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Clinical Trials/NCT05649579
NCT05649579CompletedNot Applicable

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

Peking University First Hospital1 site in 1 country146 target enrollmentStarted: September 1, 2022Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
146
Locations
1
Primary Endpoint
Proportion of patients reached disease control
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Proportion of patients reached disease control

Time Frame: 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 Outcomes

  • Changes in serum anti-BP230 antibodies(from 0 to 64 weeks)
  • Changes in peripheral blood eosinophil count(from 0 to 64 weeks)
  • Adverse events(within 64 weeks)
  • Changes in serum anti-BP180 antibodies(from 0 to 64 weeks)
  • Changes in serum total IgE(from 0 to 64 weeks)
  • Complete remission rate(within 64 weeks)
  • Relapse rate(within 64 weeks)
  • Changes in BPDAI scores(from 0 to 64 weeks)
  • Changes in itching NRS scores(from 0 to 64 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mingyue WANG

Principal Investigator

Peking University First Hospital

Study Sites (1)

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