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From the Department of Neurology (Dr. Sandberg-Wollheim), University Hospital, Lund, Sweden; Serono, Inc. (Drs. Lopez-Bresnahan, Chang, and Francis, D. Frank), Rockland, MA; Serono (M. Stam-Moraga), Geneva, Switzerland; Department of Obstetrics and Gynecology (Dr. Goodwin), University of Southern California; and Department of Neurology (Dr. Giesser), University of California, Los Angeles.
Address correspondence to Dr. Magnhild Sandberg-Wollheim, Department of Neurology, University Hospital, S-221 85 Lund, Sweden; e-mail: Magnhild.Sandberg{at}neurol.lu.se. Address reprint requests to Jason Gardner at Serono (Geneva); e-mail: Jason.Gardner{at}serono.com
Background: Although patients with multiple sclerosis (MS) are advised to stop interferon (IFN) beta-1a therapy before becoming pregnant, some patients become pregnant while on treatment.
Methods: We examined individual patient data from eight clinical trials with IFNß-1a.
Results: Of 3,361 women in the studies, 69 pregnancies were reported, of which 41 were patients receiving (or who had stopped receiving within 2 weeks prior to conception) IFNß-1a (in utero exposure group), 22 were patients who discontinued IFNß-1a treatment more than 2 weeks before conception (previous exposure group), and six were patients receiving placebo. The 41 in utero exposure pregnancies resulted in 20 healthy full-term infants, one healthy premature infant, nine induced abortions, eight spontaneous abortions, one fetal death, and one congenital anomaly (hydrocephalus). One patient was lost to follow-up. The 22 previous exposure pregnancies resulted in 20 full-term healthy infants, one healthy premature infant, and one birth-related congenital anomaly (Erb palsy)
Conclusions: The majority (21/31) of pregnancies that had the potential to go to full term produced healthy infants. The rate of spontaneous abortion was higher, but not significantly so, in the in utero exposure group compared to general population estimates. Until more exposure data become available, patients remain advised to stop IFNß therapy before becoming pregnant.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the September 27 issue to find the link for this article.
Editorial, see page 788
See also page 807
This article was previously published in electronic format as an Expedited E-Pub on August 10, 2005, at www.neurology.org.
Disclosure: M. Sandberg, MD, PhD, has received personal compensation from Serono in the form of travel support; T.M. Goodwin, MD, has acted as a consultant for Serono; B. Giesser, MD, has received honoraria from Serono; D. Frank, MSc, M. Lopez-Bresnahan, MD, M. Stam-Moraga, MSc, and P. Chang, PhD, are employees of and hold equity in Serono; G. Francis, MD, was a previous employee and held equity in Serono.
Received June 11, 2004. Accepted in final form April 11, 2005.
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