S. Roriz , C. Michel , M. Mezzarobba , M. Grit , G. Baville Valade , E. Cabrera , L. ElotmanI , A. Ambert , J.-Y. Lefrant , S. Granier , N. Boulet , Y. Gricourt
{"title":"Délai d’obtention d’une première décision finale par un Comité de Protection des Personnes pour débuter une étude de recherche clinique en France : Etude rétrospective entre 2019 et 2023","authors":"S. Roriz , C. Michel , M. Mezzarobba , M. Grit , G. Baville Valade , E. Cabrera , L. ElotmanI , A. Ambert , J.-Y. Lefrant , S. Granier , N. Boulet , Y. Gricourt","doi":"10.1016/j.revmed.2024.07.009","DOIUrl":"10.1016/j.revmed.2024.07.009","url":null,"abstract":"<div><h3>Introduction</h3><div>The study reported the time (from the initial submission to the final decision) to evaluate a clinical research project by one of the 39 French national ethics committees. The times from this final decision to the first participant inclusion and study achievement (first patient inclusion to the end of the last patient's follow-up) were also reported.</div></div><div><h3>Methods</h3><div>Clinical research projects submitted between January 1st 2019 and June 30th 2023 were analyzed according to their type (research on drugs, clinical investigations, performance studies, research implying human person), and the promotor (industry, university hospital, general hospital, private medical institution, others). The times of assessment of the project by the ethic committee (from the initial submission to the final decision), of the first participant inclusion (from the approval of the project) and of study achievement (first patient inclusion to the end of the last patient's follow-up) were calculated.</div></div><div><h3>Results</h3><div>Among 467 submitted clinical research projects, 424 were approved (90.8 %). The median time [Q1–Q3] to evaluate a project was 73 days [51–98] whatever the types of projects and promotors. In 307 accepted projects, the first patient inclusion occurred after 134 days [61–237] and was being waited for 347 days [306–510] in 39 other ones. In 122 projects, the time for study achievement was 446 days [230–731]. In 185 other projects, the inclusions were still in progress for 699 days [397–1098].</div></div><div><h3>Conclusion</h3><div>In this concerned ethic committee, a final decision was edited after a median assessment time of 73 days (with ><!--> <!-->90 % approvals), shorter than the times to include the first patient and for achieving the study.</div></div>","PeriodicalId":54458,"journal":{"name":"Revue De Medecine Interne","volume":"46 3","pages":"Pages 133-138"},"PeriodicalIF":0.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141989854","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}
Kevin Chevalier , Grégoire Martin de Frémont , Anaïs Roeser
{"title":"M. Raphaël Darbon, président de l’association de patients « France Vascularites »","authors":"Kevin Chevalier , Grégoire Martin de Frémont , Anaïs Roeser","doi":"10.1016/j.revmed.2025.02.001","DOIUrl":"10.1016/j.revmed.2025.02.001","url":null,"abstract":"","PeriodicalId":54458,"journal":{"name":"Revue De Medecine Interne","volume":"46 3","pages":"Pages 185-187"},"PeriodicalIF":0.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143529186","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}
Philippe Mertz , Véronique Hentgen , Guilaine Boursier , Ines Elhani , Laure Calas , Jerome Delon , Sophie Georgin-Lavialle
{"title":"Maladies auto-inflammatoires associées à l’IL-18","authors":"Philippe Mertz , Véronique Hentgen , Guilaine Boursier , Ines Elhani , Laure Calas , Jerome Delon , Sophie Georgin-Lavialle","doi":"10.1016/j.revmed.2024.08.003","DOIUrl":"10.1016/j.revmed.2024.08.003","url":null,"abstract":"<div><div>Autoinflammatory diseases (AIDs) are conditions characterized by dysfunction of innate immunity, causing systemic inflammation and various clinical symptoms. The field of AIDs has expanded due to improved comprehension of pathophysiological mechanisms and advancements in genomics techniques. A new emerging category of AIDs is characterized by a significant increase in interleukin 18 (IL-18), a pro-inflammatory cytokine synthesized in macrophages and activated by caspase 1 via various inflammasomes. IL-18 plays a role in the regulation of innate and adaptive immunity. IL-18 is involved in various functions, such as the proliferation, survival, and differentiation of immune cells, tissue infiltration of immune cells, polarization of immune responses, and production of other pro-inflammatory cytokines. This review analyzes the literature on IL-18 regarding its functions and its implications in the diagnosis and treatment of AIDs. IL-18-associated AIDs comprise Still's disease and diseases associated with mutations in <em>NLRC4</em>, <em>XIAP</em>, <em>CDC42</em>, and <em>PSTPIP1</em>, as well as IL-18BP deficiencies. With the exception of <em>PSTPIP1</em>-associated diseases, these conditions all carry a risk of macrophagic activation syndrome. Measuring IL-18 levels in serum can aid in the diagnosis, prognosis, and monitoring of these diseases. Therapies targeting IL-18 and its signaling pathways are currently under investigation.</div></div>","PeriodicalId":54458,"journal":{"name":"Revue De Medecine Interne","volume":"46 3","pages":"Pages 155-163"},"PeriodicalIF":0.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142001623","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":"Des ulcérations du cuir chevelu et de la jambe révélant une sarcoïdose systémique","authors":"Houria Sahel , Billel Merrouche , Nacima Djennane , Amine Hebouchi , Ammar Maireche","doi":"10.1016/j.revmed.2025.01.004","DOIUrl":"10.1016/j.revmed.2025.01.004","url":null,"abstract":"<div><h3>Introduction</h3><div>Sarcoidosis is a multisystem disorder. Skin injury can have a wide range of semiologies. Ulcerated forms have rarely been described.