Bulletin of Stomatology and Maxillofacial Surgery
ISSN 1829-006X
2025; 150–159
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IMMUNOTHERAPY USING BIOSIMILARS IN NEONATES WITH ORAL MUCOSAL AUTOIMMUNE DISEASES: A CONTROLLED PROSPECTIVE ANALYSIS

Vijay Kumar Yadav*, Taseer Bashir, Henadi Alwafi

Deptt of Pediatrics, Mahamaya Rajkiya Allopathic Medical College, Ambedkar Nagar, UP, India · Oral Medicine And Radiology, Batterjee Medical College, Jeddah Saudi Arabia · Saudi Arabia Basic Industries (United States)

Received: 2026-01-07 · Published: 2025-12-30

© 2025 The Author(s) and the original publisher.

CC BY-NC 4.0 This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
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Originally published in Bulletin of Stomatology and Maxillofacial Surgery, 2025 — https://doi.org/10.58240/1829006X-2025.21.12-150.

Original title
IMMUNOTHERAPY USING BIOSIMILARS IN NEONATES WITH ORAL MUCOSAL AUTOIMMUNE DISEASES: A CONTROLLED PROSPECTIVE ANALYSIS
Authors
Vijay Kumar Yadav, Taseer Bashir, Henadi Alwafi
Source journal
Bulletin of Stomatology and Maxillofacial Surgery
Published
2025-12-30
Licence
Creative Commons Attribution-NonCommercial 4.0 International
Original
https://doi.org/10.58240/1829006X-2025.21.12-150

Abstract

Background: Oral mucosal autoimmune diseases (OMADs) in neonates are rare but challenging to manage due to immune immaturity and limited treatment options. Corticosteroids, the standard therapy, are associated with adverse effects and inconsistent long-term outcomes. This study evaluates the efficacy and safety of biosimilar-based immunotherapy as a novel alternative. Objectives: To assess clinical response, biomarker modulation, and relapse-free survival in neonates with OMADs treated with biosimilars compared to those receiving corticosteroids. Methods: A controlled, prospective analysis was conducted involving neonates (n=80) diagnosed with OMADs. Participants were randomized into two groups: biosimilar (n=40) and corticosteroid (n=40) arms. The Neonatal Oral Mucosal Disease Activity Index (NOMDAI), CRP, and IL-6 levels were measured at baseline and day 14. Kaplan–Meier analysis was used to evaluate 12-week relapse-free survival. Safety profiles were recorded throughout the study. Results: The biosimilar group showed a statistically significant reduction in NOMDAI scores (mean Δ-4.2, p < 0.01), CRP, and IL-6 levels by day 14, compared to the corticosteroid group. Kaplan–Meier curves indicated higher relapse-free survival at 12 weeks in the biosimilar group (87.5% vs. 65%, p = 0.03). No severe adverse events were reported in either group. Conclusion: Biosimilar immunotherapy appears to be a safe, effective, and well-tolerated alternative to corticosteroids in neonates with OMADs. The study supports expanding biosimilar use in pediatric autoimmune care, with further research needed to validate long-term outcomes and optimize neonatal immunotherapeutic strategies.
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