Pregnancy outcomes in female partners of male patients treated with teriflunomide or leflunomide (an in vivo precursor of teriflunomide)
ECTRIMS Online Library. Vukusic S. 09/13/19; 278348; P1146
Sandra Vukusic
Sandra Vukusic
Contributions
Abstract

Abstract: P1146

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

S. Vukusic1, K. Hellwig2, P. Truffinet3, M. Benamor3, S. Strattman4, S. Afsar4, A. Purvis4, E.M. Poole4, P.K. Coyle5

1Hôpital Neurologique, Hospices Civils de Lyon and Université Lyon, Lyon, France, 2Ruhr-University Bochum and St. Josef-Hospital, Bochum, Germany, 3Sanofi, Chilly-Mazarin, France, 4Sanofi, Cambridge, MA, 5Stony Brook University Medical Center, New York, NY, United States

Introduction: Teriflunomide is an approved treatment for relapsing forms of multiple sclerosis (MS) or relapsing remitting MS, depending on the local label, and leflunomide (an in vivo precursor of teriflunomide) for rheumatoid arthritis. Both drugs are contraindicated in pregnant women because of the potential for foetal harm. Teriflunomide is known to be present in semen at very low levels in men receiving teriflunomide. Risk of male-mediated embryo-foetal toxicity is considered low. Evidence from preclinical data indicates no effect of teriflunomide on male fertility or damage to DNA.
Objective: To evaluate outcomes of pregnancies in female partners of male patients treated with teriflunomide or leflunomide.
Methods: Pregnancy outcomes were analysed using prospective and retrospective data from clinical trials and the post-marketing setting. Measures included primary pregnancy outcomes, adverse pregnancy and development outcomes, and birth defects using the European Surveillance of Congenital Anomalies (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classifications.
Results: A total of 88 and 144 pregnancies were reported in female partners of male patients treated with teriflunomide and leflunomide, of which 48 (54.5%) and 57 (39.6%), respectively, had known outcomes. Among the pregnancies in female partners of male patients treated with teriflunomide, there were 37 (77.1%) live births, 3 (6.3%) stillbirths, 6 (12.5%) spontaneous abortions, and 2 (4.2%) elective abortions. There were 2 foetal anomaly cases reported: congenital pes planus (outcome not reported) and congenital hip dysplasia (family had a history of congenital hip dysplasia; Pavlik Harness was used to correct). Among the pregnancies in female partners of male patients treated with leflunomide, there were 37 (64.9%) live births, of which 3 (5.3%) were pre-term [< 37 weeks], 2 (3.5%) still births, 9 (15.8%) spontaneous abortions, 8 (14.0%) elective abortions, and 1 (1.8%) ectopic pregnancy. There was 1 foetal anomaly case reported: bilateral renal agenesis (elective abortion).
Conclusions: No detectable teratogenic signal was observed in female partners of male patients receiving teriflunomide or leflunomide. To minimize any possible risk, men not wishing to father a child and their female partners should use reliable contraception, and men wishing to father a child should discontinue treatment and undergo an accelerated elimination procedure.
Disclosure: SV: Consultancy fees, speaker fees, or honoraria from Biogen, Celgene, GeNeuro, MedDay, Merck Serono, Novartis, Roche, Sanofi and Teva; research support from Biogen, GeNeuro, MedDay, Merck Serono, Novartis, Roche and Sanofi.
KH: Consultancy fees, speaker fees and research support from Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi-Genzyme and Teva.
PT, MB, AP EMP: Employee of Sanofi with ownership interest.
SS, SA: Employees of Sanofi.
PKC: Consulting fees (Accordant, Alexion, Bayer, Biogen Idec, Celgene, Genentech/Roche, Genzyme/Sanofi, Novartis, Serono, TG Therapeutics); research support (Actelion, Alkermes, Genentech/Roche, MedDay, NINDS, Novartis).
Study supported by Sanofi.

Abstract: P1146

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Pregnancy in MS

S. Vukusic1, K. Hellwig2, P. Truffinet3, M. Benamor3, S. Strattman4, S. Afsar4, A. Purvis4, E.M. Poole4, P.K. Coyle5

1Hôpital Neurologique, Hospices Civils de Lyon and Université Lyon, Lyon, France, 2Ruhr-University Bochum and St. Josef-Hospital, Bochum, Germany, 3Sanofi, Chilly-Mazarin, France, 4Sanofi, Cambridge, MA, 5Stony Brook University Medical Center, New York, NY, United States

Introduction: Teriflunomide is an approved treatment for relapsing forms of multiple sclerosis (MS) or relapsing remitting MS, depending on the local label, and leflunomide (an in vivo precursor of teriflunomide) for rheumatoid arthritis. Both drugs are contraindicated in pregnant women because of the potential for foetal harm. Teriflunomide is known to be present in semen at very low levels in men receiving teriflunomide. Risk of male-mediated embryo-foetal toxicity is considered low. Evidence from preclinical data indicates no effect of teriflunomide on male fertility or damage to DNA.
Objective: To evaluate outcomes of pregnancies in female partners of male patients treated with teriflunomide or leflunomide.
Methods: Pregnancy outcomes were analysed using prospective and retrospective data from clinical trials and the post-marketing setting. Measures included primary pregnancy outcomes, adverse pregnancy and development outcomes, and birth defects using the European Surveillance of Congenital Anomalies (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classifications.
Results: A total of 88 and 144 pregnancies were reported in female partners of male patients treated with teriflunomide and leflunomide, of which 48 (54.5%) and 57 (39.6%), respectively, had known outcomes. Among the pregnancies in female partners of male patients treated with teriflunomide, there were 37 (77.1%) live births, 3 (6.3%) stillbirths, 6 (12.5%) spontaneous abortions, and 2 (4.2%) elective abortions. There were 2 foetal anomaly cases reported: congenital pes planus (outcome not reported) and congenital hip dysplasia (family had a history of congenital hip dysplasia; Pavlik Harness was used to correct). Among the pregnancies in female partners of male patients treated with leflunomide, there were 37 (64.9%) live births, of which 3 (5.3%) were pre-term [< 37 weeks], 2 (3.5%) still births, 9 (15.8%) spontaneous abortions, 8 (14.0%) elective abortions, and 1 (1.8%) ectopic pregnancy. There was 1 foetal anomaly case reported: bilateral renal agenesis (elective abortion).
Conclusions: No detectable teratogenic signal was observed in female partners of male patients receiving teriflunomide or leflunomide. To minimize any possible risk, men not wishing to father a child and their female partners should use reliable contraception, and men wishing to father a child should discontinue treatment and undergo an accelerated elimination procedure.
Disclosure: SV: Consultancy fees, speaker fees, or honoraria from Biogen, Celgene, GeNeuro, MedDay, Merck Serono, Novartis, Roche, Sanofi and Teva; research support from Biogen, GeNeuro, MedDay, Merck Serono, Novartis, Roche and Sanofi.
KH: Consultancy fees, speaker fees and research support from Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi-Genzyme and Teva.
PT, MB, AP EMP: Employee of Sanofi with ownership interest.
SS, SA: Employees of Sanofi.
PKC: Consulting fees (Accordant, Alexion, Bayer, Biogen Idec, Celgene, Genentech/Roche, Genzyme/Sanofi, Novartis, Serono, TG Therapeutics); research support (Actelion, Alkermes, Genentech/Roche, MedDay, NINDS, Novartis).
Study supported by Sanofi.

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