Review Article
Ozanimod Therapy in Inflammatory Bowel Disease: From Concept to Real-world Application and Practical Considerations for Clinical Practice
Issue:
Volume 13, Issue 4, December 2025
Pages:
77-89
Received:
29 September 2025
Accepted:
28 October 2025
Published:
3 December 2025
Abstract: Background: Ozanimod, a selective sphingosine-1-phosphate (S1P) receptor modulator, represents the first-in-class oral small molecule therapy approved for ulcerative colitis (UC), marking a paradigm shift in inflammatory bowel disease (IBD) management. Objective: To comprehensively review ozanimod therapy in IBD, evaluating its mechanism of action, clinical efficacy, safety profile, real-world experience, and practical implementation considerations through systematic analysis of available evidence. Methods: A systematic literature review was conducted using verified clinical trial data, observational studies, and regulatory documents from January 2016 to August 2025. Studies included randomized controlled trials, real-world evidence publications, safety analyses, and mechanistic studies. Key search terms included "ozanimod," "S1P receptor modulator," "ulcerative colitis," "Crohn's disease," and "inflammatory bowel disease." Results: Analysis of clinical trials revealed that ozanimod demonstrated significant efficacy in phase 3 UC trials, with clinical remission rates of 18.4% versus 6.0% (placebo) at week 10 and 37.0% versus 18.5% at week 52. Advanced therapy-naive patients showed enhanced responses (56% vs 39% symptomatic response by week 2). Real-world studies confirmed effectiveness in treatment-refractory populations with clinical response rates of 44-58% at week 10. The safety profile was favorable with predictable adverse events and no new safety signals in long-term follow-up. Conclusions: Ozanimod represents a significant advancement in IBD therapy, offering an oral, well-tolerated treatment option with unique mechanism of action. Enhanced efficacy in treatment-naive patients supports early positioning in treatment algorithms before biologics.
Abstract: Background: Ozanimod, a selective sphingosine-1-phosphate (S1P) receptor modulator, represents the first-in-class oral small molecule therapy approved for ulcerative colitis (UC), marking a paradigm shift in inflammatory bowel disease (IBD) management. Objective: To comprehensively review ozanimod therapy in IBD, evaluating its mechanism of action,...
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Research Article
Kappa Free Light Chain Index as a Diagnostic Biomarker in Multiple Sclerosis: Validation in an Argentinian Cohort and Cut off Proposal
Silvia Graciela Ramos*,
Andrés Maria Villa,
Analisa Manin,
Viviana Novoa,
Claudio Aranda
Issue:
Volume 13, Issue 4, December 2025
Pages:
90-95
Received:
24 November 2025
Accepted:
6 December 2025
Published:
29 December 2025
DOI:
10.11648/j.iji.20251304.12
Downloads:
Views:
Abstract: Background: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS). Cerebrospinal fluid (CSF) analysis, including oligoclonal bands (OCB) and the IgG index, is central to MS diagnosis but presents technical and interpretative limitations. The kappa free light chain (κFLC) index has emerged as a promising biomarker of intrathecal immunoglobulin synthesis. Objective: To evaluate the diagnostic performance of the κFLC index in MS, determine an optimal cutoff value, and compare its accuracy with OCB detection and the IgG index. Methods: We conducted a retrospective study including 176 patients evaluated at the Neuroimmunology Laboratory of Buenos Aires, Argentina. Patients were classified into four groups: MS (n = 106), neuromyelitis optica spectrum disorders (NMOSD, n = 15), other inflammatory CNS disorders of autoimmune or infectious origin (ICNSDAI, n = 41), and paraneoplastic neurological syndromes (PNS, n = 14). κFLC, IgG, and albumin concentrations were measured in paired CSF and serum samples. The κFLC index was calculated and compared with OCB and IgG index results. Diagnostic performance was assessed using receiver operating characteristic (ROC) curve analysis. Results: The κFLC index was significantly higher in MS patients (median: 85; IQR: 30–305) compared with NMOSD (3.37), ICNSDAI (1.62), and PNS (1.96) groups (p < 0.0001). A κFLC index cutoff of 15 demonstrated 92% sensitivity and 83% specificity, with an area under the ROC curve of 0.952. The κFLC index correlated with the IgG index (ρ = 0.587, p < 0.0001) and OCB positivity (ρ = 0.586, p < 0.0001). κFLC index values ≥100 were observed almost exclusively in MS, with one exception in a patient with acute HSV-1 encephalitis. Conclusion: The κFLC index is a sensitive and reliable biomarker for intrathecal immunoglobulin synthesis in MS, offering advantages of automation, rapid processing, and objective quantification. External validation in independent cohorts is required before routine clinical implementation.
Abstract: Background: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS). Cerebrospinal fluid (CSF) analysis, including oligoclonal bands (OCB) and the IgG index, is central to MS diagnosis but presents technical and interpretative limitations. The kappa free light chain (κFLC) index has emerged as a p...
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,
Omesh Goyal*
