Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis

Not Applicable

Completed

Interventions: Biological: tablets Acarizax
Biological: dupilumab
Drug: cyclosporine

Brief 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.
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Detailed Description: Study design This randomized, 12-month trial has performed in the Clinical Outpatient Allergy Department and six other outpatient cities. All included patients has received SLIT to HDM and/or dupilumab for 12 months and were compared to patients on cyclosporine.
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Recruitment & Eligibility

Inclusion Criteria

diagnosed with AD a minimum of one year before the study (documented one year of therapy for AD)
between 18 and 45 years of age
severe AD with an Eczema Area and Severity Index (EASI) >20 points, a %BSA (body surface area) >10 points, an IsGA (Investigator Global Assessment) = 4 points, a positive skin prick test (SPT)
a positive result for specific immunoglobulin E (sIgE) to extracts of D. pteronyssinus and D. farinae and to Der p 1;
negative results for SPT and sIgE to other inhalant allergens;
no symptoms of allergic asthma and/or allergic rhinitis

Exclusion Criteria

other active dermatoses, systemic immunosuppressant treatment up to 7 months before the study, other chronic diseases,
contraindications to sublingual immunotherapy or dupilumab,
lack of written consent

Arm && Interventions

Group	Intervention	Description
SLIT HDM	tablets Acarizax	Patients received sublingual allergen immunotherapy (Acarizax), adding to symptomatic therapy for atopic dermatitis (according to recommendations).
biologic	dupilumab	Patients received dupilumab, added to symptomatic therapy for atopic dermatitis (according to recommendations.)
Combi therapy	tablets Acarizax	Patients received sublingual allergen immunotherapy (Acarizax) and dupilumab, added to symptomatic therapy for atopic dermatitis (according to recommendations).
Combi therapy	dupilumab	Patients received sublingual allergen immunotherapy (Acarizax) and dupilumab, added to symptomatic therapy for atopic dermatitis (according to recommendations).
cyclosporine	cyclosporine	Patients received cyclosporine added to symptomatic therapy for atopic dermatitis (according to recommendations).

Primary Outcome Measures

Name	Time	Method
Changes in EASI (the Eczema Area and Severity Index) scale	12 months	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 th...
Changes in BSA% (Body Surface Area) scale	12 months	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)
Changes in IsGA (investigator global assessment) scale	12 months	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).

Secondary Outcome Measures

Name	Time	Method
changes in serum concentration of IgE against D. pteronyssinus	12 months	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)
Significant reduction in IsGA scale	12 months	the proportion of patients who achieved IsGA success (defined as a ≥2-grade improvement in IsGA from baseline
changes in serum concentration of IgG4 against D. pteronyssinus	12 months	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)
changes in DLQI (Dermatology Life Quality Index ) questionnaire	12 months	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.
exacerbations of atopic dermatitis	12 months	number of exacerbations of atopic dermatitis per year of observation. Definition:in terms of the need to use systemic steroids.