Moderate-to-Severe Pemphigus Vulgaris
Conditions
Interventions
Test group:The patients were infused with 500mg of zebetozumab at week 0 and week 2 respectively. At the initial stage, glucocorticoids were given according to the condition, and then the glucocortico
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients who meet the diagnostic criteria for pemphigus vulgaris (PV), defined as: (1) Clinical presentation: flaccid blisters and/or erosions on the skin and/or mucous membranes, with a positive Nikolsky sign; (2) Histopathology: presence of intraepidermal blisters and acantholysis; (3) Direct immunofluorescence (DIF): intercellular deposition of IgG and/or C3 in the epidermis; (4) Positive anti-desmoglein 3 (anti-Dsg3) antibody, with or without positive anti-desmoglein 1 (anti-Dsg1) antibody; (5) Positive indirect immunofluorescence (IIF). (Diagnosis is confirmed if (1) and (2) are fulfilled, plus at least one of (3), (4), or (5); or if (1) and (3) are fulfilled, plus at least one of (4) or (5).); 2. Adult patients aged between 18 and 80 years; 3.Pemphigus Disease Area Index (PDAI) activity score >= 15; 4. Provision of signed informed consent; 5. Ability and willingness to adhere to the scheduled treatment and follow-up visits; 6.History of inadequate disease control with prior corticosteroid and/or immunosuppressant therapy, defined by at least one of the following: Disease relapse occurring on one or more occasions. Inability to taper the corticosteroid dose to <= 10 mg/day of prednisone (or equivalent). Presence of contraindications to immunosuppressant therapy.
Exclusion criteria
Exclusion criteria: 1.Prior treatment with any CD20 monoclonal antibody; 2.Patients aged 80 years; 3. Significant comorbid conditions, including: Severe cardiovascular, neurological, psychiatric, or autoimmune diseases. Severe hepatic or renal impairment (defined as ALT/AST >= 3 × ULN, or creatinine clearance < 60 mL/min). Uncontrolled active infections. Latent infections (with the exception of latent tuberculosis infection; however, hepatitis B surface antigen-positive patients are excluded. Patients positive for hepatitis B core antibody are eligible only if HBV DNA levels are within the normal range and both liver function tests and ultrasound imaging rule out active hepatitis or cirrhosis). History of malignancy; 4.Known hypersensitivity to Zuberitamab, any of its excipients, or murine proteins; 5.Pregnant or lactating women; 6. Recent vaccination or planned vaccination during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reduction of glucocorticoids to a maintenance dose (<=10 mg prednisone/day);Time required for anti-Dsg1 antibody levels to return to normal range;Proportion of patients with relapse, frequency of relapse episodes, and severity of relapses during the follow-up period.;The time to disease control;Complete remission;Time to complete remission and the duration of complete remission;Time to 50% reduction in PDAI score.;Proportion of patients with peripheral blood B-cell depletion after the second infusion;Total cumulative glucocorticoid dose used for pemphigus treatment prior to dose reduction to the minimum therapeutic level.;Adverse event; | — |
Countries
China
Contacts
Public ContactYongfeng Chen
Dematology Hospital of Southern Medical University
Outcome results
None listed