Rituximab, multiple sclerosis and pregnancy
ECTRIMS Online Library. Fink K. 09/11/19; 278774; P413
Katharina Fink
Katharina Fink
Contributions
Abstract

Abstract: P413

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

K. Fink1,2,3, A. Gorczyca1, J. Smith4, F. Piehl1,2,3, A. Langer-Gould4

1Karolinska University Hospital | Department of Clinical Neuroscience, Karolinska Institutet, 2Department of Neurology, Karolinska University Hospital, 3Centre for Neurology, Academic Specialist Center, Stockholm, Sweden, 4Clinical and Translational Neuroscience, Southern California Permanente Medical Group, Kaiser Permanente, Pasadena, CA, United States

Background: Women with highly active multiple sclerosis (MS) who desire pregnancy have limited safe and effective treatment options. Fingolimod (FNG) is a weak teratogen and natalizumab (NAT) use during pregnancy can result in neonatal cytopenias. However, stopping FNG or NAT can result in rebound relapses during pregnancy. Due to long lasting immunomodulatory effects extending beyond drug elimination, rituximab (RTX) is an attractive treatment for women with MS planning pregnancy.
Objective: To describe the efficacy and safety of RTX in women with MS who became pregnant.
Methods: We conducted a retrospective cohort study of women treated with RTX prior to or during pregnancy identified from 2 population-based settings: Sweden (2011-2016) and Kaiser Permanente Southern California (KPSC; 2012-3/2019). MS characteristics were obtained from the Swedish MS Register and complete electronic health records (EHR, KPSC). Pregnancy and infant outcomes were obtained from the Swedish Medical Birth Register (22 weeks gestation and beyond) and KPSC's EHR (entire pregnancy and beyond).
Results: We identified 104 pregnancies (74 Sweden) exposed to RTX prior to delivery; 47 (45%) were switched from FNG or NAT to RTX; 59 (57%) pregnancies were exposed to RTX within six months prior to conception and 6 during pregnancy. Among the 106 babies, 93 (87.7%) were normal full-term babies. Adverse outcomes were as follows: 2 major malformations, 1 stillbirth, 1 neonatal death (preterm twin); 8 preterm (including 2 sets of twins); 2 small for gestational age (SGA), and two with other adverse events in the post-natal period. Only 11 women experienced relapses during pregnancy (n=3, 2.9%) or the postpartum period (n=8, 7.7%). Of 50 pregnancies in KPSC, 10 resulted in spontaneous first trimester abortions.
Conclusions: This represents the largest cohort of RTX-exposed MS pregnancies. We provide high quality and complete data on pregnancy and maternal outcomes. Most women were exposed to RTX prior to but not during pregnancy. We observed no increase in adverse pregnancy outcomes compared to expected national incidence rates. MS relapses observed during pregnancy and postpartum period are lower than expected compared to population-based cohort and far lower than in natalizumab-treated cohorts. Our findings indicate that RTX may be a safer and more effective alternative than FNG or NAT in women with highly active MS who desire pregnancy.
Disclosure: KF, JBS and AG have nothing to declare. 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. ALG served as site-PI for two industry-sponsored RCTs (Roche, Biogen Idec).

Abstract: P413

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

K. Fink1,2,3, A. Gorczyca1, J. Smith4, F. Piehl1,2,3, A. Langer-Gould4

1Karolinska University Hospital | Department of Clinical Neuroscience, Karolinska Institutet, 2Department of Neurology, Karolinska University Hospital, 3Centre for Neurology, Academic Specialist Center, Stockholm, Sweden, 4Clinical and Translational Neuroscience, Southern California Permanente Medical Group, Kaiser Permanente, Pasadena, CA, United States

Background: Women with highly active multiple sclerosis (MS) who desire pregnancy have limited safe and effective treatment options. Fingolimod (FNG) is a weak teratogen and natalizumab (NAT) use during pregnancy can result in neonatal cytopenias. However, stopping FNG or NAT can result in rebound relapses during pregnancy. Due to long lasting immunomodulatory effects extending beyond drug elimination, rituximab (RTX) is an attractive treatment for women with MS planning pregnancy.
Objective: To describe the efficacy and safety of RTX in women with MS who became pregnant.
Methods: We conducted a retrospective cohort study of women treated with RTX prior to or during pregnancy identified from 2 population-based settings: Sweden (2011-2016) and Kaiser Permanente Southern California (KPSC; 2012-3/2019). MS characteristics were obtained from the Swedish MS Register and complete electronic health records (EHR, KPSC). Pregnancy and infant outcomes were obtained from the Swedish Medical Birth Register (22 weeks gestation and beyond) and KPSC's EHR (entire pregnancy and beyond).
Results: We identified 104 pregnancies (74 Sweden) exposed to RTX prior to delivery; 47 (45%) were switched from FNG or NAT to RTX; 59 (57%) pregnancies were exposed to RTX within six months prior to conception and 6 during pregnancy. Among the 106 babies, 93 (87.7%) were normal full-term babies. Adverse outcomes were as follows: 2 major malformations, 1 stillbirth, 1 neonatal death (preterm twin); 8 preterm (including 2 sets of twins); 2 small for gestational age (SGA), and two with other adverse events in the post-natal period. Only 11 women experienced relapses during pregnancy (n=3, 2.9%) or the postpartum period (n=8, 7.7%). Of 50 pregnancies in KPSC, 10 resulted in spontaneous first trimester abortions.
Conclusions: This represents the largest cohort of RTX-exposed MS pregnancies. We provide high quality and complete data on pregnancy and maternal outcomes. Most women were exposed to RTX prior to but not during pregnancy. We observed no increase in adverse pregnancy outcomes compared to expected national incidence rates. MS relapses observed during pregnancy and postpartum period are lower than expected compared to population-based cohort and far lower than in natalizumab-treated cohorts. Our findings indicate that RTX may be a safer and more effective alternative than FNG or NAT in women with highly active MS who desire pregnancy.
Disclosure: KF, JBS and AG have nothing to declare. 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. ALG served as site-PI for two industry-sponsored RCTs (Roche, Biogen Idec).

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