Contributions
Abstract: P322
Type: Poster
Abstract Category: Clinical aspects of MS - MS and gender
Background: The long-term effects of pregnancy on the accumulation of disability in relapsing-remitting MS (RRMS) are poorly understood. Past studies report contradictory findings including: worsening of disability, no change, or benefit.
Objective: To determine the effect of pregnancy on 10-year EDSS outcomes in a relapsing-remitting cohort of women who initiated injectable disease-modifying therapy (DMT).
Methods: Using data obtained from MSBase, we identified females with RRMS followed for a minimum 10-years after initiating treatment with their first injectable DMT. Patients were subsequently prospectively monitored on any approved DMT including switches, or no therapy. Median EDSS score changes over a 10-year period were determined. All reported pregnancies, including those that were prematurely terminated, were included in median quantile regression analyses. All analyses were adjusted for age, disease duration, baseline EDSS, DMT use, annualised relapse rate, and location. Sensitivity analyses were performed including propensity score matching on baseline and time-varying covariates.
Results: We identified 1830 females meeting inclusion criteria. 368 pregnancies for 296 females were reported, resulting in 304 live births for 226 women. 223 (61%) of pregnancies were conceived whilst on therapy. Women spent an average 82.5% of the observation period on therapy. EDSS scores increased by a median 1 point (interquartile range (IQR): 0, 2) at 10 years post-baseline. Pregnancies were independently associated with lower EDSS scores over the 10-year observation period (β-coefficient -0.27/term pregnancy; p=0.05). On adjusted analysis, comparing the proportion of follow-up spent pregnant (β-coef -3.17; p=0.01) to that spent on first-line therapy (β-coef -0.71; p< 0.001), we found that pregnancy was 4.5x more therapeutically potent than injectable DMT. Propensity score matching identified 145 women with at least 1 live birth pregnancy matched to 145 women with no pregnancies. Median 10 year EDSS score changes were significantly lower (p=0.029) in the pregnancy group (0.5; IQR: 0,1.5) relative to the no pregnancy group (1; IQR: 0,2).
Conclusion: Our study provides evidence of long-term benefit of pregnancy in women with relapsing-remitting MS who initiated injectable DMT, with a dose-response effect on disability accrual. Further we demonstrate that pregnancy is more effective in preventing disability accrual than first-line DMT in this context.
Disclosure: This investigator-initiated analysis was supported by a project grant from the NHMRC Project Grant [Grant ID 1032484], and an NHMRC Centre for Research Excellence Grant [Grant ID 1001216].
VJ has received conference travel support from Merck, Novartis and speakers honoraria from Novartis and Biogen.
TS received compensation for travel from Biogen.
TK served on scientific advisory boards for Novartis, Merck and Biogen, has received conference travel support and/or speaker honoraria from Novartis, Biogen, Sanofi, Genzyme, Teva and Merck and has received research support from Biogen.
JL has accepted conference travel support from Novartis and has received research support from Biogen.
DH received speaker honoraria and consulting fees from Biogen, Merck Serono, Teva and Novartis, as well as support for research activities from Biogen.
PD served on editorial boards and has been supported to attend meetings by EMDSerono, Biogen, Novartis, Genzyme, and TEVA Neuroscience. He has received funding for investigator-initiated trials from Biogen, Novartis, and Genzyme.
MG received consulting fees from Teva Canada Innovation, Biogen, Novartis and Genzyme Sanofi; lecture payments from Teva Canada Innovation, Novartis and EMD Serono.
AP Nothing to disclose.
GIz received speaking honoraria from Biogen, Novartis, Sanofi, Merck Serono and Teva.
PG is a Novartis, Teva-neuroscience, Biogen and Genzyme advisory board member, consultant for Merck Serono, received payments for lectures by Merck Serono, Teva-Neuroscience, and received grants for travel from Teva-Neuroscience and Novartis.
EP served on scientific advisory boards for Merck Serono, Genzyme and Biogen; he has received honoraria and travel grants from Sanofi, Novartis, Bayer Schering, Biogen, Merck Serono, Genzyme and Teva.
FGM received honoraria or research funding from Biogen, Genzyme, Novartis, and Teva Neurosciences.
FG served on scientific advisory boards for Biogen Idec, Novartis and Sanofi and received funding for travel and speaker honoraria from Biogen Idec and Merck Serono.
PS received travel grants and speaking honoraria from Bayer Schering, Biogen, Merck Serono, Novartis, Sanofi/Genzyme and Teva.
