Format

Send to

Choose Destination
Brain Sci. 2019 Sep 27;9(10). pii: E259. doi: 10.3390/brainsci9100259.

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

Author information

1
Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University, 80131 Naples, Italy. moccia.marcello@gmail.com.
2
Medical Affairs Department, Merck, 00176 Rome, Italy. antonio.capacchione@merckgroup.com.
3
Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University, 80131 Naples, Italy. robertalanzillo@libero.it.
4
Neuroimmunology Unit, IRCCS Fondazione Santa Lucia, 00142 Rome, Italy. fortunata.carbone@alice.it.
5
Laboratory of Immunology, Institute of Experimental Endocrinology and Oncology, National Research Council (IEOS-CNR), 80131 Naples, Italy. fortunata.carbone@alice.it.
6
Department of Biology, Federico II University, 80131 Naples, Italy. teresa.micillo2@unina.it.
7
Laboratory of Immunology, Institute of Experimental Endocrinology and Oncology, National Research Council (IEOS-CNR), 80131 Naples, Italy. giuseppe.matarese@unina.it.
8
Treg Cell Lab, Department of Molecular Medicine and Medical Biotechnologies, Federico II University, 80131 Naples, Italy. giuseppe.matarese@unina.it.
9
Department of Primary Care and Public Health, Imperial College, London W68RP, UK. palladino.raffaele@gmail.com.
10
Department of Public Health, Federico II University, 80131 Naples, Italy. palladino.raffaele@gmail.com.
11
Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University, 80131 Naples, Italy. vincenzo.bresciamorra2@unina.it.

Abstract

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.

KEYWORDS:

biomarker; inflammation; multiple sclerosis; oxidative; sample size

PMID:
31569668
DOI:
10.3390/brainsci9100259
Free full text

Supplemental Content

Full text links

Icon for Multidisciplinary Digital Publishing Institute (MDPI)
Loading ...
Support Center