Accelerated Up-Dosing of Subcutaneous Immunotherapy with a Registered Allergoid Birch Pollen Preparation.

BACKGROUND: Early pollen flight and new allergens prolonging the pollen season means that the time for up-dosing of allergen-specific subcutaneous immunotherapy (SCIT) outside the pollen season becomes shorter. Hence, for patients who wish or need to be up-dosed faster, an accelerated induction regimen would provide a useful treatment option. METHODS: An accelerated up-dosing regimen (0.1-0.3-0.5 mL at weekly intervals) was compared to conventional up-dosing (0.05-0.1-0.2-0.3-0.4-0.5 mL at weekly intervals) using an allergoid birch pollen SCIT preparation. After up-dosing, the maintenance dose (0.5 mL) was given 3 times at biweekly intervals. The multicenter study was performed according to an open randomized, parallel-group design. RESULTS: A total of 123 birch pollen-allergic patients (81 adults and 42 adolescents) presenting with rhinitis or rhinoconjunctivitis with or without mild asthma (FEV1 >70%) were randomized to either the conventional registered up-dosing or an accelerated regimen. In total, 96.7 and 98.4% successfully reached the maintenance dose for the conventional and accelerated regimen, respectively, without relevant differences between adults and adolescents. Both regimens were safe and well tolerated. Furthermore, significant increases (similar in size) in specific IgG and IgG4 after 3 months of treatment were observed in both groups, independent of age. CONCLUSION: The accelerated SCIT regimen was revealed to be as safe as the conventional regimen, and the immunological effects of both regimens are similar. Accordingly, the accelerated regimen may be used to up-dose patients of adult as well adolescent age within 2 weeks.

Efficacy and safety of a glutaraldehyde-modified house dust mite extract in allergic rhinitis.

BACKGROUND: Modification of allergens by glutaraldehyde in extracts used for immunotherapy reduces the risk for side effects, but therapeutic efficacy of such extracts requires further evaluation. The aim of this study was to evaluate the efficacy and safety of immunotherapy with PURETHAL Mites (PM), a single-strength glutaraldehyde-modified aluminum hydroxide-adsorbed extract of house-dust mites (HDM). METHODS: In a multicenter, randomized, placebo-controlled double-blind setting, HDM-allergic subjects (n = 140) were treated with modified allergen extract or placebo over a 1-year period. The primary outcome parameter was a combined symptom and medication score (clinical index score [CIS]). Secondary efficacy parameters were the result of a titrated conjunctival provocation test (CPT), rhinitis/rhinoconjunctivitis quality of life (RQL) score, and serum concentrations of IgE and IgG against specific HDM allergens and a documentation of adverse events (AE). RESULTS: We evaluated 140 patients (66 treatment and 74 placebo) for clinical efficacy. The allergoid treatment for 1 year resulted in significantly greater CIS improvement and higher RQL scores. The response threshold in the titrated CPT (p = 0.009) and the serum concentrations of IgG4 (p < 0.001) against Dermatophagoides pteronyssinus allergens after treatment were also significantly different between groups. In total, 88 patients (46 PM/42 placebo) out of a safety population of 145 reported 278 (158 PM/120 placebo) AE. Except for local reactions, no specific AE appeared to be associated with PURETHAL Mites (HAL-Allergy, Leiden, The Netherlands). CONCLUSION: The findings of this study indicate that allergen injection therapy with modified HDM extract is superior to placebo in allergic rhinitis therapy. The treatment was well tolerated and no serious drug-related AE were observed.