{"id":49291,"date":"2022-10-06T19:01:36","date_gmt":"2022-10-06T17:01:36","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/proderm-study-results-of-octagam-10-treatment-in-patients-with-dermatomyositis-published-in-the-new-england-journal-of-medicine\/"},"modified":"2022-10-06T19:01:36","modified_gmt":"2022-10-06T17:01:36","slug":"proderm-study-results-of-octagam-10-treatment-in-patients-with-dermatomyositis-published-in-the-new-england-journal-of-medicine","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/proderm-study-results-of-octagam-10-treatment-in-patients-with-dermatomyositis-published-in-the-new-england-journal-of-medicine\/","title":{"rendered":"ProDERM Study Results of octagam\u00ae 10% Treatment in Patients With Dermatomyositis Published in the New England Journal of Medicine"},"content":{"rendered":"<div>\n<p>\n<b>octagam<sup>\u00ae<\/sup> 10% Is Efficacious and Well-tolerated in Adults With Dermatomyositis<\/b>\n<\/p>\n<p>LACHEN, Switzerland&#8211;(BUSINESS WIRE)&#8211;Octapharma announced today the results from the ProDERM study on the efficacy and safety of octagam<sup>\u00ae<\/sup> 10% [Immune Globulin Intravenous (Human)], in adult dermatomyositis (DM) patients have been published in the <i>New England Journal of Medicine<\/i> (Aggarwal R et al. \u201c<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2117912%3Fquery%3Dfeatured_home&amp;esheet=52939109&amp;newsitemid=20221006005817&amp;lan=en-US&amp;anchor=Efficacy+and+safety+of+intravenous+immunoglobulin+in+dermatomyositis&amp;index=1&amp;md5=f34ea883fb6080eceede99e3cebd5f4a\" rel=\"nofollow noopener\" shape=\"rect\">Efficacy and safety of intravenous immunoglobulin in dermatomyositis<\/a>\u201d).\n<\/p>\n<p>\nDermatomyositis is an immune-mediated myopathy characterised by chronic inflammation of the skin and muscles, leading to cutaneous rashes and progressive muscle weakness. DM is associated with increased morbidity and mortality due to muscle weakness and visceral involvement. Prior to the ProDERM study findings, no therapy had been approved in the US or Europe for the treatment of dermatomyositis based on randomized clinical trials.\n<\/p>\n<p>\nThe <b>Pro<\/b>gress in <b>DERM<\/b>atomyositis (ProDERM) study was the first large randomized clinical trial to investigate an intravenous immunoglobulin (IVIg) (octagam<sup>\u00ae<\/sup> 10%) in dermatomyositis. The results of the study demonstrated that octagam<sup>\u00ae<\/sup> 10% is an efficacious and well-tolerated treatment for adults with dermatomyositis. The study enrolled 95 adults from 36 sites in 10 countries and reported the following key findings:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe primary endpoint of the ProDERM study was met, with a significantly higher proportion of responders in the octagam<sup>\u00ae<\/sup> 10% group compared with the placebo group (79% vs. 44%; p &lt;0.001) at Week 16 (end of the double-blind, placebo-controlled period).\n<\/li>\n<li>\nSignificantly more patients receiving octagam<sup>\u00ae<\/sup> 10% achieved a major or at least moderate improvement in the Total Improvement Score.\n<\/li>\n<li>\nThe efficacy of octagam<sup>\u00ae<\/sup> 10% was maintained through Week 40 (the end of the open-label extension period).\n<\/li>\n<li>\noctagam<sup>\u00ae<\/sup> 10% was generally well tolerated. The safety and tolerability profile of IVIg was consistent with previously reported safety outcomes for IVIg administration.\n<\/li>\n<\/ul>\n<p>\n\u201cThe lack of treatment options for dermatomyositis has hampered patient care to date,\u201d said Rohit Aggarwal, MD, MS, Medical Director of the Arthritis and Autoimmunity Center at the University of Pittsburgh School of Medicine and chair of the ProDERM study Steering Committee. \u201cThe ProDERM study \u2013 and its publication in the <i>New England Journal of Medicine<\/i> \u2013 has been a clear turning point in the management of patients with this disease, with physicians now able to offer patients an effective treatment option with proven efficacy, safety and tolerability.\u201d Wolfgang Frenzel, MD, Board Member and Head of Research and Development at Octapharma added, \u201cWe are very proud that octagam<sup>\u00ae<\/sup> 10% is the first product to demonstrate efficacy in a large, randomized controlled trial in dermatomyositis.