Therapie最新文献

{"title":"BRAF and MEK inhibitors rechallenge after an adverse drug reaction in patients with cancer: A pharmacovigilance cohort study","authors":"Emilien Ezine ,&nbsp;Angélique Da Silva ,&nbsp;Safa Idoudi ,&nbsp;Céleste Lebbe ,&nbsp;Basile Chrétien ,&nbsp;Marion Sassier ,&nbsp;Joachim Alexandre ,&nbsp;Charles Dolladille","doi":"10.1016/j.therap.2024.12.011","DOIUrl":"10.1016/j.therap.2024.12.011","url":null,"abstract":"<div><h3>Importance</h3><div>The safety profile of a rechallenge with BRAF inhibitors (BRAFi) or a combination of BRAF and MEK inhibitors (MEKi) following an adverse drug reaction (ADR) remains largely unexplored.</div></div><div><h3>Objective</h3><div>To identify the reported recurrence rate of the same ADR after a BRAFi<!--> <!-->±<!--> <!-->MEKi targeted therapy (TT) rechallenge in patients with cancer and to identify factors associated with recurrence.</div></div><div><h3>Design, setting, and participants</h3><div>In this observational, pharmacovigilance study, ADR reports were sourced from VigiBase, the World Health Organization database. The inclusion criteria encompassed all BRAFi cases (with or without MEKi) through September 01, 2023, irrespective of the primary cancer diagnosis.</div></div><div><h3>Main outcomes and measures</h3><div>The primary outcome was the reported recurrence rate of the same initial ADR following TT rechallenge. Secondary outcomes measures included were identification of variables associated with recurrence among informative rechallenges, defined as those with known recurrence status.</div></div><div><h3>Results</h3><div>Out of 21,339 ADR cases linked to TT, 4771 (22.4%) reported a rechallenge, with 563 yielding informative data (11.8%). Recurrence of the initial ADR was reported in 223 cases, resulting in a reported recurrence rate of 39.6% (95% CI: 35.7–43.7). The highest recurrence rates in a rechallenge were observed for pyrexia (47%, 95% CI: 39–55), renal failure (46%, 95% CI: 32–60), and musculoskeletal disorders (44%, 95%CI: 33–56). There was no significant influence of factors such as TT regimen (either BRAFi monotherapy or any TT combination), age, sex, or the type of cancer on reported recurrence rate.</div></div><div><h3>Conclusions and relevance</h3><div>In real-world settings, approximately two-fifths of cases with notified TT rechallenges led to a reporting of recurrence of the same initial ADR. The primary determinant of reported recurrence seems to be the nature of the initial ADR rather than the TT regimen, or any other baseline patient characteristic.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 526-535"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143041675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vaccines and the risk of Guillain-Barré syndrome: A French pharmacovigilance analysis","authors":"Marie Gligorov ,&nbsp;Bénédicte Lebrun-Vignes ,&nbsp;Kamel Masmoudi ,&nbsp;Thierry Vial ,&nbsp;Helga Junot ,&nbsp;Valérie Pourcher ,&nbsp;Sophie Demeret ,&nbsp;Nicolas Weiss ,&nbsp;Kevin Bihan","doi":"10.1016/j.therap.2025.02.007","DOIUrl":"10.1016/j.therap.2025.02.007","url":null,"abstract":"<div><h3>Aims</h3><div>Guillain-Barré syndrome (GBS) is a rare autoimmune-mediated disease that can occur in a post-vaccination context. During the vaccination surveillance program of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, reports of GBS as a possible adverse effect (AE) of SARS-CoV-2 vaccines have been reported. Our aim was to describe post-vaccine reports of GBS whatever the vaccine used.</div></div><div><h3>Methods</h3><div>Data were obtained from the French pharmacovigilance database from inception (1 January 1985) to 1st March 2022. Reports were analyzed according to the French causality assessment method but only reports with a time to onset from the beginning of the treatment and the first symptoms occurrence of less than 4<!--> <!-->weeks were included in our analysis, in accordance to the chronological criteria of the Brighton criteria.