2 years' treatment. Nasal steroid use significantly decreased in the active treatment group during May and June in both the years of treatment (p < 0.02). Only two mild local adverse events were reported in the active group and none was reported in the placebo group. Conclusions: The results of this study show that the allergoid SLIT is safe and effective in decreasing symptom scores and drug use in rhinitic patients allergic to grass pollen

Antecedentes: El objetivo de este estudio fue confirmar, en un grupo de pacientes alérgicos con rinoconjuntivitis estacional con y sin asma leve intermitente o leve persistente, la eficacia clínica y la seguridad de una inmunoterapia (IT) sublingual preestacional a través de la mucosa bucal realizada con un alergoide monomérico carbamilado (alergoide SLIT) para el tratamiento de la alergia al polen de las gramíneas. El fin secundario era evaluar el efecto que el alergoide SLIT tiene en la reactividad de la mucosa nasal. Métodos y Resultados. Se trató de un estudio comparativo doble ciego, aleatorio, controlado con placebo, realizado en un único centro. Los pacientes fueron seleccionados y asignados al azar en dos grupos: a un grupo se le administró el tratamiento activo (alergoide SLIT) durante dos años y al otro se le administró placebo. Ambos grupos recibieron el tratamiento farmacológico necesario durante todo el estudio. Se inscribieron en el estudio treinta y tres pacientes externos (20 hombres y 13 mujeres, edad promedio 30 años; entre 19-43) que asistían a nuestro centro. Durante la estación polínica, se registraron en el diario de los pacientes los síntomas y la medicación. Se expuso a los pacientes al alergeno al inicio del estudio y también al cabo de dos años de la IT para evaluar la reactividad de la mucosa nasal. Debido a que los resultados clínicos no estaban distribuidos de manera normal, se utilizaron las pruebas de Mann Whitney y de Chi cuadrado para comparar los grupos entre sí y la prueba de Wilcoxon para la comparación intragrupal. Los resultados se evaluaron después de uno y de dos años de tratamiento. Entre el primer y segundo año de tratamiento no hubo cambios en los resultados del grupo tratado con placebo, mientras que en el grupo que recibió la vacuna activa disminuyeron significativamente la rinorrea (p<0.03), los estornudos (p<0.03) y la conjuntivitis (p<0.02). Los resultados de los pacientes sintomáticos disminuyeron (p<0.03) luego de la prueba nasal después de dos años de tratamiento. El uso de esteroides nasales disminuyó significativamente en el grupo activo durante los meses de mayo y junio en los dos años de tratamiento (p<0.02). Se informaron únicamente dos casos de efectos adversos locales leves en el grupo activo y ninguno en el grupo placebo. Conclusiones: los resultados del estudio muestran que el alergoide SLIT es seguro y efectivo para disminuir no sólo los síntomas en pacientes riníticos alérgicos al polen de las gramíneas sino también el uso de medicamentos por parte de estos pacientes