Effectiveness and safety of a microcrystalline tyrosine-adjuvanted Dermatophagoides pteronyssinus allergoid immunotherapy in adult patients with allergic asthma and rhinitis: A real-life prospective observational study.

INTRODUCTION: Although clinical trials have shown the efficacy and safety of allergen-specific immunotherapy (AIT) in the treatment of allergic asthma, there is a need for real-life studies. We aimed to assess the effectiveness and safety of a microcrystalline tyrosine-adjuvanted Dermatophagoides pteronyssinus allergoid (Acarovac Plus®) in patients with house dust mite (HDM)-induced allergic asthma in a real-life study. METHODS: A subanalysis of a multicenter, prospective, observational, real-life study. Patients with rhinitis and allergic asthma caused by HDMs were assessed before AIT with Acarovac Plus® and at 6 and 12 months after this treatment. Assessment parameters were percentage of days with asthma symptoms, percentage of days on asthma medication, classification of asthma according to Spanish guidelines for the management of asthma, asthma-related quality of life (quality of life in adults with asthma questionnaire [QLAAQ]), perception of symptoms (visual analog scale [VAS]), and treatment satisfaction (treatment satisfaction questionnaire for medication [TSQM]). Safety was assessed by the number and severity of adverse reactions. RESULTS: This subanalysis included 55 patients. Treatment with Acarovac Plus® showed significant differences in the analyzed variables when the baseline visit was compared with the 12-month visit: reduction of the mean (SD) percentage of days with asthma symptoms (23.9 [9.2] vs. 5.1 [12.8]; p = .002), of the mean [SD] percentage of days on asthma medication (67.6 [42.9] vs. 45.1 [46.8]; p = .002), and of the percentage of patients with persistent asthma (78.2% vs. 38.9%; p = .009). Acarovac Plus® significantly improved asthma-related quality of life, as shown by a decrease of 1.39 points in QLAAQ score at 12 months (p < .001), and in the subjective perception of symptoms on the VAS (-3.50, p < .0001). Patients showed high treatment satisfaction according to the TSQM, and it was well tolerated. No serious adverse events were reported. CONCLUSIONS: Acarovac Plus® was effective and safe for the treatment of patients with HDM-induced allergic asthma in a real-life study.

Immunological parameters as biomarkers of response to MicroCrystalline Tyrosine-adjuvanted mite immunotherapy.

BACKGROUND: Despite the effectiveness of allergen immunotherapy (AIT), some patients are unresponsive for reasons still unknown; yet validated response biomarkers remain unavailable. OBJECTIVE: To analyze immunological parameters as biomarkers to monitor and predict clinical response to a MicroCrystalline Tyrosine-adjuvanted house dust mite (HDM) AIT in patients with allergic rhinitis (AR). METHODS: Observational, prospective, multicenter study including adult patients (aged 18-65 years) with AR, with and without asthma, sensitized to the HDM Dermatophagoides pteronyssinus (DP) and prescribed Acarovac Plus® DP 100% in the routine practice. Serum concentrations of total IgE, specific IgE, specific IgG4, IL-4, IL-5, IL-10, IL-13, and IFN-γ were compared between baseline and 12 months after AIT. The relationship between patients' baseline immunological profiles and classification as low, high, and non-responders and between their sensitization profile to DP allergens and effectiveness were analyzed. RESULTS: Of 141 patients recruited, 118 (mean [SD] age of 33.6 [9.5] years) were evaluable. One year after treatment, Der p 1-specific IgE, DP-specific IgG4, and IL-10 increased by a mean (SD) of 3.4 (13.6) kU/L (p = 0.016), 0.43 (0.55) mg/L (p < 0.0001), and 1.35 (7.56) pg/mL (p = 0.033), respectively. Non-responders showed increased baseline levels of IL-13 compared to high responders (p = 0.037). Changes in effectiveness variables between baseline and after AIT were similar regardless of the sensitization profile. CONCLUSION: Non-responsive patients to AIT showed increased baseline IL-13 concentrations, suggesting its value as prognostic biomarker. DP-specific AIT increased Der p 1-specific IgE, DP-specific IgG4, and IL-10 concentrations in patients with AR. All patients benefited from treatment regardless of their sensitization profile to major DP allergens.

Safety evaluation of a multiallergen immunotherapy treatment in polyallergic patients. APOLO observational study.

