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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ESecukinumab, a high-affinity fully human monoclonal immunoglobulin G 1K antibody that selectively binds to and inhibits interleukin-17A, improves the signs and symptoms of active ankylosing spondylitis (AS). This article presents the results of the 16-Week Efficacy and 2-Year Long-term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis trial [MEASURE 1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01358175\u0026amp;atom=%2Fspmdc%2F14%2F51%2F18.atom\u0022\u003ENCT01358175\u003C\/a\u003E], which evaluated intravenous loading and maintenance dosing of secukinumab.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInflammatory Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInflammatory Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003ESecukinumab, a high-affinity fully human monoclonal immunoglobulin G 1K antibody that selectively binds to and inhibits interleukin-17A, improves the signs and symptoms of active ankylosing spondylitis (AS). Dominique Baeten, MD, PhD, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, presented the results of the 16-Week Efficacy and 2-Year Long-term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis trial [MEASURE 1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01358175\u0026amp;atom=%2Fspmdc%2F14%2F51%2F18.atom\u0022\u003ENCT01358175\u003C\/a\u003E], which evaluated intravenous loading and maintenance dosing of secukinumab.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EThe study comprised patients with radiologically confirmed AS with an inadequate response to or intolerance of nonsteroidal anti-inflammatory drugs and\/or those who were tumor necrosis factor (TNF) na\u00efve or had an inadequate response or intolerance to \u2264 1 TNF inhibitor. Additional requirements included a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \u2265 4 (0 to 10 scale) and back pain visual analog scale score \u0026gt; 40 (0 to 100 mm). Patients with total spinal ankylosis, active infections, or ongoing inflammatory conditions other than AS were excluded.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EPatients were randomized to placebo or 1 of 2 secukinumab arms; at week 16, patients receiving placebo were separated into responder and nonresponder arms. Randomization was stratified according to whether patients had previous intolerance or inadequate response to anti-TNF therapy or were anti-TNF na\u00efve.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe primary end point was Assessment of Spondylo-arthritis International Society (ASAS) 20 response at week 16. Secondary end points at week 16 were ASAS 40, high-sensitivity C-reactive protein results, ASAS 5\/6, BASDAI, Short Form 36 physical component summary, AS quality of life, ASAS partial remission, and safety.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EThe study enrolled 371 patients, 122 to 125 in each arm. Baseline demographics and clinical characteristics were well balanced across treatment groups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EASAS 20 response at week 16 was 60.8% for the 150-mg secukinumab dose group and 59.7% for the 75-mg group vs 28.7% for the placebo group. A significant difference between each treatment group and placebo was seen at week 1 and sustained out to week 16, indicating a rapid onset of action for this drug (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .01).\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003ESimilar values were noted for ASAS 40 (150 mg, 41.6%; 75 mg, 33.1%; vs 13.1% for placebo; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .01), again starting at week 1. All secondary end points were significantly improved for both treatment arms compared with placebo.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EData at week 52 were also presented. ASAS 20 response was sustained out to week 52 (150 mg, 76.7%; 75 mg, 71.3%). ASAS 40 responses were similar (150 mg, 62.1%; 75 mg, 49.1%). BASDAI data indicated a rapid improvement at week 1 that was sustained out to week 52 (150 mg, \u22123.19; 75 mg, \u22122.86; vs \u22120.59 for placebo; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001, at week 16).\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003ESecukinumab (75 and 150 mg) significantly reduced inflammation of the sacroiliac joint (Berlin Sacroiliac Joint Total Edema Score) as assessed by magnetic resonance imaging at week 16 (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .01 vs placebo). ASAS 20 responses at week 16 were improved regardless of prior use of anti-TNF therapy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003ESecukinumab was well tolerated with no unexpected safety findings. Common adverse events included nasopharyngitis, headache, diarrhea, and upper respiratory tract infections, all of which occurred somewhat less in the treatment groups compared with placebo. There were few discontinuations due to treatment. There were 3 cases of candida infection and 1 case of grade 4 neutropenia. Two patients experienced low levels of treatment-emergent antisecukinumab antibodies.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EThis is the first non-anti-TNF biologic therapy to demonstrate efficacy in a phase 3 clinical AS trial. Regardless of prior anti-TNF exposure, clinical benefit was observed.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/51\/18.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzoeo2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}