{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,14]],"date-time":"2025-10-14T14:45:37Z","timestamp":1760453137526,"version":"3.37.3"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2021,10,28]],"date-time":"2021-10-28T00:00:00Z","timestamp":1635379200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,10,28]],"date-time":"2021-10-28T00:00:00Z","timestamp":1635379200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Chinese National Key Technology R&D Program, Ministry of Science and Technology","award":["2017YFC0907601"],"award-info":[{"award-number":["2017YFC0907601"]}]},{"name":"Medicine and Health Technology Innovation Project, Chinese Academy of Medical Sciences","award":["2019-I2M-2-008"],"award-info":[{"award-number":["2019-I2M-2-008"]}]},{"name":"zhejiang hisun pharmaceutical co., ltd"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Rheumatol"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Objective<\/jats:title>\n                <jats:p>The equivalence of the biosimilar HS016 to adalimumab (Humira) for the treatment of active ankylosing spondylitis (AS) patients has been previously validated. The aim was to compare the efficacy of HS016 and adalimumab in stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We carried out a multicenter, randomized, double-blind, parallel, positive control, phase 3 trial of patients with active AS. They were selected randomly to be subcutaneously administered 40\u00a0mg HS016 or adalimumab every 2\u00a0weeks for a total treatment period of 24\u00a0weeks in a 2:1 ratio. A health surveys were used to assess mental and physical improvements of patients as well as other factors.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>HAQ-S revealed that changes in scores from baseline in both groups were time dependent until 14\u00a0weeks and that during the first 4\u00a0weeks of treatment the changes declined rapidly. The SF-36 health survey revealed that both HS016 and adalimumab produced rapid beneficial effects against AS during the first 2\u00a0weeks of therapy, which gradually declined between 2 and 12\u00a0weeks and flattened out after 12\u00a0weeks until 24\u00a0weeks.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>This trial demonstrated that both HS016 and adalimumab produced rapid improvements in symptoms during the first 2\u00a0weeks of treatment. These findings suggest that HS016 is an alternative economical treatment for Chinese AS patients producing a rapid amelioration of symptoms, aiding them to recover their lifestyle satisfaction.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/enindex.aspx\">http:\/\/www.chictr.org.cn\/enindex.aspx<\/jats:ext-link>, ChiCTR1900022520, retrospectively registered.\n<jats:table-wrap><jats:table><jats:tbody>\n                      <jats:tr>\n                        <jats:td align=\"left\">Key points<\/jats:td>\n                      <\/jats:tr>\n                      <jats:tr>\n                        <jats:td align=\"left\"><jats:italic>\u2022 HS016 and adalimumab produced rapid AS symptom improvements during the first 2\u00a0weeks followed by a slowdown of improvements until week 4 with afterwards few improvements evaluated by HAQ-S<\/jats:italic><\/jats:td>\n                      <\/jats:tr>\n                      <jats:tr>\n                        <jats:td align=\"left\"><jats:italic>\u2022 The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S<\/jats:italic><\/jats:td>\n                      <\/jats:tr>\n                      <jats:tr>\n                        <jats:td align=\"left\"><jats:italic>\u2022 There was no significant difference in HAQ-S and SF-36 scores between HS016 and adalimumab<\/jats:italic><\/jats:td>\n                      <\/jats:tr>\n                    <\/jats:tbody><\/jats:table><\/jats:table-wrap><\/jats:p>\n              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