\u201d\n<\/p>\n<p>\n\u201cThe ProDERM trial has given clinicians much more confidence in the efficacy and safety of octagam<sup>\u00ae<\/sup> 10% for adult DM patients,\u201d said <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.octapharmausa.com%2F&amp;esheet=52939109&amp;newsitemid=20221006005817&amp;lan=en-US&amp;anchor=Octapharma+USA&amp;index=2&amp;md5=348b94e584cedc94893a2f1de0c493c1\" rel=\"nofollow noopener\" shape=\"rect\">Octapharma USA<\/a> President Flemming Nielsen. &#8220;<i>The New England Journal of Medicine<\/i> journal article is an exciting milestone for both providers and patients who previously relied on unapproved treatments for the disorder. We look forward to partnering with patient organizations and the medical community to develop educational and other support programs that will serve dermatomyositis patients.\u201d\n<\/p>\n<p>\nEarly diagnosis and treatment are important for optimal management of patients with dermatomyositis, but diagnosis can be very challenging. \u201cAt Octapharma, we are committed to improving early detection and management of this rare disease,\u201d said Olaf Walter, MD, MBA, Board Member and Head of International Business Units (IBUs) at Octapharma. \u201cOur activities include the launch of a disease awareness website for healthcare practitioners (<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.managedermatomyositis.com&amp;esheet=52939109&amp;newsitemid=20221006005817&amp;lan=en-US&amp;anchor=www.managedermatomyositis.com&amp;index=3&amp;md5=08dbff1f3db09605957df65797a49e46\" rel=\"nofollow noopener\" shape=\"rect\">www.managedermatomyositis.com<\/a>) and participation in congresses, such as the upcoming ACR (American College of Rheumatology) Convergence, taking place in November in Philadelphia, where the latest advances on this disorder are being shared.\u201d\n<\/p>\n<p>\nFollowing the results of the ProDERM study, octagam<sup>\u00ae<\/sup> 10% has received approval in the US for the \u201ctreatment of dermatomyositis in adults\u201d<sup> <\/sup>and in Europe for \u201cimmunomodulation in adults with active dermatomyositis treated with immunosuppressive drugs including corticosteroids, or with intolerance or contra-indications to those drugs.\u201d\n<\/p>\n<p>\n<b>About the ProDERM study<\/b>\n<\/p>\n<p>\nThe ProDERM study (<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02728752%3Fterm%3DNCT02728752%26draw%3D2%26rank%3D1&amp;esheet=52939109&amp;newsitemid=20221006005817&amp;lan=en-US&amp;anchor=NCT02728752&amp;index=4&amp;md5=5102b6da51633dab456f58a99650d4f4\" rel=\"nofollow noopener\" shape=\"rect\">NCT02728752<\/a>) was an international, multicenter, double-blind, randomized, placebo-controlled phase III clinical trial that investigated the efficacy, safety and tolerability of octagam<sup>\u00ae<\/sup> 10% in adults with dermatomyositis. In the initial 16-week placebo-controlled period, 95 patients from 36 sites in 10 countries were randomized to receive either octagam<sup>\u00ae<\/sup> 10% (2.0 g\/kg) or placebo every four weeks. This was followed by an open-label extension period during which all patients received octagam<sup>\u00ae<\/sup> 10% for a further 24 weeks (excluding patients who had shown clinical worsening while receiving octagam<sup>\u00ae<\/sup> 10% in the first period). The primary endpoint was the proportion of patients who responded to treatment at Week 16.\n<\/p>\n<p>\n<b>About octagam<sup>\u00ae<\/sup><\/b>\n<\/p>\n<p>\noctagam<sup>\u00ae<\/sup> 10% is a ready to use, liquid preparation of highly purified human immunoglobulin for intravenous administration. octagam<sup>\u00ae<\/sup> 10% is approved for idiopathic thrombocytopenic purpura in the USA, EU and Canada. It is also approved for use in treatment of primary immunodeficiency, secondary immunodeficiencies and Guillain Barr\u00e9 syndrome in the EU and Canada, for dermatomyositis in the EU and the USA, and for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), multifocal motor neuropathy (MMN), and Kawasaki disease in the EU.\n<\/p>\n<p>\nFOR THE US:\n<\/p>\n<p>\n<b>WARNING<\/b>\n<\/p>\n<p>\nTHROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE\n<\/p>\n<p>\nThrombosis may occur with immune globulin intravenous (IGIV) products, including octagam<sup>\u00ae<\/sup> 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of immune globulin intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. octagam<sup>\u00ae<\/sup> 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer octagam<sup>\u00ae<\/sup> 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.