BACKGROUND: In specific immunotherapy (SIT), modified extracts have been used to allow safe administration of higher allergen doses. Schedules reaching maintenance doses in approximately 1 month, which may have greater efficacy, have even been proposed. AIMS: To assess the safety and efficacy of SIT with modified (depigmented and polymerized) Dermatophagoides pteronyssinus extract in the treatment of allergic rhinitis. MATERIAL AND METHODS:Fifty patients with moderate-to-severe persistent allergic rhinitis and who were monosensitized to Dermatophagoides were included in this controlled, pragmatic, 1-year open study. The patients were randomly allocated to receive treatment with a Dermatophagoidespteronyssinus 100 % modified allergen vaccine (active group, n = 25) or pharmacological treatment only (control group, n = 25). All SIT-related adverse reactions were recorded. Efficacy was assessed primarily through the results of nasal allergen challenges, through visual analog scale (VAS) and symptom scores. RESULTS: In SIT-treated patients, significant improvements were found in symptom scores (mean reduction > 40 %), VAS scores (mean improvement > 20 %) and nasal challenges (mean increase in allergen concentration threshold > 500 %). For symptom and VAS scores, statistically significant differences between control and SIT-treated patients were recorded at 12 months. In nasal challenges statistically significant differences were observed as early as at 6 months. Control patients showed no significant differences during the study period. Local reactions were observed in 28 % of SIT-treated patients (total 24 reactions). There was only one immediate grade I systemic reaction, which was successfully treated with an antihistamine. CONCLUSIONS: SIT with this modified extract appears to be a relatively safe treatment, which can rapidly improve nasal allergenic tolerance, reduce symptom scores and improve subjective self-evaluation measured through VAS, reflecting a general improvement in patients' well-being.
RCT Entities:
BACKGROUND: In specific immunotherapy (SIT), modified extracts have been used to allow safe administration of higher allergen doses. Schedules reaching maintenance doses in approximately 1 month, which may have greater efficacy, have even been proposed. AIMS: To assess the safety and efficacy of SIT with modified (depigmented and polymerized) Dermatophagoides pteronyssinus extract in the treatment of allergic rhinitis. MATERIAL AND METHODS: Fifty patients with moderate-to-severe persistent allergic rhinitis and who were monosensitized to Dermatophagoides were included in this controlled, pragmatic, 1-year open study. The patients were randomly allocated to receive treatment with a Dermatophagoides pteronyssinus 100 % modified allergen vaccine (active group, n = 25) or pharmacological treatment only (control group, n = 25). All SIT-related adverse reactions were recorded. Efficacy was assessed primarily through the results of nasal allergen challenges, through visual analog scale (VAS) and symptom scores. RESULTS: In SIT-treated patients, significant improvements were found in symptom scores (mean reduction > 40 %), VAS scores (mean improvement > 20 %) and nasal challenges (mean increase in allergen concentration threshold > 500 %). For symptom and VAS scores, statistically significant differences between control and SIT-treated patients were recorded at 12 months. In nasal challenges statistically significant differences were observed as early as at 6 months. Control patients showed no significant differences during the study period. Local reactions were observed in 28 % of SIT-treated patients (total 24 reactions). There was only one immediate grade I systemic reaction, which was successfully treated with an antihistamine. CONCLUSIONS: SIT with this modified extract appears to be a relatively safe treatment, which can rapidly improve nasal allergenic tolerance, reduce symptom scores and improve subjective self-evaluation measured through VAS, reflecting a general improvement in patients' well-being.