https://scholars.lib.ntu.edu.tw/handle/123456789/517569
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 | Authors: | Langley R.G. TSEN-FANG TSAI Flavin S. Song M. Randazzo B. Wasfi Y. Jiang J. Li S. Puig L. |
Issue Date: | 2018 | Publisher: | Blackwell Publishing Ltd | Journal Volume: | 178 | Journal Issue: | 1 | Start page/Pages: | 114-123 | Source: | British Journal of Dermatology | 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 |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85028508389&doi=10.1111%2fbjd.15750&partnerID=40&md5=b5b0248a4dedcbdb8223eab869d6b6a4 https://scholars.lib.ntu.edu.tw/handle/123456789/517569 |
ISSN: | 0007-0963 | DOI: | 10.1111/bjd.15750 | SDG/Keyword: | 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 |
Appears in Collections: | 醫學系 |
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