{"id":53397,"date":"2023-01-30T10:02:15","date_gmt":"2023-01-30T09:02:15","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/spesolimab-meets-primary-and-key-secondary-endpoint-for-prevention-of-generalized-pustular-psoriasis-flares\/"},"modified":"2023-01-30T10:02:15","modified_gmt":"2023-01-30T09:02:15","slug":"spesolimab-meets-primary-and-key-secondary-endpoint-for-prevention-of-generalized-pustular-psoriasis-flares","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/spesolimab-meets-primary-and-key-secondary-endpoint-for-prevention-of-generalized-pustular-psoriasis-flares\/","title":{"rendered":"Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nSpesolimab EFFISAYIL<sup>\u2122<\/sup> 2 trial showed significant prevention of generalized pustular psoriasis (GPP) flares for up to 48 weeks<sup>1,2<\/sup>\n<\/li>\n<li>\nResults build on data from the EFFISAYIL<sup>\u2122<\/sup> 1 trial, demonstrating the rapid and sustained pustular and skin clearance in flaring adult GPP patients treated with spesolimab<sup>3<\/sup>\n<\/li>\n<li>\nGPP is a rare and unpredictable systemic skin disease that is distinct from plaque psoriasis in both its disease mechanism and severity<sup>4<\/sup>\n<\/li>\n<\/ul>\n<p>INGELHEIM, Germany&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/EFFISAYIL?src=hash\" target=\"_blank\" rel=\"noopener\">#EFFISAYIL<\/a>&#8211;EFFISAYIL<sup>\u2122<\/sup> 2 met its primary and key secondary endpoint, demonstrating that spesolimab, an anti-interleukin-36 receptor antibody, can prevent flares in adolescents and adults with generalized pustular psoriasis (GPP) up to 48 weeks.<sup>1,2<\/sup> Safety data were in line with previously conducted clinical trials with spesolimab.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230129005023\/en\/1698919\/1\/GPP1.pdf\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230129005023\/en\/1698919\/21\/GPP1.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20230129005023\/en\/623954\/4\/Boehringer_Ingelheim.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230129005023\/en\/623954\/21\/Boehringer_Ingelheim.jpg\"><\/a><\/p>\n<p>\n\u201cPainful GPP flares can occur suddenly, escalate quickly, and may require urgent hospital care leaving people anxious and uncertain about what the future might hold,\u201d said Carinne Brouillon, Member of the Board of Managing Directors, responsible for Human Pharma, Boehringer Ingelheim. \u201cThe EFFISAYIL<sup>\u2122<\/sup> 2 results reinforce the potential of spesolimab to prevent GPP flares, giving patients the power to plan their lives, regardless of their disease. We look forward to presenting the data later this year and sharing the findings with regulatory authorities.\u201d\n<\/p>\n<p>\nGPP is a rare skin disease, which is distinct from plaque psoriasis.<sup>4<\/sup> GPP flares greatly affect a person\u2019s quality of life and can lead to serious and life-threatening complications, including heart failure, renal failure, and sepsis.<sup>4<\/sup>\n<\/p>\n<p>\nSpesolimab (marketed as SPEVIGO<sup>\u00ae<\/sup>) is currently indicated for the treatment of GPP flares in adults.\n<\/p>\n<p>\n<b>About spesolimab<\/b>\n<\/p>\n<p>\nSpesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.<sup>4,6,7<\/sup> Spesolimab has been approved by regulatory authorities in several countries including the US, Japan, Mainland China and the European Union to treat GPP flares in adults.<sup>8,9<\/sup>\n<\/p>\n<p>\nIt is the first approved treatment to specifically target the IL-36 pathway for the treatment of GPP flares that has been evaluated in a statistically powered, randomized, placebo-controlled trial. Further spesolimab data is expected later this year, including the final EFFISAYIL<sup>\u2122<\/sup> 2 results investigating prevention of GPP flares. Spesolimab is also under investigation for the treatment of other IL-36 mediated skin diseases.