{"id":365510,"date":"2023-10-12T00:01:00","date_gmt":"2023-10-11T22:01:00","guid":{"rendered":"https:\/\/medizinonline.com\/new-real-world-data-on-long-term-prophylaxis\/"},"modified":"2023-09-07T15:47:32","modified_gmt":"2023-09-07T13:47:32","slug":"new-real-world-data-on-long-term-prophylaxis","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/new-real-world-data-on-long-term-prophylaxis\/","title":{"rendered":"New Real-World Data on Long-Term Prophylaxis"},"content":{"rendered":"\n<p><strong>Hereditary angioedema (HAE) is a rare genetic disorder that causes recurrent swelling of the skin, mucous membranes, or various internal organs at irregular intervals. International guidelines recommend long-term prophylaxis with lanadelumab or berotralstat as first-line therapy. The INTEGRATED trial evaluated the efficacy of lanadelumab and the effects of extending the dose interval in a real-world setting.<\/strong><\/p>\n\n<!--more-->\n\n<p>In the etiology of hereditary angioedema (HAE), the kallikrein-kinin system and the end product of this metabolic pathway, bradykinin, play a central role. The effects of lanadelumab &#8211; a fully humanized monoclonal antibody &#8211; are based on binding to plasma kallikrein, thereby reducing the formation of bradykinin. In Switzerland and other European countries, lanadelumab (<sup>Takhzyro\u00ae<\/sup>) is approved for the prophylaxis of recurrent attacks of HAE in patients over 12 years of age. The recommended starting dose is 300 mg every two weeks (q2w). &#8220;If patients are seizure-free, the administration interval can be extended to four <sup>weeksa<\/sup>,&#8221; explained Prof. Markus Magerl, MD, Allergie-Centrum-Charit\u00e9-Universit\u00e4tsmedizin Berlin. In addition, the INTEGRATED study demonstrated that individualized extension to other of the dose intervals also works <strong>(Fig. 1)<\/strong>. <\/p>\n\n<p class=\"has-small-font-size\"><em><sup>a<\/sup> Dose interval 4 weeks=q4w<\/em><\/p>\n\n<p><\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><a href=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25.png\"><img decoding=\"async\" data-src=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25.png\" alt=\"\" class=\"wp-image-365076 lazyload\" style=\"--smush-placeholder-width: 1437px; --smush-placeholder-aspect-ratio: 1437\/1404;width:500px\" width=\"500\" data-srcset=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25.png 1437w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-800x782.png 800w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-1160x1133.png 1160w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-120x117.png 120w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-90x88.png 90w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-320x313.png 320w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-560x547.png 560w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-240x234.png 240w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-180x176.png 180w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-640x625.png 640w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/08\/abb1_DP4_s25-1120x1094.png 1120w\" data-sizes=\"(max-width: 1437px) 100vw, 1437px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" \/><\/a><\/figure>\n<\/div>\n<h3 id=\"adjustment-of-the-dose-interval-of-lanadelumab-during-the-course-of-the-study\" class=\"wp-block-heading\">Adjustment of the dose interval of lanadelumab during the course of the study.  <\/h3>\n\n<p>The study included <sup>198b<\/sup> patients over 12 years of age with HAE type I or II who had started long-term prophylaxis (LTP) with lanadelumab from November 2017 to October 2021. Of these, 182 (91.9%) had HAE type I and 16 (8.1%) had HAE type II. The mean age was 43.4 years, 61.6% were female, and 30.8% had a history of life-threatening attacks. The mean number of seizures at baseline was 35.8 over a 12-month period. The median treatment duration with lanadelumab was 28.8 months (interquartile range: 20.4-35.7). 96% of patients were still being treated with lanadelumab at the end of data collection. When looking at dose intervals, it is noticeable that 6 months after starting lanadelumab LTP, 30% of patients had already switched to an interval &gt;2 weeks. 9.1% had an interval of four weeks and 8.1% had one of 3 weeks; 12.2% switched to a different interval. As the study progressed, the q2w dose interval was extended in an increasing number of patients<strong> (Fig. 1) <\/strong>. 36 months after <sup>Baselinec<\/sup>, the proportion of those with a 2-week interval was only 26.7%. &#8220;The others had longer intervals &#8211; most of them four weeks, some three weeks, eight weeks or other intervals,&#8221; the speaker said.  <\/p>\n\n<p class=\"has-small-font-size\"><em><sup>b<\/sup> Germany n=76, France n=86, Austria n=14, Greece n=22<\/em><br\/><em><sup>c<\/sup> before initiation of lanadelumab LTP.<\/em><\/p>\n\n<h3 id=\"conclusion-lanadelumab-improved-seizure-freedom\" class=\"wp-block-heading\">Conclusion: Lanadelumab improved seizure freedom  <\/h3>\n\n<p>Primary endpoints included the efficacy of lanadelumab on cumulative and monthly seizure-free rate (AFR) and the effect of increasing the dose interval (q2w) on AFR. The final analysis suggests that lanadelumab LTP significantly improves AFR. Monthly AFRs ranged from 16.2% to 28.3% during the pre-index <sup>event<\/sup> period and from 82.7% to 84.8% thereafter (months 1 and 2), reaching as high as &gt;95% (months 26, 36, 38, 39, and 41+). None of the patients had life-threatening seizures after the index event.  <\/p>\n\n<p class=\"has-small-font-size\"><em><sup>d<\/sup> Index event = onset of lanadelumab LTP.<\/em><\/p>\n\n<p><\/p>\n\n<p><em>Source: &#8220;Real-world Effectiveness of Lanadelumab in European Patients with HAE Type I\/II: Results from the Retrospective INTEGRATED Study,&#8221; Prof. Markus Magerl, MD, Flash Talks 000786. EEACI Annual Meeting, 9\u201311 June 2023.<\/em><\/p>\n\n<p><\/p>\n\n<p class=\"has-small-font-size\"><em>DERMATOLOGIE PRAXIS 2023; 33(4): 25<\/em><\/p>\n\n<p><\/p>\n\n<figure class=\"wp-block-table\"><table class=\"has-background\" style=\"background-color:#abb7c252\"><tbody><tr><td>Cover image: <a href=\"https:\/\/commons.wikimedia.org\/w\/index.php?title=User:LucyHAE&amp;action=edit&amp;redlink=1\" target=\"_blank\" rel=\"noopener\">LucyHAE<\/a>, wikimedia<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Hereditary angioedema (HAE) is a rare genetic disorder that causes recurrent swelling of the skin, mucous membranes, or various internal organs at irregular intervals. International guidelines recommend long-term prophylaxis with&hellip;<\/p>\n","protected":false},"author":7,"featured_media":365524,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Hereditary angioedema  ","footnotes":""},"category":[11513,11340,11391,11297,11396,11548,11503],"tags":[71049,71046,31304,71052,71051,71042,37603],"powerkit_post_featured":[],"class_list":["post-365510","post","type-post","status-publish","format-standard","has-post-thumbnail","category-congress-reports","category-dermatology-and-venereology","category-gastroenterology-and-hepatology","category-general-internal-medicine","category-genetics","category-rx-en","category-studies","tag-berotralstat-en","tag-dose-interval","tag-hereditary-angioedema","tag-integrated-study","tag-lanadelumab-en","tag-long-term-prophylaxis","tag-real-world-data","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-05 19:20:45","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":365548,"slug":"nouvelles-donnees-du-monde-reel-sur-la-prophylaxie-a-long-terme","post_title":"Nouvelles donn\u00e9es du monde r\u00e9el sur la prophylaxie \u00e0 long terme","href":"https:\/\/medizinonline.com\/fr\/nouvelles-donnees-du-monde-reel-sur-la-prophylaxie-a-long-terme\/"},"it_IT":{"locale":"it_IT","id":365574,"slug":"nuovi-dati-reali-sulla-profilassi-a-lungo-termine","post_title":"Nuovi dati reali sulla profilassi a lungo termine","href":"https:\/\/medizinonline.com\/it\/nuovi-dati-reali-sulla-profilassi-a-lungo-termine\/"},"pt_PT":{"locale":"pt_PT","id":365438,"slug":"novos-dados-do-mundo-real-sobre-a-profilaxia-a-longo-prazo","post_title":"Novos dados do mundo real sobre a profilaxia a longo prazo","href":"https:\/\/medizinonline.com\/pt-pt\/novos-dados-do-mundo-real-sobre-a-profilaxia-a-longo-prazo\/"},"es_ES":{"locale":"es_ES","id":365485,"slug":"nuevos-datos-reales-sobre-la-profilaxis-a-largo-plazo","post_title":"Nuevos datos reales sobre la profilaxis a largo plazo","href":"https:\/\/medizinonline.com\/es\/nuevos-datos-reales-sobre-la-profilaxis-a-largo-plazo\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/365510","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=365510"}],"version-history":[{"count":3,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/365510\/revisions"}],"predecessor-version":[{"id":365631,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/365510\/revisions\/365631"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/365524"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=365510"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=365510"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=365510"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=365510"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}