Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509243
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-05
Brief Title:
Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DuHDM
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
Methods Patients diagnosed with severe AD were included in a randomized placebo-controlled double-blind 12-month trial they received SLIT to HDM andor 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
Methods Patients diagnosed with severe AD were included in a randomized placebo-controlled double-blind 12-month trial they received SLIT to HDM andor 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
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 andor dupilumab for 12 months and were compared to patients on cyclosporine
Patients Patients were eligible if they met the following criteria were diagnosed with AD a minimum of one year before the study documented one year of therapy for AD were between 18 and 45 years of age had 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 and a positive result for specific immunoglobulin E sIgE to extracts of D pteronyssinus and D farinae and to Der p 1 had negative results for SPT and sIgE to other inhalant allergens and had no symptoms of allergic asthma andor allergic rhinitis The diagnosis of severe AD was based on the guidelines of the Polish Dermatological Society with more restrictive cut-off points on the EASI BSA and IsGA scales as presented in the inclusion criteria to limit the study group to the most advanced forms of AD14
The exclusion criteria included the following other active dermatoses systemic immunosuppressant treatment up to 7 months before the study other chronic diseases contraindications to sublingual immunotherapy or sarilumab and lack of written consent The dermatologist assessed signs of AD at each study visit
Treatment The patients have received SLIT-HDM ACARIZAX ALk Abello Denmark with 12 SQ-HDMs of a standardized allergen extract of the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae 5050 The Acarizax tablets were removed from the blister unit immediately after opening the blister and placed under the tongue where they were dissolved Swallowing was avoided for approximately 2 minutes Food and beverages were not ingested for 5 minutes after intake of the tablet The daily dose was one tablet every day for 12 months Dupilumab treatment was administered according to established recommendations Briefly the patient received a single initial dose of 600 mg of dupilumab followed by subsequent doses of 300 mg every 2 weeks
All patients used emollients During therapy patients with clinical signs of bacterially infected skin were allowed to receive treatment with topical mupirocin orand a 7-day course of amoxicillin orand prednisolone 05 mgkg for seven days for any occurrence of skin exacerbation including superinfection In the control group cyclosporine was administered at 35 mgkg at the start of therapy with the possibility of modifying the dose according to symptoms after a minimum of 6 months of therapy Further treatment was administered for a minimum of another six months 12 months in total Treatment was discontinued if adverse effects occurred
In all groups oral antihistamines such as desloratadine and topical medications were added depending on the individual disease If there was clinical worsening of AD reported significant severity of itching the appearance of erythroderma and new skin lesions of a large area the patient also received oral glucocorticosteroids at a dose of 10 mg of encortolon per 7 days
Symptomatic treatment was assessed via the following medication scores one point for daily use of desloratadine mometasone furoate cream or mupirocin ointment 7 points for every course of amoxicillin and 10 points for the course of encortolon The patients were required to record symptomatic drug use on the diary card
The statistical analysis was performed using Statistica version 812 SoftPol Cracow Poland Nonparametric tests were used because the data were not normally distributed The Wilcoxon test was used to analyse differences between the groups ANOVA was used to compare the scale scores Differences were considered significant at p 005
Patients Patients were eligible if they met the following criteria were diagnosed with AD a minimum of one year before the study documented one year of therapy for AD were between 18 and 45 years of age had 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 and a positive result for specific immunoglobulin E sIgE to extracts of D pteronyssinus and D farinae and to Der p 1 had negative results for SPT and sIgE to other inhalant allergens and had no symptoms of allergic asthma andor allergic rhinitis The diagnosis of severe AD was based on the guidelines of the Polish Dermatological Society with more restrictive cut-off points on the EASI BSA and IsGA scales as presented in the inclusion criteria to limit the study group to the most advanced forms of AD14
The exclusion criteria included the following other active dermatoses systemic immunosuppressant treatment up to 7 months before the study other chronic diseases contraindications to sublingual immunotherapy or sarilumab and lack of written consent The dermatologist assessed signs of AD at each study visit
Treatment The patients have received SLIT-HDM ACARIZAX ALk Abello Denmark with 12 SQ-HDMs of a standardized allergen extract of the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae 5050 The Acarizax tablets were removed from the blister unit immediately after opening the blister and placed under the tongue where they were dissolved Swallowing was avoided for approximately 2 minutes Food and beverages were not ingested for 5 minutes after intake of the tablet The daily dose was one tablet every day for 12 months Dupilumab treatment was administered according to established recommendations Briefly the patient received a single initial dose of 600 mg of dupilumab followed by subsequent doses of 300 mg every 2 weeks
All patients used emollients During therapy patients with clinical signs of bacterially infected skin were allowed to receive treatment with topical mupirocin orand a 7-day course of amoxicillin orand prednisolone 05 mgkg for seven days for any occurrence of skin exacerbation including superinfection In the control group cyclosporine was administered at 35 mgkg at the start of therapy with the possibility of modifying the dose according to symptoms after a minimum of 6 months of therapy Further treatment was administered for a minimum of another six months 12 months in total Treatment was discontinued if adverse effects occurred
In all groups oral antihistamines such as desloratadine and topical medications were added depending on the individual disease If there was clinical worsening of AD reported significant severity of itching the appearance of erythroderma and new skin lesions of a large area the patient also received oral glucocorticosteroids at a dose of 10 mg of encortolon per 7 days
Symptomatic treatment was assessed via the following medication scores one point for daily use of desloratadine mometasone furoate cream or mupirocin ointment 7 points for every course of amoxicillin and 10 points for the course of encortolon The patients were required to record symptomatic drug use on the diary card
The statistical analysis was performed using Statistica version 812 SoftPol Cracow Poland Nonparametric tests were used because the data were not normally distributed The Wilcoxon test was used to analyse differences between the groups ANOVA was used to compare the scale scores Differences were considered significant at p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None