Abstract Details

Title Natalizumb in Active MS during Pregnancy: Efficacy, Safety, and the Consequences for Foetal Haematopoiesis

Topic MS and Related Diseases

Presentation(s) P02 - (-)

Poster/Presentation
Number 125

Objective

Background BACKGROUND: Despite partial protection from disease activity during pregnancy, still a considerable percentage of women with MS - up to 25% according to literature - suffer relapses and disease progression while being pregnant. While some relapses are mild/moderate and respond to steroids and/or IV immunoglobulins, others can lead to accelerated disability progression despite first-line therapy and may require abortion and immunosuppressive therapy, e.g. mitoxantrone and cyclophosphamide. In our prospective observation, we describe the effect of natalizumab given due to highly active MS. We monitored the course of MS and pregnancy, and the development of the newborns.

Design/Methods DESIGN/METHODS: We retreated 9 MS patients with rapid disease progression with natalizumab. 1 to 9 infusions were applied (mean number infusions = 3.4). Natalizumab concentrations in 5 mother/child-matched sera were determined by quantitative ELISA. 2 more pregnancies are on-going; their outcome will be presented at the time of the meeting.

Results RESULTS: Course of disease stabilised in all patients after initiation of natalizumab therapy and all pregnancies were carried out with a mostly normal follow up of child development up to now. Mild to moderate hematologic abnormalities were observed in 8 children with hematologic alterations accounting for 7, ranging from mild thrombocytopenia and hypogammaglobulinemia to haemolytic anaemia. Natalizumab was detectable in the umbilical cord blood in all the 5 newborns.

Conclusions CONCLUSIONS: Despite the need of validation in larger cohorts, our results provide the preliminary rationale for applying natalizumab in pregnant women with RRMS and high disease activity during pregnancy. So far only reversible haematological side effects in the newborns were documented, however, long term monitoring of their postnatal development is required.

Authors/Disclosures
Aiden Haghikia, MD (Hannover Medical School) PRESENTER	Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. The institution of Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Galapagos. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck Serono. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyverna. Dr. Haghikia has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neuraxpharm. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Biogen. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Sanofi. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Novartis. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Merck Serono. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Celgene.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Julian Zimmermann (Kamillus Klinik Asbach)	No disclosure on file
Martin Marziniak, PhD (Klinik fur Neurologie)	No disclosure on file
Tania Kuempfel, MD (Institut for Klinische Neuroimmunologie)	Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB Pharma. Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen/Horizon.
	No disclosure on file
	No disclosure on file
Tatiana Plavina, PhD	No disclosure on file
Ralf Gold, MD (Neurologische Universitaetsklinik)	Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Gold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer Vital. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharamaceuticals. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Publishers. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Biogen. The institution of Dr. Gold has received research support from Novartis. The institution of Dr. Gold has received research support from Biogen.
Kerstin Hellwig (St. Josef Hospital Bochum)	Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from BMS .

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