Contributions
Abstract: P1161
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Both natalizumab (NTZ) and fingolimod (FTY) are highly effective in the treatment of relapsing-remitting MS (RRMS). However, no head-to-head clinical trials have been conducted so far and observational studies comparing the efficacy of the two drugs have produced conflicting results.
Aims: To investigate the efficacy of NTZ and FTY in a cohort of RRMS patients in an observational, retrospective study of prospectively collected data.
Methods: We included all consecutive RRMS patients who started NTZ or FTY in three Italian MS centres with a follow-up till 24 months, collecting clinical (relapses, EDSS score) and brain MRI data. We used propensity score (PS) matching analysis to compare the two treatment groups.
Results: From our database of 281 patients, after 1:1 PS matching, we compared 102 patients in both groups, with similar baseline features. At a 2-year follow-up, both drugs resulted highly effective in reducing annualized relapse rate from 1.35 to 0.21 (NTZ) and from 1.21 to 0.21 (FTY), without significant statistical difference between the two arms (p=ns). The proportion of relapse-free patients was 78.9% with NTZ and 68.5% with FTY (p=ns). At MRI, 2-year combined unique activity was found in 25.0% of patients treated with NTZ and 28.1% of those with FTY (p=ns). The proportion of patients with 6-month confirmed disease progression at 12 and 24 months was 1.0 vs 1.9% and 6.9 vs 3.8% for NTZ vs FTY, respectively (p=ns). We found a higher proportion of patients with confirmed regression of disability in the NTZ group (14.7 vs 3.8%, p=0.008). The percentage of patients with 2-year no evidence of disease activity (NEDA-3) was 54.7% (NTZ) vs 40.0% (FTY) (p=ns).
Conclusions: Both NTZ and FTY were highly effective in our cohort and NTZ was superior in inducing regression of disability.
Disclosure:
E.Curti has served on scientific advisory boards for Merck Serono; has received funding for travel from Biogen, Merck Serono, Novartis and Sanofi Genzyme.
D. Ferraro has received travel grants and/or speaker honararia from Merck Serono, Biogen, TEVA, Novartis, Sanofi-Genzyme.
P. Sola received travel grants and/or speaking honoraria from TEVA, Merck Serono, Biogen, Sanofi-Aventis, Novartis.
F. Granella has received research grants for his Institution from Biogen; has served on scientific advisory boards for Biogen, Novartis, Sanofi Genzyme and Merck Serono; has received funding for travel from Biogen, Merck Serono and Sanofi Genzyme.
E. Tsantes: nothing to disclose.
E. Baldi: nothing to disclose.
L. Caniatti: nothing to disclose.
Abstract: P1161
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Both natalizumab (NTZ) and fingolimod (FTY) are highly effective in the treatment of relapsing-remitting MS (RRMS). However, no head-to-head clinical trials have been conducted so far and observational studies comparing the efficacy of the two drugs have produced conflicting results.
Aims: To investigate the efficacy of NTZ and FTY in a cohort of RRMS patients in an observational, retrospective study of prospectively collected data.
Methods: We included all consecutive RRMS patients who started NTZ or FTY in three Italian MS centres with a follow-up till 24 months, collecting clinical (relapses, EDSS score) and brain MRI data. We used propensity score (PS) matching analysis to compare the two treatment groups.
Results: From our database of 281 patients, after 1:1 PS matching, we compared 102 patients in both groups, with similar baseline features. At a 2-year follow-up, both drugs resulted highly effective in reducing annualized relapse rate from 1.35 to 0.21 (NTZ) and from 1.21 to 0.21 (FTY), without significant statistical difference between the two arms (p=ns). The proportion of relapse-free patients was 78.9% with NTZ and 68.5% with FTY (p=ns). At MRI, 2-year combined unique activity was found in 25.0% of patients treated with NTZ and 28.1% of those with FTY (p=ns). The proportion of patients with 6-month confirmed disease progression at 12 and 24 months was 1.0 vs 1.9% and 6.9 vs 3.8% for NTZ vs FTY, respectively (p=ns). We found a higher proportion of patients with confirmed regression of disability in the NTZ group (14.7 vs 3.8%, p=0.008). The percentage of patients with 2-year no evidence of disease activity (NEDA-3) was 54.7% (NTZ) vs 40.0% (FTY) (p=ns).
Conclusions: Both NTZ and FTY were highly effective in our cohort and NTZ was superior in inducing regression of disability.
Disclosure:
E.Curti has served on scientific advisory boards for Merck Serono; has received funding for travel from Biogen, Merck Serono, Novartis and Sanofi Genzyme.
D. Ferraro has received travel grants and/or speaker honararia from Merck Serono, Biogen, TEVA, Novartis, Sanofi-Genzyme.
P. Sola received travel grants and/or speaking honoraria from TEVA, Merck Serono, Biogen, Sanofi-Aventis, Novartis.
F. Granella has received research grants for his Institution from Biogen; has served on scientific advisory boards for Biogen, Novartis, Sanofi Genzyme and Merck Serono; has received funding for travel from Biogen, Merck Serono and Sanofi Genzyme.
E. Tsantes: nothing to disclose.
E. Baldi: nothing to disclose.
L. Caniatti: nothing to disclose.