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
Journal
British Journal of Dermatology
Journal Volume
178
Journal Issue
1
Pages
114-123
Date Issued
2018
Author(s)
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?
SDGs
Other Subjects
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
Publisher
Blackwell Publishing Ltd
Type
journal article