- Meeting abstract
- Open Access
Subcutaneous allergen immunotherapy with dermatophagoides pteronyssinus in patient with local allergic rhinitis
World Allergy Organization Journal volume 8, pageA263 (2015)
In this study we investigated the efficacy and safety of subcutaneous allergen immunotherapy (AIT) with Dermatophagoides pteronyssinus (DP) in patients with local allergic rhinitis (LAR).
A randomized, double-blind, placebo-controled, parallel-group, phase II study was conducted. Thirty-six subjects with LAR to DP were randomized to receive Pangraminâ PLUS, ALK, 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.
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 systemic treatment. No systemic reactions occurred.
We prove that AIT with Dermatophagoides Pteronyssinus is an effective and well-tolerated treatment in LAR patients. This phase II study provides the indication for AIT in LAR.