Bullous pemphigoid
Conditions
Interventions
Control group:Corticosteroid combined with minocycline
Experimental group:Abrocitinib as oral treatment
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older, regardless of gender; 2. Patients diagnosed with BP: (1) Clinical manifestations: having clinical features of BP, multiple itchy red patches and hives on the skin, multiple tense blisters and erosions on the skin; (2) Histopathology: typical findings include subepidermal blisters with inflammatory infiltration of eosinophils and mononuclear cells in the dermis. For non-bullous or atypical patients, subepidermal clefts and/or spongiosis with eosinophils may be present; 3. Immunofluorescence: direct immunofluorescence shows deposition of IgG and/or C3 (and less commonly other Ig classes) along the epidermal basement membrane. Indirect immunofluorescence shows IgG antibodies against the basement membrane zone or, rarely, IgA and IgE class antibodies binding to the epidermal side of salt-split normal skin; 4. Autoantibodies: enzyme-linked immunosorbent assay detects positive anti-BP180 and/or anti-BP230 antibodies in serum; diagnosis of BP can be made if at least one of histopathology, immunofluorescence, or autoantibodies meets BP characteristics, with or without typical clinical manifestations; 5. Moderate to severe BP: BPDAI >= 20 points; 6. Willingness to cooperate with long-term outpatient follow-up and treatment. If the above four criteria are not simultaneously met, the subject cannot participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients who have used any JAK inhibitors within 3 months prior to enrollment; 2. Patients with severe underlying diseases, including severe heart failure, liver or kidney dysfunction, malignant tumors, cerebrovascular diseases, or mental disorders; during the screening period, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal; liver function Child-Pugh class C; creatinine clearance <30 mL/min; 3. Patients with risk factors for deep vein thrombosis or pulmonary embolism, such as advanced age, obesity, history of DVT or PE, surgery, or prolonged bed rest; 4. Trial group: currently using other corticosteroids, tetracyclines, immunosuppressants, or biologics unrelated to abrocitinib and cannot discontinue them; 5. Control group: currently using immunosuppressants or biologics and cannot discontinue them; 6. Patients currently with other autoimmune diseases; 7. Patients with current or past malignant tumors; 8. Patients who require long-term oral DPP-4 inhibitors for diabetes or immune checkpoint inhibitors such as PD-1 due to chemotherapy for malignant tumors; 9. Patients with severe active infections; 10. Patients allergic to drug components; 11. Pregnant or breastfeeding women; 12. Patients who do not follow medical advice during diagnosis and treatment or need to change, adjust, or discontinue the treatment plan due to other systemic diseases; 13. Incomplete basic information or medical records; 14. Patients deemed by the investigator, based on clinical judgment, as unsuitable for enrollment or long-term follow-up; if all the above exclusion criteria are not simultaneously met, the subject cannot participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity control rate;Complete remission rate; | — |
Countries
China
Contacts
Public ContactMingyue Wang
Department of Dermatology, Peking University First Hospital, Beijing, China.
Outcome results
None listed