Contributions
Abstract: 204
Type: Scientific Session
Abstract Category: Therapy - Long-term treatment monitoring
Background: Different randomized clinical trials support the early start of disease modifying therapies (DMTs) in multiple sclerosis (MS). However, there is still an ongoing discussion on the timing of treatment start for achieving the best control on the long term disability progression. The Danish, Italian and Swedish national MS registries, the MSBase and the OFSEP of France merged data for specific projects in the Big Multiple Sclerosis Data (BMSD) Network.
Objectives: to estimate the optimal time to start DMTs to prevent the long-term disability accumulation in MS.
Methods: A cohort of DMT-treated RRMS patients, with ≥10 years follow-up, ≥3 years cumulative DMTs exposure and ≥3 Expanded Disability Status Scale (EDSS) score evaluations was selected from the pooled cohort of the BMSD Network. A set of pairwise (1:1) propensity score (PS) matching analyses, with 10 different cut-offs for early vs delayed treatment (>0.5 year up to >5.0 years, using 0.5 year intervals), have been conducted to allow an unbiased comparison between groups. The logistic model to predict PS included as covariates: age at onset of the disease, sex, baseline EDSS, number of relapses in the 2 years prior DMT start, number of EDSS evaluations, decade of birth, Registry source. To estimate the risk of reaching 12 months-confirmed EDSS progression (EDSSpr), a set of Cox models, adjusted for disease duration and relapses after DMT start as time-dependent covariates, were calculated.
Results: A cohort of 11,871 RRMS patients (Female 71.0%) was retrieved. The median (interquartile range) age at onset was 27.7(22.3-34.6) years, median follow-up was 13.2 (11.4-15.4) years and median time to the first DMT start was 3.8 (1.5-8.5) years. During the follow-up an EDSSpr was reached by 4,138 (34.9%) patients. The lowest hazard ratio (HR) with relative 95% confidence interval (CI) for the PS matched models was obtained by a cutoff of treatment start within 6 months from disease onset (n=873 per group). Early treatment significantly reduced the risk of reaching an EDSSpr (HR (95%CI), 0.72(0.59-0.90); p=0.003). All the subsequent comparisons between early and delayed treatment were not statistically significant.
Conclusions: Real-world data from the BMSD network indicate that the optimal time to start DMTs in MS to prevent the long-term disability accumulation is within 6 months from the disease onset.
Disclosure: This project was supported by Biogen International (Zug, Switzerland) on the basis of a Sponsored Research Agreement in place with the Big MS Data Network.
PI has served on scientific advisory boards for Biogen Idec, Bayer, Teva, Roche, Merck Serono, Novartis and Genzyme and has received funding for travel and/or Speaker honoraria from Sanofi Aventis, Genzyme, Biogen Idec, Teva, Merck Serono and Novartis.
GL has nothing to disclose.
HB received compensation for serving on scientific advisory boards and as a consultant for Biogen, Novartis; speaker honoraria from Biogen Australia, Merck Serono Australia, Novartis Australia; travel support from Biogen Australia, Merck Serono Australia; research support from the CASS Foundation (Australia), Merck Serono Australia, the Royal Melbourne Hospital.
JH has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker's fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from BiogenIdec, Merck-Serono, TEVA, Sanofi-Genzyme and Bayer-Schering. His MS research is funded by the Swedish Research Council and the Swedish Brain Foundation.
RH is an employee of Biogen and holds stock.
NKH Koch-Henriksen has received honoraria for lecturing and participation in advisory councils, travel expenses for attending congresses and meetings and financial support for monitoring the Danish Multiple Sclerosis Treatment Register from Bayer-Schering, Merck Serono, Biogen Idec, Teva, Sanofi-Aventis and Novartis.
MM has served on scientific advisory board for Biogen Idec and Teva and has received honoraria for lecturing from Biogen Idec, Merck Serono, Sanofi-Aventis and Teva. She has received support for congress participation from Biogen Idec, Merck Serono, Novartis and Genzyme.
FP is an employee of Biogen.
TS received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen; speaker honoraria from Novartis.
PSS has served on scientific advisory boards for Merck Serono, Teva, Novartis, Sanofi-Aventis and Biogen Idec and has received research support from Biogen Idec, Novartis and Sanofi-Aventis and received speaker honoraria from Merck Serono, Novartis, Teva, Sanofi-Aventis, Biogen Idecand Genzyme.
SV received consulting and lecturing fees, travel grants and research support from Biogen, Celgene, Genentech, Genzyme, Medday pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi Aventis and Teva Pharma.
MT has served on scientific Advisory Boards for Biogen, Novartis, Roche and Genzyme; has received speaker honoraria and travel support from Biogen Idec, Sanofi-Aventis, Merck Serono, Teva, Genzyme and Novartis; and has received research grants for her Institution from Biogen Idec, Merck Serono and Novartis.