</div></div><div><h3>Results</h3><div>Three hundred and seventy-five (375) reports of GBS according to these selection criteria were retained for analysis. The data indicate a higher proportion of men (59%), with a median age of 54<!--> <!-->years and a median time-to-onset after vaccination of 12<!--> <!-->days. Around 45% of the reports were recorded with SARS-CoV-2 vaccines of which 68% involved post-mRNA vaccines and more precisely 56% post-tozinameran.</div></div><div><h3>Conclusion</h3><div>This study suggests that Guillain-Barré syndrome may be a rare but potentially severe adverse event that can occur in the first few weeks after vaccination whatever its nature. Even if a vaccine was injected in the weeks preceding the first signs of GBS, it is essential to perform a complete etiological assessment (search for bacterial or viral infection, particularly <em>Campylobacter jejuni</em>, etc.) in order to rule out another cause before considering its role in the onset of GBS. Continued pharmacovigilance survey of marketed vaccines is necessary to update or even harmonize its SmPCs.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 580-588"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between antidepressant drugs and falls in older adults: A mediation analysis in the World Health Organization's pharmacovigilance database","authors":"Elise-Marie Minoc ,&nbsp;Cédric Villain ,&nbsp;Basile Chrétien ,&nbsp;Soumia Benbrika ,&nbsp;Marie Heraudeau ,&nbsp;Claire Lafont ,&nbsp;Clémence Béchade ,&nbsp;Thierry Lobbedez ,&nbsp;Véronique Lelong-Boulouard ,&nbsp;Charles Dolladille","doi":"10.1016/j.therap.2025.01.004","DOIUrl":"10.1016/j.therap.2025.01.004","url":null,"abstract":"<div><h3>Objectives</h3><div>The objective is to investigate the association between antidepressant drugs intake and falls reporting, as well as the potential mediators in-between, in older adults.</div></div><div><h3>Methods</h3><div>In VigiBase®, the World Health Organization's pharmacovigilance database, we performed a disproportionality analysis to probe the putative associations between each antidepressant drugs class (non-selective monoamine reuptake inhibitors [NSMRIs], selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], alpha-2-adrenergic receptor antagonists, and “other antidepressants”) and reports of falls in people aged 65 and over (<span><span>NCT05628467</span><svg><path></path></svg></span>). The reporting odds ratios and their 95% confidence interval were derived from logistic regression models with adjustment for confounders. We studied the falls-inducing mechanisms (delirium, hyponatremia, hypotension) by using causal mediation analyses and by using a disproportionality analysis for the co-occurrence of falls and these events.</div></div><div><h3>Results</h3><div>Our main analysis included 86,200 cases of falls reporting in older adults (of which 57% were 75 and over). A significant association was found between falls and every antidepressant drugs class, except for NSMRIs. According to causal mediation analysis, a direct effect on the falls reports was shown for alpha-2-adrenergic receptor antagonists and for “other antidepressants”. According to the co-reports analyses, all antidepressant drugs classes except SNRIs were associated with the co-event fall-delirium; SSRIs, alpha-2-adrenergic receptor antagonists, and “other antidepressants” with fall-hypotension; all antidepressant drugs classes except NSMRIs with fall-hyponatremia.</div></div><div><h3>Conclusions</h3><div>In multivariate disproportionality analyses, all antidepressant drugs classes were associated with signals of disproportionate reporting of falls in older adults, except for NSMRIs. In mediation analyses, a direct effect on the falls reports was only found for alpha-2-adrenergic receptor antagonists. Single-mediators based models seem insufficient to explain the diversity of clinical settings resulting in falls. These findings underline the necessity of a comprehensive analysis of all clinical and pharmacological features in older falling adults treated with antidepressant drugs.