{"id":247,"date":"2022-09-26T22:40:40","date_gmt":"2022-09-26T22:40:40","guid":{"rendered":"https:\/\/naglazymehcp-dev-001.azurewebsites.net\/en-us\/naglazyme\/?page_id=247"},"modified":"2023-04-19T16:20:01","modified_gmt":"2023-04-19T16:20:01","slug":"sustained-benefits","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/sustained-benefits\/","title":{"rendered":"Sustained Benefits"},"content":{"rendered":"<div id=\"acf-block-643d5100b6cc2\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-643d5100b6d11\" class=\"block-wysiwyg\">\n            <h1>The Long-Term Impact of NAGLAZYME<sup>\u00ae<\/sup> (galsulfase) on MPS VI<\/h1>\n<h2>Regardless of phenotype or age, NAGLAZYME demonstrated consistent and sustained improvement in a 10\u2010year Resurvey Study<\/h2>\n<p>The Resurvey Study was performed to examine the long\u2010term impact of NAGLAZYME<sup>\u00ae<\/sup> (galsulfase) on disease progression. This 10\u2010year follow-up obtained data on medical histories and clinical assessments (n=59) of NAGLAZYME\u2010treated and untreated patients who participated in an original Survey Study establishing demographics and clinical progression of patients with MPS VI. Throughout the study period, NAGLAZYME\u2010treated patients received therapy for an average of 6.8 years. The findings in the Resurvey Study were consistent with the results of clinical trials of long\u2010term use of NAGLAZYME in the treatment of MPS VI.<sup>1<\/sup><\/p>\n<h3>NAGLAZYME therapy resulted in improved endurance across all age groups<sup>1<\/sup><\/h3>\n<h4>Improvements in endurance in patients who completed the 6-minute walk test (6MWT) at follow-up<sup>1<\/sup><\/h4>\n    <\/div>\n\n<figure id=\"acf-block-643d5100b6d3d\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/10\/Endurance-graph.png?v=0.33\" alt=\"Endurance graph\" \/>            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-643d5100b6d53\" class=\"block-wysiwyg\">\n            <ul>\n<li>Among 54 NAGLAZYME-treated patients, 46 were able to complete the 6MWT; they walked 21% farther than at baseline, a mean improvement of 65.7 m<sup>1<\/sup><\/li>\n<li>The subgroup of adult patients (\u226518 years old) showed a sustained 22% improvement in endurance<sup>1<\/sup><\/li>\n<li>Results from the Resurvey Study are consistent with improvement demonstrated in the phase 3 trial<sup>1,2<\/sup><\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-643d5100b6d6c\" class=\"block call-to-action\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"\">\n\t\t\t\t<div class=\"overlay\"><\/div>\n\t\t\t\t<div class=\"cta-content\">\n\t\t\t\t    \t\t\t\t\t<div class=\"cta-content-main\">\n                        <div class=\"content-block\">\n\t\t\t\t\t        \t\t\t\t\t        \t\t\t\t\t\t    \t\t\t\t\t\t        <p>As exemplified by these clinical trial data, the walk test has emerged as a proven, trusted, and relatively simple method of measuring improved endurance in patients with MPS VI. The test demonstrates how performance impairment is a measure of disease progression.<sup>3<\/sup><\/p>\n\t\t\t\t\t\t    \t\t\t\t\t    <\/div>\n\t\t\t\t\t                        <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-643d5100b6d76\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-643d5100b6d87\" class=\"block-wysiwyg\">\n            <p>The mean 6MWT distance for the full NAGLAZYME enzyme replacement therapy (ERT) group (n=54) changed from 304.0 \u00b1 108.4 m at baseline to 320.4 \u00b1 195.7 m at 10 years, an increase of 16.4 \u00b1 155.9 m.<sup>1<\/sup><\/p>\n<h3>Regardless of age, NAGLAZYME improved pulmonary function at the 10\u2010year follow\u2010up<sup>1<\/sup><\/h3>\n<h4>Pulmonary function across all age groups in the NAGLAZYME-treated patients<sup>1<\/sup><\/h4>\n    <\/div>\n\n<figure id=\"acf-block-643d5100b822c\">\n    <div class=\"image image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2023\/04\/thumbnail_Pulmonary-function-graph2.png?v=0.33\" alt=\"Pulmonary function graph\" \/>            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-643d5100b8252\" class=\"block-wysiwyg\">\n            <p>The mean change in forced vital capacity (FVC) from baseline was 0.37 L (P&lt;0.0001) in the NAGLAZYME\u2010treated group (n=48) and \u22120.70 L in the untreated group (n=3). The mean change in forced expiratory volume in 1 second (FEV1) from baseline was 0.21 L (P=0.001) in both the treated &lt;13\u2010year\u2010old and \u226513\u2010year\u2010old age group patients (n=47) and \u22120.60 L in the untreated group (n=3).<sup>1<\/sup><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-643d5100b825e\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-643d5100b8270\" class=\"block-wysiwyg\">\n            <h3>Across ages and phenotypes, uGAG levels normalized with NAGLAZYME<sup>1<\/sup><\/h3>\n<h4>Urinary GAG levels in all NAGLAZYME\u2010treated patients<sup>1<\/sup><\/h4>\n    <\/div>\n\n<figure id=\"acf-block-643d5100b8287\">\n    <div class=\"image image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/10\/Urinary-GAG-levels-Graph.png?v=0.33\" alt=\"Urinary GAG levels graph\" \/>            <\/div>\n            <figcaption><p><small><sup>a<\/sup>uGAG levels &gt;200 \u03bcg\/mg are associated with rapidly progressing disease; uGAG levels \u2264200 \u03bcg\/mg are associated with slowly progressing disease.