Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis
NCT Number: NCT06509243
Acronym: DuHDM
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atopic Dermatitis
Interventions: BIOLOGICAL: tablets Acarizax|BIOLOGICAL: dupilumab|DRUG: cyclosporine
Sponsor: Medical University of Silesia
Sex: ALL
Age: ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-10
Completion Date: 2024-04-10
Locations: SUM, Zabrze, Poland

Summary:
Severe atopic dermatitis (AD) is a complex disease requiring systemic treatment. This study aimed to assess the effectiveness of combined therapy consisting of dupilumab and sublingual dust mite allergen immunotherapy (SLIT-HDM) in patients with severe AD and HDM allergies.

Methods: Patients diagnosed with severe AD were included in a randomized, placebo-controlled, double-blind 12-month trial; they received SLIT to HDM and/or dupilumab for 12 months and were compared to patients on cyclosporine. EASI, %BSA, and IsGA changes were analyzed in the different treatment arms from the beginning to the end of the 12th month. The secondary outcomes were the proportion of patients who achieved IsGA success and reduced medication scores.

Primary Outcome Measures: Changes in EASI (the Eczema Area and Severity Index) scale, objective improvement of skin lesions in the course of atopic dermatitis based on assessment using standardized questionnaire tests EASI. The EASI assessed disease extent on a scale of 0 to 6 in 4 defined body regions plus an assessment of erythema, infiltration, and/or population; excoriation; and lichenification, each on a scale of 0 to 3. A formula was then used to calculate the total score for each of the 4 regions, which were then added together. Interpretation of the EASI result: 0 = no change, 0.1-1.0 = almost no change, 1.1-7.0 = mild in intensity, 7.1-21.0 = moderate intensity, 21.1-50.0 = high intensity, 50.1-72.0 = very severe (points), 12 months|Changes in BSA% (Body Surface Area) scale, Ii atopic dermatitis, %BSA was categorised according to severity bands: clear (0%), mild (\> 0 to \< 16%), moderate (16 to \< 40%), and severe (40-100%) (percentage), 12 months|Changes in IsGA (investigator global assessment) scale, The IsGA is a doctor-assessed outcome that evaluates overall AD severity on a 5-point scale ranging from clear (0) to severe (4) or very severe (5)., 12 months
Secondary Outcome Measures: Significant reduction in IsGA scale, the proportion of patients who achieved IsGA success (defined as a ≥2-grade improvement in IsGA from baseline, 12 months|changes in DLQI (Dermatology Life Quality Index ) questionnaire, DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is de-signed for people aged 16 years and above., 12 months|exacerbations of atopic dermatitis, number of exacerbations of atopic dermatitis per year of observation. Definition:in terms of the need to use systemic steroids., 12 months|changes in serum concentration of IgG4 against D. pteronyssinus, assessment of allergen-specific IgG4 concentration in blood serum after 6 and 12 months of treatment in arms with the addition of sublingual immunotherapy SLIT-HDM (AU/L), 12 months|changes in serum concentration of IgE against D. pteronyssinus, assessment of allergen-specific IgE concentration in blood serum after 6 and 12 months of treatment in arms with the addition of sublingual immunotherapy SLIT-HDM (kU/L), 12 months