Contributions
Abstract: P987
Type: Poster
Abstract Category: Pathology and pathogenesis of MS - Environmental risk factors
Background: Several studies highlighted the role of 25-hydroxy-vitamin D (VitD) in modulating multiple sclerosis (MS) inflammatory activity. Moreover, higher VitD levels were associated to a better outcome during interferon-beta (IFNb) therapy.
Aim: To investigate the correlation between VitD levels and disease activity under fingolimod (FTY) treatment.
Methods: Relapsing remitting (RR) MS patients who started FTY at San Raffaele (Milan), with VitD serum level at baseline were prospectively followed for 2 years. VitD levels were adjusted for month of blood collection, age and sex. A linear regression analysis was performed considering the annualized relapse rate, the number of new/enlarging T2 lesions and gadolinum enhancing (Gd+) lesions at brain MRI scans performed under FTY, and the NEDA (non-evidence of disease activity) status as outcomes. Categorical analyses using VitD values retrieved from literature were also carried out.
Results: 235 RRMS patients were enrolled. Female:male ratio was 2.3:1, mean age at FTY start was 38.4±9.6 and mean disease duration was 9.9±7.1. Baseline VitD was on average 61.36 nmol/l (10.11-215.1): 95 patients had VitD< 50 nmol/l (Category-1), 83 subjects had values of 50-74.9 nmol/l (Category-2), 35 patients had values of 75-99.9 nmol/l (Category-3) and 22 subjects had VitD>100 nmol/l (Category-4). No linear association was found between baseline VitD levels and the tested clinical outcomes. However, we observed that patients with the higher VitD levels (Category-4) had a lower mean number of new/enlarging T2 lesions at MRI scans performed at baseline, 1 and 2-year compared to Category-1 (p-value=0.008, 0.037 and 0.005 respectively). Similar results were found also when comparing Category-4 to Category-2, where patients had a higher number of new/enlarging T2 lesions at 1 and 2-year MRI (p-value=0.024 and 0.015) and also a higher number of Gd+ lesions at 2-year (p-value=0.04).
Conclusions: In the tested cohort, the mean baseline VitD levels didn"t seem to significantly modulate the clinical and MRI activity under FTY over 2-year follow-up, probably because FTY had already a significant efficacy with 48% of patients being NEDA in our cohort. However, patients with baseline VitD levels in the higher range had lower MRI activity at baseline and during the 2-year follow-up, confirming previous data on IFNb treated patients. Further data are needed to better investigate the effect of Vitamin D in MS patients treated with FTY.
Disclosure: M.A. Rocca received speakers honoraria from Biogen Idec, Novartis, Genzyme, Sanofi-Aventis and Excemed and receives research support from the Italian Ministry of Health and Fondazione Italiana Sclerosi Multipla.
M. Filippi is Editor-in-Chief of the Journal of Neurology; serves on scientific advisory board for Teva Pharmaceutical Industries; has received compensation for consulting services and/or speaking activities from Biogen Idec, Excemed, Novartis, and Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Teva Pharmaceutical Industries, Novartis, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, Cure PSP, Alzheimer´s Drug Discovery Foundation (ADDF), the Jacques and Gloria Gossweiler Foundation (Switzerland), and ARiSLA (Fondazione Italiana di Ricerca per la SLA).
F. Martinelli Boneschi received honoraria for activities with Teva Neuroscienze, Sanofi-Genzyme and Biogen
G. Comi has received compensation for consulting services with the following companies: Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche, Almirall, Chugai, Receptos, Forward Pharma and compensation for speaking activities from Novartis, Teva, Sanofi, Genzyme, Merk, Biogen, Excemed, Roche.
V. Martinelli has received honoraria for consulting and speaking activities from Biogen-Idec, Merck, Bayer, TEVA, Novartis and Genzyme.
F. Esposito received honoraria from TEVA and Merck.
L. Ferre": nothing to disclose.
G. Sferruzza: nothing to disclose.
E. Mascia: nothing to disclose.
F. Clarelli: nothing to disclose.
G. Dalla Costa: nothing to disclose.
M. Radaelli: nothing to disclose.
F. Sangalli: nothing to disclose.
A. Nuara: nothing to disclose.
C. Guaschino: nothing to disclose.
This study is supported by the “Fondazione Italiana Sclerosi Multipla”, project 2013/R/13
Abstract: P987
Type: Poster
Abstract Category: Pathology and pathogenesis of MS - Environmental risk factors
Background: Several studies highlighted the role of 25-hydroxy-vitamin D (VitD) in modulating multiple sclerosis (MS) inflammatory activity. Moreover, higher VitD levels were associated to a better outcome during interferon-beta (IFNb) therapy.
