Contributions
Abstract: P354
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Epidemiology
Introduction: The majority of persons diagnosed with multiple sclerosis (MS) experience their first MS symptoms in the reproductive age.
Teriflunomide (TFL, Aubagio â) 14mg, was first released in Denmark for relapsing-remitting MS in December 2013. Treatment with TFL is contraindicated in women of childbearing potential who are not using reliable contraception. TFL can be transmitted via semen and a low risk of male-mediated embryo-foetal toxicity is described.
Objective: To report pregnancy outcomes of TFL exposed women and partners to TFL exposed men: gestation week < week 37, abortions and congenital malformations, the frequency of caesarean section, live born and stillborn, birth weight and Apgar score.
Methods: Prospective cohort study comparing pregnancy outcomes of TFL exposed men and women, matched on age at conception, 1:4 with controls from the background population. Data on TFL treated patients treated 1st of January 2014 to 31st of December 2016 for at least 30 consecutive days prior to conception, and with conception occurring up to two years after treatment discontinuation were extracted from The Danish Multiple Sclerosis Registry and merged with several national reproductive registries. Logistic regression was used to analyse the association between TFL exposure and any adverse event.
Results: A total of 31 pregnancies were recorded, 18 of partners to a TFL exposed man and 13 women. Among these, all 18 partners of men exposed to TFL completed their pregnancies: livebirth (18), gestation time >37 weeks (17), gestation time 33-36 weeks (1), birth weight normal in relation to gestation week (18), spontaneous and elective abortion (0), congenital malformation (plagiocephali/flat head syndrome) (1), normal delivery (14), induced delivery (2), caesarean section (2), Apgar score ≥7 (18). Among the 13 pregnancies in women exposed to TFL: elective abortion (11), spontaneous abortion (0), livebirth (2), gestation time >37 weeks (2), birth weight normal (2), congenital malformations (0), normal delivery (1), induced delivery (1), Apgar score ≥7 (2). The TFL group was associated with a 22% reduction in the odds of any adverse event relative to controls, although this association was not significant (OR 0.78; 95% CI 0.16-3.72, p=0.753).
Conclusion: Pregnancy outcomes were consistent with those of the background population. The malformation reported of the partner to a TFL exposed man is comparable to the rate of plagiocephaly reported in Denmark.
Disclosure: Funding: This work was supported by Sanofi
Disclosures:
Johanna Balslev Andersen:J.B.A. has nothing to disclose.
Julie Yoon Moberg:J.Y. Moberg has received travel and educational grants from Biogen Denmark A/S, Merck A/S, Roche Pharmaceuticals A/S, Sanofi Genzyme Denmark and Teva Denmark A/S and has acted as a speaker for Biogen Denmark A/S, Sanofi Genzyme Denmark, and Teva Denmark A/S.
Tim Spelman: TS received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen; speaker honoraria from Novartis
Melinda Magyari:M.M. has served on scientific advisory board for Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received honoraria for lecturing from Biogen, Merck, Novartis, Sanofi, has received support for congress participation from Biogen, Genzyme, Teva, Roche.
Abstract: P354
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Epidemiology
Introduction: The majority of persons diagnosed with multiple sclerosis (MS) experience their first MS symptoms in the reproductive age.
Teriflunomide (TFL, Aubagio â) 14mg, was first released in Denmark for relapsing-remitting MS in December 2013. Treatment with TFL is contraindicated in women of childbearing potential who are not using reliable contraception. TFL can be transmitted via semen and a low risk of male-mediated embryo-foetal toxicity is described.
Objective: To report pregnancy outcomes of TFL exposed women and partners to TFL exposed men: gestation week < week 37, abortions and congenital malformations, the frequency of caesarean section, live born and stillborn, birth weight and Apgar score.
Methods: Prospective cohort study comparing pregnancy outcomes of TFL exposed men and women, matched on age at conception, 1:4 with controls from the background population. Data on TFL treated patients treated 1st of January 2014 to 31st of December 2016 for at least 30 consecutive days prior to conception, and with conception occurring up to two years after treatment discontinuation were extracted from The Danish Multiple Sclerosis Registry and merged with several national reproductive registries. Logistic regression was used to analyse the association between TFL exposure and any adverse event.
Results: A total of 31 pregnancies were recorded, 18 of partners to a TFL exposed man and 13 women. Among these, all 18 partners of men exposed to TFL completed their pregnancies: livebirth (18), gestation time >37 weeks (17), gestation time 33-36 weeks (1), birth weight normal in relation to gestation week (18), spontaneous and elective abortion (0), congenital malformation (plagiocephali/flat head syndrome) (1), normal delivery (14), induced delivery (2), caesarean section (2), Apgar score ≥7 (18). Among the 13 pregnancies in women exposed to TFL: elective abortion (11), spontaneous abortion (0), livebirth (2), gestation time >37 weeks (2), birth weight normal (2), congenital malformations (0), normal delivery (1), induced delivery (1), Apgar score ≥7 (2). The TFL group was associated with a 22% reduction in the odds of any adverse event relative to controls, although this association was not significant (OR 0.78; 95% CI 0.16-3.72, p=0.753).
Conclusion: Pregnancy outcomes were consistent with those of the background population. The malformation reported of the partner to a TFL exposed man is comparable to the rate of plagiocephaly reported in Denmark.
Disclosure: Funding: This work was supported by Sanofi
Disclosures:
Johanna Balslev Andersen:J.B.A. has nothing to disclose.
Julie Yoon Moberg:J.Y. Moberg has received travel and educational grants from Biogen Denmark A/S, Merck A/S, Roche Pharmaceuticals A/S, Sanofi Genzyme Denmark and Teva Denmark A/S and has acted as a speaker for Biogen Denmark A/S, Sanofi Genzyme Denmark, and Teva Denmark A/S.
Tim Spelman: TS received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen; speaker honoraria from Novartis
Melinda Magyari:M.M. has served on scientific advisory board for Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received honoraria for lecturing from Biogen, Merck, Novartis, Sanofi, has received support for congress participation from Biogen, Genzyme, Teva, Roche.