Disease activity during pregnancy and pregnancy outcomes in patients with multiple sclerosis treated with Alemtuzumab – A case series from the German MS and Pregnancy Registry (P1.367)

Objective: to assess MS disease activity during pregnancy after alemtuzumab (ALZ) treatment. to document pregnancy outcomes in ALZ exposed pregnancies [ALZ Background: More than 25% of women with multiple sclerosis (MS) and high disease activity experience relapses during pregnancy. Data on relapse activity during pregnancy in ALZ treated women are scarce. Design/Methods: 15 women with ALZ treatment before pregnancy were prospectively enrolled into the German Multiple Sclerosis and Pregnancy Registry. Detailed information on the course of MS (relapses before ALZ, during ALZ, pregnancy and postpartum) and obstetrical information was obtained with a standardized questionnaire. Results: 7 pregnancies were exposed to ALZ [last ALZ median 42 days (range 1–108) before LMP]; the remaining 8 unexposed pregnancies became pregnant after a median of 168 days (range 129–1074). The mean age at conception was 30.0±4.1 years. So far 12 infants are born, one newborn whose mother received the last ALZ 2 months prior to LMP with only one kidney and hydronephrosis and one newborn whose mother received the last ALZ one day before LMP with hypospadia. Three pregnancies are ongoing and their outcome will be reported at the time of the meeting. No preterm birth occurred. Although the median number of relapses in the year before ALZ was 2 (range 1–5) and 8 women were treated with second line drugs before ALZ, none of our women had a relapse during pregnancy and only one woman postpartum so far. Conclusions: Depleting antibodies as ALZ might be an interesting option for women with MS and high disease activity, who plan a pregnancy, as the drug itself is cleared shortly after the exposure but the biological effect continues. However, more information on the occurrence of secondary autoimmune disorders and the specific interaction with pregnancy is needed. Study Supported by: The German MS and pregnancy registry is partly supported by Allmiral, Bayer Healthcare, Biogen-Idec Germany, Teva Pharma, Sanofi Aventis, Merck Serono, Novartis Pharma and Genzyme. Disclosure: Dr. Hellwig has received personal compensation for activities with Bayer Schering, Biogen Idec, Merck Serono, Teva Aventis and Novartis. Dr. Hellwig has received research support from the German Research Foundation. Dr. Ziemssen has received personal compensation for activities with Dr. Rosenkranz has received personal compensation for activities with Bayer Healthcare, Biogen, Genzyme Sanofi, Novartis, Roche, and Sanofi as a speaker or consultant. Dr. Thiel has nothing to disclose. Dr. Limmroth has received personal compensation for activities with Sanofi Genzyme for advisory board and speaker. Dr. Faiss has received personal compensation for activities with Novartis, BayerHealthcare, TEVA, Biogen, Merck-Serono, Genzyme, and Boehringer Ingelheim as a speaker. Dr. van Loh has nothing to disclose. Dr. Loos has nothing to disclose. Dr. Lassek has received personal compensation for activities with Teva, Merck Serono, Genzyme -Sanofi, Novartis, Bayer, and Biogen. Dr. Klemm has nothing to disclose. Dr. Goetze has nothing to disclose. Dr. Emrich has nothing to disclose. Dr. Wessels has nothing to disclose. Dr. Pernauer has nothing to disclose. Dr. Wagner has nothing to disclose. Dr. Gold has received personal compensation for activities with Bayer HealthCare, Biogen, Merck Serono, Novartis, and Teva Neuroscience as a speaker. Dr. Gold has received personal compensation in an editorial capacity for Sage. Dr. Gold has received research support from Bayer HealthCare, Biogen, Merck Serono, Novartis, and Teva Neuroscience. Dr. Gerbershagen has received personal compensation for speaking from Merck Serono, Sanofi Aventis, Bayer, Biogen and Bionorica.,,,,,,