{"id":357,"date":"2019-10-28T15:45:03","date_gmt":"2019-10-28T15:45:03","guid":{"rendered":"https:\/\/www.octagamus.net\/dermotymositis\/?page_id=357"},"modified":"2022-09-20T03:09:54","modified_gmt":"2022-09-20T03:09:54","slug":"fda-approved-ivig-therapy","status":"publish","type":"page","link":"https:\/\/octagamusa.com\/dermatomyositis\/hcp\/fda-approved-ivig-therapy\/","title":{"rendered":"Evidence"},"content":{"rendered":"\n<h2>The First and Only IVIg Therapy With a Successful Phase 3 Study Resulting in FDA Approval for Dermatomyositis in Adults<sup>1-3<\/sup><\/h2>\n<p>ProDERM is a multicenter, prospective, double blind, randomized clinical trial to evaluate the long-term efficacy, tolerability &amp; safety of IVIg in a large multinational population of adults with DM.<\/p>\n<ul>\n<li>Enrolled 95 adult patients from 36 sites in 10 countries (17 sites in the US)\n<ul>\n<li>Included patients who were receiving standard immunosuppression (corticosteroids and\/or immunosuppressants) or who previously failed or were intolerant to standard immunosuppression<\/li>\n<li>Study design allowed patients to switch treatment if they deteriorated<\/li>\n<\/ul>\n<\/li>\n<li>47 subjects received octagam 10% and 48 subjects received placebo in an initial 16&#8209;week, double-blinded First Period, followed by a 6-month, open-label Extension Period, during which all subjects who were eligible to continue received octagam 10% every 4&nbsp;weeks. Forty-five subjects in the initial octagam group and 46 subjects in the placebo group entered the Extension Period<\/li>\n<li>Enabled recruitment of a large number of patients for such a rare disease\n<ul>\n<li>Large patient population helps make results applicable in clinic practice, given the heterogenous nature of DM<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<div class=\"fig-caption\">\n<p><img class=\"alignnone wp-image-503 size-large\" alt=\"\" width=\"1024\" height=\"739\" data-src=\"https:\/\/octagamusa.com\/dermatomyositis\/wp-content\/uploads\/sites\/4\/2021\/10\/ProDERM_Study_Chart-e1630691713137-1024x739.png\" srcset=\"https:\/\/octagamusa.com\/dermatomyositis\/wp-content\/uploads\/sites\/4\/2021\/10\/ProDERM_Study_Chart-e1630691713137-1024x739.png 1024w, https:\/\/octagamusa.com\/dermatomyositis\/wp-content\/uploads\/sites\/4\/2021\/10\/ProDERM_Study_Chart-e1630691713137-300x216.png 300w, https:\/\/octagamusa.com\/dermatomyositis\/wp-content\/uploads\/sites\/4\/2021\/10\/ProDERM_Study_Chart-e1630691713137-768x554.png 768w, https:\/\/octagamusa.com\/dermatomyositis\/wp-content\/uploads\/sites\/4\/2021\/10\/ProDERM_Study_Chart-e1630691713137-1536x1108.png 1536w, https:\/\/octagamusa.com\/dermatomyositis\/wp-content\/uploads\/sites\/4\/2021\/10\/ProDERM_Study_Chart-e1630691713137-2048x1477.png 2048w, https:\/\/octagamusa.com\/dermatomyositis\/wp-content\/uploads\/sites\/4\/2021\/10\/ProDERM_Study_Chart-e1630691713137-100x72.png 100w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<p class=\"small\">CD=confirmed deterioration.<\/p>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>The First and Only IVIg Therapy With a Successful Phase 3 Study Resulting in FDA Approval for Dermatomyositis in Adults1-3&#8230;<\/p>\n","protected":false},"author":17,"featured_media":505,"parent":3,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-357","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Octagam 10% Evidence - ProDERM Study in Adults with Dermatomyositis<\/title>\n<meta name=\"description\" content=\"Review phase 3 clinical trial data for octagam 10% (Immune Globulin Intravenous [Human] 10% Liquid Preparation) for Dermatomyositis in adults. 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