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NCT Number: NCT05649579

Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

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.

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Key information

Conditions

Bullous Pemphigoid Autoimmune Diseases Immune System Diseases Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dupixent

Primary outcomes

  1. 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

  1. Complete remission rate

    Time frame: within 64 weeks

    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.

  2. Relapse rate

    Time frame: within 64 weeks

    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.

  3. Adverse events

    Time frame: within 64 weeks

    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.

  4. Changes in BPDAI scores

    Time frame: from 0 to 64 weeks

    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).

  5. Changes in itching NRS scores

    Time frame: from 0 to 64 weeks

    Pruritus was evaluated via itching numeric rating scale (NRS), ranging from 0 (no itch) to 10 points (worst imaginable itch).

  6. Changes in serum anti-BP180 antibodies

    Time frame: from 0 to 64 weeks

  7. Changes in serum anti-BP230 antibodies

    Time frame: from 0 to 64 weeks

  8. Changes in serum total IgE

    Time frame: from 0 to 64 weeks

  9. Changes in peripheral blood eosinophil count

    Time frame: from 0 to 64 weeks

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 14, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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