Contributions
Abstract: EP1678
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: Cortical lesions (CLs) are typical of multiple sclerosis (MS) and have been recently incorporated into the MRI diagnostic criteria for MS. Up to date no study has included CLs into the “No Evidence of Disease Activity” (NEDA) status.
Objective. We evaluated the occurrence of NEDA3+CLs in relapsing remitting MS (RRMS) patients treated with natalizumab and fingolimod.
Methods: Natalizumab or fingolimod treated RRMS patients were enrolled in a 2-year longitudinal study with clinical and MRI evaluations performed biannually and annually, respectively. MRI examination included the 3D-double inversion recovery (DIR) sequence to detect CLs. NEDA3+CLs condition was evaluated at baseline (T0) and then annually (T1 and T2).
Results: Eighty-six propensity-matched RRMS patients were included in the study. At T2, NEDA3+CLs was achieved in 72.2% of natalizumab and 11.1% of fingolimod treated patients (p< 0.005), as also confirmed by the survival analysis (p< 0.005). This difference was mainly explained by the significantly different impact of treatment on CLs accumulation, namely, 11.1% of natalizumab-treated and 61.1% of fingolimod-treated MS patients presented new CLs (p< 0.005). At T2, but not at T1, the occurrence of new WM lesions was lower in natalizumab- than in fingolimod-treated patients (p< 0.05). NEDA-3 survival analysis disclosed a trend in favour of natalizumab (p=0.070).
Conclusion: The inclusion of CLs in the NEDA status highlighted the higher efficacy of natalizumab compare to fingolimod in suppressing focal demyelinating lesions, especially in the cortex of MS patients.
Disclosure: Puthenparampil Marco received travel grant from Novartis, Almirall, Genzyme, Biogen Idec, Teva and Sanofi Aventis; he has been consultant for Genzyme and Biogen Idec. Federle Lisa reports grants and personal fees from Novartis, grants and personal fees from Genzyme Sanofi, grants and personal fees from Biogen Italia, grants and personal fees from Almirall, grants and personal fees from Teva, grants and personal fees from Merck Serono, outside the submitted work. Cazzola Chiara, Sofia Zywicki and Erica Stropparo have nothing to disclose. Rinaldi Francesca serves as an advisory board member of Biogen-Idec and has received funding for travel and speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Aventis, Teva and Bayer Schering Pharma. Perini Paola has received funding for travel and speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Aventis, and Bayer Schering Pharma and has been consultant for Merck Serono, Biogen Idec and Teva. Gallo Paolo has been a consultant for Bayer Schering, Biogen Idec, Genzyme, Merck Serono and Novartis; has received funding for travel and speaker honoraria from Merck-Serono, Biogen Idec, Sanofi-Aventis, Novartis Pharma and Bayer-Schering Pharma, Teva; has received research support from Bayer, Biogen Idec/Elan, MerkSerono, Genzyme and Teva; and has received research grant from the University of Padova, Veneto Region of Italy, the Italian Association for Multiple Sclerosis, the Italian Ministry of Public Health.
Abstract: EP1678
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: Cortical lesions (CLs) are typical of multiple sclerosis (MS) and have been recently incorporated into the MRI diagnostic criteria for MS. Up to date no study has included CLs into the “No Evidence of Disease Activity” (NEDA) status.
Objective. We evaluated the occurrence of NEDA3+CLs in relapsing remitting MS (RRMS) patients treated with natalizumab and fingolimod.
Methods: Natalizumab or fingolimod treated RRMS patients were enrolled in a 2-year longitudinal study with clinical and MRI evaluations performed biannually and annually, respectively. MRI examination included the 3D-double inversion recovery (DIR) sequence to detect CLs. NEDA3+CLs condition was evaluated at baseline (T0) and then annually (T1 and T2).
Results: Eighty-six propensity-matched RRMS patients were included in the study. At T2, NEDA3+CLs was achieved in 72.2% of natalizumab and 11.1% of fingolimod treated patients (p< 0.005), as also confirmed by the survival analysis (p< 0.005). This difference was mainly explained by the significantly different impact of treatment on CLs accumulation, namely, 11.1% of natalizumab-treated and 61.1% of fingolimod-treated MS patients presented new CLs (p< 0.005). At T2, but not at T1, the occurrence of new WM lesions was lower in natalizumab- than in fingolimod-treated patients (p< 0.05). NEDA-3 survival analysis disclosed a trend in favour of natalizumab (p=0.070).
Conclusion: The inclusion of CLs in the NEDA status highlighted the higher efficacy of natalizumab compare to fingolimod in suppressing focal demyelinating lesions, especially in the cortex of MS patients.
Disclosure: Puthenparampil Marco received travel grant from Novartis, Almirall, Genzyme, Biogen Idec, Teva and Sanofi Aventis; he has been consultant for Genzyme and Biogen Idec. Federle Lisa reports grants and personal fees from Novartis, grants and personal fees from Genzyme Sanofi, grants and personal fees from Biogen Italia, grants and personal fees from Almirall, grants and personal fees from Teva, grants and personal fees from Merck Serono, outside the submitted work. Cazzola Chiara, Sofia Zywicki and Erica Stropparo have nothing to disclose. Rinaldi Francesca serves as an advisory board member of Biogen-Idec and has received funding for travel and speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Aventis, Teva and Bayer Schering Pharma. Perini Paola has received funding for travel and speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Aventis, and Bayer Schering Pharma and has been consultant for Merck Serono, Biogen Idec and Teva. Gallo Paolo has been a consultant for Bayer Schering, Biogen Idec, Genzyme, Merck Serono and Novartis; has received funding for travel and speaker honoraria from Merck-Serono, Biogen Idec, Sanofi-Aventis, Novartis Pharma and Bayer-Schering Pharma, Teva; has received research support from Bayer, Biogen Idec/Elan, MerkSerono, Genzyme and Teva; and has received research grant from the University of Padova, Veneto Region of Italy, the Italian Association for Multiple Sclerosis, the Italian Ministry of Public Health.