Evidence of the efficacy and safety of house dust mite subcutaneous immunotherapy in elderly allergic rhinitis patients: a randomized, double-blind placebo-controlled trial

Abstract

BackgroundAllergen specific immunotherapy (AIT) in elderly patients is controversial, and there is still little evidence supporting the safety and efficacy of this treatment in this population. The study objective was to evaluate the safety and efficacy of AIT for house dust mite allergens in patients over 65 years of age with allergic rhinitis (AR) and a documented allergy to house dust mites. The primary endpoint was the change from baseline in the mean average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS) difference in the least square means for the label compared to placebo.MethodsFifty-eight AR elderly patients who were monosensitized to house dust mites were individually randomized in comparable numbers to one of two parallel groups with the following interventions: 2 years of perennial AIT using PURETHAL Mites or placebo. The symptoms and medication scores were presented as the AAdSS and TCRS. Quality of life, based on the rhinoconjunctivitis quality of life questionnaire (RQLQ), nasal allergen provocation responsiveness, serum allergen-specific IgG4 to D. pteronyssinus and D. farinae and Der p1 and Der p2 were monitored. The intent-to-treat population was analysed.ResultsAfter 24 months of AIT, AAdSS significantly decreased from 4.27 ± 1.58 to 1.82 ± 0.71 (p < 0.05). The TCRS was significantly decreased after 2 years of AIT. Serum-specific IgG4 against D. pteronyssinus, D. farinae, Der p1, and Der p2 increased during the AIT trial in the study group. The RQLQ score was significantly improved in patients who received AIT, from 1.86 (95% CI 1.51–1.78) to 1.26 (95% CI 1.09–1.55). Two mild systemic anaphylactic reactions (degree I) were reported after injections in the active group during the AIT therapy.ConclusionThe DBPC trial showed AIT for house dust mite allergens was effective and safe in elderly patients with allergic rhinitis.Trial registrationThis randomized, double-blinded placebo-controlled (DBPC) trial was conducted at one centre (ClinicalTrials.gov no. NCT03209245)

Prolonged effect of allergen sublingual immunotherapy to grass pollen

“…These results are comparable to those of other studies that include similar parameters, such as various configurations of symptoms and medication scores in younger patients after AIT to grass pollen. 15,16 Another confirmation of the long-term efficiency of AIT is the significant improvement in the TCS based on the analysis of only the rhinitis domain as the primary endpoint of our study. This result is important for elderly patients because nasal problems significantly reduce quality of life.…”

“…[12][13][14] There remains an insufficient quantity of data regarding allergen-specific immunotherapy in elderly people, and only one study has confirmed a prolonged effect of AIT in the elderly. 15 However, as mentioned previously, the need for this type of treatment is clear and has been confirmed according to new EAACI recommendations concerning AIT. 4 Based on our results, it appears that the prolonged efficacy after discontinuation of AIT to grass pollen was good and was similar to the effect in the younger group.…”

ARIA guideline 2019: treatment of allergic rhinitis in the German health system

“…The immunological situation of elderly allergic patients may differ from that of children and younger adults. A limited number of studies have shown that AIT can also be effective in a population of elderly patients [140,141]. For a universal recommendation, however, more data are required.…”

Evolution of subcutaneous allergen immunotherapy (part 1): from first developments to mechanism-driven therapy concepts

“…A DBPC study with a mite allergoid documented a significant (64%) improvement in SS in patients aged over 65 years compared with baseline. At 24 months, the SS reduction was 52% compared with the placebo group [59].…”