Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study

Mamitaro Ohtsuki, Hiroshi Kubo, Hitomi Morishima, Ryosuke Goto, Richuan Zheng, Hidemi Nakagawa, Mamitaro Ohtsuki, Hiroshi Kubo, Hitomi Morishima, Ryosuke Goto, Richuan Zheng, Hidemi Nakagawa

Abstract

Previous global studies of guselkumab have demonstrated clinical benefits in patients with psoriasis. The aim of this 52-week, phase 3 study was to evaluate efficacy and safety of guselkumab in Japanese patients with moderate to severe plaque-type psoriasis. Patients randomly received guselkumab 50 mg or 100 mg at weeks 0, 4 and every 8 weeks, or placebo with cross-over to guselkumab 50 mg or 100 mg at week 16. Co-primary end-points were the proportion of patients achieving Investigator's Global Assessment (IGA) cleared/minimal (0/1) and 90% or more improvement in Psoriasis Area and Severity Index (PASI-90) at week 16. Overall, 192 patients were randomized to placebo, guselkumab 50 mg or 100 mg. At week 16, patients in the placebo group were crossed over to guselkumab 50 mg or 100 mg. At week 16, a significantly (P < 0.001) higher proportion of patients receiving guselkumab 50 mg and 100 mg versus placebo achieved IGA 0/1 (92.3% and 88.9% vs 7.8%) and PASI-90 (70.8% and 69.8% vs 0%). Patients in guselkumab 50 mg and 100 mg groups achieved significant improvement versus placebo in PASI-75 (89.2% and 84.1% vs 6.3%, P < 0.001) at week 16; improvement was maintained through week 52. Incidences of treatment-emergent adverse events were comparable among the groups through week 16; the most commonly reported was nasopharyngitis. No new safety concerns were observed until week 52. In conclusion, guselkumab treatment demonstrated superior efficacy over placebo and was well tolerated in Japanese patients with moderate to severe plaque-type psoriasis.

Keywords: Japan; guselkumab; interleukin-23; long term; plaque psoriasis.

© 2018 Janssen Pharmaceutical K.K. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

Figures

Figure 1
Figure 1
Study design. *During the cross‐over at week 16, patients in guselkumab groups received placebo. †The last study drug administration in the double‐blind treatment phase occurred at week 44. Patients received treatment at week 52 only if they agreed to continue participation in the long‐term extension phase of the study.
Figure 2
Figure 2
Patient disposition. TEAE, treatment emergent adverse event. The “other” reason was patient did not meet the tuberculosis screening inclusion criterion.
Figure 3
Figure 3
Efficacy outcomes through week 52. (a) Proportion of patients achieving IGA 0/1. (b) Proportion of patients achieving IGA 0. (c) Proportion of patients achieving PASI‐75. (d) Proportion of patients achieving PASI‐90. (e) Proportion of patients achieving PASI‐100. *P < 0.001 for guselkumab versus placebo. IGA 0/1, Investigator Global Assessment score of cleared (0) or minimal (1); IGA 0, Investigator Global Assessment score of 0 (cleared); PASI‐75, 75% or more improvement in Psoriasis Area and Severity Index score from baseline; PASI‐90, 90% or more improvement in Psoriasis Area and Severity Index score from baseline; PASI‐100, 100% improvement in Psoriasis Area and Severity Index score from baseline.

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