Contributions
Abstract: EP1700
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Natalizumab (NTZ) has proved to be highly effective in MS, arresting inflammation and improving clinical outcomes. However, its effect on cognition has been poorly investigated.
Aim of the study: To evaluate the efficacy of natalizumab (NTZ) by incorporating cognitive outcomes (Co) into NEDA (no evidence of disease activity)-3 criteria (NEDA-3/Co). To evaluate at therapy initiation the presence of clinical and neuropsychological parameters that may influence NTZ efficacy.
Methods: NTZ-treated patients were enrolled in a two-year longitudinal study. At therapy initiation, brain MRI, neurological examination by means of the expanded disability status scale (EDSS) and neuropsychological assessment by means of the Brief Repeatable Battery of Neuropsychological Tests (BRB-NT) were performed. Thereafter, EDSS evaluation was performed every 6 months, brain MRI every year and neuropsychological assessment at the end of the follow-up. NEDA-3 was evaluated at the end of follow up and was defined as no evidence of clinical activity (i.e., no relapse and no increase in EDSS= clinically silent patient, CS) and no evidence of MRI activity (i.e., no evidence of new/enlarging T2 lesions, no evidence of gadolinium enhancing lesions= MRI silent patient, MRIS). MS patients with no evidence of cognitive decline (no evidence of cognitive impairment in at least one further item) at year 2 were defined as neuropsychological silent (cognitive silent, CoS) patients.
Results: On May 2017, 123 patients concluded the two-year follow-up: 83% were CS, 80% were CoS and 73% were MRIS. 77 patients (63%) were NEDA-3, and 80.5% of these (62 patients= 50% of the total number) were also NEDA-3/Co. CS, MRIS, CoS and NEDA-3 percentages did not differ between treatment-naïve and previously-treated patients. CoS rates did not matched to CS or MRIS rates. No clinical parameter at baseline was found to predicted NEDA-3/Co. However, normal Word List Generation test at therapy initiation was mildly associated to a higher probability of NEDA-3/Co (OR 4.95, IC95% 1.3-18.8, p< 0.05).
Conclusion: The inclusion of cognitive evaluation into NEDA-3 further proved the high efficacy of NTZ in MS patients. Since cognitive decline in MS is mainly related to cortical grey matter damage, the incorporation of cognitive impairment into NEDA-3 may help to monitor the effect of therapies on the neurodegenerative component of MS.
Disclosure: Federle Lisa has received funding for travel from Novartis, Merck Serono, Biogen Idec, Sanofi-Genzyme, Bayer Schering Pharma, Almirall, Teva and honoraria from MerkSerono, Teva and Almirall. Puthenparampil Marco received travel grant from Novartis, Sanofi-Genzyme, Biogen Idec, Almirall, Teva and Sanofi Aventis and honoraria from Almirall; he has been consultant for Genzyme. Cazzola Chiara has nothing to disclose. Alice Riccardi has received onoraria from Biogen, Novartis, Teva and Merck Serono. Puthenparampil Marco received travel grant from Novartis, Sanofi-Genzyme, Biogen Idec, Almirall, Teva and Sanofi Aventis and honoraria from Almirall; he has been consultant for Genzyme Federle Lisa has received funding for travel from Novartis, Merck Serono, Biogen Idec, Sanofi-Genzyme, Bayer Schering Pharma, Almirall, Teva and honoraria from MerkSerono, Teva and Almirall. Miante Silvia received travel grant form Biogen Idec, Novartis, Sanofi Aventis and Teva Zito Antonio has nothing to disclose. Erica Stropparo has nothing to disclose. Cazzola Chiara has nothing to disclose. Toffanin Elisabetta has nothing to disclose. Ruggiero Susanna has nothing to disclose. Mario Ermani has nothing to disclose. Francesca Grassivaro has nothing to disclose. Davide Poggiali received travel grant from Biogen Idec, Novartis, Sanofi Aventis and Teva. 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: EP1700
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Natalizumab (NTZ) has proved to be highly effective in MS, arresting inflammation and improving clinical outcomes. However, its effect on cognition has been poorly investigated.