RB received speaker honoraria from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva; research grants from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi, Teva; congress and travel/accommodation expense compensations by Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva
GIu had travel/accommodation/meeting expenses funded by Bayer Schering, Biogen, Merck Serono, Novartis, Sanofi Aventis, and Teva.
DS received honoraria as a consultant on scientific advisory boards by Bayer-Schering, Novartis and Sanofi and compensation for travel from Novartis, Biogen, Sanofi, Teva and Merck-Serono.
SH received honoraria and consulting fees from Novartis, Bayer Schering and Sanofi, and travel grants from Novartis, Biogen Idec and Bayer Schering.
JO serves on scientific advisory boards for Biogen, Genzyme and Novartis; has received speaker honoraria from Biogen, Bayer-Schering, Genzyme, Merck-Serono, Novartis and Teva and research grants from Biogen, Merck Serono, Novartis and Teva.
FV is an advisory board member for Teva Biogen Merck Serono and Novartis.
PMC Nothing to disclose.
CR received speaker honoraria from Bayer Schering, Novartis and Biogen, congress and travel expense compensations from Biogen, Teva, Merck Serono and Bayer Schering.
JLS accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support from Bayer Health Care, Biogen, Genzyme Sanofi, Merck Serono, Novartis and Teva.
SH Unrestricted educational grant from Merck Serono and travel grants from Biogen Idec, Genzyme, Novartis and Sanofi.
MLS Nothing to disclose.
AL is a Bayer, Biogen, Genzyme, Merck Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen, Merck, Novartis, Sanofi, and Teva. Her institution received research grants from Bayer, Biogen, Merck, Novartis, Sanofi, and Teva.
MT received speaker honoraria from Biogen-Idec, Bayer-Schering, Sanofi, Merck-Serono, Teva, and Novartis; has received research grants for her Institution from Biogen-Idec, Merck-Serono, and Novartis.
HB served on scientific advisory boards for Biogen, Novartis and Sanofi and has received conference travel support from Novartis, Biogen and Sanofi. He serves on steering committees for trials conducted by Biogen and Novartis, and has received research support from Merck Serono, Novartis and Biogen.
We would also like to acknowledge the MSBase Foundation for its support of this project. The MSBase Foundation is an independent not for profit organisation which receives support in the form of grants from the National Health and Medical Research Council (NHMRC) Australia, Merck, Merck Serono, Biogen, Novartis, and Genzyme a Sanofi company.
Abstract: P322
Type: Poster
Abstract Category: Clinical aspects of MS - MS and gender
Background: The long-term effects of pregnancy on the accumulation of disability in relapsing-remitting MS (RRMS) are poorly understood. Past studies report contradictory findings including: worsening of disability, no change, or benefit.
Objective: To determine the effect of pregnancy on 10-year EDSS outcomes in a relapsing-remitting cohort of women who initiated injectable disease-modifying therapy (DMT).
Methods: Using data obtained from MSBase, we identified females with RRMS followed for a minimum 10-years after initiating treatment with their first injectable DMT. Patients were subsequently prospectively monitored on any approved DMT including switches, or no therapy. Median EDSS score changes over a 10-year period were determined. All reported pregnancies, including those that were prematurely terminated, were included in median quantile regression analyses. All analyses were adjusted for age, disease duration, baseline EDSS, DMT use, annualised relapse rate, and location. Sensitivity analyses were performed including propensity score matching on baseline and time-varying covariates.
Results: We identified 1830 females meeting inclusion criteria. 368 pregnancies for 296 females were reported, resulting in 304 live births for 226 women. 223 (61%) of pregnancies were conceived whilst on therapy. Women spent an average 82.5% of the observation period on therapy. EDSS scores increased by a median 1 point (interquartile range (IQR): 0, 2) at 10 years post-baseline. Pregnancies were independently associated with lower EDSS scores over the 10-year observation period (β-coefficient -0.27/term pregnancy; p=0.05). On adjusted analysis, comparing the proportion of follow-up spent pregnant (β-coef -3.17; p=0.01) to that spent on first-line therapy (β-coef -0.71; p< 0.001), we found that pregnancy was 4.5x more therapeutically potent than injectable DMT. Propensity score matching identified 145 women with at least 1 live birth pregnancy matched to 145 women with no pregnancies. Median 10 year EDSS score changes were significantly lower (p=0.029) in the pregnancy group (0.5; IQR: 0,1.5) relative to the no pregnancy group (1; IQR: 0,2).
Conclusion: Our study provides evidence of long-term benefit of pregnancy in women with relapsing-remitting MS who initiated injectable DMT, with a dose-response effect on disability accrual. Further we demonstrate that pregnancy is more effective in preventing disability accrual than first-line DMT in this context.
