Efficacy of Sublingual Immunotherapy in Patients with Atopic Dermatitis Sensitized to Dust Mite Allergens

Study Methodology and Population

A total of 91 patients with AD over the age of 3 were included in the Brazilian randomized, double-blind, placebo-controlled study conducted from May 2018 to June 2020. All had a SCORAD (SCORing Atopic Dermatitis) score ≥ 15 with a positive skin prick test and/or IgE antibodies against Dermatophagoides pteronyssinus in the blood. They were stratified into 2 groups by age (< 12 and ≥ 12 years) and received either increasing doses of sublingual immunotherapy or placebo, 3 days a week for 18 months. Maintenance doses were reached after 3 months of therapy. Patients continued their original AD therapies (topical corticosteroids, immunosuppression, short-term systemic corticosteroids in the case of severe AD exacerbation, or omalizumab). Exclusion criteria were as follows:

• pregnancy and breastfeeding,
• immunosuppressive therapy for inflammatory diseases other than asthma bronchiale and AD,
• use of dupilumab for severe AD treatment.

Clinical evaluations were conducted before the start of therapy and subsequently every 3 months for 18 months. The primary parameter measured was a reduction in SCORAD by ≥ 15 points. Other measures included O-(objective) SCORAD, EASI (Eczema Area and Severity Index) score improvements by 50, 75, and 90%, visual analog scales (VAS) for symptoms and pruritus, the proportion of patients with IGA (Investigator’s Global Assessment) 0/1 (“clear or nearly clear skin”), and DLQI (Dermatology Life Quality Index) reductions by ≥ 4 points. All patients also underwent lesion swabs for culture.

Results

A total of 66 patients completed the study (35 on SLIT and 31 on placebo). Many had concomitant allergic rhinitis, asthma bronchiale, or keratoconjunctivitis, and one-third tested positive for Staph. aureus. Only 3 patients in each group underwent short-term systemic corticosteroid therapy.

The mean entry SCORAD value was 46.9. After 18 months, a ≥ 15-point reduction was found in 74.2% vs. 58% of patients in the SLIT vs. placebo group (relative risk [RR] 1.28; 95% confidence interval [CI] 0.89–1.83), but the overall difference was not statistically significant. A statistically significant SCORAD reduction occurred in 55.6% of patients on SLIT versus 34.5% on placebo (mean difference 20.4%; 95% CI 3.89–37.3), and in O-SCORAD in 56.8% vs. 34.9% of patients (mean difference 21.3%; 95% CI 0.66–41.81).

A higher proportion of patients on SLIT achieved IGA 0/1 compared to the placebo group (14 out of 35 vs. 5 out of 31 patients, RR 2.63; 95% CI 1.09–6.39). A non-significant reduction in DLQI by ≥ 4 points was achieved by 68.5% of patients on SLIT compared to 80.6% on placebo (RR 0.87; 95% CI 0.65–1.16).

No significant differences were observed in EASI scores, DLQI, and VAS for symptoms and pruritus. The most common adverse effects in both groups were headaches and abdominal pain.

Conclusion

This clinical study demonstrated that sublingual immunotherapy administered for 18 months led to clinical improvement in patients with AD sensitized to house dust mite allergens, based on tools evaluating AD severity (SCORAD). According to the described study, sublingual immunotherapy is an effective and safe adjunct treatment for patients with atopic dermatitis sensitized to house dust mite allergens.

(mafi)

Source:

Langer S. S., Cardili R. N., Lima Melo J. M. et al. Efficacy of house dust mite sublingual immunotherapy in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol Pract 2022; 10 (2): 539–549, doi: 10.1016/j.jaip.2021.10.060.