Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

NCT05649579 | Completed FDA Drug

• 1 other identifier: 2022Y446
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Complete remission rate

  within 64 weeks

• Relapse rate

  within 64 weeks

• Adverse events

  within 64 weeks

• Changes in BPDAI scores

  from 0 to 64 weeks

• Changes in itching NRS scores

  from 0 to 64 weeks

Interventions

Dupilumab DRUG

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.

Also known as: Dupixent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Ruijin Hospital: collaborator
• Chinese Academy of Medical Sciences: collaborator
• West China Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Shandong Provincial Institute of Dermatology and Venereology: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mingyue Wang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

CN (1)