Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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 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).
- 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).
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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The diagnosis of BP requires clinical manifestations and immunological or pathological evidences.
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Dupilumab treatment should continue for at least 4 weeks and possibly longer.
Exclusion Criteria:
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Drug-induced BP, γ-1 pemphigoid
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Patients with less than 4 weeks of follow-up
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Patients were given any other biologicals within 6 months before the first dupilumab administration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
Sponsors and Collaborators
- Peking University First Hospital
- Ruijin Hospital
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- West China Hospital
- Second Xiangya Hospital of Central South University
- Shandong Provincial Institute of Dermatology and Venereology
Investigators
- Principal Investigator: Mingyue Wang, Peking University First Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022Y446