Real-world outcomes with rituximab vs. conventional therapy in pemphigus vulgaris: a single-center Romanian cohort

TL;DR

This study compares rituximab and conventional therapy for treating pemphigus vulgaris in Romania, finding rituximab more effective in controlling the disease and preventing relapses.

Contribution

The study provides real-world evidence from Eastern Europe on rituximab's efficacy in pemphigus vulgaris treatment.

Findings

Rituximab achieved faster disease control with 100% of patients controlled within 12 months, compared to 55.6% with conventional therapy.

Rituximab-treated patients had no relapses, while all conventionally treated patients experienced relapses.

Rituximab was associated with higher cumulative corticosteroid doses but fewer relapses and steroid-related toxicities.

Abstract

Pemphigus vulgaris (PV) is a rare but potentially life-threatening autoimmune blistering disease. Rituximab has recently gained prominence as a first-line treatment for moderate-to-severe PV, yet real-world evidence from Eastern Europe remains limited. This study compares clinical outcomes of rituximab versus conventional corticosteroid-based therapy in a Romanian PV cohort.

We conducted a retrospective, single-center observational study including 17 patients diagnosed with PV between January 2021 and July 2025 in Iași, Romania. All patients initially received systemic corticosteroids with azathioprine or mycophenolate mofetil when indicated. Rituximab became available through the national reimbursement program in June 2024 and was prescribed for refractory or moderate-to-severe disease. Clinical outcomes assessed included time to disease control, remission and relapse rates, cumulative corticosteroid exposure, and adverse events.

Eight patients received rituximab and nine received conventional therapy. Rituximab led to faster disease control, with 100% of patients achieving control within 12 months compared with 55.6% in the conventional group. Complete remission at last follow-up was higher in the rituximab group (75%) than in the conventional group (44.4%). No relapses occurred in rituximab-treated patients during follow-up, whereas all patients treated conventionally experienced relapses (34 episodes in total). The cumulative corticosteroid dose was higher in the rituximab group (median 19.5 g vs. 15.5 g) due to prior exposure before therapy switch. Adverse events differed by treatment: rituximab was associated primarily with early infusion-related reactions and infections, while conventional therapy caused steroid-related toxicities.

In this real-world cohort, rituximab demonstrated superior disease control and relapse prevention compared with conventional therapy. Despite limited follow-up, findings support earlier use of rituximab in PV management to reduce relapse burden and long-term corticosteroid exposure. Broader access to rituximab and improved diagnostic resources could meaningfully improve outcomes in resource-limited settings.