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 561-571"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reintroduction of cotrimoxazole in a Stevens-Johnson case with other antibacterial sulfonamide (sulfadiazine) among suspects","authors":"Ilaria Matei ,&nbsp;Valérie Beaulieu ,&nbsp;Camille Ollivier ,&nbsp;Bénédicte Lebrun-Vignes ,&nbsp;Kamar Bel Hareth ,&nbsp;Saskia Ingen-Housz-Oro ,&nbsp;Haudrey Assier","doi":"10.1016/j.therap.2025.03.002","DOIUrl":"10.1016/j.therap.2025.03.002","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 613-615"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HOPIPRAC : Interface de pharmacovigilance pour la détection de cas d’évènements indésirables dans un entrepôt de données hospitalier","authors":"Layal El Aridi ,&nbsp;Hélène Jantzem ,&nbsp;André Happe ,&nbsp;Jean Michel Cauvin ,&nbsp;Dominique Carlhant-Kowalski ,&nbsp;Greta Gourier","doi":"10.1016/j.therap.2025.02.002","DOIUrl":"10.1016/j.therap.2025.02.002","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;La notification spontanée est la méthode de référence pour le recueil des effets indésirables des médicaments (EIM). Mais, elle reste insuffisante. La recherche textuelle dans le dossier médical électronique a ouvert une nouvelle voie dans la collecte des EIM. Néanmoins, ces méthodes présentent certaines limites. Les entrepôts de données constituent un environnement numérique riche regroupant tous les supports d’un dossier médical informatique. Le centre de données cliniques (CDC) du CHU de Brest a développé un outil métier pour la pharmacovigilance, l’interface HOPIPRAC, apportant une autonomie dans l’interrogation de l’ensemble de la base de données hospitalière à la détection de cas de suspicion d’EIM à partir des dossiers patients informatisés.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthode&lt;/h3&gt;&lt;div&gt;La source de donnée utilisée était l’entrepôt de données du CHU de Brest. La mise au point de l’outil informatique et les différents tests se sont succédé sur une période entre 2015 et 2018. Un test de validation de l’outil a été proposé reposant sur le choix d’un signal positif issu de l’expérience brestoise antérieure (valvulopathie avec Benfluorex). L’outil de requête dans l’entrepôt de données hospitalières permet également de réaliser d’autres formes d’interrogation pour identifier de nouveaux risques, en particulier avec les nouveaux médicaments mis sur le marché, comme le Nivolumab. L’outil a été testé pour identifier et analyser les toxidermies bulleuses décrites comme les plus sévères et très souvent spécifiques d’une origine médicamenteuse.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultat&lt;/h3&gt;&lt;div&gt;Le test de validation a permis de retrouver 98 % des cas historiques enregistrés dans la base nationale de pharmacovigilance, ainsi que de nouveaux cas potentiels non signalés au CRPV (Centre Régional de Pharmacovigilance) de Brest. La cohorte nivolumab a permis de retrouver 34 cas d’EIM. Parmi ces cas, 82 % étaient graves et certains étaient inattendus à la date de l’extraction. La requête concernant les toxidermies a permis de retrouver 137 cas dont 56 % n’avaient pas été déclarés au CRPV de Brest. Concernant le (Syndrome de Stevens Johnson (SJS), 28 % des cas ont été associés à des antinéoplasiques (7 cas), notamment les inhibiteurs des tyrosines kinases (sorafenib, vemurafenib, regorafenib) issus des thérapies innovantes, alors que ce risque est décrit comme rare dans les résumés des caractéristiques des produits des spécialités de ces 3médicaments.