An international registry tracking pregnancy outcomes in women treated with dimethyl fumarate
ECTRIMS Online Library. Hellwig K. 09/13/19; 278349; P1147
Kerstin Hellwig
Kerstin Hellwig
Contributions
Abstract

Abstract: P1147

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

K. Hellwig1, D. Rog2, C. McGuigan3, K. Chen4, B. Parks4, C.C. Jones4

1Neurological Clinic, University of Bochum, Bochum, Germany, 2Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford, United Kingdom, 3Department of Neurology, St. Vincent's University Hospital, Dublin, Ireland, 4Biogen, Cambridge, MA, United States

Introduction: Nearly 2/3 of patients with multiple sclerosis (MS) are women, many of
whom are in their childbearing years. Delayed-release dimethyl fumarate (DMF) exposure during pregnancy has demonstrated no safety signals in clinical trial and post-marketing report data. The DMF product label recommends use during pregnancy only if potential benefit justifies the potential risk to the foetus. An international registry (NCT01911767) is studying pregnancy outcomes in women with MS exposed to DMF.
Objectives and Aims: To assess pregnancy outcomes in an ongoing registry of women with MS exposed to DMF.
Methods: Women exposed to DMF since 1 day before the 1st day of their last menstrual period before conception or during pregnancy were prospectively evaluated. Data were collected at enrolment, 6-7 months of gestation, 4 weeks after estimated delivery date, and at 4, 12, and 52 weeks after birth. Ectopic and molar pregnancies, birth defects, congenital anomalies or infant death occurring at ≤52 weeks of age, and maternal death at ≤12 weeks post-delivery, were reported. Potential birth defects were adjudicated by an external expert. Gestational size was classified as small (< 10th percentile), appropriate (10th-90th), or large (>90th) based standardized growth charts.
Results:
As of 3 October 2018, 236 patients were enrolled. Median gestational week at 1st DMF exposure was 1 (range: 1,13) and mean foetal DMF exposure duration was 5.7 (SD: 6.4) weeks. Of the 194 pregnancy outcomes reported to date, 177 (91%) were live births and 17 (9%) foetal loss. Of infants with known gestational age (n=174), 160 (92%) births were full term and 14 (8%) premature (< 37 weeks). There were 16 spontaneous abortions and 1 foetal death at ≥28 weeks of gestation. No ectopic or molar pregnancies, infant or maternal deaths were reported. Infants (144 with gestational size data) were classified as small 13 (9%), appropriate 119 (83%), and large 12 (8%). Seven (4.0%) infants had 7 confirmed birth defects: ventricular septal defect (2), pyloric stenosis, transposition of the great vessels, developmental dysplasia of hip, hydronephrosis, and 1 premature infant with multiple defects.
Conclusions: The observed pregnancy outcome frequencies from the interim analysis did not exceed those observed in the MS and general populations. No safety signal was observed. Ongoing recruitment will enable essential information about DMF exposure during pregnancy to continue to be provided.

Supported by:
Biogen
Disclosure: Kerstin Hellwig: has served on scientific advisory board for Bayer, Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received speaker honoraria and research support from Bayer, Biogen, Merck, Novartis, Sanofi, Genzyme, Teva has received support for congress participation from Bayer, Biogen, Genzyme, Teva, Roche and Merck
David Rog: received consulting fees from Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva Neuroscience; research support from Biogen, GW Pharma, Merck Serono, Mitsubishi, Novartis, Sanofi, and Teva Neuroscience.
Christopher McGuigan: honoraria for consultancy work and/or research funding from Actelion, Biogen, Merck, Novartis, Roche and Sanofi-Genzyme
Kun Chen: employee of and holds stock/stock options in Biogen
Becky Parks: employee of and holds stock/stock options in Biogen
Cynthia C. Jones: employee of and holds stock/stock options in Biogen
Supported by: Biogen

Abstract: P1147

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

K. Hellwig1, D. Rog2, C. McGuigan3, K. Chen4, B. Parks4, C.C. Jones4

1Neurological Clinic, University of Bochum, Bochum, Germany, 2Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford, United Kingdom, 3Department of Neurology, St. Vincent's University Hospital, Dublin, Ireland, 4Biogen, Cambridge, MA, United States

Introduction: Nearly 2/3 of patients with multiple sclerosis (MS) are women, many of
whom are in their childbearing years. Delayed-release dimethyl fumarate (DMF) exposure during pregnancy has demonstrated no safety signals in clinical trial and post-marketing report data. The DMF product label recommends use during pregnancy only if potential benefit justifies the potential risk to the foetus. An international registry (NCT01911767) is studying pregnancy outcomes in women with MS exposed to DMF.
Objectives and Aims: To assess pregnancy outcomes in an ongoing registry of women with MS exposed to DMF.
Methods: Women exposed to DMF since 1 day before the 1st day of their last menstrual period before conception or during pregnancy were prospectively evaluated. Data were collected at enrolment, 6-7 months of gestation, 4 weeks after estimated delivery date, and at 4, 12, and 52 weeks after birth. Ectopic and molar pregnancies, birth defects, congenital anomalies or infant death occurring at ≤52 weeks of age, and maternal death at ≤12 weeks post-delivery, were reported. Potential birth defects were adjudicated by an external expert. Gestational size was classified as small (< 10th percentile), appropriate (10th-90th), or large (>90th) based standardized growth charts.
Results:
As of 3 October 2018, 236 patients were enrolled. Median gestational week at 1st DMF exposure was 1 (range: 1,13) and mean foetal DMF exposure duration was 5.7 (SD: 6.4) weeks. Of the 194 pregnancy outcomes reported to date, 177 (91%) were live births and 17 (9%) foetal loss. Of infants with known gestational age (n=174), 160 (92%) births were full term and 14 (8%) premature (< 37 weeks). There were 16 spontaneous abortions and 1 foetal death at ≥28 weeks of gestation. No ectopic or molar pregnancies, infant or maternal deaths were reported. Infants (144 with gestational size data) were classified as small 13 (9%), appropriate 119 (83%), and large 12 (8%). Seven (4.0%) infants had 7 confirmed birth defects: ventricular septal defect (2), pyloric stenosis, transposition of the great vessels, developmental dysplasia of hip, hydronephrosis, and 1 premature infant with multiple defects.
Conclusions: The observed pregnancy outcome frequencies from the interim analysis did not exceed those observed in the MS and general populations. No safety signal was observed. Ongoing recruitment will enable essential information about DMF exposure during pregnancy to continue to be provided.

Supported by:
Biogen
Disclosure: Kerstin Hellwig: has served on scientific advisory board for Bayer, Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received speaker honoraria and research support from Bayer, Biogen, Merck, Novartis, Sanofi, Genzyme, Teva has received support for congress participation from Bayer, Biogen, Genzyme, Teva, Roche and Merck
David Rog: received consulting fees from Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva Neuroscience; research support from Biogen, GW Pharma, Merck Serono, Mitsubishi, Novartis, Sanofi, and Teva Neuroscience.
Christopher McGuigan: honoraria for consultancy work and/or research funding from Actelion, Biogen, Merck, Novartis, Roche and Sanofi-Genzyme
Kun Chen: employee of and holds stock/stock options in Biogen
Becky Parks: employee of and holds stock/stock options in Biogen
Cynthia C. Jones: employee of and holds stock/stock options in Biogen
Supported by: Biogen

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