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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.