Therapie最新文献

{"title":"Photodistributed cutaneous vasculitis: An uncommon side effect for topical ketoprofen.","authors":"Nadia Fetoui Ghariani, Nour El Imene Ouni, Sawssen Layouni, Marwa Thabouti, Haifa Mkhinini, Maha Lahouel, Badreddine Sriha, Chaker Ben Salem, Najet Ghariani, Mohamed Denguezli","doi":"10.1016/j.therap.2025.01.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143410854","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":"[Infusion-related reactions with human polyclonal immunoglobulins: Analysis from the French National Pharmacovigilance Database].","authors":"Aurélie Bobet, Justine Bravo, Eyrian Aubin-Beale, Blandine Bertin, François Montastruc, Romain Barus","doi":"10.1016/j.therap.2025.01.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.002","url":null,"abstract":"<p><strong>Objectives: </strong>Infusion-related reactions to immunoglobulins are well documented. The objective of this study was to characterize these reactions using real-world data to provide clinically relevant information.</p><p><strong>Methods: </strong>This descriptive study analyzed cases of infusion-related reactions reported in the French National Pharmacovigilance Database for immunoglobulins administered via intravenous or subcutaneous routes up to December 27, 2023.</p><p><strong>Results: </strong>During the study period, 239 cases of infusion-related reactions were reported, primarily associated with intravenous immunoglobulins (97.4%). In over half of the cases (51%), the reactions presented as flu-like syndromes. These reactions typically occurred during the first cycle for IV immunoglobulins and the fourth cycle for SC immunoglobulins. Following the onset of an infusion-related reaction, the infusion was most commonly discontinued (87.7%) or the infusion rate reduced (9.1%). In 64 cases, resolution of the reaction allowed the continuation of treatment with reduced infusion rates (65%), premedication (28%), or both (7%). Resumption of the infusion did not lead to recurrence in 60% of cases. For subsequent cycles, administration of the same formulation (n=100) resulted in recurrence in 40% of cases, while switching to a different formulation (n=16) was associated with recurrence in 75% of cases.</p><p><strong>Conclusion: </strong>Infusion-related reactions to immunoglobulins most frequently present as flu-like syndromes or cardiovascular disturbances, which are typically resolved by reducing the infusion rate or discontinuing the infusion. Resumption of the infusion is feasible following resolution, using a reduced rate or premedication. The findings suggest that switching to a different formulation of the same administration route does not confer a practical advantage.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383365","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":"Addictovigilance: The Edge of reason?","authors":"Maryse Lapeyre-Mestre, Joelle Micallef","doi":"10.1016/j.therap.2025.01.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081097","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":"Adagrasib-induced photodistributed hyperpigmentation: Two case reports and pathogenetic hypothesis.","authors":"Julien Lebled, Jean-Paul Claudel, Marie-Sarah Agier, Laurent Plantier, Bérenger Largeau, Annie-Pierre Jonville-Bera","doi":"10.1016/j.therap.2024.12.014","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.014","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081135","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, Anne Lise Pinault, Lucie-Marie Scailteux, Marie-Noelle Beyens, Audrey Fresse, Nadine Petitpain","doi":"10.1016/j.therap.2024.12.013","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.013","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-18","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":"BRAF and MEK inhibitors rechallenge after an adverse drug reaction in patients with cancer: A pharmacovigilance cohort study.","authors":"Emilien Ezine, Angélique Da Silva, Safa Idoudi, Céleste Lebbe, Basile Chrétien, Marion Sassier, Joachim Alexandre, Charles Dolladille","doi":"10.1016/j.therap.2024.12.011","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.011","url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-10","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":"COVID-19 infection and risk of adverse drug reactions: Cohort study.","authors":"Paul-Benoît Fargier, Marlène Damin-Pernik, Manon Launay, Amandine Gagneux-Brunon, Florelle Bellet, Marie-Noëlle Beyens","doi":"10.1016/j.therap.2024.12.012","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.012","url":null,"abstract":"<p><strong>Aim: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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, P=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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-10","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":"[Impact of dronabinol shortage on a population of chronic pain patients: A retrospective observational study].","authors":"Salomé Winckel, Laurie Ferret, Laure Dujardin, Amélie Boursier","doi":"10.1016/j.therap.2024.12.010","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.010","url":null,"abstract":"<p><strong>Objective: </strong>A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.