Prospective, multi-centre, non-interventional study on the use, tolerability and safety of the One Strength dose escalation scheme with NOVo Helisen® hoUSe dust mites in everyday practice - NOVUS

开始日期2023-07-19

申办/合作机构

Allergopharma GmbH & Co. KG

100 项与 BIA-152957 相关的临床结果

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100 项与 BIA-152957 相关的转化医学

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100 项与 BIA-152957 相关的专利（医药）

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项与 BIA-152957 相关的文献（医药）

2018-10-01·Immunotherapy

Tolerability and Positive Efficacy Results after Subcutaneous Immunotherapy with Parietaria Judaica Depot Extract

Article

作者: Colomer, Noelia ; Flores, Isabel ; Martínez, Alberto ; Enrique, Ernesto ; Alba, Pilar ; Gómez-Fernández, María Cruz ; Andreu, Carmen ; Madariaga-Goirigolzarri, Begoña ; de Rojas, Dolores Hernández-Fernandez ; Landeta, Araitz ; Asturias, Juan Andrés

Aim: To evaluate tolerability and efficacy of Parietaria judaica subcutaneous immunotherapy on patients with allergic rhinoconjunctivitis. Patients & methods: 51 patients were assigned to build-up scheme (six increasing doses) of P. judaica depot native extract, plus three maintenance monthly administrations. Results: Out of 470 administered doses, only 3.8% elicited systemic reactions (1.5% nonspecific and 2.3% grade I). Concerning the exploratory efficacy parameters: cutaneous reactivity at the final visit versus baseline was significantly decreased; specific titers of IgG and IgG4 increased significantly and patients showed a significant decrease in the rhinitis symptoms score. Conclusion: P. judaica subcutaneous immunotherapy (Allergovac® depot ROXALL Medicina España S.A., Zamudio, Spain) with an abbreviated up-dosing scheme showed an adequate safety and tolerability profile and induced preliminary efficacy changes.

European Annals of Allergy and Clinical Immunology

Clinical assessment of tolerability, immunological and cutaneous reactivity effects of an abbreviated schedule with Olea europaeanative extract of subcutaneous immunotherapy

Article

作者: Madariaga, B. ; Asturias, J.A. ; Hernandez, M. ; Valverde, L. ; Gonzalo Garijo, M.A. ; Begona, L. ; Cruz Gomez Fernandez, M. ; Saenz De San Pedro, B. ; Mur, M.P. ; Martinez, A.

SummaryObjectives. To evaluate the tolerability and efficacy of Olea europaea subcutaneous immunotherapy (SCIT) on patients with rhinoconjunctivitis. Methods. In this open clinical trial patients were assigned to an abbreviated build-up scheme. The outcomes were: number, percentage, and severity of adverse reactions. Secondary outcomes included: changes in immunoglobulin titers and changes in dose-response skin prick tests. Results. Only 8 systemic reactions were registered, which represented 7/47 (14.9%) of patients and 8/429 (1.9%) of administered doses. Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system. Cutaneous reactivity decreased significantly. Conclusions. Olea europaea SCIT (Allergovac® depot ROXALL Medicina España S.A.) showed a good safety and tolerability profile. Immunological changes with induction of blocking IgG and decreases in cutaneous reactivity were detected in the patients.

100 项与 BIA-152957 相关的药物交易

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