https://scholars.lib.ntu.edu.tw/handle/123456789/517569
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.author | Langley R.G. | en_US |
dc.contributor.author | TSEN-FANG TSAI | en_US |
dc.contributor.author | Flavin S. | en_US |
dc.contributor.author | Song M. | en_US |
dc.contributor.author | Randazzo B. | en_US |
dc.contributor.author | Wasfi Y. | en_US |
dc.contributor.author | Jiang J. | en_US |
dc.contributor.author | Li S. | en_US |
dc.contributor.author | Puig L. | en_US |
dc.creator | Langley R.G.;Tsen-Fang Tsai;Flavin S.;Song M.;Randazzo B.;Wasfi Y.;Jiang J.;Li S.;Puig L. | - |
dc.date.accessioned | 2020-10-22T07:27:48Z | - |
dc.date.available | 2020-10-22T07:27:48Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 0007-0963 | - |
dc.identifier.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85028508389&doi=10.1111%2fbjd.15750&partnerID=40&md5=b5b0248a4dedcbdb8223eab869d6b6a4 | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/517569 | - |
dc.description.abstract | Background: Guselkumab, an anti-interleukin-23 monoclonal antibody, has demonstrated significant efficacy in phase III psoriasis trials. Objectives: To evaluate the efficacy and safety of guselkumab in patients with moderate-to-severe plaque psoriasis who had an inadequate response to ustekinumab. Methods: In this phase III, randomized, double-blind study, 871 patients received open-label ustekinumab (45?mg or 90?mg) at weeks 0 and 4. At week 16, 268 patients with an inadequate response to ustekinumab [Investigator's Global Assessment (IGA) ??2] were randomized (double-blind) to guselkumab 100?mg or to continue ustekinumab; 585 of 871 patients (67%) with IGA 0/1 at week 16 continued open-label ustekinumab. The primary end point was the number of visits at which randomized patients achieved IGA 0/1 and at least a two-grade improvement (from week 16) from week 28 to week 40. Improvement ??90% or 100% in Psoriasis Area and Severity Index (PASI 90/100) and Dermatology Life Quality Index (DLQI) of 0/1 were also assessed. Results: The mean number of visits at which patients achieved IGA 0/1 and at least a two-grade improvemen (week 28–40) was significantly greater in the guselkumab group vs. the randomized ustekinumab group (1·5 vs. 0·7; P?<?0·001); greater proportions of patients in the guselkumab group achieved IGA 0/1 and at least a two-grade improvement at week 28 (31·1% vs. 14·3%; P?=?0·001) and week 52 (36·3% vs. 17·3%; P?<?0·001). Greater proportions of patients treated with guselkumab achieved PASI 90, PASI 100 and DLQI 0/1 at week 52. After week 16, 64·4% of patients in the guselkumab group and 55·6% in the ustekinumab group had at least one adverse event (AE); infections were the most frequent AE type. Overall, 6·7% (n?=?9) of patients in the guselkumab group had at least one serious AE compared with 4·5% (n?=?6) for the ustekinumab group. Conclusions: Patients treated with ustekinumab who did not achieve an IGA of 0/1 by week 16 derived significant benefit from switching to guselkumab. ? 2017 British Association of Dermatologists | - |
dc.publisher | Blackwell Publishing Ltd | - |
dc.relation.ispartof | British Journal of Dermatology | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | adalimumab; apremilast; cyclosporine; etanercept; etretin; guselkumab; infliximab; methotrexate; tofacitinib; ustekinumab; biological product; dermatological agent; guselkumab; monoclonal antibody; ustekinumab; abscess; adult; appendicitis; Article; backache; bacterial arthritis; basal cell carcinoma; bile duct cancer; connective tissue disease; controlled study; Dermatology Life Quality Index; double blind procedure; drug efficacy; drug response; drug safety; drug treatment failure; drug withdrawal; epididymitis; female; heart infarction; human; immunogenicity; infection; injection site reaction; major clinical study; male; multicenter study; musculoskeletal disease; open study; pancreas carcinoma; periodontitis; phase 3 clinical trial; priority journal; Psoriasis Area and Severity Index; psoriasis vulgaris; psoriatic arthritis; PUVA; randomized controlled trial; rhinopharyngitis; salpingitis; squamous cell skin carcinoma; transitional cell carcinoma; upper respiratory tract infection; urinary tract infection; clinical trial; patient-reported outcome; psoriasis; treatment outcome; Adult; Antibodies, Monoclonal; Biological Products; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Patient Reported Outcome Measures; Psoriasis; Treatment Outcome; Ustekinumab | - |
dc.title | Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1111/bjd.15750 | - |
dc.identifier.pmid | 28635018 | - |
dc.identifier.scopus | 2-s2.0-85028508389 | - |
dc.relation.pages | 114-123 | - |
dc.relation.journalvolume | 178 | - |
dc.relation.journalissue | 1 | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.openairetype | journal article | - |
item.grantfulltext | none | - |
item.cerifentitytype | Publications | - |
item.fulltext | no fulltext | - |
crisitem.author.dept | Dermatology | - |
crisitem.author.dept | Dermatology-NTUH | - |
crisitem.author.orcid | 0000-0002-1498-1474 | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
顯示於: | 醫學系 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。