Pregnancy And Fetal Outcomes After Paternal Exposure To Disease Modifying Drugs For Multiple Sclerosis (P4.157)

OBJECTIVE: to assess pregnancy and fetal outcomes after father’s exposure to DMD (Disease Modifying Drugs), using the previously collected Italian Pregnancy Dataset (Amato et al., Neurology 2010). BACKGROUND: there is a dearth of information on the role of paternal exposure to DMD for multiple sclerosis (MS) on pregnancy and fetal outcomes. METHODS: we recruited MS male patients, prospectively followed-up in 21 Italian MS Centres, whose partners were pregnant in the period 2002-2008. Patients were divided into two groups: drug-exposed patients (EP: suspension of the drug less than 4 weeks from conception) and non-exposed patients (NEP: suspension of the drug at least 4 weeks from conception or never treated). All the subjects were administered a structured interview which gathered detailed information on pregnancy course and outcomes, as well as on possible confounders. Multivariate logistic and linear models were used for group comparisons. RESULTS: data on 78 pregnancies were collected (six exposed to glatiramer acetate (GA), 36 to beta-interferons (BIFN), 36 non-exposed). We observed 75 full-term deliveries, 41 in couples with exposed and 34 with non-exposed fathers. Paternal DMD exposure was not significantly associated with an increased risk of spontaneous abortion (p >0.351). Mean birth-weight and length were not significantly different for paternal exposure or non-exposure to DMD (p>0.781). There was also no difference in terms of frequency of preterm delivery (EP: 7 out of 41 patients, 17,1%; NEP: 3 out of 34 patients, 8.8%; p=0.240). Caesarean delivery was the only predictor of preterm delivery. These findings were confirmed in the multivariate analysis. The proportion of spontaneous abortion and caesarean delivery in case of paternal exposure to DMD fell within the estimates for the general population. We did not observe any major pregnancy or delivery complications or baby malformations after paternal DMD exposure. CONCLUSIONS: Data in our cohort show that father’s exposure to GA and BIFN is safe, so that MS fathers can continue taking these therapies at conception. Disclosure: Dr. Amato has received personal compensation for activities with Biogen Idec, Merck & Co., Inc., Serono, Inc., Teva Neuroscience, Genzyme Corporation, Novartis, Bayer Pharmaceuticals Corporation, and Almirall. Dr. Giannini has received personal compensation for activities with Biogen Idec. Dr. Portaccio has received personal compensation for activities with Biogen Idec, Bayer Pharmaceuticals Corp., and Merck Serono as a scientific advisory board member and speaker. Dr. Portaccio has received research support from Biogen Idec, Bayer Schering, Merck Serono, and Sanofi-Aventis Pharmaceuticals Inc. Dr. Ghezzi has received personal compensation for activities with Merck Serono, Teva Neuroscience, Biogen Idec, Bayer Schering, Novartis, and Actelion Pharmaceuticals. Dr. Hakiki has nothing to disclose. Dr. Pasto9 has received personal compensation for activities with Biogen Idec. Dr. Razzolini has nothing to disclose. Dr. Pecori has received research support from Novartis. Dr. Sturchio has nothing to disclose. Dr. De Giglio has nothing to disclose. Dr. Pozzilli has received personal compensation for activities with Merck Serono, Genzyme Corp., Biogen Idec, Bayer Pharmaceuticals Corp., Novartis, and Teva Neuroscience. Dr. Paolicelli has received personal compensation for activities with Merck Serono and Bayer Schering as a consultant, and with Biogen Idec as a speaker. Dr. Trojano has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals Inc., Biogen Idec, Novartis and Bayer Schering as a consultant or speaker. Dr. Trojano has received research support from Merck Serono, Biogen Idec and Novartis. Dr. Marrosu has received personal compensation for activities with Biogen Idec and Merck Serono. Dr. Marrosu has received personal compensation in an editorial capacity for Neurological Sciences. Dr. Marrosu has received research support from Serono Foundation, Biogen Idec, Schering AG, Sanofi-Aventis Pharmaceuticals Inc. Dr. Patti has received personal compensations for activities with Merck Serono, Bayer Schering, and Dompe Biotec. Dr. Mancardi has received personal compensation for activities with Biogen Idec, Bayer Pharmaceuticals Corp., and Merck Serono. Dr. Solaro has nothing to disclose. Dr. Totaro has received personal compensation for activities with Bayer Shering, Biogen Idec, Merck Serono, Sanofi-Aventis Pharmaceuticals Inc., Teva Neuroscience, and Novartis as a speaker or consultant. Dr. Tola has nothing to disclose. Dr. De Luca has nothing to disclose. Dr. Lugaresi has received personal compensation for activities with Biogen Idec, Bayer Schering, Merck Serono, Novartis and Sanofi-Aventis Pharmaceuticals Inc. as a speaker. Dr. Lugaresi has received research support from Biogen Idec, Bayer Schering, Merck Serono, Novartis and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Moiola has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals Inc., and Biogen Idec., Dr. Martinelli has received personal compensation for activities with Biogen Idec, Merck Serono, and Bayer Schering. Dr. Comi has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals Inc., Novartis, Merck Serono, Biogen Idec, Bayer Pharmaceuticals Corp., Teva Neuroscience, and Actellion.