Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: a Multicenter Retrosepctive Study

Conditions
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Bullous Pemphigoid

Intervention / Treatment
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* Drug: Dupilumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dupilumab|Duplimab was administered according to the guidelines of the atopic dermatitis treatment regimen, which involved the first dose of 600 mg followed by 300 mg every two weeks. Because of comorbidities or the side effects of corticosteroid, some patients used dupilumab in the initial course of treatment, while others added dupilumab when the traditional drugs proved ineffective. The discontinuation was a joint decision between treating dermatologists and patients. Concomitant medicine was decided by clinicians, depending on the assessing of disease status and patients' choices, and reduced according to international guidelines.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients reached disease control | Disease control was defined as the point at which new lesions or pruritic symptoms cease to form and existing lesions start to heal. | within 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate | 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. | within 64 weeks | 
| Relapse rate | 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. | within 64 weeks | 
| Adverse events | 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. | within 64 weeks | 
| Changes in BPDAI scores | 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). | from 0 to 64 weeks | 
| Changes in itching NRS scores | Pruritus was evaluated via itching numeric rating scale (NRS), ranging from 0 (no itch) to 10 points (worst imaginable itch). | from 0 to 64 weeks | 
| Changes in serum anti-BP180 antibodies |  | from 0 to 64 weeks | 
| Changes in serum anti-BP230 antibodies |  | from 0 to 64 weeks | 
| Changes in serum total IgE |  | from 0 to 64 weeks | 
| Changes in peripheral blood eosinophil count |  | from 0 to 64 weeks |