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Cited by 341

The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.

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

Langley, R.G., Tsai, T.‐F., Flavin, S., Song, M., Randazzo, B., Wasfi, Y., Jiang, J., Li, S., Puig, L.·2018·British Journal of Dermatology
DOI 10.1111/bjd.15750
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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.

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Metadata

Authors
Langley, R. G., Tsai, T. ‐., Flavin, S., Song, M., Randazzo, B., Wasfi, Y., Jiang, J., Li, S., & Puig, L.
Venue
British Journal of Dermatology
Publisher
Oxford University Press (OUP)
Published
2017-10-10
Volume
178
Issue
1
Pages
114-123
ISSN
  • 0007-0963 (ISSN-L)
  • 1365-2133
DOI
10.1111/bjd.15750
OpenAlex
W2697574135
Cited by
341
References
20
FWCI
13.92
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.1111/bjd.15750
The paper
Langley, R. G., Tsai, T. ‐., Flavin, S., Song, M., Randazzo, B., Wasfi, Y., Jiang, J., Li, S., & Puig, L. (2018). 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. British Journal of Dermatology. https://doi.org/10.1111/bjd.15750

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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