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Lanzillo R.,University of Naples Federico II | Quarantelli M.,National Research Council Italy | Quarantelli M.,University of Naples Federico II | Bonavita S.,The Second University of Naples | And 8 more authors.
Acta Neurologica Scandinavica | Year: 2012

Background- No head-to-head study has been performed yet to assess whether natalizumab is more effective than classical immunomodulators in multiple sclerosis (MS). Aim- To retrospectively compare the efficacy of natalizumab vs IFN beta 1a SC (44μg; Rebif®) on clinical and radiological findings in two matched cohorts of patients with MS. Patients and methods- We retrospectively enrolled two cohorts of 42 patients (F/M: 35/7) with relapsing-remitting multiple sclerosis treated with natalizumab or IFN beta 1a for at least 12 consecutive months. Outcome measures were annualized relapse rate (ARR), changes in expanded disability status scale (EDSS) score, and number of contrast-enhancing lesions (CELs) at magnetic resonance imaging (MRI). Results- In both groups, the ARR in the 12months of treatment was lower than in the 12months before therapy (0.24 vs 1.50 in natalizumab-treated group, P<0.0000; 0.55 vs 1.10 in IFN beta 1a-treated group, P=0.0006), being the effect of natalizumab significantly stronger (P=0.0125). EDSS reduction was significantly different between the two groups in favor of natalizumab (P=0.0018). The frequency and number of CELs per patient were decreased in both groups. In the second year, the treatment affected ARR and EDSS progression in the two groups of patients similarly to the first year, whereas number of CELs decreased more significantly in natalizumab group (P=0.008). Conclusions- After 12 and 24months of therapy, natalizumab was more effective than IFN beta 1a SC on both disease activity and disability progression. Prospective head-to-head studies would be helpful to further evaluate the differences observed in the MRI outcomes. © 2011 John Wiley & Sons A/S.


Lanzillo R.,University of Naples Federico II | Bonavita S.,The Second University of Naples | Quarantelli M.,University of Naples Federico II | Quarantelli M.,National Research Council Italy | And 8 more authors.
Neurological Sciences | Year: 2013

Natalizumab is one option for multiple sclerosis patients responding poorly to classical immunomodulators, but pilot studies did not point to its effectiveness as a second-line therapy. Aim of this study was to assess the efficacy of natalizumab as second-line therapy in patients switching from disease modifying therapies (DMTs) in a clinical setting. We retrospectively selected patients who had been treated with natalizumab for at least 12 months after switching from one or more DMTs. We collected clinical and neuroradiological data and we analysed the reduction in annualised relapse rate (ARR), the change of Expanded Disability Status Scale (EDSS) and the reduction of contrast-enhancing lesions (CELs) at magnetic resonance imaging (MRI) of the brain at 12 months of natalizumab and of previous DMT therapy. Fifty patients were included in the analysis (11 males, 39 females).We observed a reduction of ARR on natalizumab (p = 0.000) and a statistically significant different trend of relapse event between the two treatments (p = 0.0149). EDSS was stable during natalizumab therapy whilst it showed an increase on DMTs (p = 0.0244). The number of CELs decreased significantly (p = 0.006) during the 12 months of treatment with natalizumab, whilst it was stable on DMTs. Natalizumab showed to decrease ARR, stabilize EDSS, increase the percentage of CELs free patients and decrease the number of CELs in a group of 50 poor responders to classical DMT, after the first 12 months of therapy. © 2012 Springer-Verlag.

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