Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05649579
• Other study ID #: 2022Y446
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: December 2023
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ?-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

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

Drug:
• Dupilumab
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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Peking University First Hospital	Chinese Academy of Medical Sciences, Ruijin Hospital, Second Xiangya Hospital of Central South University, Shandong Provincial Institute of Dermatology and Venereology, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in serum anti-BP180 antibodies		from 0 to 64 weeks
Secondary	Changes in serum anti-BP230 antibodies		from 0 to 64 weeks
Secondary	Changes in serum total IgE		from 0 to 64 weeks
Secondary	Changes in peripheral blood eosinophil count		from 0 to 64 weeks