ArticleFrontiers in medicine2025
Real-world outcomes with rituximab vs. conventional therapy in pemphigus vulgaris: a single-center Romanian cohort.
Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07769333 (Effectiveness of Rituximab With Corticosteroids Versus Standard Oral Corticosteroids Plus Azathioprine in Participants With Moderate-to-Severe Pemphigus Vulgaris), which is not on this map. Not yet cited in PubMed.
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Effectiveness of Rituximab With Corticosteroids Versus Standard Oral Corticosteroids Plus Azathioprine in Participants With Moderate-to-Severe Pemphigus Vulgaris: A Quasi-Experimental Study
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12 authors.
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Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: 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.
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