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

Chao Ji38 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pemphigus Pemphigus Vulgaris (PV)

Interventions

Ofatumumab subcutaneous injectionDRUG

To compare the efficacy and safety of two treatment strategies: ofatumumab combined with corticosteroids versus corticosteroids along with azathioprine, in pemphigus patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pemphigus Disease Area Index (PDAI）

Pemphigus Disease Area Index (PDAI). PDAI activity score cutoffs were defined as 0 to 8 for mild, 9 to 24 for moderate, and 25 or higher for severe disease.

Time frame: 36 week