Randomized dose-response study of subcutaneous immunotherapy with a Dermatophagoides pteronyssinus extract in patients with respiratory allergy.
نویسندگان
چکیده
AIM To evaluate the efficacy of Dermatophagoides pteronyssinus (DPT) subcutaneous immunotherapy in allergic rhinoconjunctivitis patients. PATIENTS & METHODS This 17-week double-blind study randomized 136 patients (95 evaluable) to five dose groups of DPT depot extract (0.0625-0.75 skin prick test [SPT] units) or placebo, administered in a six updosing schedule. RESULTS A dose-response was observed for clinical efficacy (allergen concentration needed to induce a positive nasal provocation test response from baseline to final visit) and safety (adverse reactions). Local and systemic reactions occurred with 14.8 and 6.4% of administered doses, respectively; a single anaphylactic reaction occurred in each of Groups 3, 4 and 5 (0.3% of doses). CONCLUSION The risk-benefit profile appeared most favorable with a DPT dose of 0.125 SPT units.
منابع مشابه
Phase I study of subcutaneous allergen immunotherapy with Dermatophagoides pteronyssinus in patients with allergic rhinoconjunctivitis with or without asthma.
AIM A double-blind placebo-controlled study was conducted according to EMA guidelines, to evaluate safety, tolerability and short-term treatment effects of three updosing regimens of Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy. PATIENTS & METHODS Forty-eight patients were randomized to groups: A (six weekly doses), B (eight weekly doses) or C (eight doses, two clustered...
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INTRODUCTION T cell receptor excision circles (TREC) on CD31+ T cells are related to recent thymic emigrant cells (RTEs). The involvement of the functional thymic tissue occurs early in the IgE-mediated allergic reaction, and in response to specific immunotherapy (SIT). AIM Evaluation of specific immunotherapy effects on TREC number in peripheral T cells in patients allergic to Dermatophagoid...
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عنوان ژورنال:
- Immunotherapy
دوره 8 3 شماره
صفحات -
تاریخ انتشار 2016