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Open AccessArticle

Sample Size for Oxidative Stress and Inflammation When Treating Multiple Sclerosis with Interferon-β1a and Coenzyme Q10

1
Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University, 80131 Naples, Italy
2
Medical Affairs Department, Merck, 00176 Rome, Italy
3
Neuroimmunology Unit, IRCCS Fondazione Santa Lucia, 00142 Rome, Italy
4
Laboratory of Immunology, Institute of Experimental Endocrinology and Oncology, National Research Council (IEOS-CNR), 80131 Naples, Italy
5
Department of Biology, Federico II University, 80131 Naples, Italy
6
Treg Cell Lab, Department of Molecular Medicine and Medical Biotechnologies, Federico II University, 80131 Naples, Italy
7
Department of Primary Care and Public Health, Imperial College, London W68RP, UK
8
Department of Public Health, Federico II University, 80131 Naples, Italy
*
Author to whom correspondence should be addressed.
Brain Sci. 2019, 9(10), 259; https://doi.org/10.3390/brainsci9100259
Received: 23 August 2019 / Revised: 23 September 2019 / Accepted: 25 September 2019 / Published: 27 September 2019
(This article belongs to the Special Issue Advances in Multiple Sclerosis Research)
Studying multiple sclerosis (MS) and its treatments requires the use of biomarkers for underlying pathological mechanisms. We aim to estimate the required sample size for detecting variations of biomarkers of inflammation and oxidative stress. This is a post-hoc analysis on 60 relapsing-remitting MS patients treated with Interferon-β1a and Coenzyme Q10 for 3 months in an open-label crossover design over 6 months. At baseline and at the 3 and 6-month visits, we measured markers of scavenging activity, oxidative damage, and inflammation in the peripheral blood (180 measurements). Variations of laboratory measures (treatment effect) were estimated using mixed-effect linear regression models (including age, gender, disease duration, baseline expanded disability status scale (EDSS), and the duration of Interferon-β1a treatment as covariates; creatinine was also included for uric acid analyses), and were used for sample size calculations. Hypothesizing a clinical trial aiming to detect a 70% effect in 3 months (power = 80% alpha-error = 5%), the sample size per treatment arm would be 1 for interleukin (IL)-3 and IL-5, 4 for IL-7 and IL-2R, 6 for IL-13, 14 for IL-6, 22 for IL-8, 23 for IL-4, 25 for activation-normal T cell expressed and secreted (RANTES), 26 for tumor necrosis factor (TNF)-α, 27 for IL-1β, and 29 for uric acid. Peripheral biomarkers of oxidative stress and inflammation could be used in proof-of-concept studies to quickly screen the mechanisms of action of MS treatments. View Full-Text
Keywords: multiple sclerosis; inflammation; oxidative; biomarker; sample size multiple sclerosis; inflammation; oxidative; biomarker; sample size
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MDPI and ACS Style

Moccia, M.; Capacchione, A.; Lanzillo, R.; Carbone, F.; Micillo, T.; Matarese, G.; Palladino, R.; Brescia Morra, V. Sample Size for Oxidative Stress and Inflammation When Treating Multiple Sclerosis with Interferon-β1a and Coenzyme Q10. Brain Sci. 2019, 9, 259.

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