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Discussion&lt;/h3&gt;&lt;div&gt;L’interface HOPIPRAC est un outil informatique innovant pour l’évaluation de la sécurité des médicaments. Elle permet aux pharmacovigilants d’avoir un accès autonome aux données médicales hospitalières électroniques. Ses applications en routine sont : 1- l’amplification d’un signal de pharmacovigilance obtenu par notification spontanée ; 2- le suivi des effets indésirables de cohortes de patients exposés à un médicament spécifique et 3- la cartographie de certaine","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 572-579"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Subcutaneous rituximab in indolent primary cutaneous B cell lymphoma: A case series of 5 patients with the evaluation of the medico economic impact","authors":"Carla Fassanaro ,&nbsp;Laurent Mortier ,&nbsp;Olivier Carpentier ,&nbsp;Inès Arib ,&nbsp;Benoit Dervaux ,&nbsp;Sarah Faiz","doi":"10.1016/j.therap.2025.04.001","DOIUrl":"10.1016/j.therap.2025.04.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 619-620"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144045041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lichenoid drug eruption and apalutamide: Analyses from pharmacovigilance databases and disproportionality analysis","authors":"Viktoryia Prontskus ,&nbsp;Anne Lise Pinault ,&nbsp;Lucie-Marie Scailteux ,&nbsp;Marie-Noelle Beyens ,&nbsp;Audrey Fresse ,&nbsp;Nadine Petitpain","doi":"10.1016/j.therap.2024.12.013","DOIUrl":"10.1016/j.therap.2024.12.013","url":null,"abstract":"<div><h3>Introduction</h3><div>Apalutamide is an oral androgen receptor pathway inhibitor used to treat non-metastatic castration-resistant prostate cancer at high risk of developing metastases. Skin toxicity of apalutamide is documented, including a few cases of lichenoid drug eruptions (LDE). The objective of our study is to qualitatively and quantitatively describe LDE associated with apalutamide using data from the French Pharmacovigilance Database (FPVD) and Vigibase.</div></div><div><h3>Methods</h3><div>FPVD and Vigibase were queried on August 5, 2024, for reports of LDE associated with apalutamide. Disproportionality analysis was performed using VigiBase®, calculating the reporting odds ratio (ROR) and Bayesian confidence propagation neural network information components (IC).</div></div><div><h3>Results</h3><div>Qualitatively, we identified and analyzed 16 cases of apalutamide related-LDE. The average age of male patients was 75 years. The median time to LDE onset was 4 months. Clinically, LDE presented as maculopapular rashes, lichenified aspects, lichen planus, lichenoid keratosis, and psoriasiform aspects. Management typically involved apalutamide discontinuation (81,2%) and corticosteroid therapy (56,2%), with favourable outcomes in 10 cases (62,5%). Quantitatively, disproportionality analysis showed significant ROR and IC for LDE and apalutamide (ROR 6.5, 95% CI 6.0–7.0; IC 2.4, IC025 1.6–3.3).</div></div><div><h3>Conclusion</h3><div>Skin rash and pruritus reactions are frequently observed with apalutamide, possibly because of its chemical structure. Our qualitative and quantitative analysis of LDE cases observed among apalutamide exposed patients support a safety signal. LDE generally resolved with topical corticosteroids, but often required the discontinuation of apalutamide. When faced with a LDE, clinicians should consider exposure to apalutamide as one of the potential causes.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 546-552"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 infection and risk of adverse drug reactions: Cohort study","authors":"Paul-Benoît Fargier ,&nbsp;Marlène Damin-Pernik ,&nbsp;Manon Launay ,&nbsp;Amandine Gagneux-Brunon ,&nbsp;Florelle Bellet ,&nbsp;Marie-Noëlle Beyens","doi":"10.1016/j.therap.2024.12.012","DOIUrl":"10.1016/j.therap.2024.12.012","url":null,"abstract":"<div><h3>Aim</h3><div>During coronavirus disease 2019 (COVID-19), the incidence rate of adverse drug reactions (ADRs) in hospitalized patients seemed higher than before the pandemic. Severe inflammation triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was cited as an explanation. We aimed to determine whether COVID-19 infection was associated with a higher risk of ADRs compared to other infectious diseases.