Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

Peking University First Hospital146 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

146

Conditions

Bullous Pemphigoid

Interventions

DupilumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: within 4 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: from 0 to 64 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.