</div></div><div><h3>Case report</h3><div>A 56-year-old woman was operated on for a scalp mass. The pathological study shows tuberculoid granulomas with caseous necrosis of the right temporalis muscle. Two years later, she consulted for ulcerations of the scalp and right leg. Histological examination of the scalp lesion and a back lesion showed gigantocellular granulomas without caseous necrosis. Thoraco-abdomino-pelvic CT scan revealed hilar and abdominopelvic lymphadenopathy. On brain magnetic resonance imaging, signs of myositis of the right temporalis muscle involvement were noted. The diagnosis of ulcerated multisystem sarcoidosis was made. A spectacular improvement was noted after seven months of treatment with systemic prednisone, without recurrence after three years.</div></div><div><h3>Conclusion</h3><div>We report an original observation of cutaneous ulcerations revealing multisystemic sarcoidosis. Diagnosis of this rare form relies on skin biopsy and exclusion of other cutaneous granulomatoses. The evolution of ulcerative sarcoidosis is usually satisfactory with the usual treatments of sarcoidosis.</div></div>","PeriodicalId":54458,"journal":{"name":"Revue De Medecine Interne","volume":"46 3","pages":"Pages 174-178"},"PeriodicalIF":0.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076798","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":"Complications virales des biothérapies/thérapies ciblées anti-inflammatoires","authors":"Lionel Piroth , Florian Moretto , Thibaut Sixt , Mathieu Blot","doi":"10.1016/j.revmed.2024.12.007","DOIUrl":"10.1016/j.revmed.2024.12.007","url":null,"abstract":"<div><div>By the end of the nineties, new immunomodulatory options impacting on the determinants of many immune-mediated diseases became available. These drugs were also called biologicals. Their use was associated with a significant improvement in the management of the patients and on their clinical evolution over time. On the other hand, their use was found to be also associated with an over-risk of infectious complications, in particular of viral origin, even though the savings of other at-risk treatments (e.g. corticosteroids or cyclophosphamide) allowed by these new therapies could have contributed to reduce it. These viral infections may be linked to an increased susceptibility to new infections because of impaired immunity and/or lower responsiveness to vaccination, to a higher risk of reactivation of latent infections, and to a higher severity than observed in the general population. Viruses mostly involved are respiratory (influenza, RSV, and SARS-CoV2), Varicella-Zoster, hepatitis B, or JC viruses, in particular. The viral risk depends not only on the type of biologicals, but also on the underlying disease, the associated comorbidities, the associated treatments, the epidemiological environment, and the individual and collective immunity. At an individual level, prevention and management of the infectious risk are of utmost importance in the global management of patients on biologicals.</div></div>","PeriodicalId":54458,"journal":{"name":"Revue De Medecine Interne","volume":"46 3","pages":"Pages 146-154"},"PeriodicalIF":0.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416644","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":"Human papillomavirus et lupus systémique : une revue systématique","authors":"Tiphaine Goulenok , Karim Sacré","doi":"10.1016/j.revmed.2024.11.001","DOIUrl":"10.1016/j.revmed.2024.11.001","url":null,"abstract":"<div><h3>Background</h3><div>Human papillomavirus (HPV) infections cause cancer of the cervix, vagina, vulva, anus, penis and upper respiratory tract. The prevention of HPV-induced cancers is a public health issue. Patients with systemic lupus are at increased risk of persistent HPV infection and cervical cancer due to treatment-induced immunosuppression. HPV vaccination and screening for precancerous lesions are two effective means of preventing cervical cancer. Despite the demonstrated safety and efficacy of the HPV vaccine, coverage of HPV vaccination in SLE adults remains low. Screening for cervical cancer is only carried out as recommended in one lupus patient in two. Catch-up HPV vaccination, therapeutic vaccination and vaginal self-sampling are innovative prevention strategies adapted to patients at risk of HPV-induced cancer.</div></div><div><h3>Conclusions</h3><div>Measures to prevent HPV-induced cancers are insufficiently implemented in patients managed for systemic lupus. Healthcare professionals and patients need to be made aware of the importance of HPV preventing vaccination.</div></div>","PeriodicalId":54458,"journal":{"name":"Revue De Medecine Interne","volume":"46 3","pages":"Pages 164-173"},"PeriodicalIF":0.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142645328","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":"Impact carbone des hôpitaux : la téléconsultation est-elle une bonne alternative pour baisser l’émission des gaz à effet de serre ?","authors":"Joris Galland , Emilie Forestier , Axelle Dubant","doi":"10.1016/j.revmed.2025.02.004","DOIUrl":"10.1016/j.revmed.2025.02.004","url":null,"abstract":"","PeriodicalId":54458,"journal":{"name":"Revue De Medecine Interne","volume":"46 3","pages":"Pages 129-132"},"PeriodicalIF":0.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143473387","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}