Subcutaneous Allergen Immunotherapy in Patient with ''local Allergic Rhinitis'' Sensitized to Dermatophagoides Pteronyssinus

RationaleThis study investigated the efficacy and safety of subcutaneous allergen immunotherapy (AIT) with Dermatophagoides pteronyssinus(DP) in patients with local allergic rhinitis (LAR).MethodsA randomized, double-blind, placebo-controlled, parallel-group, phase II study was conducted. Thirty-six subjects with LAR to DP were randomized to receive AIT (Pangraminâ PLUS, ALK-Abelló, S.A., Dermatophagoides pteronyssinus) (AIT-DP) or placebo for 24 months. The primary endpoint was total symptoms (TSS) and total medication scores (TMS). Secondary endpoints included: total combined symptom+medication scores (TCS), daily symptoms score (DSS), daily medication score (DMS), medication free days (MFD), skin testing, nasal allergen provocation test (NAPT-DP), and adverse events. Serum and nasal lavage samples were obtained for immunological studies.ResultsTwenty-eight patients completed the study. AIT-DP produced a significant improvement in the primary endpoints compared to placebo (a 47% of reduction in TSS (0.60 vs 1.14; p<0.001) and a 51.2% in TMS (0.65 vs 1.34; p=0.002). Moreover, at 6-12-18-24 months significant improvements in TCS (p=0.046; p=0.037; p=0.011; p=0.007) and DSS (p=0.003; p=0.012; p<0.001; p<0.001); and at 24 months in DMS (p=0.014), and MFD (p=0.031) compared to placebo were observed. AIT-DP induced an objective improvement in nasal tolerance to NAPT-DP at 6-12-18-24 months (p=0.003; p<0.001; p<0.001; p<0.001) compared to placebo, with negative responses in the 50% of patients. AIT-DP was well-tolerated, one patient had a local moderate reaction solved without pharmacologic treatment. No systemic reactions occurred.ConclusionsWe prove that AIT with Dermatophagoides Pteronyssinus is an effective and well-tolerated treatment in LAR patients. With this work we provide the indication for AIT in LAR. RationaleThis study investigated the efficacy and safety of subcutaneous allergen immunotherapy (AIT) with Dermatophagoides pteronyssinus(DP) in patients with local allergic rhinitis (LAR). This study investigated the efficacy and safety of subcutaneous allergen immunotherapy (AIT) with Dermatophagoides pteronyssinus(DP) in patients with local allergic rhinitis (LAR). MethodsA randomized, double-blind, placebo-controlled, parallel-group, phase II study was conducted. Thirty-six subjects with LAR to DP were randomized to receive AIT (Pangraminâ PLUS, ALK-Abelló, S.A., Dermatophagoides pteronyssinus) (AIT-DP) or placebo for 24 months. The primary endpoint was total symptoms (TSS) and total medication scores (TMS). Secondary endpoints included: total combined symptom+medication scores (TCS), daily symptoms score (DSS), daily medication score (DMS), medication free days (MFD), skin testing, nasal allergen provocation test (NAPT-DP), and adverse events. Serum and nasal lavage samples were obtained for immunological studies. A randomized, double-blind, placebo-controlled, parallel-group, phase II study was conducted. Thirty-six subjects with LAR to DP were randomized to receive AIT (Pangraminâ PLUS, ALK-Abelló, S.A., Dermatophagoides pteronyssinus) (AIT-DP) or placebo for 24 months. The primary endpoint was total symptoms (TSS) and total medication scores (TMS). Secondary endpoints included: total combined symptom+medication scores (TCS), daily symptoms score (DSS), daily medication score (DMS), medication free days (MFD), skin testing, nasal allergen provocation test (NAPT-DP), and adverse events. Serum and nasal lavage samples were obtained for immunological studies. ResultsTwenty-eight patients completed the study. AIT-DP produced a significant improvement in the primary endpoints compared to placebo (a 47% of reduction in TSS (0.60 vs 1.14; p<0.001) and a 51.2% in TMS (0.65 vs 1.34; p=0.002). Moreover, at 6-12-18-24 months significant improvements in TCS (p=0.046; p=0.037; p=0.011; p=0.007) and DSS (p=0.003; p=0.012; p<0.001; p<0.001); and at 24 months in DMS (p=0.014), and MFD (p=0.031) compared to placebo were observed. AIT-DP induced an objective improvement in nasal tolerance to NAPT-DP at 6-12-18-24 months (p=0.003; p<0.001; p<0.001; p<0.001) compared to placebo, with negative responses in the 50% of patients. AIT-DP was well-tolerated, one patient had a local moderate reaction solved without pharmacologic treatment. No systemic reactions occurred. Twenty-eight patients completed the study. AIT-DP produced a significant improvement in the primary endpoints compared to placebo (a 47% of reduction in TSS (0.60 vs 1.14; p<0.001) and a 51.2% in TMS (0.65 vs 1.34; p=0.002). Moreover, at 6-12-18-24 months significant improvements in TCS (p=0.046; p=0.037; p=0.011; p=0.007) and DSS (p=0.003; p=0.012; p<0.001; p<0.001); and at 24 months in DMS (p=0.014), and MFD (p=0.031) compared to placebo were observed. AIT-DP induced an objective improvement in nasal tolerance to NAPT-DP at 6-12-18-24 months (p=0.003; p<0.001; p<0.001; p<0.001) compared to placebo, with negative responses in the 50% of patients. AIT-DP was well-tolerated, one patient had a local moderate reaction solved without pharmacologic treatment. No systemic reactions occurred. ConclusionsWe prove that AIT with Dermatophagoides Pteronyssinus is an effective and well-tolerated treatment in LAR patients. With this work we provide the indication for AIT in LAR. We prove that AIT with Dermatophagoides Pteronyssinus is an effective and well-tolerated treatment in LAR patients. With this work we provide the indication for AIT in LAR.