Efficacy and Safety Evaluation of Anti-CD20 Monoclonal Antibody Combined with Azathioprine and Corticosteroids in the Treatment of Pemphigus Vulgaris

Chao Ji

Status: Completed

Conditions: Pemphigus Vulgaris (PV); Pemphigus

Treatments: Drug: Ofatumumab subcutaneous injection

Study type: Observational

Funder types: Other

Identifiers

NCT06654817

MRCTA,ECFAH OfFMU|2024]565

Details and patient eligibility

About

A prospective cohort study was conducted, following patients for 36 weeks from January 1, 2023, to April 30, 2024. Patients meeting the diagnostic criteria were nonrandomly grouped based on screening results. The primary endpoints were time to disease control and skin healing. Secondary endpoints included complete remission rates, relapse rates, corticosteroid doses, pemphigus disease area index (PDAI), dermatology life quality index (DLQI), visual analogue scale (VAS) pain scores, CD19+ B cell percentages, desmoglein-specific antibodies, and adverse events.

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe pemphigus who have poor control of previous external medications and require systemic treatment have a PDAI (Pemphigus Area and Activity Score) greater than 9 points.

Exclusion criteria

• Patients with serious basic diseases, with hepatitis B and three positive cases, and with a history of immunoglobulin related diseases.

Trial design

38 participants in 2 patient groups

experimental group

Description:

ofatumumab combined with corticosteroids versus corticosteroids To compare the efficacy and safety of two treatment strategies: ofatumumab combined with corticosteroids versus corticosteroids along with azathioprine, in pemphigus patients. A prospective cohort study was conducted, following patients for 36 weeks from January 1, 2023, to April 30, 2024. Patients meeting the diagnostic criteria were nonrandomly grouped based on screening results. The primary endpoints were time to disease control and skin healing. Secondary endpoints included complete remission rates, relapse rates, corticosteroid doses, pemphigus disease area index (PDAI), dermatology life quality index (DLQI), visual analogue scale (VAS) pain scores, CD19+ B cell percentages, desmoglein-specific antibodies, and adverse events.

Treatment:

Drug: Ofatumumab subcutaneous injection

control group

Description:

the standard treatment of corticosteroids plus azathioprine