\n<\/p>\n<p>\nFor full prescribing information, including complete boxed warning, please click <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Foctagamusa.com%2Foctagam10%2Fwp-content%2Fuploads%2Fsites%2F3%2F2021%2F07%2Foctagam10-full-prescribing-information.pdf&amp;esheet=52939109&amp;newsitemid=20221006005817&amp;lan=en-US&amp;anchor=here&amp;index=5&amp;md5=753c7628901c69dd932c9ea0651023dc\" rel=\"nofollow noopener\" shape=\"rect\">here<\/a>. To learn more about octagam<sup>\u00ae<\/sup> 10% for the treatment of dermatomyositis, please click <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fconnect.octapharmausa.com%2Foctagam%2Fdm%2Fpr_link_learnmore%3Ftrid%3D1000020762965%26utm_source%3Dpress%2Brelease%26utm_medium%3Dpress%2Brelease%26utm_campaign%3Ddmannouncement&amp;esheet=52939109&amp;newsitemid=20221006005817&amp;lan=en-US&amp;anchor=here&amp;index=6&amp;md5=92e0fc39bd5240b038606211c45003d0\" rel=\"nofollow noopener\" shape=\"rect\">here<\/a>.\n<\/p>\n<p>\n<b>About Octapharma<\/b>\n<\/p>\n<p>\nHeadquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.\n<\/p>\n<p>\nOctapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: immunotherapy, hematology, and critical care.\n<\/p>\n<p>\nOctapharma has seven R&amp;D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 180 plasma donation centers across Europe and the US.\n<\/p>\n<p>\nThe company\u2019s American subsidiary, Octapharma USA, is located in Paramus, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility.\n<\/p>\n<p>\nWebsite: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.octapharma.com&amp;esheet=52939109&amp;newsitemid=20221006005817&amp;lan=en-US&amp;anchor=www.octapharma.com&amp;index=7&amp;md5=d1d1e9f5dd6af351625a40f44d17a2ed\" rel=\"nofollow noopener\" shape=\"rect\">www.octapharma.com<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nOctapharma AG<br \/>\n<br \/>Ivana Spotakova, Communications Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#105;l&#116;o&#x3a;i&#x76;a&#x6e;a&#x2e;s&#x70;o&#x74;a&#x6b;o&#x76;a&#x40;o&#x63;&#116;&#x61;&#112;&#x68;&#97;&#x72;&#109;&#x61;&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x69;&#x76;&#97;&#110;&#97;&#46;&#x73;&#x70;&#x6f;&#116;&#97;ko&#x76;&#x61;&#x40;&#111;&#99;t&#x61;&#x70;&#x68;&#97;&#114;&#109;a&#x2e;&#x63;&#x6f;&#109;<\/a>, Tel.: +41793474607\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>octagam\u00ae 10% Is Efficacious and Well-tolerated in Adults With Dermatomyositis LACHEN, Switzerland&#8211;(BUSINESS WIRE)&#8211;Octapharma announced today the results from the ProDERM study on the efficacy and safety of octagam\u00ae 10% [Immune Globulin Intravenous (Human)], in adult dermatomyositis (DM) patients have been published in the New England Journal of Medicine (Aggarwal R et al. \u201cEfficacy and safety &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/proderm-study-results-of-octagam-10-treatment-in-patients-with-dermatomyositis-published-in-the-new-england-journal-of-medicine\/\">[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-49291","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>ProDERM Study Results of octagam\u00ae 10% Treatment in Patients With Dermatomyositis Published in the New England Journal of Medicine - 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\/proderm-study-results-of-octagam-10-treatment-in-patients-with-dermatomyositis-published-in-the-new-england-journal-of-medicine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ProDERM Study Results of octagam\u00ae 10% Treatment in Patients With Dermatomyositis Published in the New England Journal of Medicine - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"octagam\u00ae 10% Is Efficacious and Well-tolerated in Adults With Dermatomyositis LACHEN, Switzerland&#8211;(BUSINESS WIRE)&#8211;Octapharma announced today the results from the ProDERM study on the efficacy and safety of octagam\u00ae 10% [Immune Globulin Intravenous (Human)], in adult dermatomyositis (DM) patients have been published in the New England Journal of Medicine (Aggarwal R et al. \u201cEfficacy and safety ... 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