Abstract: 204
Type: Scientific Session
Abstract Category: Therapy - Long-term treatment monitoring
Background: Different randomized clinical trials support the early start of disease modifying therapies (DMTs) in multiple sclerosis (MS). However, there is still an ongoing discussion on the timing of treatment start for achieving the best control on the long term disability progression. The Danish, Italian and Swedish national MS registries, the MSBase and the OFSEP of France merged data for specific projects in the Big Multiple Sclerosis Data (BMSD) Network.
Objectives: to estimate the optimal time to start DMTs to prevent the long-term disability accumulation in MS.
Methods: A cohort of DMT-treated RRMS patients, with ≥10 years follow-up, ≥3 years cumulative DMTs exposure and ≥3 Expanded Disability Status Scale (EDSS) score evaluations was selected from the pooled cohort of the BMSD Network. A set of pairwise (1:1) propensity score (PS) matching analyses, with 10 different cut-offs for early vs delayed treatment (>0.5 year up to >5.0 years, using 0.5 year intervals), have been conducted to allow an unbiased comparison between groups. The logistic model to predict PS included as covariates: age at onset of the disease, sex, baseline EDSS, number of relapses in the 2 years prior DMT start, number of EDSS evaluations, decade of birth, Registry source. To estimate the risk of reaching 12 months-confirmed EDSS progression (EDSSpr), a set of Cox models, adjusted for disease duration and relapses after DMT start as time-dependent covariates, were calculated.
Results: A cohort of 11,871 RRMS patients (Female 71.0%) was retrieved. The median (interquartile range) age at onset was 27.7(22.3-34.6) years, median follow-up was 13.2 (11.4-15.4) years and median time to the first DMT start was 3.8 (1.5-8.5) years. During the follow-up an EDSSpr was reached by 4,138 (34.9%) patients. The lowest hazard ratio (HR) with relative 95% confidence interval (CI) for the PS matched models was obtained by a cutoff of treatment start within 6 months from disease onset (n=873 per group). Early treatment significantly reduced the risk of reaching an EDSSpr (HR (95%CI), 0.72(0.59-0.90); p=0.003). All the subsequent comparisons between early and delayed treatment were not statistically significant.
Conclusions: Real-world data from the BMSD network indicate that the optimal time to start DMTs in MS to prevent the long-term disability accumulation is within 6 months from the disease onset.
Disclosure: This project was supported by Biogen International (Zug, Switzerland) on the basis of a Sponsored Research Agreement in place with the Big MS Data Network.
PI has served on scientific advisory boards for Biogen Idec, Bayer, Teva, Roche, Merck Serono, Novartis and Genzyme and has received funding for travel and/or Speaker honoraria from Sanofi Aventis, Genzyme, Biogen Idec, Teva, Merck Serono and Novartis.
GL has nothing to disclose.
HB received compensation for serving on scientific advisory boards and as a consultant for Biogen, Novartis; speaker honoraria from Biogen Australia, Merck Serono Australia, Novartis Australia; travel support from Biogen Australia, Merck Serono Australia; research support from the CASS Foundation (Australia), Merck Serono Australia, the Royal Melbourne Hospital.
JH has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker's fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from BiogenIdec, Merck-Serono, TEVA, Sanofi-Genzyme and Bayer-Schering. His MS research is funded by the Swedish Research Council and the Swedish Brain Foundation.
RH is an employee of Biogen and holds stock.
NKH Koch-Henriksen has received honoraria for lecturing and participation in advisory councils, travel expenses for attending congresses and meetings and financial support for monitoring the Danish Multiple Sclerosis Treatment Register from Bayer-Schering, Merck Serono, Biogen Idec, Teva, Sanofi-Aventis and Novartis.
MM has served on scientific advisory board for Biogen Idec and Teva and has received honoraria for lecturing from Biogen Idec, Merck Serono, Sanofi-Aventis and Teva. She has received support for congress participation from Biogen Idec, Merck Serono, Novartis and Genzyme.
FP is an employee of Biogen.
TS received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen; speaker honoraria from Novartis.
PSS has served on scientific advisory boards for Merck Serono, Teva, Novartis, Sanofi-Aventis and Biogen Idec and has received research support from Biogen Idec, Novartis and Sanofi-Aventis and received speaker honoraria from Merck Serono, Novartis, Teva, Sanofi-Aventis, Biogen Idecand Genzyme.
SV received consulting and lecturing fees, travel grants and research support from Biogen, Celgene, Genentech, Genzyme, Medday pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi Aventis and Teva Pharma.
MT has served on scientific Advisory Boards for Biogen, Novartis, Roche and Genzyme; has received speaker honoraria and travel support from Biogen Idec, Sanofi-Aventis, Merck Serono, Teva, Genzyme and Novartis; and has received research grants for her Institution from Biogen Idec, Merck Serono and Novartis.