Title : Effect of rituximab on clinical and serological profile of all cases of pemphigus: A prospective observational study
Abstract:
Introduction: Pemphigus vulgaris (PV), characterized by autoantibodies targeting desmoglein (DSG) 3 and 1, presents a therapeutic challenge. Rituximab, in combination with corticosteroids, is a primary treatment option. This prospective observational study investigates the impact of Rituximab on the clinical and serological profiles of Pemphigus patients.
Objectives:
Primary Objective: Assess the efficacy of Rituximab (RTX) in Pemphigus patients.
Secondary Objective: Evaluate the safety profile of RTX in Pemphigus patients.
Methods: Patients with Pemphigus, regardless of Pemphigus Disease Area Index (PDAI) scores, were enrolled with informed consent. Efficacy was evaluated through PDAI scores, clinical responses, Visual Analogue Scale (VAS) assessments for itching and pain, Physician Global Assessment (PGA), Dermatology Life Quality Index (DLQI), and monitoring of adverse events (AEs) at baseline, 3, 6, and 12 months post-RTX infusion. Serum levels of anti-desmoglein (Dsg) 1 and Dsg 3 were measured at similar intervals.
Results: Twenty-five Pemphigus patients were treated with RTX, with a mean age of 38.58 ± 11.77 years and a mean follow-up of 16.22 ± 3.45 months. Significant reductions in PDAI scores, anti-Dsg 1 and Dsg 3 levels, pain severity, and prednisolone dosages were observed within 1 to 3 months. Median time to achieve complete remission (CR) was 3-4 months, with a median CR duration and relapse time of 9 and 12 months, respectively. Newly diagnosed patients (NDPs) exhibited higher CR rates, longer remission durations, and lower relapse risks compared to previously treated patients (PTPs). No infusion reactions occurred, but four patients reported side effects like facial palsy, dental abscess, scabies, and myiasis.
Conclusion: Rituximab administration in Pemphigus patients showed favorable efficacy and safety profiles for both NDPs and PTPs. Complete remission was typically achieved within 3-4 months. These findings underscore the potential of RTX as a promising treatment option for Pemphigus, with implications for disease monitoring and management.
