Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
| West China Hospital | OTHER |
| Second Xiangya Hospital of Central South University |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mingyue Wang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
Not provided
| ID | Term |
|---|---|
| D010391 | Pemphigoid, Bullous |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| OTHER |
| Shandong Provincial Institute of Dermatology and Venereology | OTHER |
Not provided
Not provided
Not provided
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 |
| D007154 | Immune System Diseases |