Pemphigus
Conditions
Interventions
Tevatolimab Group:Tevatolimab 160mg (2mL)/vial subcutaneous injection once weekly or according to clinical assessment, combined with prednisone (initial dose 0.5mg/kg/d for moderate patients, 1mg/kg/d
Rituximab Group:Rituximab 100mg (on weeks 0 and 2) intravenous infusion, combined with prednisone (initial dose 0.5mg/kg/d for moderate patients, 1mg/kg/d for severe patients, maximum 1.5mg/kg/d)
Sponsors
Affiliated Dermatology Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with pemphigus ((1) skin/mucosa flaccid blisters/erosions, positive Nikolsky; (2) histopathology showing intraepidermal blisters and acantholysis; (3) direct immunofluorescence showing intercellular IgG/C3 deposition) OR diagnosed with bullous pemphigoid ((1) skin/mucosa tense blisters/erosions, negative Nikolsky; (2) histopathology showing subepidermal blisters; (3) direct immunofluorescence showing linear IgG/C3 deposition along basement membrane zone); 2. Aged 18–70 years; 3. First-time treatment with telitacicept or rituximab; 4. Signed informed consent; 5. Able to comply with treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients aged under 18 years old or over 70 years old; 2. There are contraindications for medication, including severe cardiovascular diseases, severe liver and kidney damage, severe active infections, a history of severe infusion reactions, a history of severe allergies to related drugs, a history of tumors, pregnant and lactating women, those who have recently received or plan to receive vaccinations, and patients who have previously been treated with biological agents such as telitacicept or rituximab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving complete remission without treatment at week 26; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative glucocorticoid dose (prednisone equivalent);Proportion of patients achieving complete remission with minimum maintenance dose;Relapse rate;Reduction in pathogenic autoantibodies (DSG1/3);Pemphigus Disease Area Index (PDAI) score;Dermatology Life Quality Index (DLQI) score;Pemphigus pathogenic autoantibodies (DSG1/3); | — |
Countries
China
Contacts
Public ContactLiu Hong
Affiliated Dermatology Hospital of Shandong First Medical University
Outcome results
None listed