Contributions
Abstract: P722
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Nowadays the risk of progressive multifocal leukoencephalopathy (PML) is stratified in multiple sclerosis (MS) patients treated with natalizumab but disease activity risk after changing versus maintaining natalizumab has not been evaluated.
Objective: To compare no evidence of disease activity (NEDA) when changing versus maintaining natalizumab after stratification of PML risk in MS patients treated with natalizumab.
Patients and methods: All MS patients treated in our MS Unit with natalizumab at least during two years before stratifying their PML risk and followed-up at least one year after that moment were selected. A PML risk stratification moment (STRm) was established: the first time levels of JC virus antibodies were determined for patients with at least two years of treatment. Their treatment after the STRm (natalizumab versus fingolimod after two months of washout) was selected depending on their JC virus status. Clinical (MS relapses, Expanded Disability Status Scale (EDSS) worsening) and Magnetic Resonance Imaging (MRI) data (new T2 and Gadolinium enhancing lesions) were studied. NEDA (no relapses, no EDSS worsening and no brain MRI activity) after one year of follow-up was evaluated.
Results: 84 patients were included, 44 patients (52.4% of the cohort) continued treatment with natalizumab and 40 patients (47.6%) switched to fingolimod. The proportion of NEDA after one year of follow-up was higher in the group maintaining natalizumab (81.8% versus 60%, p< 0.05). There were no significant differences in number of relapses or in proportion of patients having relapses (15.9% with natalizumab vs 25%, p=0.30). Only one patient in each group experienced a one-point EDSS worsening. Regarding MRI, a higher proportion of patients who withdrew natalizumab showed new T2 lesions in comparison with those who maintained treatment (22.5% vs 6.9%, p=0.044) as well as Gadolinium enhancing lesions (25.6% vs 0%, p< 0.001) one year after the STRm. In the multivariate analysis, natalizumab treatment, an older age at onset and a lower number of relapses during the two years before STRm were independent factors for NEDA after one year of STRm.
Conclusion: Patients who withdraw natalizumab due to PML risk have a high risk of no NEDA after one year due to radiological disease activity.
Disclosure:
L.Romero-Pinel received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
E.Matas received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
L.Bau received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
MA Mañé-Martínez received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
A.Cobo-Calvo received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
N.Iranzo received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
I.León received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
M.Jato: nothing to disclose.
JJ.Hernández-Regadera received funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
A. Martínez-Yélamos received received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
S. Martínez-Yélamos received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
Abstract: P722
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Nowadays the risk of progressive multifocal leukoencephalopathy (PML) is stratified in multiple sclerosis (MS) patients treated with natalizumab but disease activity risk after changing versus maintaining natalizumab has not been evaluated.
Objective: To compare no evidence of disease activity (NEDA) when changing versus maintaining natalizumab after stratification of PML risk in MS patients treated with natalizumab.
Patients and methods: All MS patients treated in our MS Unit with natalizumab at least during two years before stratifying their PML risk and followed-up at least one year after that moment were selected. A PML risk stratification moment (STRm) was established: the first time levels of JC virus antibodies were determined for patients with at least two years of treatment. Their treatment after the STRm (natalizumab versus fingolimod after two months of washout) was selected depending on their JC virus status. Clinical (MS relapses, Expanded Disability Status Scale (EDSS) worsening) and Magnetic Resonance Imaging (MRI) data (new T2 and Gadolinium enhancing lesions) were studied. NEDA (no relapses, no EDSS worsening and no brain MRI activity) after one year of follow-up was evaluated.
Results: 84 patients were included, 44 patients (52.4% of the cohort) continued treatment with natalizumab and 40 patients (47.6%) switched to fingolimod. The proportion of NEDA after one year of follow-up was higher in the group maintaining natalizumab (81.8% versus 60%, p< 0.05). There were no significant differences in number of relapses or in proportion of patients having relapses (15.9% with natalizumab vs 25%, p=0.30). Only one patient in each group experienced a one-point EDSS worsening. Regarding MRI, a higher proportion of patients who withdrew natalizumab showed new T2 lesions in comparison with those who maintained treatment (22.5% vs 6.9%, p=0.044) as well as Gadolinium enhancing lesions (25.6% vs 0%, p< 0.001) one year after the STRm. In the multivariate analysis, natalizumab treatment, an older age at onset and a lower number of relapses during the two years before STRm were independent factors for NEDA after one year of STRm.
Conclusion: Patients who withdraw natalizumab due to PML risk have a high risk of no NEDA after one year due to radiological disease activity.
Disclosure:
L.Romero-Pinel received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
E.Matas received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
L.Bau received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
MA Mañé-Martínez received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
A.Cobo-Calvo received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
N.Iranzo received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
I.León received research support, funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
M.Jato: nothing to disclose.
JJ.Hernández-Regadera received funding for travel and congress expenses from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
A. Martínez-Yélamos received received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.
S. Martínez-Yélamos received research support, funding for travel and congress expenses and honoraria from speaking engagements and scientific advisory board from Biogen Idec, Teva Pharmaceutical Industries LTD, Sanofi-Aventis, Novartis, Bayer HealthCare Pharmaceuticals and Merck Serono.