{"id":66919,"date":"2024-02-16T11:04:45","date_gmt":"2024-02-16T16:04:45","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/?p=66919"},"modified":"2024-02-16T14:11:04","modified_gmt":"2024-02-16T19:11:04","slug":"new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/","title":{"rendered":"New drug approvals are reshaping the landscape of Eosinophilic Esophagitis (EoE) treatment"},"content":{"rendered":"<p style=\"font-weight: 400\"><em>The FDA has granted approval for two medications in the treatment of Eosinophilic Esophagitis (EoE)\u2014the first oral medication tailored for adults and the exclusive therapeutic option for children. Evan Dellon, MD, MPH, internationally known for his work with EoE, and colleagues continue to focus on optimizing usage for effective, personalized outcomes.<\/em><\/p>\n<hr \/>\n<p style=\"font-weight: 400\">Eosinophilic Esophagitis (EoE) is an allergic inflammatory disorder that affects the esophagus, causing distressing symptoms such as difficulty swallowing in adolescents and adults, and vomiting and abdominal pain in children. <a href=\"https:\/\/www.med.unc.edu\/medicine\/gi\/people\/evan-s-dellon\/\">Evan Dellon, MD, MPH<\/a>, a gastroenterologist at the University of North Carolina, has been at the forefront of groundbreaking developments in EoE treatment.<\/p>\n<figure id=\"attachment_6676\" class=\"thumbnail wp-caption alignright\" style=\"width: 285px\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-6676\" src=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-819x1024.jpeg\" alt=\"Evan S. Dellon, MD, MPH\" width=\"275\" height=\"344\" srcset=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-819x1024.jpeg 819w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-240x300.jpeg 240w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-768x960.jpeg 768w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-1229x1536.jpeg 1229w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-1638x2048.jpeg 1638w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-600x750.jpeg 600w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-301x376.jpeg 301w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-scaled.jpeg 2048w\" sizes=\"auto, (max-width: 275px) 100vw, 275px\" \/><figcaption class=\"caption wp-caption-text\">Evan S. Dellon, MD, MPH<\/figcaption><\/figure>\n<p style=\"font-weight: 400\"><a href=\"https:\/\/www.cghjournal.org\/article\/S1542-3565(21)00684-4\/fulltext\">His efforts<\/a>, published in the journal <i>Clinical Gastroenterology and Hepatology <\/i>helped lead to the recent FDA approval of budesonide, the sole oral therapy designed for individuals aged 11 and older with EoE\u2014a significant milestone Dr. Dellon and colleagues have been diligently working towards for more than 10 years. Prior to this approval patients had to make \u201chome brews\u201d of budesonide slurries by adapting asthma medications that were originally formulated for nebulizer machines.<\/p>\n<p style=\"font-weight: 400\"><a href=\"https:\/\/www.takeda.com\/newsroom\/newsreleases\/2024\/fda-approves-eohilia\/\">Takeda Pharmaceuticals announced<\/a> the twice-daily treatment will be available in single-dose stick packs (2mg\/10mL) by the end of February. Dr. Dellon, part of the research team, demonstrated budesonide&#8217;s efficacy in achieving histologic remission and improving swallowing ability in patients.<\/p>\n<p style=\"font-weight: 400\">Key findings from the two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies include:<\/p>\n<ul>\n<li>53.1% (<a href=\"https:\/\/www.cghjournal.org\/article\/S1542-3565(21)00456-0\/fulltext\">Study 1<\/a>) and 38% (<a href=\"https:\/\/www.cghjournal.org\/article\/S1542-3565(21)00684-4\/fulltext\">Study 2<\/a>) of patients receiving budesonide achieved histologic remission compared to 1% (Study 1) and 2.4% (Study 2) in the placebo group.<\/li>\n<li>Patients taking budesonide reported less difficulty swallowing.<\/li>\n<li>Budesonide has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.<\/li>\n<\/ul>\n<h3 style=\"font-weight: 400\">Pediatric Patients with EoE<\/h3>\n<p style=\"font-weight: 400\">Additionally, the <a href=\"https:\/\/www.sanofi.com\/en\/media-room\/press-releases\/2024\/2024-01-25-19-30-00-2817342\">FDA recently approved dupilumab for pediatric patients<\/a> aged one to eleven, marking a significant advancement in addressing this condition.<\/p>\n<p style=\"font-weight: 400\">Previously, there was a void in approved medications for pediatric EoE patients. Dr. Dellon was one of the lead investigators, along with <a href=\"https:\/\/www.med.unc.edu\/childrensresearch\/directory\/sabina-mir-md\/\">Sabina Mir, MD,<\/a> UNC pediatric gastroenterologist, who headed UNC as a clinical trial site for the study that influenced this approval.