Contributions
Abstract: 207
Type: Scientific Session
Abstract Category: Clinical aspects of MS - MS and gender
Objective: To determine the risk for relapses and disability and pregnancy outcomes in women with multiple sclerosis (MS) who stopped fingolimod (FTY) while planning a pregnancy (group A) versus those who stopped FTY with a positive pregnancy testing (group B).
Background: The magnitude of relapse or disability risk after FTY withdrawal in women with MS planning a pregnancy is unknown but severe return of disease activity was described.
Methods: Pregnancies were prospectively collected in the German MS and pregnancy registry (n=140) and by six international collaborators (n=16) up to September 2017. 6 pregnancies are ongoing. Detailed information on course of MS and pregnancy, relapses, disability and outcome of pregnancy was obtained.
Results: 46 women of group A stopped FTY 295 days [61-312] prior to the last menstrual period (LMP); 110 of group B had a median exposure of 35.4 days [1-123 ] after LMP. 10 (21.7%) women in group A experienced a relapse between FTY stop and the beginning of pregnancy. After conception, more (13/46 (28.3%) women of group A had 17 relapses during the three trimesters of pregnancy compared to 26/110 (23.6%) group B with 33 relapses (p=0.203). Significant more women in the unexposed group relapsed during the first trimester (p=0.04). EDSS remained stable in the majority of the women but 1 woman (5.13%) in group A and 9 (7.69%) of group B showed a substantial EDSS worsening of ≥ 2 EDSS points 6 months pp (p=0.732). 39 (25%) women had 45 relapses in the first 6 months postpartum. Women who restarted FTY during the first 30 days (n=31) pp had a non-significantly reduced relapse risk during the first 6 months (OR 0.3 95% 0.08-1.05 p=0.06) Relapses during pregnancy were the only significant predictor for relapses postpartum (OR 5.82 95% CI 2.39-14.17).
Conclusion: Despite the natural protection of pregnancy, at least one third of women treated with FTY before or up to pregnancy will experience a relapse during pregnancy. Women who stopped FTY > 2 month prior to the last LMP experience more relapses before pregnancy and in the first trimester of pregnancy. The large majority of women will not experience permanent disability but 6-8% of women show a significant EDSS worsening (≥2) 6 months pp.
Disclosure:
- Spalmai Hemat: nothing to disclosure
- Maria Houtchens: nothing to disclosure
- Angela Vidal-Jordana: nothing to disclosure
- Michael Guger: nothing to disclosure
- Doriana Landi: Merck-Serono, Sanofi Genzyme, Teva, Biogen, Novartis, Roche
- Miguel D´Haeseleer: Biogen, Sanofi Genzyme, Teva, Merck Serono, Novartis, Roche, Pietro Annovazzi: Merck, Biogen, Teva, Sanofi-Genzyme, Almirall, Roche and Novartis
- Mar Tintoré: nothing to disclosure
- Sandra Thiel: nothing to disclosure
- Ralf Gold: Bayer Biogen, Novartis, Teva, Merck, Novartis, Sanofi -Genzyme
- Kerstin Hellwig: Bayer Biogen, Novartis, Teva, Merck, Novartis Sanofi -Genzyme, Adboards, Roche
Abstract: 207
Type: Scientific Session
Abstract Category: Clinical aspects of MS - MS and gender
Objective: To determine the risk for relapses and disability and pregnancy outcomes in women with multiple sclerosis (MS) who stopped fingolimod (FTY) while planning a pregnancy (group A) versus those who stopped FTY with a positive pregnancy testing (group B).
Background: The magnitude of relapse or disability risk after FTY withdrawal in women with MS planning a pregnancy is unknown but severe return of disease activity was described.
Methods: Pregnancies were prospectively collected in the German MS and pregnancy registry (n=140) and by six international collaborators (n=16) up to September 2017. 6 pregnancies are ongoing. Detailed information on course of MS and pregnancy, relapses, disability and outcome of pregnancy was obtained.
Results: 46 women of group A stopped FTY 295 days [61-312] prior to the last menstrual period (LMP); 110 of group B had a median exposure of 35.4 days [1-123 ] after LMP. 10 (21.7%) women in group A experienced a relapse between FTY stop and the beginning of pregnancy. After conception, more (13/46 (28.3%) women of group A had 17 relapses during the three trimesters of pregnancy compared to 26/110 (23.6%) group B with 33 relapses (p=0.203). Significant more women in the unexposed group relapsed during the first trimester (p=0.04). EDSS remained stable in the majority of the women but 1 woman (5.13%) in group A and 9 (7.69%) of group B showed a substantial EDSS worsening of ≥ 2 EDSS points 6 months pp (p=0.732). 39 (25%) women had 45 relapses in the first 6 months postpartum. Women who restarted FTY during the first 30 days (n=31) pp had a non-significantly reduced relapse risk during the first 6 months (OR 0.3 95% 0.08-1.05 p=0.06) Relapses during pregnancy were the only significant predictor for relapses postpartum (OR 5.82 95% CI 2.39-14.17).
Conclusion: Despite the natural protection of pregnancy, at least one third of women treated with FTY before or up to pregnancy will experience a relapse during pregnancy. Women who stopped FTY > 2 month prior to the last LMP experience more relapses before pregnancy and in the first trimester of pregnancy. The large majority of women will not experience permanent disability but 6-8% of women show a significant EDSS worsening (≥2) 6 months pp.
Disclosure:
- Spalmai Hemat: nothing to disclosure
- Maria Houtchens: nothing to disclosure
- Angela Vidal-Jordana: nothing to disclosure
- Michael Guger: nothing to disclosure
- Doriana Landi: Merck-Serono, Sanofi Genzyme, Teva, Biogen, Novartis, Roche
- Miguel D´Haeseleer: Biogen, Sanofi Genzyme, Teva, Merck Serono, Novartis, Roche, Pietro Annovazzi: Merck, Biogen, Teva, Sanofi-Genzyme, Almirall, Roche and Novartis
- Mar Tintoré: nothing to disclosure
- Sandra Thiel: nothing to disclosure
- Ralf Gold: Bayer Biogen, Novartis, Teva, Merck, Novartis, Sanofi -Genzyme
- Kerstin Hellwig: Bayer Biogen, Novartis, Teva, Merck, Novartis Sanofi -Genzyme, Adboards, Roche