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Plasma neurofilament light chain to evaluate response during cladribine treatment in multiple sclerosis
Valerio Nicolella1, Marco Varelli2, Stefania Fasano2
1Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University of Naples, Naples, Italy.
Introduction:
Cladribine treatment in year 1 and 2 provides high efficacy on multiple sclerosis(MS) outcomes over 4 years. Use of biomarkers of neuro-axonal damage, such as plasma neurofilament light chain (pNfL), might support prognostication and treatment decisions.
Objectives:
To:1)investigate pNfL variations over time in people with MS(pwMS) treated with cladribine;2)compare pNfL levels during cladribine treatment to age- and sex-matched controls;3) assess pNfL prediction on clinical and radiological outcomes.
Methods:
This retrospective analysis of longitudinally-collected data included 258 pwMS treated with cladribine and 304 age and sex-matched controls. During follow-up,in pwMS,we collected evidence of disease activity (EDA3).
Results:
When compared with pNfL before or in the first 3 months of treatment,pNfL was lower between 3 and 12 months(Coeff = -182.05; 95 %CI = -303.73, -60.36; p = 0.004), between 12 and 24 months (Coeff = -149.98; 95 %CI = -272.41, -27.55; p = 0.017) and after 24 months from the first cladribine dosing (Coeff = -280.32; 95 %CI = -280.32,-29.86; p = 0.016). When compared with controls,pNfL was higher in pwMS before or in the first 3 months of cladribine treatment(Coeff = 7.43; 95 %CI = 2.45, 12.40; p = 0.004), but was similar between 3 and 12 months(Coeff = -1.04; 95 %CI = -3.36, 1.27; p- = 0.376), between 12 and 24 months(Coeff = 1.48; 95 %CI = -0.60, 3.55; p = 0.162) and after 24 months(Coeff = 2.23; 95 %CI = -0.47, 5.08; p = 0.103). We observed no significant associations between baseline pNfL and EDA(11 patients,4.26 %).
Conclusions:
Cladribine significantly reduced pNfL levels, which stabilized at values comparable to matched healthy controls, confirming its strong efficacy with minimal disease activity during follow-up.
