Contributions
Abstract: P368
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - MS and gender
Background: Multiple Sclerosis (MS) predominantly affects women of childbearing age. Disease-modifying therapies (DMTs) reduce the risk of future neurological disability, but data on potential negative effects on birth outcomes for more novel DMTs is still limited. While interferons and glatiramer acetate are considered safe at time of conception, discontinuation before planning pregnancy is typically recommended for more effective oral and biological DMTs. Hence, women may be at risk of relapses during the period between DMT discontinuation and the expectedly protective effects of pregnancy.
Objective: To describe DMT use, birth outcomes and relapse rates among women treated with DMTs shortly before pregnancy in a nation-wide cohort.
Methods: MS disease characteristics including treatment episodes given within 2 weeks preconception and relapses were extracted from the Swedish MS Register and data on pregnancies and birth outcomes from the Swedish Medical Birth Register. We identified women who had undergone pregnancies until at least 22 weeks of gestation during the period of Jan 1st 2011 - Dec 31st 2016.
Results: Out of 1211 pregnancies, 446 were exposed to DMTs during the observed time period. Eight pregnancies were exposed to 2 different DMTs, contributing to 2 exposed pregnancies each. Thus, the number of exposed pregnancies amounted to 454, of which 200 were exposed to injectable interferons, 122 to natalizumab, 58 to rituximab, 49 to glatiramer acetate, 13 to dimethyl fumarate, 4 to fingolimod and 2 to alemtuzumab. The remaining 6 pregnancies followed hematopoietic stem cell transplantation at some point before the defined time period.
Conclusions: Along with first-line injectable DMTs, natalizumab and rituximab were the most commonly prescribed DMTs in women shortly before pregnancy. With regard to rituximab this represents the largest cohort reported so far. Data on safety aspects, including neonatal and delivery outcomes, and disease activity parameters will be included in the final presentation. Findings will be of importance for risk-benefit assessments in relation to pregnancy planning for women exposed to MS DMTs.
Disclosure: AG: nothing to disclose.
PA: nothing to disclose.
FP has received research grants from Biogen, Novartis, and Genzyme, and fees for serving as Chair of DMC in clinical trials with Parexel.
ALG: nothing to disclose.
KF has received an unrestricted research grant from Biogen and has served on advisory boards for Teva, Merck and Roche. K.F. has held lectures for Merck and Biogen.
Abstract: P368
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - MS and gender
Background: Multiple Sclerosis (MS) predominantly affects women of childbearing age. Disease-modifying therapies (DMTs) reduce the risk of future neurological disability, but data on potential negative effects on birth outcomes for more novel DMTs is still limited. While interferons and glatiramer acetate are considered safe at time of conception, discontinuation before planning pregnancy is typically recommended for more effective oral and biological DMTs. Hence, women may be at risk of relapses during the period between DMT discontinuation and the expectedly protective effects of pregnancy.
Objective: To describe DMT use, birth outcomes and relapse rates among women treated with DMTs shortly before pregnancy in a nation-wide cohort.
Methods: MS disease characteristics including treatment episodes given within 2 weeks preconception and relapses were extracted from the Swedish MS Register and data on pregnancies and birth outcomes from the Swedish Medical Birth Register. We identified women who had undergone pregnancies until at least 22 weeks of gestation during the period of Jan 1st 2011 - Dec 31st 2016.
Results: Out of 1211 pregnancies, 446 were exposed to DMTs during the observed time period. Eight pregnancies were exposed to 2 different DMTs, contributing to 2 exposed pregnancies each. Thus, the number of exposed pregnancies amounted to 454, of which 200 were exposed to injectable interferons, 122 to natalizumab, 58 to rituximab, 49 to glatiramer acetate, 13 to dimethyl fumarate, 4 to fingolimod and 2 to alemtuzumab. The remaining 6 pregnancies followed hematopoietic stem cell transplantation at some point before the defined time period.
Conclusions: Along with first-line injectable DMTs, natalizumab and rituximab were the most commonly prescribed DMTs in women shortly before pregnancy. With regard to rituximab this represents the largest cohort reported so far. Data on safety aspects, including neonatal and delivery outcomes, and disease activity parameters will be included in the final presentation. Findings will be of importance for risk-benefit assessments in relation to pregnancy planning for women exposed to MS DMTs.
Disclosure: AG: nothing to disclose.
PA: nothing to disclose.
FP has received research grants from Biogen, Novartis, and Genzyme, and fees for serving as Chair of DMC in clinical trials with Parexel.
ALG: nothing to disclose.
KF has received an unrestricted research grant from Biogen and has served on advisory boards for Teva, Merck and Roche. K.F. has held lectures for Merck and Biogen.