Aim: To investigate the correlation between VitD levels and disease activity under fingolimod (FTY) treatment.
Methods: Relapsing remitting (RR) MS patients who started FTY at San Raffaele (Milan), with VitD serum level at baseline were prospectively followed for 2 years. VitD levels were adjusted for month of blood collection, age and sex. A linear regression analysis was performed considering the annualized relapse rate, the number of new/enlarging T2 lesions and gadolinum enhancing (Gd+) lesions at brain MRI scans performed under FTY, and the NEDA (non-evidence of disease activity) status as outcomes. Categorical analyses using VitD values retrieved from literature were also carried out.
Results: 235 RRMS patients were enrolled. Female:male ratio was 2.3:1, mean age at FTY start was 38.4±9.6 and mean disease duration was 9.9±7.1. Baseline VitD was on average 61.36 nmol/l (10.11-215.1): 95 patients had VitD< 50 nmol/l (Category-1), 83 subjects had values of 50-74.9 nmol/l (Category-2), 35 patients had values of 75-99.9 nmol/l (Category-3) and 22 subjects had VitD>100 nmol/l (Category-4). No linear association was found between baseline VitD levels and the tested clinical outcomes. However, we observed that patients with the higher VitD levels (Category-4) had a lower mean number of new/enlarging T2 lesions at MRI scans performed at baseline, 1 and 2-year compared to Category-1 (p-value=0.008, 0.037 and 0.005 respectively). Similar results were found also when comparing Category-4 to Category-2, where patients had a higher number of new/enlarging T2 lesions at 1 and 2-year MRI (p-value=0.024 and 0.015) and also a higher number of Gd+ lesions at 2-year (p-value=0.04).
Conclusions: In the tested cohort, the mean baseline VitD levels didn"t seem to significantly modulate the clinical and MRI activity under FTY over 2-year follow-up, probably because FTY had already a significant efficacy with 48% of patients being NEDA in our cohort. However, patients with baseline VitD levels in the higher range had lower MRI activity at baseline and during the 2-year follow-up, confirming previous data on IFNb treated patients. Further data are needed to better investigate the effect of Vitamin D in MS patients treated with FTY.
Disclosure: M.A. Rocca received speakers honoraria from Biogen Idec, Novartis, Genzyme, Sanofi-Aventis and Excemed and receives research support from the Italian Ministry of Health and Fondazione Italiana Sclerosi Multipla.
M. Filippi is Editor-in-Chief of the Journal of Neurology; serves on scientific advisory board for Teva Pharmaceutical Industries; has received compensation for consulting services and/or speaking activities from Biogen Idec, Excemed, Novartis, and Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Teva Pharmaceutical Industries, Novartis, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, Cure PSP, Alzheimer´s Drug Discovery Foundation (ADDF), the Jacques and Gloria Gossweiler Foundation (Switzerland), and ARiSLA (Fondazione Italiana di Ricerca per la SLA).
F. Martinelli Boneschi received honoraria for activities with Teva Neuroscienze, Sanofi-Genzyme and Biogen
G. Comi has received compensation for consulting services with the following companies: Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche, Almirall, Chugai, Receptos, Forward Pharma and compensation for speaking activities from Novartis, Teva, Sanofi, Genzyme, Merk, Biogen, Excemed, Roche.
V. Martinelli has received honoraria for consulting and speaking activities from Biogen-Idec, Merck, Bayer, TEVA, Novartis and Genzyme.
F. Esposito received honoraria from TEVA and Merck.
L. Ferre": nothing to disclose.
G. Sferruzza: nothing to disclose.
E. Mascia: nothing to disclose.
F. Clarelli: nothing to disclose.
G. Dalla Costa: nothing to disclose.
M. Radaelli: nothing to disclose.
F. Sangalli: nothing to disclose.
A. Nuara: nothing to disclose.
C. Guaschino: nothing to disclose.
This study is supported by the “Fondazione Italiana Sclerosi Multipla”, project 2013/R/13