Contributions
Abstract: 204
Type: Oral
Abstract Category: Clinical aspects of MS - 6 MS and gender
Objective: To assess hematological abnormalities (HA) and MS disease activity after exposure to natalizumab (NTZ) during pregnancy in women with highly active multiple sclerosis (MS).
Background: Severe rebound after NTZ withdrawal might also occur during pregnancy, but anemia and thrombocytopenia will occure in 75% of newborns after NTZ exposure after the 30th gestational week.
The best timepoint when to stop NTZ during pregnancy in women with active MS is not known.
Methods: In this prospective, observational case series we compared relapses during pregnancy and HA in newborns of mothers exposed to NTZ less than 24 weeks (< gw24group), less than 30 weeks
(< gw30group) and more than 30 weeks (>gw30group) during pregnancy in women enrolled into the German Multiple Sclerosis and Pregnancy Registry. So far 40 women were enrolled in the study.
Results: The distribution of the 40 women who received NTZ during pregnancy was as follows:
< gw24group: n=6; < gw30group: n=21; >gw30group: n=13. Of 32 newborns with available blood count 15 were born with HA, 1/3 (33.34 %) in the < gw24group, 7/18 (38.89%) in the < gw30group and 7/11 (63.64%) in the >gw30group (p=0.382). In detail, 8 anaemias [< gw24group: 0; < gw30group:
4 (22.22%); >gw30group: 4 (36.36%); p=0.4] and 10 thrombozytopenias [< gw24group: 1 (33.34%)
< gw30group: 4 (22.22%); >gw30group: 5 (45.45%); p=0.423] were observed. Only one newborn received a specific treatment (3x4.5mg iron po/d). 4 women experienced a relapse during pregnancy, 3 (50%) in the
< gw24group and 1 (7.69%) in the >gw30group (p=0.001). Postpartum 8 relapses were observed: 3 (50%) in the < gw24group and 5 (23.8%) in the < gw30group. Of the 23 women who started MS therapy
(n=22 NTZ, n=1 fingolimod), 4 experienced a relapse, all from the < gw30group.
Conclusion: Fewer newborns in the < gw24group and < gw30group were born with HA in comparison with >gw30group, but significantly more relapses occurred in the < gw24group during pregnancy. Postapartum relapses were only observed in the < gw24group and < gw30group. If necessary NTZ withdrawal around 30th gw seems to be the best option for mother and child but in cases of aggressive MS and higher disability the continuation after gw 30 might be necessary to avoid postpartum relapses.
Disclosure:
T. Kümpfel has received travel expenses and speaker honoraria from Bayer Healthcare, Teva Pharma, Merck-Serono, Novartis, Genzyme, Sanofi-Aventis, Roche Pharma, CLB Behring and Biogen-Idec as well as grant support from Bayer-Schering AG and Novartis not related to this work
S. Thiel has nothing to disclose
I. Meinl has nothing to disclose
R. Gold serves on scientific advisory boards for Teva, BIOGEN, Bayer Schering Pharma and Novartis; he has received speaker honoraria from Biogen, Teva, Bayer Schering Pharma and Novartis; he received Research Support from Teva, Biogen, Bayer Schering, Genzyme, Merck Serono and Novartis not related to this work
K. Hellwig has been supported by the German Research Council Deutsche Forschungsgemeinschaft and has received speaker honoraria from Biogen, Teva Sanofi-Aventis, Novartis, Bayer Healthcare and Merck Serono not related to this work
Abstract: 204
Type: Oral
Abstract Category: Clinical aspects of MS - 6 MS and gender
Objective: To assess hematological abnormalities (HA) and MS disease activity after exposure to natalizumab (NTZ) during pregnancy in women with highly active multiple sclerosis (MS).
Background: Severe rebound after NTZ withdrawal might also occur during pregnancy, but anemia and thrombocytopenia will occure in 75% of newborns after NTZ exposure after the 30th gestational week.
The best timepoint when to stop NTZ during pregnancy in women with active MS is not known.
Methods: In this prospective, observational case series we compared relapses during pregnancy and HA in newborns of mothers exposed to NTZ less than 24 weeks (< gw24group), less than 30 weeks
(< gw30group) and more than 30 weeks (>gw30group) during pregnancy in women enrolled into the German Multiple Sclerosis and Pregnancy Registry. So far 40 women were enrolled in the study.
Results: The distribution of the 40 women who received NTZ during pregnancy was as follows:
< gw24group: n=6; < gw30group: n=21; >gw30group: n=13. Of 32 newborns with available blood count 15 were born with HA, 1/3 (33.34 %) in the < gw24group, 7/18 (38.89%) in the < gw30group and 7/11 (63.64%) in the >gw30group (p=0.382). In detail, 8 anaemias [< gw24group: 0; < gw30group:
4 (22.22%); >gw30group: 4 (36.36%); p=0.4] and 10 thrombozytopenias [< gw24group: 1 (33.34%)
< gw30group: 4 (22.22%); >gw30group: 5 (45.45%); p=0.423] were observed. Only one newborn received a specific treatment (3x4.5mg iron po/d). 4 women experienced a relapse during pregnancy, 3 (50%) in the
< gw24group and 1 (7.69%) in the >gw30group (p=0.001). Postpartum 8 relapses were observed: 3 (50%) in the < gw24group and 5 (23.8%) in the < gw30group. Of the 23 women who started MS therapy
(n=22 NTZ, n=1 fingolimod), 4 experienced a relapse, all from the < gw30group.
Conclusion: Fewer newborns in the < gw24group and < gw30group were born with HA in comparison with >gw30group, but significantly more relapses occurred in the < gw24group during pregnancy. Postapartum relapses were only observed in the < gw24group and < gw30group. If necessary NTZ withdrawal around 30th gw seems to be the best option for mother and child but in cases of aggressive MS and higher disability the continuation after gw 30 might be necessary to avoid postpartum relapses.
Disclosure:
T. Kümpfel has received travel expenses and speaker honoraria from Bayer Healthcare, Teva Pharma, Merck-Serono, Novartis, Genzyme, Sanofi-Aventis, Roche Pharma, CLB Behring and Biogen-Idec as well as grant support from Bayer-Schering AG and Novartis not related to this work
S. Thiel has nothing to disclose
I. Meinl has nothing to disclose
R. Gold serves on scientific advisory boards for Teva, BIOGEN, Bayer Schering Pharma and Novartis; he has received speaker honoraria from Biogen, Teva, Bayer Schering Pharma and Novartis; he received Research Support from Teva, Biogen, Bayer Schering, Genzyme, Merck Serono and Novartis not related to this work
K. Hellwig has been supported by the German Research Council Deutsche Forschungsgemeinschaft and has received speaker honoraria from Biogen, Teva Sanofi-Aventis, Novartis, Bayer Healthcare and Merck Serono not related to this work