{"id":10915,"date":"2024-09-06T19:11:52","date_gmt":"2024-09-06T17:11:52","guid":{"rendered":"https:\/\/www.afaf.asso.fr\/?p=10915"},"modified":"2024-09-06T22:01:14","modified_gmt":"2024-09-06T20:01:14","slug":"un-essai-pilote-randomise-de-phase-2-evalue-la-securite-et-la-potentielle-efficacite-de-letravirine-parmi-les-patients-atteints-dataxie-de-friedreich","status":"publish","type":"post","link":"https:\/\/www.afaf.asso.fr\/2024\/09\/06\/un-essai-pilote-randomise-de-phase-2-evalue-la-securite-et-la-potentielle-efficacite-de-letravirine-parmi-les-patients-atteints-dataxie-de-friedreich\/","title":{"rendered":"Un essai pilote randomis\u00e9 de phase 2 \u00e9value la s\u00e9curit\u00e9 et la potentielle efficacit\u00e9 de l\u2019etravirine parmi les patients atteints d\u2019Ataxie de Friedreich"},"content":{"rendered":"\n

Dans cet article<\/a>, Paparella et al<\/em> publient les r\u00e9sultats d\u2019un essai pilote randomis\u00e9 proposant l\u2019utilisation de l\u2019etravirine, (m\u00e9dicament antir\u00e9troviral utilis\u00e9 dans la prise en charge de l\u2019infection par le VIH), dans une strat\u00e9gie de repositionnement m\u00e9dicamenteux. Vous trouverez ci-dessous la traduction du r\u00e9sum\u00e9 de cet article, dont le contenu int\u00e9gral est disponible en ligne sur le lien ci-dessous, ainsi que la reproduction de 2 figures de l\u2019article. Pour aller plus loin, nous vous proposerons un \u201datelier visio\u201d d\u2019explication de cet article scientifique. Vous pouvez aussi nous contacter \u00e0 recherche@afaf.asso.fr<\/a>.<\/p>\n\n\n\n

R\u00e9f\u00e9rence<\/strong><\/p>\n\n\n\n

A Pilot Phase 2 Randomized Trial to Evaluate the Safety and Potential Efficacy of Etravirine in Friedreich Ataxia Patients (nih.gov)<\/a> Paparella G, Strag\u00e0 C, Pesenti N, Dal Molin V, Martorel GA, Merotto V, Genova C, Piazza A, Piccoli G, Panzeri E, Rufini A, Testi R, Martinuzzi A. A Pilot Phase 2 Randomized Trial to Evaluate the Safety and Potential Efficacy of Etravirine in Friedreich Ataxia Patients. Children (Basel). 2024 Aug 9;11(8):958. doi: 10.3390\/children11080958. PMID: 39201893; PMCID: PMC11352957.<\/p>\n\n\n\n