<sup>10<\/sup>\n<\/p>\n<p>\n<b>About the EFFISAYIL<\/b><sup><b>\u2122<\/b><\/sup><b> clinical trial program<\/b>\n<\/p>\n<p>\nThe EFFISAYIL<sup>\u2122<\/sup> clinical trial program includes:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nEFFISAYIL<sup>\u2122<\/sup> 1: Treatment with spesolimab demonstrated rapid pustular and skin clearance in patients with GPP flares, sustained over 12 weeks.<sup>3<\/sup> These results supported the approval of spesolimab (SPEVIGO<sup>\u00ae<\/sup>) as the first specific treatment for GPP flares in adults in major markets including the US, Japan, Mainland China and the European Union.<sup>8,9<\/sup>\n<\/li>\n<li>\nEFFISAYIL<sup>\u2122<\/sup> 2: A multicenter, randomized, double-blind, placebo-controlled Phase IIb study evaluating the efficacy and safety of maintenance treatment with subcutaneous (SC) spesolimab for the prevention of GPP flares and sustained control of GPP symptoms in adolescents and adults.<sup>1,2<\/sup>\n<\/li>\n<li>\nEFFISAYIL<sup>\u2122<\/sup> ON: To evaluate the long-term safety and efficacy of Spesolimab in patients with GPP, who have completed previous Spesolimab trials.<sup>5<\/sup>\n<\/li>\n<\/ul>\n<p>\nResults from the EFFISAYIL<sup>\u2122<\/sup> 2 and EFFISAYIL<sup>\u2122<\/sup> ON trials will be presented later this year.\n<\/p>\n<p>\nFor the full press release including \u2018Notes to Editors\u2019 and references please visit: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.boehringer-ingelheim.com%2Fhuman-health%2Fskin-diseases%2Fgpp%2Fspesolimab-meets-key-endpoint-for-gpp-flare-prevention&amp;esheet=53293147&amp;newsitemid=20230129005023&amp;lan=en-US&amp;anchor=press+release&amp;index=1&amp;md5=a982d23b0c3e5cf0fc3d8a51e2d045d6\" rel=\"nofollow noopener\" shape=\"rect\"><b>press release<\/b><\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Boehringer Ingelheim<\/b><br \/><b>Corporate Communications<br \/>\n<br \/>Media + PR<\/b><br \/>Laura Lessenich<br \/>\n<br \/>Phone: +49 (6132) 77-173436<br \/>\n<br \/>Email: <a target=\"_blank\" href=\"&#109;&#x61;i&#108;&#x74;o&#58;&#x70;r&#x65;&#x73;&#115;&#x40;b&#111;&#x65;h&#114;&#x69;n&#x67;&#x65;&#114;&#x2d;&#x69;&#110;&#x67;e&#108;&#x68;e&#105;&#x6d;&#46;&#x63;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;r&#x65;s&#x73;&#64;&#x62;&#111;&#x65;&#104;&#x72;&#105;n&#x67;e&#x72;-&#x69;&#110;&#x67;&#101;&#x6c;&#104;&#x65;&#105;m&#x2e;c&#x6f;m<\/a>\n<\/p>\n<p>\n<b>Additional information: <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.boehringer-ingelheim.com&amp;esheet=53293147&amp;newsitemid=20230129005023&amp;lan=en-US&amp;anchor=www.boehringer-ingelheim.com&amp;index=2&amp;md5=ad27eebeb12445e77116d9f8ff00279f\" rel=\"nofollow noopener\" shape=\"rect\">www.boehringer-ingelheim.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Spesolimab EFFISAYIL\u2122 2 trial showed significant prevention of generalized pustular psoriasis (GPP) flares for up to 48 weeks1,2 Results build on data from the EFFISAYIL\u2122 1 trial, demonstrating the rapid and sustained pustular and skin clearance in flaring adult GPP patients treated with spesolimab3 GPP is a rare and unpredictable systemic skin disease that is &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/spesolimab-meets-primary-and-key-secondary-endpoint-for-prevention-of-generalized-pustular-psoriasis-flares\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53397","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/spesolimab-meets-primary-and-key-secondary-endpoint-for-prevention-of-generalized-pustular-psoriasis-flares\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Spesolimab meets primary and key secondary endpoint for prevention of generalized pustular psoriasis flares - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Spesolimab EFFISAYIL\u2122 2 trial showed significant prevention of generalized pustular psoriasis (GPP) flares for up to 48 weeks1,2 Results build on data from the EFFISAYIL\u2122 1 trial, demonstrating the rapid and sustained pustular and skin clearance in flaring adult GPP patients treated with spesolimab3 GPP is a rare and unpredictable systemic skin disease that is ... 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