Background Family planning is an important consideration for women with multiple sclerosis (MS), who are often diagnosed during their reproductive years. Currently, limited data are available on pregnancy outcomes in patients exposed to interferon-beta (IFN-beta) before or during pregnancy. Here, we present the cumulative pregnancy exposure data and prevalence of pregnancy and infant outcomes in IFN-beta-exposed pregnant women with MS from the European IFN-beta Pregnancy Registry. Methods Using spontaneous and solicited reports, the registry collected data from 26 countries of the European Economic Area, consisting of information on women with MS identifying themselves to one of the Marketing Authorisation Holders (Bayer, Biogen, Merck KGaA, and Novartis) or healthcare professionals as pregnant and exposed to IFN-beta during pregnancy or within 1 month before conception. The outcomes collected by the registry included ectopic pregnancies, spontaneous abortions, elective terminations, live, and stillbirths with or without congenital anomalies. The prevalence of pregnancy outcomes was put in context with those reported in the general population. Results Between 2009 and 2017, the registry collected 948 pregnancy reports with a known pregnancy outcome. Overall, 82.0% (777/948) of pregnancies resulted in live birth without congenital anomaly. When comparing IFN-beta-exposed pregnancies with the general population, the prevalence of spontaneous abortions (10.7% vs. 10-21%) and congenital anomalies in live births (2.1% vs. 2.1-4.1%) were found to be within reported ranges. Conclusions The data gathered from these pregnancy cases suggest no evidence that IFN-beta exposure before conception and/or during pregnancy adversely increases the rate of congenital anomalies or spontaneous abortions.
Background: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy. Methods: Pregnancy cases with exposure to interferon beta-1b reported to Bayer’s pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study. Results: As of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78–2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population. Conclusions: These PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.
Objective: To review the neurologic manifestations of AIDS in patients who were admitted to Hospital Guilherme Álvaro (HGA) due to any clinical manifestation of the disease. Design: Case series. Patients: All HIV+ patients admitted to the Faculty Hospital (HGA) between July 96 and April 97 were included in this review. Results: From the 117 HIV+ patients admitted to hospitalization due to AIDS-related symptoms, 50 (42.7%) presented neurologic manifestations. The most prevalent of these was neurotoxoplamosis (68%), but a variety of other neurologic diseases were observed. Only 36% of these 50 patients had neurological signs and symptoms as the main complaint for admission, 12% of the patients had at least complained of some neurologic dysfunction at the time of admission and 10% had no neurologic complaints at all. The remaining 42% (21 patients) only complained of neurologic manifestations of AIDS when specifically asked. Conclusions: The prevalence of neurologic manifestations of AIDS is very high in patients admitted to hospital. Even in the absence of neurologic-related complaints, these patients have to be carefully questioned and examined in the search for an underlying neurologic complication which may present high morbidity and mortality.
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