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Background: A recent cohort study in women with multiple sclerosis (MS) reported no increase in the prevalence of adverse pregnancy outcomes after exposure to interferon beta (IFNβ) before or during pregnancy. However, differing prevalence by maternal characteristics is unknown. Objectives: To describe the prevalence of serious adverse pregnancy outcomes (SAPOs) among pregnant women with MS exposed to only IFNβ and those unexposed to any MS disease-modifying drugs, with stratification by maternal characteristics. Methods: This cohort study extracted register data from Finland (1996-2014) and Sweden (2005-2014) on pregnant women with MS who were 1) dispensed only IFNβ within 6 months before the last menstrual period (LMP) or during pregnancy (IFNβ-exposed, n = 718 pregnancies) and 2) without dispensed MS disease-modifying drugs (unexposed, n = 1397 pregnancies). The prevalence (%) of SAPOs (consisting of elective terminations due to fetal anomaly, major congenital anomalies in live birth, and stillbirth) with 95% CIs was analyzed with stratification by maternal characteristics at LMP: time since MS diagnosis, duration of MS treatment, maternal age, and presence of chronic disease. Results: The prevalence of SAPOs appeared similar among the IFNβ-exposed and unexposed groups when MS was diagnosed ≤2 years (0.9% [95% CI 0.1%-3.2%] vs 3.0% [1.6%- 5.2%]) or 3-5 years (2.4% [0.9%-5.1%] vs 6.0% [4.0%-8.6%]) before LMP, and was comparable for >5 years (3.3% [1.4%-6.4%] vs 3.0% [1.7%-4.8%]). When stratified by duration of MS treatment, the prevalence among the IFNβ-exposed vs unexposed with ≤2-year treatment was 1.3% (0.4%-3.4%) vs 4.6% (2.9%-6.9%), 3- to 5-year treatment 1.7% (0.5%-4.4%) vs 4.9% (2.9%-7.7%), and >5-year treatment 4.3% (1.9%- 8.3%) vs 2.7% (1.2%-5.0%). The prevalence was similar among the IFNβ- exposed vs unexposed in strata by maternal age (≤20, 21-25, 26-30, 31-35, 36-40, >40 years) and presence of chronic diseases (yes/no). Conclusions: In this population-based observational study, the descriptive prevalence of SAPOs appeared similar with IFNβ exposure before or during pregnancy, when pregnant women with MS were stratified by maternal characteristics. [ABSTRACT FROM AUTHOR]

Background: Interferon-beta (IFN-beta) is a commonly used treatment for multiple sclerosis (MS). Current guidelines recommend cessation of treatment during pregnancy, however the results of past studies on the safety of prenatal exposure to IFN-beta have been conflicting. A large scale study of a population of MS women is therefore warranted. Objectives: To assess whether, among those born to women with MS, infants prenatally exposed to IFN-beta show evidence of smaller size at birth relative to infants which were not prenatally exposed to any MS disease modifying drugs. Methods: Swedish and Finnish register data was used. Births to women with MS in Sweden and Finland between 2005–2014 for which a birth measurement for weight, height, and head circumference was available were included. The exposure window was from 6 months prior to LMP to the end of pregnancy. Results: In Sweden, 411 pregnancies were identified as exposed to IFN-beta during the exposure window, and 835 pregnancies were counted as unexposed to any MS DMD. The corresponding numbers for Finland were 232 and 331 respectively. Infants prenatally exposed to interferon-beta were on average 28 grams heavier (p = 0.17), 0.01 cm longer (p = 0.95), and had head circumferences 0.14 cm larger (p = 0.13) in Sweden. In Finland, infants were 50 grams lighter (p = 0.27), 0.02 cm shorter (p = 0.92) and had head circumferences 0.22 cm smaller (p = 0.15) relative to those unexposed. Conclusions: This study provides evidence that exposure to IFN-beta during pregnancy does not influence birth weight, length, or head circumference. [ABSTRACT FROM AUTHOR]

Background: Previous studies reported no increase in the prevalence of adverse pregnancy outcomes after exposure to interferon-beta (IFN-beta). However, no study has investigated if the prevalence of these outcomes after IFN-beta exposure is modified by maternal and newborn characteristics. Our objective was to describe the stratified prevalence of adverse pregnancy outcomes among women with multiple sclerosis (MS) exposed only to IFN-beta or unexposed to any MS disease modifying drugs (MSDMDs)., Methods: This population-based cohort study using Finnish (1996-2014) and Swedish (2005-2014) register data included pregnancies of women with MS exposed only to IFN-beta 6 months before or during pregnancy (n=718) or unexposed to MSDMDs (n=1397). The outcome prevalences were described stratified by maternal and newborn characteristics, with 95% confidence intervals (CIs). Confounder-adjusted analyses were performed if the prevalence results indicated modified effect of IFN-beta in specific strata., Results: The stratified analysis indicated that the prevalence of serious (anomaly or stillbirth) and other adverse pregnancy outcomes was similar among the exposed and unexposed, with no statistically significant difference. Among women treated for MS >5 years, serious adverse pregnancy outcomes occurred in 4.3% (95%CI: 1.9-8.3%) of pregnancies exposed only to IFN-beta 6 months before or during pregnancy and in 2.7% (95%CI: 1.2-5.0%) of unexposed pregnancies. The confounder adjusted analyses did not support the hypothesis that MS treatment duration before pregnancy would modify the risk of adverse pregnancy outcomes after exposure to IFN-beta 6 months before or during pregnancy., Conclusion: The prevalence of adverse pregnancy outcomes was not increased after IFN-beta exposure, when pregnancies of women with MS were stratified by maternal and newborn characteristics. The stratified results were similar to the unstratified results in the same population., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Aim: This reports some of the first incidence rate (IR) estimates of second primary malignancies (SPMs) in men with metastatic castration-resistant prostate cancer (mCRPC) in three countries. Patients & methods: Claims data from the German Pharmacoepidemiological Research Database; registry data from the Prostate Cancer Data Base Sweden; and combined registry-claims data from the US Surveillance, Epidemiology and End Results-Medicare database were analyzed to obtain overall survival and incidence of SPMs in men with mCRPC. Results: SPMs occurred in 308 German (n = 2360), 273 Swedish (n = 2849) and 172 US (n = 2234) men with mCRPC. IRs of SPMs were 79.0 (95% CI: 70.4-88.4), 101.7 (95% CI: 90.3-114.5) and 59 (95% CI: 50-68) per 1000 person-years in German, Swedish and US cohorts, respectively. Conclusion: These studies report some of the first IR estimates of SPMs in men with mCRPC, providing a historical risk estimate of SPM in this patient population.