Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
- Conditions
- Bullous Pemphigoid
- Registration Number
- NCT05649579
- Lead Sponsor
- Peking University First Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients reached disease control 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 Outcome Measures
Name Time Method 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 Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Changes in serum anti-BP180 antibodies from 0 to 64 weeks Changes in serum total IgE from 0 to 64 weeks Relapse rate within 64 weeks Relapse was defined as the appearance of three or more new lesions a month or at least one eczematous lesion with a diameter \>10cm or urticarial plaque that does not heal within one week, or the extension of established lesions or daily pruritus in a patient who has achieved disease control.
Changes in BPDAI scores from 0 to 64 weeks Disease severity was assessed using the bullous pemphigoid disease area index (BPDAI) score and was classified into mild (BPDAI≤19), moderate (20≤BPDAI≤56), and severe (BPDAI≥57).
Complete remission rate within 64 weeks Complete remission is defined as the absence of new or established lesions or pruritus while the patient is receiving minimal therapy or off therapy for at least 2 months.
Changes in itching NRS scores from 0 to 64 weeks Pruritus was evaluated via itching numeric rating scale (NRS), ranging from 0 (no itch) to 10 points (worst imaginable itch).
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China