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Published on: March 20, 2021
Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a
Ahmed Abdelhak1,2,3, Andre Huss3, Alexander Stahmann4
1Department of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany.
Background:
Defining clinical and subclinical progression in multiple sclerosis (MS) is challenging. Patient history, expanded disability status scale (EDSS), and magnetic resonance imaging (MRI) all have shortcomings and may underestimate disease dynamics. Emerging serum biomarkers such as glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) proved useful in many cross-sectional studies. However, longitudinal data on patients with progressive MS is scarce.
Objectives:
To assess whether the serum biomarkers GFAP and NfL might differentiate between patients with progressive vs. non-progressive disease stages and predict the disease course according to the Lublin criteria.
Methods:
EmBioProMS is a pilot, observational, prospective, multicentric study funded by the German Multiple Sclerosis Society (DMSG). 200 patients with MS according to the 2017 McDonald criteria and history of relapse-independent progression at any time (progressive MS, PMS), younger than 65 years, and with EDSS ≤ 6.5 will be recruited in 6 centres in Germany. At baseline, month 6, and 18, medical history, EDSS, Nine-Hole-Peg-Test (9-HPT), Timed-25-Foot-Walk-Test (T-25FW), Symbol-Digit-Modalities-Test (SDMT), serum GFAP, and NfL, MRI (at least baseline and month 18) and optional optical coherence tomography (OCT) will be performed. Disease progression before and during the study is defined by confirmed EDSS progression, increase by ≥ 20% in 9-HPT or T-25FW time.
Conclusions:
This longitudinal multicentre study will reveal to what extent the prediction of disease progression in patients with PMS will be improved by the analysis of serum biomarkers in conjunction with routine clinical data and neuroimaging measures.
Insights
This study investigates serum biomarkers glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) for predicting multiple sclerosis (MS) progression. Findings will clarify their role alongside clinical data in managing progressive MS.
Area of Science:
- Neuroscience
- Biomarker Research
- Clinical Neurology
Background:
- Defining clinical and subclinical progression in multiple sclerosis (MS) is challenging using traditional methods like Expanded Disability Status Scale (EDSS) and MRI.
- Emerging serum biomarkers, glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL), show promise but require longitudinal validation in progressive MS (PMS).
Purpose of the Study:
- To evaluate if serum GFAP and NfL levels can distinguish between progressive and non-progressive MS stages.
- To assess the predictive power of GFAP and NfL for disease course according to the Lublin criteria.
Main Methods:
- A prospective, multicentric pilot study (EmBioProMS) involving 200 patients with progressive MS.
- Regular assessments include EDSS, neurological tests (9-HPT, T-25FW, SDMT), serum GFAP/NfL, and MRI over 18 months.
- Disease progression defined by confirmed EDSS changes or significant worsening in functional tests.
Main Results:
- Data collection ongoing; results pending.
- This study aims to establish the predictive value of novel biomarkers.
Conclusions:
- The study will determine the extent to which serum biomarkers (GFAP, NfL) enhance the prediction of disease progression in PMS.
- Findings are expected to improve the management of progressive multiple sclerosis by integrating biomarker data with clinical and imaging measures.