Aim: Assessment of safety, tolerability and changes in global clinical impression with an multiallergen immunotherapy treatment without dilutional effect in polyallergic patients. Patients & methods: This observational prospective study included patients with allergic rhinitis-rhinoconjunctivitis with or without asthma between 5 and 60 years old receiving immunotherapy treatment with a mixture of two allergenic sources. All adverse events were recorded. Global clinical impression, tolerability subjective assessment and satisfaction were also assessed. Results: 130 patients were analyzed. Nine clinically relevant local adverse reactions were reported in six patients (4.6%). Six systemic reactions (grades 0-I) occurred in four patients (3.1%). Patients improved significantly in their global clinical impression. Good tolerability subjective assessment and satisfaction values were also observed. Conclusion: This multiallergen immunotherapy treatment without dilutional effect can be considered as a potential therapeutic alternative for polyallergic patients suffering from allergic rhinitis.

Real-life effect of a microcrystalline tyrosine adjuvanted mite immunotherapy in patients with allergic rhinitis.

Aim: Evaluate the effectiveness and safety of immunotherapy with Acarovac Plus® in a 1-year prospective multicentered real-life study. Methods: A total of 118 adults with allergic rhinitis sensitized to Dermatophagoides received subcutaneous immunotherapy with Acarovac Plus. Treatment outcomes were evaluated at baseline, 6 months and 1 year after treatment initiation. Primary end point was the evolution of the combined symptom and medication score. Secondary end points included other effectiveness outcomes and measurement of product tolerability. Results: Acarovac Plus induced significant improvements in primary and secondary end points after 6 months compared with baseline. These differences persisted after 1 year of treatment (p < 0.001; baseline vs 1 year): combined symptom and medication score (1.60 vs 0.79). No serious adverse events were recorded. Conclusion: Acarovac Plus for 1 year was effective and well tolerated in a real-life setting.

Influencia de la preparación de la corteza de Rhizophora mangle L. en el proceso de extracción sólido-líquido / Effect of the Rhizophora mangle L. bark preparation on the process of solid-liquid extraction

Introducción: la corteza de Rhizophora mangle L., rica por su contenido de taninos, es la fuente de materia prima en la obtención de productos farmacéuticos desarrollados en el Centro Nacional de Sanidad Agropecuaria. Para que los extractos obtenidos a partir de esta corteza tengan la calidad requerida, esta debe ser secada y molinada antes de pasar a la etapa de lixiviación. Objetivos: evaluar diferentes métodos de secado y diferentes tamaños de partículas sobre el rendimiento del extracto acuoso de la corteza de R. mangle. Métodos: se emplearon 3 métodos de secado (en estufa, al sol y a la sombra) y 2 tamaños promedios de partículas de la corteza de R. mangle para evaluar la calidad del extracto por determinación del contenido de sólidos solubles totales, taninos totales y actividad antimicrobiana in vitro. Para la comparación estadística de los resultados se utilizó el programa Statgraphycs. Resultados: se observó que el secado en estufa y al sol son los más recomendados para este fin, además se obtuvieron extractos con cortezas molinadas con diferentes tamaños promedios de partículas y no se encontraron diferencias significativas en la evaluación de estos. Conclusiones: los métodos de secado estudiados permitieron obtener buenos resultados en la evaluación de la corteza; con el secado en estufa seguido del secado al sol se lograron los menores tiempos de operación.

Introduction: Rhizophora mangle L. bark, rich in tannin content, is the source of raw material for pharmaceuticals manufactured at the National Center for Animal and Plant Health (CENSA). For the extracts obtained from the bark to have the required quality, it is necessary that the bark be dried and grounded before lixiviation. Objectives: to evaluate different drying methods and several particle sizes on account of R. mangle aqueous extract yield. Methods: Three drying methods (oven, sun and shade) and 2 average bark particle sizes were used to evaluate the extract quality by determining the total soluble solid content, total tannins and in vitro antimicrobial activity. The Statgraphycs program was used to statistically compare the results. Results: it was observed that the oven drying and the sun drying were the most recommended methods; additionally, no significant differences were found in the extracts obtained from several average grounded bark particle sizes. Conclusions: the studied drying methods allowed achieving good results in the evaluation of the bark. The oven drying followed by the sun drying accounted for the shortest operating times.

