ECTRIMS eLearning

Efficacy of natalizumab and fingolimod in multiple sclerosis in real world clinical setting: a 2-year follow-up study
Author(s): ,
R Totaro
Affiliations:
Department of Neurology, San Salvatore Hospital, L'Aquila
,
M Danni
Affiliations:
Department of Neurology, University of Ancona, Ancona
,
P Bellantonio
Affiliations:
Department of Neurology, IRCCS NEUROMED, Pozzilli
,
G Costantino
Affiliations:
Department of Neurology, Ospedali Riuniti di Foggia, Foggia
,
R Cerqua
Affiliations:
Department of Neurology, University of Ancona, Ancona
,
C Di Carmine
Affiliations:
Department of Neurology, San Salvatore Hospital, L'Aquila
,
R Fantozzi
Affiliations:
Department of Neurology, IRCCS NEUROMED, Pozzilli
,
S Sciamanna
Affiliations:
Department of Neurology, San Salvatore Hospital, L'Aquila
,
A Fuiani
Affiliations:
Department of Neurology, Ospedali Riuniti di Foggia, Foggia
,
C Carrocci
Affiliations:
Department of Neurology, San Salvatore Hospital, L'Aquila
,
D Alunni Fegatelli
Affiliations:
Department of Public Health and Infectious Diseases, University of Rome 'Sapienza', Rome
,
A Farcomeni
Affiliations:
Department of Public Health and Infectious Diseases, University of Rome 'Sapienza', Rome
,
D Centonze
Affiliations:
Department of Neurology, IRCCS NEUROMED, Pozzilli
,
C Marini
Affiliations:
University of L'Aquila, L'Aquila, Italy
,
L Provinciali
Affiliations:
Department of Neurology, University of Ancona, Ancona
A Carolei
Affiliations:
University of L'Aquila, L'Aquila, Italy
ECTRIMS Learn. Totaro R. 09/15/16; 146496; P656
Dr. Rocco Totaro
Dr. Rocco Totaro
Contributions
Abstract

Abstract: P656

Type: Poster

Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression

Background and objectives: Although natalizumab and fingolimod are established second-line treatment for multiple sclerosis (MS) patients, to date only few observational studies compared efficacy between the treatments in real clinical setting, while there are still no head-to-head trial comparing their efficacy.

The aim of this multicenter study was to compare the efficacy of natalizumab and fingolimod in relapsing-remitting MS (RR-MS) patients in real-world clinical setting.

Methods: We enrolled 337 patients starting either natalizumab or fingolimod for RR-MS referred to four MS centers between March 2007 and July 2013. Out of 337 patients included, 226 were women and 111 men. Mean age was 36.7±9.4 years and mean duration of the disease was 9.3±6.9 years.

The main end point was the proportion of patients showing disease activity at 2-year follow-up. Disease activity was defined by the occurrence of relapse and/or confirmed Expanded Disability Status Scale (EDSS) progression and/or new or newly enlarging T2 lesions and/or gadolinium enhancing lesions at MRI.

Results: Out of 337 patients, 162 were treated with natalizumab and 175 with fingolimod.

The incidence of disease activity was 25.3% in the natalizumab group and 45.1% in the fingolimod group.

Multivariate logistic regression analysis showed that natalizumab (B=-0.787, P=0.001) and baseline EDSS values (B=-0.315, P=0.008) negatively influenced the probability to present new disease activity. Patients with baseline higher values of EDSS or patients treated with natalizumab had lower incidence of disease activity.

Conclusions: Results from 2-year follow-up of treatment suggest higher efficacy of natalizumab compared to fingolimod in terms of proportion of patients with disease activity.

Disclosure: RT received funding for travel or speaker honoraria from Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi-Aventis, and TEVA.

Abstract: P656

Type: Poster

Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression

Background and objectives: Although natalizumab and fingolimod are established second-line treatment for multiple sclerosis (MS) patients, to date only few observational studies compared efficacy between the treatments in real clinical setting, while there are still no head-to-head trial comparing their efficacy.

The aim of this multicenter study was to compare the efficacy of natalizumab and fingolimod in relapsing-remitting MS (RR-MS) patients in real-world clinical setting.

Methods: We enrolled 337 patients starting either natalizumab or fingolimod for RR-MS referred to four MS centers between March 2007 and July 2013. Out of 337 patients included, 226 were women and 111 men. Mean age was 36.7±9.4 years and mean duration of the disease was 9.3±6.9 years.

The main end point was the proportion of patients showing disease activity at 2-year follow-up. Disease activity was defined by the occurrence of relapse and/or confirmed Expanded Disability Status Scale (EDSS) progression and/or new or newly enlarging T2 lesions and/or gadolinium enhancing lesions at MRI.

Results: Out of 337 patients, 162 were treated with natalizumab and 175 with fingolimod.

The incidence of disease activity was 25.3% in the natalizumab group and 45.1% in the fingolimod group.

Multivariate logistic regression analysis showed that natalizumab (B=-0.787, P=0.001) and baseline EDSS values (B=-0.315, P=0.008) negatively influenced the probability to present new disease activity. Patients with baseline higher values of EDSS or patients treated with natalizumab had lower incidence of disease activity.

Conclusions: Results from 2-year follow-up of treatment suggest higher efficacy of natalizumab compared to fingolimod in terms of proportion of patients with disease activity.

Disclosure: RT received funding for travel or speaker honoraria from Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi-Aventis, and TEVA.

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