</p><p><strong>Method: </strong>A retrospective observational study of patients treated with dronabinol was conducted. Collected data included socio-demographic, pharmacological and clinical data. Pain intensity and its interference, the intensity of other pain dimensions (mood, relationship with others, etc.) and quality of sleep were collected before discontinuation (dronabinol dosage balanced, M0) and at the end of discontinuation (dronabinol stopped for several weeks, M3). The patient's perception of his state of health evolution was collected at the end of the shortage.</p><p><strong>Results: </strong>Health deterioration was reported by 86% of patients after 3 months of rupture. Pain intensity and its interference with patients' daily lives increased significantly. Patients' sleep deteriorated significantly. The number of patients with permanent pain increased 5-fold (n=2 at M0 and n=10 at M3). The number of patients with more than 20 painful attacks per 24hours increased 2-fold (n=2 at M0 and n=4 at M3).</p><p><strong>Conclusion: </strong>Although data on the efficiency of dronabinol are currently limited, this supply disruption has had negative clinical consequences for our patients. With drug shortages multiplying in recent years, the marketing of new specialties and therefore the availability of therapeutic alternatives could help reduce the clinical impact of a possible new dronabinol shortage in these refractory chronic pain patients.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012200","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":"Comment la réforme de la T2A peut-elle permettre de financer des produits de santé innovants ?","authors":"Xavier Armoiry ,&nbsp;Nejma Saidani ,&nbsp;Martine Aoustin ,&nbsp;Dorothée Camus ,&nbsp;Auriane Cano-Chancel ,&nbsp;Sophie Carlier ,&nbsp;Albane Degrassat-Théas ,&nbsp;Anne-Aurélie Epis de Fleurian ,&nbsp;Anne Grumblat ,&nbsp;Aurélie Lavorel ,&nbsp;Mégane Lesaignoux ,&nbsp;Tess Martin ,&nbsp;Adrien Michaud ,&nbsp;Jonathan Morizot ,&nbsp;Nathalie Préaubert ,&nbsp;Valery-Pierre Riche ,&nbsp;Isabelle Durand Zaleski","doi":"10.1016/j.therap.2024.11.001","DOIUrl":"10.1016/j.therap.2024.11.001","url":null,"abstract":"<div><div>En France, les activités de court séjour des établissements de santé, publics et privés, sont financés depuis 2004 par la tarification à l’activité (T2A). Le principe est de permettre une rémunération qui dépend essentiellement de la nature et du volume des activités. La T2A a permis une transformation majeure par rapport à l’ancien système de financement en particulier pour les établissements publics qui fonctionnaient sous dotation globale et une convergence des modes de rémunération entre secteurs public et privé. Cependant, des rapports officiels et l’expression publique de nombreux acteurs de la santé hospitalière ont aussi souligné des limites à ce mode de financement, conduisant à plusieurs projets de réforme. Dans ce contexte, la table ronde 3 des Ateliers de Giens, réunissant des experts académiques et/ou hospitaliers, institutionnels et industriels, s’est interrogée sur l’impact des nouvelles réformes de la T2A sur l’accès aux produits de santé innovants des hôpitaux. Après un travail de cadrage de la problématique et l’établissement de constats, la table ronde a proposé six recommandations générales qui seraient autant de pistes visant à améliorer l’accès aux produits de santé innovants pour la population prise en charge en milieu hospitalier.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 61-76"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How to facilitate the wider use of pharmacogenetic tests?","authors":"Céline Verstuyft ,&nbsp;Dominique Dewolf ,&nbsp;Olivier Blin ,&nbsp;Virginie Florentin ,&nbsp;Laurent Mesnard ,&nbsp;Boris Chaumette ,&nbsp;Estelle Ayme-Dietrich ,&nbsp;Laure Raymond ,&nbsp;Marie Lang ,&nbsp;Antonin Lamazière ,&nbsp;Béatrice Allard ,&nbsp;Laurence Samelson ,&nbsp;Liliane Lamezec ,&nbsp;Marie-Anne Loriot ,&nbsp;Antoine Le Bozec ,&nbsp;Nicolas Picard","doi":"10.1016/j.therap.2024.11.010","DOIUrl":"10.1016/j.therap.2024.11.010","url":null,"abstract":"<div><div>4P medicine (personalized, preventive, predictive, and participatory) is experiencing a remarkable rise, and pharmacogenetics is an essential part of it. However, several obstacles are hindering its deployment. This round table brought together a group of experts to take stock of the situation, reflecting on ways to facilitate the prescription of these tests and the dissemination of the results on a national scale. The experts looked at the methods of prescribing and communicating pharmacogenetic data in the current situation as well as in the coming years, with the arrival of artificial intelligence software. The questions relating to the reimbursement of tests — as topical as ever — were also discussed, as this is a way to allow all patients to access these tests. Numerous recommendations have been formulated on these various points, aimed at facilitating prescription management for healthcare professionals, and ensuring the retention and use of the results throughout the patient's life. Finally, better patient information was recommended, as well as strengthening the involvement of healthcare professionals and industry stakeholders in this process, with insistence on the necessary training and commitment to ensure its success.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 103-112"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955594","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}