Comparison of clinical efficacy and cost-effectiveness of rituximab infusion and intravenous dexamethasone pulse therapy in pemphigus vulgaris- An open, prospective, randomized controlled, pilot study.

Abstract

Introduction: Rituximab (Rtx) and dexamethasone pulse (DP) are the two commonly used therapeutic regimens in pemphigus vulgaris (PV).

Objectives: To compare the clinical efficacy, side effect profile, cost-effectiveness, and changes in desmoglein levels in PV patients treated with RTX biosimilar and DP.

Methods: This open-label, prospective randomized controlled study included 50 active PV patients from November 2018 to September 2023 at a tertiary center in New Delhi. Patients were randomized into two groups: Group A (Rtx) and Group B (DP), both receiving oral prednisolone in a tapering regimen with azathioprine or mycophenolate mofetil. Follow-ups were conducted monthly until remission, then quarterly for at least a year or until relapse. Primary outcomes were remission rates and time to remission; secondary outcomes included relapse rates, adverse events, and cost-effective analysis. Serum anti-desmoglein titers were measured at baseline, remission, and relapse.

Results: Both groups achieved disease control in 96% of patients within a median of one month. Remission rates were 92% in the RTX group and 84% in the DP group, with a similar median time to remission of three months. Relapse occurred twice as frequently in the DP group (76% vs. 39%) after a median of 10.5 months. Serum anti-Dsg1 and anti-Dsg3 declined significantly at remission and rose again at relapse. Adverse events, including gastrointestinal and general disorders, were more common in the DP group. Cost analysis revealed RTX was 20% more cost-effective than DP.

Conclusion: While both regimens were equally effective in inducing remission in PV, RTX offered superior long-term disease control, fewer relapses and adverse events, along with greater cost-effectiveness.