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

Andrzej Bożek, Krzysztof Kołodziejczyk, Renata Kozłowska, Giorgio Walter Canonica, Andrzej Bożek, Krzysztof Kołodziejczyk, Renata Kozłowska, Giorgio Walter Canonica

Abstract

Background: Allergen 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.

Methods: Fifty-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.

Results: After 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.

Conclusion: The DBPC trial showed AIT for house dust mite allergens was effective and safe in elderly patients with allergic rhinitis.

Trial registration: This randomized, double-blinded placebo-controlled (DBPC) trial was conducted at one centre (ClinicalTrials.gov no. NCT03209245).

Keywords: Allergic rhinitis; Elderly; House dust mite; Immunotherapy.

Figures

Fig. 1
Fig. 1
Number of participants assessed for eligibility who completed the study
Fig. 2
Fig. 2
Decrease in the TCRS score in the active and placebo group during the study. Asterisk least square mean change in TCRS score was significant compared to baseline, p < 0.05
Fig. 3
Fig. 3
Decrease in HDM-specific IgE levels (SE) compared with placebo 3 and 6 years after the start of treatment. D. pter—the mean change of IgE against D. pteronyssinus from baseline after 2 years of AIT or placebo, D. far—the mean change of IgE against D. farinae from baseline after 2 years of AIT or placebo, Derp1—the mean change of IgE against antigen D. pter 1 from baseline after 2 years of AIT or placebo, D. pter 2—the mean change of IgE against antigen D. pter 2 from baseline after 2 years of AIT or placebo. There were significant changes between the active and placebo group in all analysed parameters
Fig. 4
Fig. 4
Increase in HDM-specific IgG4 levels (SE) after 12 and 24 months following the start of treatment. D. pter_—the mean change of IgG4 against D. pteronyssinus from baseline, D. far—mean change of IgG4 against D. farinae from baseline, Derp1—the mean change of IgG4against antigen D pter 1 from baseline, Derp2—the mean change of IgG4 against antigen D pter 2 from baseline

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Source: PubMed

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