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Lanzillo, R., Quarantelli, M., Pozzilli, C., Trojano, M., Amato, M.P., Marrosu, M.G., Francia, A., Florio, C., Orefice, G., Tedeschi, G., Bellantonio, P., Annunziata, P., Grimaldi, L.M., Comerci, M., Brunetti, A., Bonavita, V., Alfano, B., Marini, S., Brescia Morra, V.
No evidence for an effect on brain atrophy rate of atorvastatin add-on to interferon β1b therapy in relapsing-remitting multiple sclerosis (the ARIANNA study)
(2016) Multiple Sclerosis, 22 (9), pp. 1163-1173. 
https://www.scopus.com/inward/record.uri?eid=2-s2.0-84979581719&partnerID=40&md5=1efece7e8bacbab087d89b4901da92df
DOI: 10.1177/1352458515611222
AFFILIATIONS: Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Via Pansini 5, Italy; 
National Research Council (CNR), Biostructure and Bioimaging Institute (IBB), Naples Multiple Sclerosis Centre, Italy; 
Department of Neurology and Psychiatry, Sapienza University, Italy; 
Department of Neurosciences and Organs of Senses, University of Bari, Italy; 
Department of NEUROFARBA, University of Florence, Italy; 
Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Italy; 
Multiple Sclerosis Regional Center, Azienda Ospedaliera Antonio Cardarelli, Italy; 
Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Second University of Naples, Italy; 
IRCCS Neuromed-Pozzilli (IS), Italy; 
Department of Neurological, Neurosurgical and Behavioural Sciences, University of Siena, Italy; 
Neurology Unit, Fondazione Istituto San Raffaele G. Giglio, Italy; 
Department of Biomedical Advanced Sciences, Federico II University, Italy; 
IDC Hermitage Capodimonte, Italy; 
Dimensione Ricerca S.r.l., Italy
ABSTRACT: Background: A previous phase 2 trial has suggested that statins might delay brain atrophy in secondary progressive multiple sclerosis. Objectives: The objective of this study was to evaluate the effect of atorvastatin add-on therapy on cerebral atrophy in relapsing-remitting multiple sclerosis. Methods: This randomised, placebo-controlled study compared atorvastatin 40 mg or placebo add-on therapy to interferon β1b for 24 months. Brain magnetic resonance imaging, multiple sclerosis functional composite score, Rao neuropsychological battery and expanded disability status scale were evaluated over 24 months. Results: A total of 154 patients were randomly assigned, 75 in the atorvastatin and 79 in the placebo arms, with a comparable drop-out rate (overall 23.4%). Brain atrophy over 2 years was not different in the two arms (-0.38% and -0.32% for the atorvastatin and placebo groups, respectively). Relapse rate, expanded disability status scale, multiple sclerosis functional composite score or cognitive changes were not different in the two arms. Patients withdrawing from the study had a higher number of relapses in the previous 2 years (P=0.04) and a greater probability of relapsing within 12 months. Conclusions: Our results suggest that the combination of atorvastatin and interferon β1b is not justified in early relapsing-remitting multiple sclerosis and adds to the body of evidence indicating an absence of significant radiological and clinical benefit of statins in relapsing-remitting multiple sclerosis. © SAGE Publications.
CORRESPONDENCE ADDRESS: Lanzillo, R.; Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Via Pansini 5, Italy; email: robertalanzillo@libero.it

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Signoriello, E.a , Lanzillo, R.b , Brescia Morra, V.b , Di Iorio, G.a , Fratta, M.a , Carotenuto, A.b , Lus, G.a 
Lymphocytosis as a response biomarker of natalizumab therapeutic efficacy in multiple sclerosis
(2016) Multiple Sclerosis, 22 (7), pp. 921-925. 
https://www.scopus.com/inward/record.uri?eid=2-s2.0-84973455035&partnerID=40&md5=b9ac703c0418eba67b06124f01293f1b
DOI: 10.1177/1352458515604381
AFFILIATIONS: aMultiple Sclerosis Center, II Division of Neurology, Department of Clinical and Experimental Medicine, Second University of Naples, via Pansini 5, Naples, Italy; 
bDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University-School of Medicine, Italy
ABSTRACT: Background: Natalizumab is an effective therapy in relapsing-remitting multiple sclerosis (RRMS), as it reduces lymphocyte transmigration through the blood-brain barrier (BBB) and induces lymphocytosis. Objectives: To analyse natalizumab-induced lymphocytosis (NIL) as a biomarker of drug efficacy. Materials and methods: We enrolled 50 relapsing-remitting (RR) and progressive-relapsing (PR) natalizumab-treated patients who had received at least 16 infusions and had been tested for lymphocyte count 24 hours before each administration. Clinical, MRI and hematological data were collected. Patients were divided into responders and sub-optimal responders according to the experience of at least one clinical and/or instrumental relapse during the treatment. Results: In 15 (30%) patients, an instrumental/clinical (14) or only instrumental (one) relapse occurred. We found a statistically significant difference in the mean percentage of the lymphocytes between the two groups over the first ten administrations (p=0.04). The comparison between the time-to-relapse in the groups with high and low levels of lymphocytes showed that the group with a low NIL had a greater risk of relapse (p=0.03). Conclusions: We suggest that NIL could be a biomarker of therapeutic efficacy in patients with RRMS treated with natalizumab, and that the risk of relapse may be higher in patients with a lower-than-expected NIL. © SAGE Publications.
AUTHOR KEYWORDS: Biomarkers;  multiple sclerosis;  Natalizumab
DOCUMENT TYPE: Article