Traduction du r\u00e9sum\u00e9 de l\u2019article<\/strong><\/p>\n\n\n\n

Contexte <\/strong><\/em>: Un effort de repositionnement des m\u00e9dicaments a soutenu l’utilisation de l’etravirine, un m\u00e9dicament anti-VIH, comme m\u00e9dicament modificateur dans l’ataxie de Friedreich (AF). L’etravirine augmente la prot\u00e9ine frataxine et corrige les d\u00e9fauts biochimiques dans les cellules d\u00e9riv\u00e9es de patients atteints d\u2019AF. En raison de ces r\u00e9sultats et du fait du profil de s\u00e9curit\u00e9 favorable de l’etravirine, nous avons men\u00e9 un essai clinique pilote ouvert de phase 2 pour \u00e9valuer la s\u00e9curit\u00e9 et l’efficacit\u00e9 potentielle de l’etravirine chez les patients atteints de l’ataxie de Friedreich.
M\u00e9thode <\/em><\/strong>: Trente-cinq patients ont \u00e9t\u00e9 r\u00e9partis en trois groupes de gravit\u00e9 et randomis\u00e9s pour recevoir de l’etravirine \u00e0 raison de 200 mg\/jour ou 400 mg\/jour. Ils ont \u00e9t\u00e9 trait\u00e9s pendant 4 mois. Les crit\u00e8res d’\u00e9valuation de la s\u00e9curit\u00e9 \u00e9taient le nombre et le type d’\u00e9v\u00e9nements ind\u00e9sirables et le nombre d’abandons. Les crit\u00e8res d’efficacit\u00e9 \u00e9taient repr\u00e9sent\u00e9s par les changements dans l’absorption maximale d’oxyg\u00e8ne et la charge de travail mesur\u00e9e par un test d’effort incr\u00e9mental, le score SARA, les mesures cardiaques, les mesures de la qualit\u00e9 de vie et de l’invalidit\u00e9. Les donn\u00e9es ont \u00e9t\u00e9 recueillies 4 mois avant le d\u00e9but du traitement (T – 4), au d\u00e9but (T0), \u00e0 la fin (T4) et 4 mois apr\u00e8s la fin du traitement (T + 4).
R\u00e9sultats <\/em><\/strong>: L’etravirine a \u00e9t\u00e9 bien tol\u00e9r\u00e9e et les effets ind\u00e9sirables ont \u00e9t\u00e9 g\u00e9n\u00e9ralement l\u00e9gers. Quatre mois de traitement par etravirine n’ont pas augment\u00e9 de mani\u00e8re significative l’absorption maximale d’oxyg\u00e8ne, mais ont \u00e9t\u00e9 associ\u00e9s \u00e0 un changement dans la progression du score SARA (p<0,001), par rapport aux 4 mois pr\u00e9c\u00e9dant et suivant le traitement. Il a \u00e9galement \u00e9t\u00e9 montr\u00e9 une augmentation significative la charge de travail maximale ( p = 0,021). Aucun changement n’a \u00e9t\u00e9 observ\u00e9 dans les mesures cardiaques. Les mesures de l’\u00e9tat de sant\u00e9 et de la qualit\u00e9 de vie ont montr\u00e9 une aggravation lors de la suspension du m\u00e9dicament.
Conclusion <\/strong><\/em>: Dans cet essai ouvert, le traitement par etravirine s’est av\u00e9r\u00e9 s\u00fbr, bien tol\u00e9r\u00e9 et a sensiblement am\u00e9lior\u00e9 la fonction neurologique et les performances \u00e0 l’effort. M\u00eame si un effet placebo ne peut \u00eatre exclu, ces r\u00e9sultats sugg\u00e8rent que l’etravirine peut repr\u00e9senter un agent th\u00e9rapeutique potentiel dans l\u2019AF m\u00e9ritant d’\u00eatre test\u00e9 dans un essai clinique randomis\u00e9 contr\u00f4l\u00e9 par placebo.<\/p>\n\n\n\n

Figures de l\u2019article et explications<\/strong><\/p>\n\n\n\n

Figure 1 : Dans cette figure les auteurs rapportent le d\u00e9roul\u00e9 de l\u2019\u00e9tude. L’\u00e9tude comporte 5 visites comprenant une p\u00e9riode de traitement de 4 mois (les patients recevaient la dose de 200 mg\/j ou de 400 mg\/j), pr\u00e9c\u00e9d\u00e9e de 4 mois et suivie de 4 mois suppl\u00e9mentaires d’\u00e9tude en l’absence de traitement. Les visites renseignaient notamment un test d\u2019effort, l\u2019\u00e9chelle SARA, des param\u00e8tres biologiques de tol\u00e9rance, et des param\u00e8tres cardiaques ( ECG, \u00e9chographie cardiaque).\"figure<\/p>\n\n\n\n

Figure 3. Dans cette figure les auteurs illustrent une partie des r\u00e9sultats de l\u2019essai, montrant les valeurs de l’absorption maximale d’oxyg\u00e8ne et la charge de travail mesur\u00e9e par un test d’effort incr\u00e9mental, le score SARA, les mesures cardiaques (\u00e9paisseur du mur septal et mesure de l\u2019index Sokomow-Lyon sur l\u2019ECG), lors des principales visites de l\u2019\u00e9tude ( T-4, T0, T4, T+4). La significativit\u00e9 de la variation des valeurs est rep\u00e9r\u00e9e par * ( < 0.05) ou *** ( <0.001).<\/p>\n\n\n\n

\"r\u00e9sultats<\/p>\n","protected":false},"excerpt":{"rendered":"

Dans cet article, Paparella et al publient les r\u00e9sultats d\u2019un essai pilote randomis\u00e9 proposant l\u2019utilisation de l\u2019etravirine, (m\u00e9dicament antir\u00e9troviral utilis\u00e9 dans la prise en charge de l\u2019infection par le VIH), dans une strat\u00e9gie de repositionnement m\u00e9dicamenteux. Vous trouverez ci-dessous la traduction du r\u00e9sum\u00e9 de cet article, dont le contenu int\u00e9gral est disponible en ligne sur […]<\/p>\n","protected":false},"author":1,"featured_media":10927,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"ocean_front_end_style_editor":"no","ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"on","ocean_gallery_id":[],"footnotes":""},"categories":[43],"tags":[],"class_list":["post-10915","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-informations_recherche","entry","has-media","owp-thumbs-layout-horizontal","owp-btn-normal","owp-tabs-layout-section","has-no-thumbnails"],"yoast_head":"\nUn essai pilote randomis\u00e9 de phase 2 \u00e9value la s\u00e9curit\u00e9 et la potentielle efficacit\u00e9 de l\u2019etravirine parmi les patients atteints d\u2019Ataxie de Friedreich - 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