Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

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

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 Overview

• Status: Completed
• Conditions: Bullous Pemphigoid
• Intervention / Treatment: Drug: Dupilumab

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: West China Hospital; Ruijin Hospital; Second Xiangya Hospital of Central South University; Shandong Provincial Institute of Dermatology and Venereology; Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Mingyue Wang, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Skin Diseases, Vesiculobullous; Pemphigoid, Bullous
• Other Study ID Numbers: 2022Y446

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes