NCT05649579
Completed
Not Applicable
Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: a Multicenter Retrosepctive Study
ConditionsBullous Pemphigoid
DrugsDupilumab
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bullous Pemphigoid
- Sponsor
- Peking University First Hospital
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Proportion of patients reached disease control
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study was designed to be a retrospective, multicentre, observational study to evaluate the efficacy and safety of dupilumab in the treatment of bullous pemphigoid and to find predictors of efficacy.
Investigators
Mingyue WANG
Principal Investigator
Peking University First Hospital
Eligibility Criteria
Inclusion Criteria
- •Adult bullous pemphigoid patients treated with dupilumab between January 1, 2021, and July 31, 2022, at six leading dermatology departments in the Chinese Collaborative Network for Autoimmune Bullous Diseases.
- •The diagnosis of BP requires clinical manifestations and immunological or pathological evidences.
- •Dupilumab treatment should continue for at least 4 weeks and possibly longer.
Exclusion Criteria
- •Drug-induced BP, γ-1 pemphigoid
- •Patients with less than 4 weeks of follow-up
- •Patients were given any other biologicals within 6 months before the first dupilumab administration
Outcomes
Primary Outcomes
Proportion of patients reached disease control
Time Frame: within 4 weeks
Disease control was defined as the point at which new lesions or pruritic symptoms cease to form and existing lesions start to heal.
Secondary Outcomes
- Changes in serum anti-BP230 antibodies(from 0 to 64 weeks)
- Changes in peripheral blood eosinophil count(from 0 to 64 weeks)
- Adverse events(within 64 weeks)
- Changes in serum anti-BP180 antibodies(from 0 to 64 weeks)
- Changes in serum total IgE(from 0 to 64 weeks)
- Complete remission rate(within 64 weeks)
- Relapse rate(within 64 weeks)
- Changes in BPDAI scores(from 0 to 64 weeks)
- Changes in itching NRS scores(from 0 to 64 weeks)
Study Sites (1)
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