</div></div><div><h3>Methods</h3><div>A monocentric historic cohort, “exposed/unexposed” study, was conducted in the university hospital of Saint-Étienne (inclusion period from March 05, 2020 to April 16, 2020 for “COVID-19” and from January to December 2019 for “non-COVID-19”). All ADRs reported in patients’ medical records were retrospectively assessed using Bégaud et al.’s algorithm. A multivariable Cox regression was performed to assess the hazard ratio (HR).</div></div><div><h3>Results</h3><div>The incidence rate of 4.64 ADRs per person-month in the “COVID-19” group did not differ from the 3.52 ADRs per person-month in the “non-COVID-19” group (multivariable adjusted HR 1.29, 95% confidence interval [CI], 0.91–1.81, <em>P</em> <!-->=<!--> <!-->0.1436). COVID-19 patients had more hepatobiliary disorders whereas non-COVID-19 patients had more renal and urinary disorders. Classes of drugs mostly involved in ADRs occurrence were antibiotics, followed by antithrombotics in both groups. Compared to patients with no ADR, patients with ADRs had higher C-reactive protein (CRP) levels and a lower estimated glomerular filtration rate (eGFR).</div></div><div><h3>Conclusion</h3><div>In this study, the incidence rate in hospitalized patients with COVID-19 was not statistically different from that in the group with another infection. High CRP levels, as well as low eGFR, were the main risk factors for the occurrence of ADRs and should be considered in further ADR prevention strategies.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 536-545"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methylphenidate-associated eosinophilia in a child: A case report","authors":"Aurélie Bobet ,&nbsp;Marion Broquere ,&nbsp;Philippe Pauly ,&nbsp;Thiébaut-Noël Willig ,&nbsp;Haleh Bagheri","doi":"10.1016/j.therap.2025.04.002","DOIUrl":"10.1016/j.therap.2025.04.002","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 620-623"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144754376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of SARS-CoV-2 vaccination of pregnant women: Luxembourg's cohort study and literature review.","authors":"Victoria Ugolini, Nadine Petitpain, Didier Menzies, Dominique Swiegot, Audrey Fresse, Isabel De La Fuente Garcia, Anne-Cécile Vuillemin","doi":"10.1016/j.therap.2025.07.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.07.001","url":null,"abstract":"<p><strong>Aims of the study: </strong>European countries rapidly advised coronavirus disease 2019 (COVID-19) vaccination during pregnancy based on the evidence of first and reassuring data, especially with mRNA vaccines. Besides the close European pharmacovigilance monitoring, Luxembourg set up a prospective study cohort of women vaccinated during pregnancy to collect maternal and embryofetal outcomes.</p><p><strong>Methods: </strong>The study was conducted between June 2021 and October 2023, based on the national vaccination registry. Women were contacted by email and all reported events were retrospectively reviewed by an expert group.</p><p><strong>Results: </strong>The cohort involved 2335 vaccinated pregnant women of which 476 (20.4%) provided an answer, with 383 (80.5%) reporting no adverse events, 88 (18.5%) reporting a total of 90 adverse events (five reports not assessable). Vaccines were almost exclusively messenger RNA (mRNA) vaccines. Between the women who reported an adverse event and those who did not, no significant difference was identified for vaccine rank and pregnancy trimester. Among the 90 reported events, 73 (81,9%) were considered as without link with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination. Among the 17 adverse events having a non-excluded link with the vaccine, 16 (94%) had a favorable outcome and/or no pathophysiological explanation in regard to the vaccine. Rates of congenital anomalies and miscarriages were reassuringly lower than in the general population.</p><p><strong>Conclusion: </strong>Our Luxembourgish cohort study provided results consistent with other European pharmacovigilance surveys and literature data, in agreement with the overall safety of the vaccination against SARS-Cov-2 with mRNA vaccine during pregnancy.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}