It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!

Sportiello, Liberata; Capuano, Annalisa

doi:10.3389/fphar.2023.1113557

Cited by 4 publications

(2 citation statements)

References 29 publications

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“…EudraVigilance is one of the widest databases in pharmacovigilance, collecting disparate information from different countries and populations. In our study, we could observe DMT-related adverse events in a population subgroup that is typically underrepresented or excluded in pre-authorisation clinical trials and in which the mother is affected by a serious illness (such as multiple sclerosis), which requires treatment, or a condition that untreated may pose significant risk to the foetus [21,55]. Therefore, spontaneous reporting during the post-authorisation phase is one primary source of information on adverse reactions occurring during pregnancy or breastfeeding.…”

Section: Strengths and Limitsmentioning

confidence: 92%

Disease-Modifying Therapies (DMTs) in Pregnant and Lactating Women with Multiple Sclerosis: Analysis of Real-World Data from EudraVigilance Database

Sportiello,

Di Napoli,

Balzano

et al. 2023

Pharmaceuticals

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(1) Background: The purpose of study was to compare the safety profile of glatiramer with natalizumab, alemtuzumab and ocrelizumab in pregnant and lactating women affected by multiple sclerosis (MS). (2) Methods: Individual case safety reports (ICSRs) were retrieved from the European spontaneous reporting system database (EudraVigilance). The reporting odds ratios (RORs) were computed to compare the reporting probability of events between natalizumab, alemtuzumab and ocrelizumab vs. glatiramer. (3) Results: A total of 1236 ICSRs reporting at least one DMT as a suspected drug were selected. More adverse drug reactions (ADRs) unrelated to pregnancy and breastfeeding (n = 1171; 32.6%) were reported than ADRs specific to pregnancy and breastfeeding (n = 1093; 30.4%). The most frequently reported unrelated ADR was MS relapse. Alemtuzumab and natalizumab seem to have a lower reporting probability of MS relapse compared to glatiramer (ROR 0.17, 95% CI 0.07–0.45 and ROR 0.34, 95% CI 0.20–0.57). Among pregnancy- and breastfeeding-related ADRs, the first most reported event was spontaneous abortion (n = 321; 8.9%). Natalizumab and ocrelizumab were associated with a higher reporting probability of spontaneous abortion compared to glatiramer (ROR 2.22, 95% CI 1.58–3.12; ROR 2.18, 95% CI 1.34–3.54, respectively), while alemtuzumab had a lower reporting frequency (ROR 0.32, 95% CI 0.17–0.60). (4) Conclusions: This study did not suggest any strong or new insights for DMTs in this special subpopulation. However, further studies need to be performed.

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Section: Strengths and Limitsmentioning

confidence: 92%

Disease-Modifying Therapies (DMTs) in Pregnant and Lactating Women with Multiple Sclerosis: Analysis of Real-World Data from EudraVigilance Database

Sportiello,

Di Napoli,

Balzano

et al. 2023

Pharmaceuticals

Self Cite

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“…Since the start of the pandemic, there has been a strong focus on medications to treat COVID-19. Studies have investigated repurposing medications to treat COVID-19 [ 10 – 12 ], but there is a lack of information about the use and safety of the use of these during pregnancy, and pregnant women have commonly been excluded from such clinical trials [ 13 , 14 ]. Developing guidelines for the management of pregnant women diagnosed with COVID-19, and keeping them updated, has been a challenging, ongoing task [ 15 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

Medication Use Among Pregnant Women With SARS‐CoV‐2 Infection and Risk of Hospitalization—A Study in Two Brazilian Hospitals

Rohweder,

Pereira,

Micheletti

et al. 2024

Journal of Pregnancy

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There is limited evidence about the use of medications among pregnant women with COVID‐19, as well as risk factors for hospitalization due to COVID‐19 in pregnancy. We aimed to describe the use of medications among SARS‐CoV‐2‐positive pregnant women at the time around infection and identify predictors for hospitalization due to COVID‐19 in two hospitals in Brazil. This is a hospital record‐based study among pregnant women with positive SARS‐CoV‐2 tests between March 2020 and August 2022 from two Brazilian hospitals. Characteristics of sociodemographic, obstetrical, and COVID‐19 symptoms were extracted retrospectively. The prevalence use of medications was based on self‐reported use, and this was administered at the hospital. Logistic regression was used to estimate predictors of hospitalization due to COVID‐19. There were 278 pregnant women included in the study, of which 41 (14.7%) required hospitalization due to COVID‐19. The remaining 237 (85.3%) had mild symptoms or were asymptomatic. Most of the women had the infection in the third trimester (n = 149; 53.6%). The most prevalent medications used across all trimesters were analgesics (2.4% to 20.0%), antibacterials (15.0% to 23.1%), and corticosteroids (7.2% to 10.4%). Pre‐ or gestational hypertensive disorder (odds ratio (OR) 4.94, 95% confidence interval (CI) 1.65, 14.87) and having at least one dose of vaccine against SARS‐CoV‐2 (OR 0.13, 95% CI 0.04, 0.39) were associated with hospitalization due to COVID‐19. Analgesics, antibacterials, and corticosteroids were the most frequently used medications among pregnant women with COVID‐19. Women with hypertensive disorders have almost a five‐fold increased risk of hospitalization due to COVID‐19. Vaccination was the strongest protective factor for severe COVID‐19. The COVID‐19 vaccination among pregnant women should be promoted, and pregnant women diagnosed with COVID‐19 who have hypertensive disorders should be closely monitored.

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The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice

Azria,

Haaser,

Schmitz

et al. 2024

American Journal of Obstetrics and Gynecology

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It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!

Abstract: Sportiello L and Capuano A (2023), It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!.

Cited by 4 publications

References 29 publications

Disease-Modifying Therapies (DMTs) in Pregnant and Lactating Women with Multiple Sclerosis: Analysis of Real-World Data from EudraVigilance Database

Disease-Modifying Therapies (DMTs) in Pregnant and Lactating Women with Multiple Sclerosis: Analysis of Real-World Data from EudraVigilance Database

Medication Use Among Pregnant Women With SARS‐CoV‐2 Infection and Risk of Hospitalization—A Study in Two Brazilian Hospitals

The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice

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