Disease activity in women with multiple sclerosis treated with rituximab and natalizumab
ECTRIMS Online Library. Razaz N. 09/12/19; 279137; P777
Neda Razaz
Neda Razaz
Contributions
Abstract

Abstract: P777

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

N. Razaz1, F. Piehl2, K.A. McKay3, K. Fink2

1Clinical Epidemiology Unit, 2Department of Clinical Neuroscience, Karolinska Institutet, Department of Neurology, 3Centre for Molecular Medicine, Department of Clinical Neuroscience, Karolinkska Institute, Stockholm, Sweden

Background: MS predominantly affects women, many of which are in fertile age. Management of relapse risks during pregnancy in the era of highly effective disease modulatory treatments (DMTs) represents a major clinical problem, since risks of disease activation has to be weighed against possible risks for the child and contemporary data is limited for newer MS DMTs.
Objective: To evaluate risks of disease reactivation during pregnancy and postpartum following rituximab (RTX) and natalizumab (NTZ) suspension in women with MS.
Methods: All women with MS disease onset before childbirth from 1987 to 2016 were identified through the Swedish MS Registry, a nationwide quality register, with substratification into two groups:. Women treated with RTX and NTZ within 6 months prior to conception and those who were untreated with any DMTs within 6 months of conception. Relapses were evaluated 1-year pre-pregnancy, during pregnancy, and 1-year postpartum. The association between treatment type and relapse rate during pregnancy and 1-year postpartum was examined using Poisson regression.
Results: We identified 1413 pregnancies in women with MS (mean [standard deviation] age at delivery, 32.5 [4.5] years). Of these, 41 (2.90%) were treated with RTX and 44 (3.11%) with NTZ, and 1328 were untreated within 6 months prior to conception. In the treated cohort, approximately 80% of women resumed a DMT after delivery. The frequency of relapse during pregnancy was 2.4% in the RTX-treated, 13.6% in the NTZ-treated and 8.3% in the untreated pregnancies. Relapse rates 1-year postpartum were also significantly lower in RTX-treated pregnancies compared with the untreated pregnancies (crude rate ratio [RR] 0.07, 95%CI 0.03-0.18) and was also lower in NTZ-treated pregnancies compared with the untreated pregnancies (crude RR 0.31, 95%CI 0.20-0.47). Relapses in the postpartum year were related to relapses in the year prior to conception (p = 0.019); however, relapse rate during pregnancy (p = 0.87) or disease duration (p=0.23) did not predict relapse rates 1-year postpartum.
Conclusions: Disease activity during pregnancy and the postpartum period was lower among women with MS who were treated with rituximab within 6 months of conception, relative to natalizumab-treated and untreated patients. These findings suggest that RTX exerts long acting effects on MS disease activity that encompass pregnancy and post-partum periods.
Disclosure: NR receives funding from the Canadian Institutes of Health Research. KF has received a research grant from Biogen.
FP has received research grants from Biogen, Genzyme, Merck KGaA and Novartis, and fees for serving as Chair of DMC in clinical trials with Parexel.
KAM receives research funding from the European Committee for Treatment and Research in Multiple Sclerosis and the Canadian Institutes of Health Research.

Abstract: P777

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

N. Razaz1, F. Piehl2, K.A. McKay3, K. Fink2

1Clinical Epidemiology Unit, 2Department of Clinical Neuroscience, Karolinska Institutet, Department of Neurology, 3Centre for Molecular Medicine, Department of Clinical Neuroscience, Karolinkska Institute, Stockholm, Sweden

Background: MS predominantly affects women, many of which are in fertile age. Management of relapse risks during pregnancy in the era of highly effective disease modulatory treatments (DMTs) represents a major clinical problem, since risks of disease activation has to be weighed against possible risks for the child and contemporary data is limited for newer MS DMTs.
Objective: To evaluate risks of disease reactivation during pregnancy and postpartum following rituximab (RTX) and natalizumab (NTZ) suspension in women with MS.
Methods: All women with MS disease onset before childbirth from 1987 to 2016 were identified through the Swedish MS Registry, a nationwide quality register, with substratification into two groups:. Women treated with RTX and NTZ within 6 months prior to conception and those who were untreated with any DMTs within 6 months of conception. Relapses were evaluated 1-year pre-pregnancy, during pregnancy, and 1-year postpartum. The association between treatment type and relapse rate during pregnancy and 1-year postpartum was examined using Poisson regression.
Results: We identified 1413 pregnancies in women with MS (mean [standard deviation] age at delivery, 32.5 [4.5] years). Of these, 41 (2.90%) were treated with RTX and 44 (3.11%) with NTZ, and 1328 were untreated within 6 months prior to conception. In the treated cohort, approximately 80% of women resumed a DMT after delivery. The frequency of relapse during pregnancy was 2.4% in the RTX-treated, 13.6% in the NTZ-treated and 8.3% in the untreated pregnancies. Relapse rates 1-year postpartum were also significantly lower in RTX-treated pregnancies compared with the untreated pregnancies (crude rate ratio [RR] 0.07, 95%CI 0.03-0.18) and was also lower in NTZ-treated pregnancies compared with the untreated pregnancies (crude RR 0.31, 95%CI 0.20-0.47). Relapses in the postpartum year were related to relapses in the year prior to conception (p = 0.019); however, relapse rate during pregnancy (p = 0.87) or disease duration (p=0.23) did not predict relapse rates 1-year postpartum.
Conclusions: Disease activity during pregnancy and the postpartum period was lower among women with MS who were treated with rituximab within 6 months of conception, relative to natalizumab-treated and untreated patients. These findings suggest that RTX exerts long acting effects on MS disease activity that encompass pregnancy and post-partum periods.
Disclosure: NR receives funding from the Canadian Institutes of Health Research. KF has received a research grant from Biogen.
FP has received research grants from Biogen, Genzyme, Merck KGaA and Novartis, and fees for serving as Chair of DMC in clinical trials with Parexel.
KAM receives research funding from the European Committee for Treatment and Research in Multiple Sclerosis and the Canadian Institutes of Health Research.

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