Clinically isolated syndrome, oligoclonal bands and multiple sclerosis

Abstract

Objective Clinically isolated syndrome (CIS) is a first demyelinating episode targeting the central nervous system. It can later fulfill the diagnostic criteria for multiple sclerosis (MS) or remain as a single event with no further clinical or paraclinical evidence of disease. Given the difficulty of predicting the long‐term course of the disease at the moment of the first episode, we intended to examine clinical and laboratory features associated with MS conversion, underlining the prognostic value of oligoclonal bands (OCBs) determination. Methods We analyzed patients with an episode compatible with CIS (not fulfilling the 2010 McDonald criteria) as the first manifestation of MS (according to the same criteria), observed in our MS clinic (n = 82). Results From our cohort, 76.8% of patients converted to MS. OCBs were present at baseline in 68.0% of MS patients, but also in 73.7% of stable CIS patients (P = .77). After stratification of the results by treatment, there was also no statistically significant association between the presence of OCBs and conversion to MS. Additionally, positive OCBs did not predict earlier conversion to MS. Conclusions Our study outlines the high prevalence of positive OCBs in patients with CIS, even in those who, until now, do not fulfill the 2010 diagnostic criteria for MS. This raises questions about the early assumption of MS diagnosis based on OCB status. A very hasty diagnosis could result in chronic treatment initiation and a possibly lifelong stigma in patients who might never develop new lesions or have a second attack.

Clinical Validation of a Multi-protein, Serum-based Assay for Disease Activity Assessments in Multiple Sclerosis

“…Detection of early-stage MS remains challenging when using conventional clinical or radiographic assessments. [17][18][19] We believe that the MSDA Test utilizes a well-balanced sensitivity and specificity combination, which can play a key role in the identification of patients with subradiographic and subclinical MS prior to detection of clear clinical or radiographic manifestations. This more sensitive detection will allow for optimal and timely treatment, which can positively impacts patient outcomes.…”

“…15,16 Although the McDonald criteria was recently updated to combine clinical manifestations and radiographic imaging, 15 these criteria do not always accurately predict disease course, activity, progression, recurrence, or treatment response. 13,17,18 To date, there are no validated clinical tests that leverage multiple serum biomarkers to track disease activity or disease progression in patients with MS. As such, there is an unmet need for clinically validated, objective, quantitative tests that can accurately monitor MS disease activity and progression. 14,19 A multi-protein, serum-based biomarker assay was developed to quantitatively measure disease activity using protein concentrations of 18 biomarkers in the serum of patients with all types of MS.…”

“…15, 16 Although the McDonald criteria was recently updated to combine clinical manifestations and radiographic imaging, 15 these criteria do not always accurately predict disease course, activity, progression, recurrence, or treatment response. 13, 17, 18 To date, there are no validated clinical tests that leverage multiple serum biomarkers to track disease activity or disease progression in patients with MS. As such, there is an unmet need for clinically validated, objective, quantitative tests that can accurately monitor MS disease activity and progression. 14, 19…”

Onset of progressive motor impairment in patients with critical central nervous system demyelinating lesions

“…19,20 The cause for the discrepancy in the presence of CSF abnormalities with different clinical courses of MS is unclear. The prevalence of oligoclonal bands across the clinical courses of MS is variable; 64.7% in radiologically isolated syndrome, 21 63%-73.3% in clinically isolated syndrome, [22][23][24] 82%-95% in relapsing remitting MS, 22,25,26 85% in SPMS, 22 and 78%-91.1% in PPMS. 22,27,28 Duration of disease at the time when CSF studies are performed, number of inflammatory attacks, and total CNS lesion burden likely contribute to this, and may explain lower frequency of oligoclonal bands and/or elevated immunoglobulin G (IgG) index in the highly restricted MRI lesion burden group.…”

Analytical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis

“…[10] Nonetheless, use of any of these assessments do not always accurately predict disease activity, course, progression, recurrence, or response to treatment. [11][12][13] As such, there is an unmet clinical need for objective and quantitative measures that can accurately diagnose MS, monitor disease activity, and promote individualized disease management. [13,14] One major area of focus in MS is the identification of biomarkers in biological fluids, such as CSF or blood, to track pathogenesis, disease activity, and progression.…”