<\/p>\n<p style=\"font-weight: 400\">\u201cThis is the first medication to be approved for this younger population of children with EoE, addressing a critical need for therapy in this group and providing a treatment that can improve multiple EoE disease features and hopefully prevent complications like future esophageal stricturing,&#8221; Dr. Dellon said.<\/p>\n<h3 style=\"font-weight: 400\">Dupilumab for Adolescents and Adults<\/h3>\n<p style=\"font-weight: 400\">It\u2019s been almost two years since dupilumab was first approved to treat individuals 12 and older with EoE, another milestone that to which <a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2205982\">Dr. Dellon\u2019s research contributed<\/a>. He says the real-world use of dupilumab mirrors the promising outcomes observed during the clinical trials.<\/p>\n<p style=\"font-weight: 400\">\u201cIt&#8217;s been very impactful, I have probably more than 100 people on it now,\u201d Dellon said. \u201cI had a large cohort of patients who just didn&#8217;t respond to other treatments and were waiting for something like this to become available.\u201d<\/p>\n<p style=\"font-weight: 400\">Historically, physicians relied on food elimination diets, off-label treatments, such as stomach acid reducers (proton pump inhibitors) or asthma steroid medications (which are swallowed to coat the esophagus rather than inhaled) and stretching the esophagus with dilation during endoscopy.<\/p>\n<p style=\"font-weight: 400\">\u201cMany of them had esophageal strictures so the esophagus was mechanically stretched to help them decrease their symptoms of trouble swallowing,\u201d Dellon said. \u201cAfter three or six months, they would come back and the esophagus would just shrink back again, because all the inflammation was still going on.\u201d<\/p>\n<p style=\"font-weight: 400\"><a href=\"https:\/\/www.cghjournal.org\/article\/S1542-3565(23)00665-1\/fulltext\">A study<\/a> published in the journal <em>Clinical Gastroenterology and Hepatology<\/em> by Christopher Lee, MD, UNC internal medicine resident, and Dr. Dellon analyzed 46 patients with severe EoE who had undergone multiple esophageal dilations. They found that many patients experienced remission and sustained improvements in esophageal diameter upon dupilumab treatment. Although, these findings are promising more research is needed to determine longer-term treatment outcomes for severe EoE and whether dupilumab could be used earlier, for example right after diagnosis, for these most affected patients.<\/p>\n<h3 style=\"font-weight: 400\">The Road Ahead<\/h3>\n<p style=\"font-weight: 400\">As the spotlight remains on EoE treatment, the focus now shifts to understanding dupilumab\u2019s optimal utilization, considering factors such as disease progression, response variations, and dosing frequence long-term. Clinical trial participants had EoE an average duration of five years since diagnosis, coupled with unresponsiveness to proton pump inhibitors, when they entered the study. However, uncertainty lingers regarding whether newly diagnosed patients will exhibit similar responses or fare better than those in the trials. Additionally, the efficacy of dupilumab in more severe cases of EoE needs to be studied in more depth, and several studies related to this are opening soon at UNC and other sites. Dupilumab\u2019s recommended dosage for EoE treatment is a weekly regimen, a departure from its alternative bi-weekly uses in treating asthma and eczema.<\/p>\n<p style=\"font-weight: 400\">\u201cThat was primarily because we only saw symptom benefit with weekly dosing in the approval study,\u201d Dellon said. \u201cHowever, the question is, as people feel well, can you decrease the intensity of the therapy long term? It&#8217;s a very expensive medicine, so understanding how to best use those resources is pretty critical.\u201d<\/p>\n<p style=\"font-weight: 400\">Interestingly, a series of trials explored the impact of medications that removed eosinophils (white blood cells that inflame the esophagus) from the body on EoE. The assumption was patients would get better.<\/p>\n<p style=\"font-weight: 400\">\u201cWhat we saw in these studies were that the eosinophils went away on the biopsies, so the medication was working biologically, but there were still other persistent changes when you look under the microscope that didn&#8217;t get better,\u201d Dellon said. \u201cAnd when you look at the esophagus, it wasn&#8217;t improved visually either and patient&#8217;s symptoms didn&#8217;t improve. This raises this question of, well, what else is driving the disease if it\u2019s not the eosinophil?