Influencia de la preparación de la corteza de Rhizophora mangle L en el proceso de extracción sólido-líquido / Influencia de la preparación de la corteza de Rhizophora mangle L en el proceso de extracción sólido-líquido / Effect of the Rhizophora mangle L bark preparation on the process of solid-liquid extraction / Effect of the Rhizophora mangle L bark preparation on the process of solid-liquid extraction

Introducción: la corteza de Rhizophora mangle L, rica por su contenido de taninos, es la fuente de materia prima en la obtención de productos farmacéuticos desarrollados en el Centro Nacional de Sanidad Agropecuaria. Para que los extractos obtenidos a partir de esta corteza tengan la calidad requerida, esta debe ser secada y molinada antes de pasar a la etapa de lixiviación. Objetivos: evaluar diferentes métodos de secado y diferentes tamaños de partículas sobre el rendimiento del extracto acuoso de la corteza de R mangle. Métodos: se emplearon 3 métodos de secado (en estufa, al sol y a la sombra) y 2 tamaños promedios de partículas de la corteza de R. mangle para evaluar la calidad del extracto por determinación del contenido de sólidos solubles totales, taninos totales y actividad antimicrobiana in vitro. Para la comparación estadística de los resultados se utilizó el programa Statgraphycs. Resultados: se observó que el secado en estufa y al sol son los más recomendados para este fin, además se obtuvieron extractos con cortezas molinadas con diferentes tamaños promedios de partículas y no se encontraron diferencias significativas en la evaluación de estos. Conclusiones: los métodos de secado estudiados permitieron obtener buenos resultados en la evaluación de la corteza; con el secado en estufa seguido del secado al sol se lograron los menores tiempos de operación(AU)

Introducción: la corteza de Rhizophora mangle L, rica por su contenido de taninos, es la fuente de materia prima en la obtención de productos farmacéuticos desarrollados en el Centro Nacional de Sanidad Agropecuaria. Para que los extractos obtenidos a partir de esta corteza tengan la calidad requerida, esta debe ser secada y molinada antes de pasar a la etapa de lixiviación. Objetivos: evaluar diferentes métodos de secado y diferentes tamaños de partículas sobre el rendimiento del extracto acuoso de la corteza de R mangle. Métodos: se emplearon 3 métodos de secado (en estufa, al sol y a la sombra) y 2 tamaños promedios de partículas de la corteza de R. mangle para evaluar la calidad del extracto por determinación del contenido de sólidos solubles totales, taninos totales y actividad antimicrobiana in vitro. Para la comparación estadística de los resultados se utilizó el programa Statgraphycs. Resultados: se observó que el secado en estufa y al sol son los más recomendados para este fin, además se obtuvieron extractos con cortezas molinadas con diferentes tamaños promedios de partículas y no se encontraron diferencias significativas en la evaluación de estos. Conclusiones: los métodos de secado estudiados permitieron obtener buenos resultados en la evaluación de la corteza; con el secado en estufa seguido del secado al sol se lograron los menores tiempos de operación(AU)

Introduction: Rhizophora mangle L bark, rich in tannin content, is the source of raw material for pharmaceuticals manufactured at the National Center for Animal and Plant Health (CENSA). For the extracts obtained from the bark to have the required quality, it is necessary that the bark be dried and grounded before lixiviation. Objectives: to evaluate different drying methods and several particle sizes on account of R mangle aqueous extract yield. Methods: Three drying methods (oven, sun and shade) and 2 average bark particle sizes were used to evaluate the extract quality by determining the total soluble solid content, total tannins and in vitro antimicrobial activity. The Statgraphycs program was used to statistically compare the results. Results: it was observed that the oven drying and the sun drying were the most recommended methods; additionally, no significant differences were found in the extracts obtained from several average grounded bark particle sizes. Conclusions: the studied drying methods allowed achieving good results in the evaluation of the bark. The oven drying followed by the sun drying accounted for the shortest operating times.(AU)

Introduction: Rhizophora mangle L bark, rich in tannin content, is the source of raw material for pharmaceuticals manufactured at the National Center for Animal and Plant Health (CENSA). For the extracts obtained from the bark to have the required quality, it is necessary that the bark be dried and grounded before lixiviation. Objectives: to evaluate different drying methods and several particle sizes on account of R mangle aqueous extract yield. Methods: Three drying methods (oven, sun and shade) and 2 average bark particle sizes were used to evaluate the extract quality by determining the total soluble solid content, total tannins and in vitro antimicrobial activity. The Statgraphycs program was used to statistically compare the results. Results: it was observed that the oven drying and the sun drying were the most recommended methods; additionally, no significant differences were found in the extracts obtained from several average grounded bark particle sizes. Conclusions: the studied drying methods allowed achieving good results in the evaluation of the bark. The oven drying followed by the sun drying accounted for the shortest operating times.(AU)