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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
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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175099/ https://www.ncbi.nlm.nih.gov/pubmed/29905383 http://dx.doi.org/10.1111/1346-8138.14504 |
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author | Ohtsuki, Mamitaro Kubo, Hiroshi Morishima, Hitomi Goto, Ryosuke Zheng, Richuan Nakagawa, Hidemi |
author_facet | Ohtsuki, Mamitaro Kubo, Hiroshi Morishima, Hitomi Goto, Ryosuke Zheng, Richuan Nakagawa, Hidemi |
author_sort | Ohtsuki, Mamitaro |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6175099 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-61750992018-10-15 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 Ohtsuki, Mamitaro Kubo, Hiroshi Morishima, Hitomi Goto, Ryosuke Zheng, Richuan Nakagawa, Hidemi J Dermatol Original Articles 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. John Wiley and Sons Inc. 2018-06-15 2018-09 /pmc/articles/PMC6175099/ /pubmed/29905383 http://dx.doi.org/10.1111/1346-8138.14504 Text en © 2018 Janssen Pharmaceutical K.K. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Ohtsuki, Mamitaro Kubo, Hiroshi Morishima, Hitomi Goto, Ryosuke Zheng, Richuan Nakagawa, Hidemi 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175099/ https://www.ncbi.nlm.nih.gov/pubmed/29905383 http://dx.doi.org/10.1111/1346-8138.14504 |
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