<sup>4<\/sup><\/small><\/p>\n<\/figcaption>\n    <\/figure>\n\n<div id=\"acf-block-643d5100b829f\" class=\"block-wysiwyg\">\n            <ul>\n<li>uGAG levels decreased 87.9% from a mean of 321.34 \u00b1 199.86 \u00b5g\/mg creatinine at baseline to levels below 100 \u00b5g\/mg<sup>1<\/sup><\/li>\n<li>100% of the patients (n=55) treated with NAGLAZYME had uGAG levels &lt;100 \u00b5g\/mg creatinine at 10-year follow-up<sup>1<\/sup>\n<ul>\n<li>This includes 33 patients who presented with the rapidly progressing phenotype at baseline<sup>1<\/sup><\/li>\n<li>Results from the Resurvey Study are consistent with the decrease in uGAG levels seen in the phase 3 trial<sup>1,5<\/sup><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-643d5100b82b4\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-643d5100b82c4\" class=\"block-wysiwyg\">\n            <h3>Regardless of phenotype, NAGLAZYME slows disease progression<\/h3>\n<h4>Slowly progressing patients benefit from NAGLAZYME<sup>1<\/sup><\/h4>\n<p><strong>Resurvey Study endurance results (6MWT) of patients with uGAG levels \u2264200 \u03bcg\/mg<sup>1<\/sup><\/strong><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-643d5100b82ed\" class=\"block split-content equal-bias\" data-muted-autoplay=\"false\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                <div class=\"content-block first-block\">\n                                                                                                                                                                                                                                                                                    \n                                    \n                                                                                                                \n                                    \n                                    <figure>\n                                        <div class=\"image image-rounded\">\n                                                                                            <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/10\/significant.png?v=0.33\" alt=\"\" \/>                                                                                    <\/div>\n                                                                            <\/figure>\n                                                                                    <\/div>\n                    \n                                            <div class=\"content-block second-block\">\n                                                                                                <ul>\n<li>MPS VI patients with uGAG levels &lt;100 \u00b5g\/mg showed a 19% improvement in endurance<sup>1<\/sup><\/li>\n<li>Patients with uGAG levels of 100-200 \u00b5g\/mg showed an 11% improvement in endurance<sup>1<\/sup><\/li>\n<\/ul>\n<h4>NAGLAZYME slowed disease progression in patients with the rapidly progressing phenotype<\/h4>\n<ul>\n<li>6MWT and pulmonary function remained stable in patients with baseline uGAG levels &gt;200 \u00b5g\/mg<sup>1<\/sup><\/li>\n<\/ul>\n<p><a href=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/importance-of-compliance\/\">Learn more about the role compliance plays in MPS VI management <\/a><a class=\"nxt_page\" href=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/rate-of-progression\/\">\u00bb<\/a><\/p>\n                                                                                    <\/div>\n                                                \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-643d5100b831d\" class=\"block references\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t    \t\t\t    <h4>References:\n<\/h4>\n\t\t\t\t\t\t                <ol>\n                                                                                                                        <li><span>Giugliani R, Lampe C, Guffon N, <em>et al<\/em>. Natural history and galsulfase treatment in mucopolysaccharidosis VI (MPS VI, Maroteaux\u2013Lamy syndrome)\u201410-year follow-up of patients who previously participated in an MPS VI Survey Study. <em>Am J Med Genet A<\/em>. 2014;164A(8):1953-1964. doi:10.1002\/ajmg.a.36584.\n<\/span><\/li>\n                                                                                                                                                <li><span>Harmatz P, Giugliani R, Schwartz I, <em>et al<\/em>; MPS VI Phase 3 Study Group. Enzyme replacement therapy for mucopolysaccharidosis VI: a phase 3, randomized, double-blind, placebo-controlled, multinational study of recombinant human N-acetylgalactosamine 4-sulfatase (recombinant human arylsulfatase B or rhASB) and follow-on, open-label extension study. <em>J Pediatr.<\/em> 2006;148(4):533-539. doi:10.1016\/j.jpeds.2005.12.014.\n<\/span><\/li>\n                                                                                                                                                <li><span>McDonald A, Steiner R, Kuehl K, Turbeville S. Clinical utility of endurance measures for evaluation of treatment in patients with mucopolysaccharidosis VI (Maroteaux-Lamy syndrome). <em>J Pediatr Rehabil Med<\/em>. 2010;3(2):119-127. doi:10.3233\/PRM-2020-0114.\n<\/span><\/li>\n                                                                                                                                                <li><span>Swiedler SJ, Beck M, Bajbouj M, <em>et al<\/em>. Threshold effect of urinary glycosaminoglycans and the walk test as indicators of disease progression in a survey of subjects with mucopolysaccharidosis VI (Maroteaux\u2013Lamy syndrome). <em>Am J Med Genet A<\/em>. 2005;134A(2):144-150. doi:10.1002\/ajmg.a.30579.\n<\/span><\/li>\n                                                                                                                                                <li><span>Harmatz P, Giugliani R, Schwartz IVD, <em>et al<\/em>; MPS VI Study Group. Long-term follow-up of endurance and safety outcomes during enzyme replacement therapy for mucopolysaccharidosis VI: final results of three clinical studies of recombinant human N-acetylgalactosamine 4-sulfatase. <em>Mol Genet Metab<\/em>. 2008;94(4):469-475. doi:10.1016\/j.ymgme.2008.04.001.\n<\/span><\/li>\n                                                            <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-247","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Sustained Benefits - BioMarin Naglazyme HCP EN-US<\/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:\/\/hcp.biomarin.com\/en-us\/naglazyme\/sustained-benefits\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sustained Benefits - 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