Disclosure: This investigator-initiated analysis was supported by a project grant from the NHMRC Project Grant [Grant ID 1032484], and an NHMRC Centre for Research Excellence Grant [Grant ID 1001216].
VJ has received conference travel support from Merck, Novartis and speakers honoraria from Novartis and Biogen.
TS received compensation for travel from Biogen.
TK served on scientific advisory boards for Novartis, Merck and Biogen, has received conference travel support and/or speaker honoraria from Novartis, Biogen, Sanofi, Genzyme, Teva and Merck and has received research support from Biogen.
JL has accepted conference travel support from Novartis and has received research support from Biogen.
DH received speaker honoraria and consulting fees from Biogen, Merck Serono, Teva and Novartis, as well as support for research activities from Biogen.
PD served on editorial boards and has been supported to attend meetings by EMDSerono, Biogen, Novartis, Genzyme, and TEVA Neuroscience. He has received funding for investigator-initiated trials from Biogen, Novartis, and Genzyme.
MG received consulting fees from Teva Canada Innovation, Biogen, Novartis and Genzyme Sanofi; lecture payments from Teva Canada Innovation, Novartis and EMD Serono.
AP Nothing to disclose.
GIz received speaking honoraria from Biogen, Novartis, Sanofi, Merck Serono and Teva.
PG is a Novartis, Teva-neuroscience, Biogen and Genzyme advisory board member, consultant for Merck Serono, received payments for lectures by Merck Serono, Teva-Neuroscience, and received grants for travel from Teva-Neuroscience and Novartis.
EP served on scientific advisory boards for Merck Serono, Genzyme and Biogen; he has received honoraria and travel grants from Sanofi, Novartis, Bayer Schering, Biogen, Merck Serono, Genzyme and Teva.
FGM received honoraria or research funding from Biogen, Genzyme, Novartis, and Teva Neurosciences.
FG served on scientific advisory boards for Biogen Idec, Novartis and Sanofi and received funding for travel and speaker honoraria from Biogen Idec and Merck Serono.
PS received travel grants and speaking honoraria from Bayer Schering, Biogen, Merck Serono, Novartis, Sanofi/Genzyme and Teva.
RB received speaker honoraria from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva; research grants from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi, Teva; congress and travel/accommodation expense compensations by Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva
GIu had travel/accommodation/meeting expenses funded by Bayer Schering, Biogen, Merck Serono, Novartis, Sanofi Aventis, and Teva.
DS received honoraria as a consultant on scientific advisory boards by Bayer-Schering, Novartis and Sanofi and compensation for travel from Novartis, Biogen, Sanofi, Teva and Merck-Serono.
SH received honoraria and consulting fees from Novartis, Bayer Schering and Sanofi, and travel grants from Novartis, Biogen Idec and Bayer Schering.
JO serves on scientific advisory boards for Biogen, Genzyme and Novartis; has received speaker honoraria from Biogen, Bayer-Schering, Genzyme, Merck-Serono, Novartis and Teva and research grants from Biogen, Merck Serono, Novartis and Teva.
FV is an advisory board member for Teva Biogen Merck Serono and Novartis.
PMC Nothing to disclose.
CR received speaker honoraria from Bayer Schering, Novartis and Biogen, congress and travel expense compensations from Biogen, Teva, Merck Serono and Bayer Schering.
JLS accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support from Bayer Health Care, Biogen, Genzyme Sanofi, Merck Serono, Novartis and Teva.
SH Unrestricted educational grant from Merck Serono and travel grants from Biogen Idec, Genzyme, Novartis and Sanofi.
MLS Nothing to disclose.
AL is a Bayer, Biogen, Genzyme, Merck Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen, Merck, Novartis, Sanofi, and Teva. Her institution received research grants from Bayer, Biogen, Merck, Novartis, Sanofi, and Teva.
MT received speaker honoraria from Biogen-Idec, Bayer-Schering, Sanofi, Merck-Serono, Teva, and Novartis; has received research grants for her Institution from Biogen-Idec, Merck-Serono, and Novartis.
HB served on scientific advisory boards for Biogen, Novartis and Sanofi and has received conference travel support from Novartis, Biogen and Sanofi. He serves on steering committees for trials conducted by Biogen and Novartis, and has received research support from Merck Serono, Novartis and Biogen.
We would also like to acknowledge the MSBase Foundation for its support of this project. The MSBase Foundation is an independent not for profit organisation which receives support in the form of grants from the National Health and Medical Research Council (NHMRC) Australia, Merck, Merck Serono, Biogen, Novartis, and Genzyme a Sanofi company.