Randomized dose-response study of subcutaneous immunotherapy with a Dermatophagoides pteronyssinus extract in patients with respiratory allergy.

Autor: Moreno V; Servicio de Alergología, Hospital Blanca Paloma, Huelva, Spain., Alvariño M; Servicio de Alergología, Hospital de Manises, Manises, Spain., Rodríguez F; Servicio de Alergología, Hospital Marqués de Valdecilla, Santander, Spain., Roger A; Unidad de Alergología, Hospital Germans Trias i Pujol, Badalona, Spain., Peña-Arellano MI; Servicio de Alergología, Hospital Vega Baja (Orihuela), San Bartolomé, Spain., Lleonart R; Servicio de Alergología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain., Pagán JA; Servicio Alergia, Hospital Virgen de la Arrixaca, El Palmar, Spain., Navarro JA; Servicio de Alergología, Hospital Donostia, Donostia, Spain., Navarro LA; Servicio de Alergología, Hospital Luís Alcanyís, Xátiva, Spain., Vidal C; Servicio de Alergología, Complejo Hospitalario Universitario de Santiago (Hospital de Conxo), Santiago de Compostela, Spain., Ponte-Tellechea A; R&D Department, Bial Industrial Farmacéutica S.A., Zamudio, Spain., Gómez-Fernández MC; R&D Department, Bial Industrial Farmacéutica S.A., Zamudio, Spain., Madariaga-Goirigolzarri B; R&D Department, Bial Industrial Farmacéutica S.A., Zamudio, Spain., Asturias JA; R&D Department, Bial Industrial Farmacéutica S.A., Zamudio, Spain., Hernández-Fernandez de Rojas D; Servicio de Alergología, IIS, Hospital Universitari La Fe, Valencia, Spain.
Jazyk: angličtina
Zdroj: Immunotherapy [Immunotherapy] 2016; Vol. 8 (3), pp. 265-77. Date of Electronic Publication: 2016 Jan 12.
DOI: 10.2217/imt.15.124
Abstrakt: 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.
Databáze: MEDLINE