Aim of the study: To evaluate the efficacy of natalizumab (NTZ) by incorporating cognitive outcomes (Co) into NEDA (no evidence of disease activity)-3 criteria (NEDA-3/Co). To evaluate at therapy initiation the presence of clinical and neuropsychological parameters that may influence NTZ efficacy.
Methods: NTZ-treated patients were enrolled in a two-year longitudinal study. At therapy initiation, brain MRI, neurological examination by means of the expanded disability status scale (EDSS) and neuropsychological assessment by means of the Brief Repeatable Battery of Neuropsychological Tests (BRB-NT) were performed. Thereafter, EDSS evaluation was performed every 6 months, brain MRI every year and neuropsychological assessment at the end of the follow-up. NEDA-3 was evaluated at the end of follow up and was defined as no evidence of clinical activity (i.e., no relapse and no increase in EDSS= clinically silent patient, CS) and no evidence of MRI activity (i.e., no evidence of new/enlarging T2 lesions, no evidence of gadolinium enhancing lesions= MRI silent patient, MRIS). MS patients with no evidence of cognitive decline (no evidence of cognitive impairment in at least one further item) at year 2 were defined as neuropsychological silent (cognitive silent, CoS) patients.
Results: On May 2017, 123 patients concluded the two-year follow-up: 83% were CS, 80% were CoS and 73% were MRIS. 77 patients (63%) were NEDA-3, and 80.5% of these (62 patients= 50% of the total number) were also NEDA-3/Co. CS, MRIS, CoS and NEDA-3 percentages did not differ between treatment-naïve and previously-treated patients. CoS rates did not matched to CS or MRIS rates. No clinical parameter at baseline was found to predicted NEDA-3/Co. However, normal Word List Generation test at therapy initiation was mildly associated to a higher probability of NEDA-3/Co (OR 4.95, IC95% 1.3-18.8, p< 0.05).
Conclusion: The inclusion of cognitive evaluation into NEDA-3 further proved the high efficacy of NTZ in MS patients. Since cognitive decline in MS is mainly related to cortical grey matter damage, the incorporation of cognitive impairment into NEDA-3 may help to monitor the effect of therapies on the neurodegenerative component of MS.
Disclosure: Federle Lisa has received funding for travel from Novartis, Merck Serono, Biogen Idec, Sanofi-Genzyme, Bayer Schering Pharma, Almirall, Teva and honoraria from MerkSerono, Teva and Almirall. Puthenparampil Marco received travel grant from Novartis, Sanofi-Genzyme, Biogen Idec, Almirall, Teva and Sanofi Aventis and honoraria from Almirall; he has been consultant for Genzyme. Cazzola Chiara has nothing to disclose. Alice Riccardi has received onoraria from Biogen, Novartis, Teva and Merck Serono. Puthenparampil Marco received travel grant from Novartis, Sanofi-Genzyme, Biogen Idec, Almirall, Teva and Sanofi Aventis and honoraria from Almirall; he has been consultant for Genzyme Federle Lisa has received funding for travel from Novartis, Merck Serono, Biogen Idec, Sanofi-Genzyme, Bayer Schering Pharma, Almirall, Teva and honoraria from MerkSerono, Teva and Almirall. Miante Silvia received travel grant form Biogen Idec, Novartis, Sanofi Aventis and Teva Zito Antonio has nothing to disclose. Erica Stropparo has nothing to disclose. Cazzola Chiara has nothing to disclose. Toffanin Elisabetta has nothing to disclose. Ruggiero Susanna has nothing to disclose. Mario Ermani has nothing to disclose. Francesca Grassivaro has nothing to disclose. Davide Poggiali received travel grant from Biogen Idec, Novartis, Sanofi Aventis and Teva. 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.