\u201d<\/p>\n<p style=\"font-weight: 400\">The ultimate goal is to tailor treatment strategies based on the specific pathogenic mechanisms driving each patient&#8217;s condition. Dr. Dellon&#8217;s aims for a future where a comprehensive understanding of EoE profiles guides the selection of biologics, dietary interventions, and steroid therapies with precision. This personalized approach holds the promise of more effective and sustainable outcomes for individuals grappling with the challenges of Eosinophilic Esophagitis.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has granted approval for two medications in the treatment of Eosinophilic Esophagitis (EoE)\u2014the first oral medication tailored for adults and the exclusive therapeutic option for children. Evan Dellon, MD, MPH, internationally known for his work with EoE, and colleagues continue to focus on optimizing usage for effective, personalized outcomes. Eosinophilic Esophagitis (EoE) is &hellip; <a href=\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\" aria-label=\"Read more about New drug approvals are reshaping the landscape of Eosinophilic Esophagitis (EoE) treatment\">Read more<\/a><\/p>\n","protected":false},"author":112673,"featured_media":6676,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[97,2],"tags":[673],"class_list":["post-66919","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gastroenterology","category-news","tag-673","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New drug approvals are reshaping the landscape of Eosinophilic Esophagitis (EoE) treatment | Department of Medicine<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New drug approvals are reshaping the landscape of Eosinophilic Esophagitis (EoE) treatment | Department of Medicine\" \/>\n<meta property=\"og:description\" content=\"The FDA has granted approval for two medications in the treatment of Eosinophilic Esophagitis (EoE)\u2014the first oral medication tailored for adults and the exclusive therapeutic option for children. Evan Dellon, MD, MPH, internationally known for his work with EoE, and colleagues continue to focus on optimizing usage for effective, personalized outcomes. Eosinophilic Esophagitis (EoE) is &hellip; Read more\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\" \/>\n<meta property=\"og:site_name\" content=\"Department of Medicine\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/UNCDeptMedicine\" \/>\n<meta property=\"article:published_time\" content=\"2024-02-16T16:04:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-02-16T19:11:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-scaled.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"2048\" \/>\n\t<meta property=\"og:image:height\" content=\"2560\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Morgan Duerden\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@uncdeptmedicine\" \/>\n<meta name=\"twitter:site\" content=\"@uncdeptmedicine\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Morgan Duerden\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\"},\"author\":{\"name\":\"Morgan Duerden\",\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/#\/schema\/person\/99bd6d3f6c7b07d9e318254957f14bf9\"},\"headline\":\"New drug approvals are reshaping the landscape of Eosinophilic Esophagitis (EoE) treatment\",\"datePublished\":\"2024-02-16T16:04:45+00:00\",\"dateModified\":\"2024-02-16T19:11:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\"},\"wordCount\":1035,\"image\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-scaled.jpeg\",\"keywords\":[\"2024\"],\"articleSection\":[\"Gastroenterology and Hepatology\",\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\",\"url\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\",\"name\":\"New drug approvals are reshaping the landscape of Eosinophilic Esophagitis (EoE) treatment | Department of Medicine\",\"isPartOf\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-scaled.jpeg\",\"datePublished\":\"2024-02-16T16:04:45+00:00\",\"dateModified\":\"2024-02-16T19:11:04+00:00\",\"author\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/#\/schema\/person\/99bd6d3f6c7b07d9e318254957f14bf9\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.med.unc.edu\/medicine\/news\/new-drug-approvals-are-reshaping-the-landscape-of-eosinophilic-esophagitis-eoe-treatment\/#primaryimage\",\"url\":\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-scaled.jpeg\",\"contentUrl\":\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/Dellon-photo-UNC-2016-scaled.jpeg\",\"width\":2048,\"height\":2560,\"caption\":\"Evan S. 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Evan Dellon, MD, MPH, internationally known for his work with EoE, and colleagues continue to focus on optimizing usage for effective, personalized outcomes. 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