https://scholars.lib.ntu.edu.tw/handle/123456789/518155
標題: | Evolution of the inclusion/exclusion criteria and primary endpoints in pivotal trials of biologics and small oral molecules for the treatment of psoriasis | 作者: | Hsu S.-H. TSEN-FANG TSAI |
關鍵字: | Alefacept; anti-interleukin; anti-tumor necrosis factor; apremilast; biologics; clinical trials; design; efalizumab; psoriasis; tofacitinib | 公開日期: | 2020 | 出版社: | Taylor and Francis Ltd | 卷: | 13 | 期: | 3 | 起(迄)頁: | 211-232 | 來源出版物: | Expert Review of Clinical Pharmacology | 摘要: | Introduction: Primary endpoints and inclusion/exclusion criteria of biologics and small oral molecules for psoriasis treatment have been evolving due to a better understanding of the pathogenesis and potential risks. Areas covered: We analyzed the designs of key phase 3 pivotal trials of all biologics and small oral molecules approved for moderate to severe plaque psoriasis from published data on the ClinicalTrials.gov website and literature in the PubMed database. Alefacept, efalizumab, anti-tumor necrosis factors, anti-interleukin (IL)-12/IL-23, anti-IL-17 and anti-IL-23 inhibitors were discussed chronologically. Small oral molecules including tofacitinib and apremilast were also reviewed. Expert opinion: The primary endpoints of trials of biologics have been raised progressively and psoriasis area and severity index (PASI) 100 can now be readily achievable by the recent biologics. For safety, 5-year observation periods have become a gold standard after the report of progressive multifocal leukoencephalopathy after efalizumab. Also, the need for tuberculosis (TB) prophylaxis has also been relaxed in one trial of risankizumab. Small oral molecules are the future of affordable effective treatment for psoriasis, but the safety concerns must be overcome as reflected by their more stringent exclusion criteria. More biologic switch data and inclusion of patients previously excluded, e.g. viral hepatitis, are still needed. ? 2020, ? 2020 Informa UK Limited, trading as Taylor & Francis Group. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85083552760&doi=10.1080%2f17512433.2020.1743175&partnerID=40&md5=8c5968756a40075f7beb4136b05ade66 https://scholars.lib.ntu.edu.tw/handle/123456789/518155 |
ISSN: | 1751-2433 | DOI: | 10.1080/17512433.2020.1743175 | SDG/關鍵字: | adalimumab; alefacept; antipsoriasis agent; apremilast; biological product; briakinumab; brodalumab; certolizumab pegol; efalizumab; etanercept; guselkumab; infliximab; itolizumab; ixekizumab; risankizumab; secukinumab; tildrakizumab; tofacitinib; tumor necrosis factor inhibitor; ustekinumab; biological product; dermatological agent; biological therapy; disease severity; gold standard; human; phase 3 clinical trial (topic); Psoriasis Area and Severity Index; psoriasis vulgaris; Review; bioassay; methodology; pathology; patient selection; phase 3 clinical trial (topic); procedures; psoriasis; severity of illness index; Biological Products; Clinical Trials, Phase III as Topic; Dermatologic Agents; Endpoint Determination; Humans; Patient Selection; Psoriasis; Research Design; Severity of Illness Index |
顯示於: | 醫學系 |
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