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Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation
INTRODUCTION: Risankizumab has demonstrated efficacy and safety in phase 3 studies in patients with moderate to severe plaque psoriasis. This randomized clinical trial assessed the efficacy and safety of risankizumab in patients with moderate to severe plaque psoriasis in the Russian Federation. MET...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9464287/ https://www.ncbi.nlm.nih.gov/pubmed/35917057 http://dx.doi.org/10.1007/s13555-022-00776-0 |
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author | Odnopozova, Liudmila Edin, Anton Sukharev, Alexey Wu, Tianshuang Aydin, Kerstin Kelly, Maureen Khotko, Alkes |
author_facet | Odnopozova, Liudmila Edin, Anton Sukharev, Alexey Wu, Tianshuang Aydin, Kerstin Kelly, Maureen Khotko, Alkes |
author_sort | Odnopozova, Liudmila |
collection | PubMed |
description | INTRODUCTION: Risankizumab has demonstrated efficacy and safety in phase 3 studies in patients with moderate to severe plaque psoriasis. This randomized clinical trial assessed the efficacy and safety of risankizumab in patients with moderate to severe plaque psoriasis in the Russian Federation. METHODS: Patients with moderate to severe plaque psoriasis were randomized 4:1 to 16 weeks of double-blind treatment with risankizumab 150 mg or placebo (period A; dosing at baseline and week 4) followed by an open-label extension (period B) during which all patients received risankizumab 150 mg at weeks 16, 28, and 40 and were followed up to week 52. The primary study endpoint was the proportion of patients achieving ≥ 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 16, and secondary endpoints included Static Physician’s Global Assessment scores and the Dermatology Life Quality Index. Treatment-emergent adverse events were monitored throughout the two study periods. RESULTS: Of the 50 patients who entered period A, 41 were randomized to receive risankizumab and 9 to receive placebo. Forty-eight patients entered period B, and 47 completed the study. A significantly larger proportion of risankizumab-treated patients achieved PASI 90 at week 16 compared with placebo-treated patients [response rate difference: 38.8% (95% CI 7.8–69.7%; P = 0.035)]. Consistently higher proportions of risankizumab-treated patients achieved secondary endpoints compared with the placebo-treated patients. Safety profiles were similar between the treatment groups, and no patients discontinued the study drug owing to adverse events. CONCLUSION: Risankizumab was efficacious and well tolerated in patients with moderate to severe plaque psoriasis in the Russian Federation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03518047. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-022-00776-0. |
format | Online Article Text |
id | pubmed-9464287 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-94642872022-09-12 Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation Odnopozova, Liudmila Edin, Anton Sukharev, Alexey Wu, Tianshuang Aydin, Kerstin Kelly, Maureen Khotko, Alkes Dermatol Ther (Heidelb) Original Research INTRODUCTION: Risankizumab has demonstrated efficacy and safety in phase 3 studies in patients with moderate to severe plaque psoriasis. This randomized clinical trial assessed the efficacy and safety of risankizumab in patients with moderate to severe plaque psoriasis in the Russian Federation. METHODS: Patients with moderate to severe plaque psoriasis were randomized 4:1 to 16 weeks of double-blind treatment with risankizumab 150 mg or placebo (period A; dosing at baseline and week 4) followed by an open-label extension (period B) during which all patients received risankizumab 150 mg at weeks 16, 28, and 40 and were followed up to week 52. The primary study endpoint was the proportion of patients achieving ≥ 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 16, and secondary endpoints included Static Physician’s Global Assessment scores and the Dermatology Life Quality Index. Treatment-emergent adverse events were monitored throughout the two study periods. RESULTS: Of the 50 patients who entered period A, 41 were randomized to receive risankizumab and 9 to receive placebo. Forty-eight patients entered period B, and 47 completed the study. A significantly larger proportion of risankizumab-treated patients achieved PASI 90 at week 16 compared with placebo-treated patients [response rate difference: 38.8% (95% CI 7.8–69.7%; P = 0.035)]. Consistently higher proportions of risankizumab-treated patients achieved secondary endpoints compared with the placebo-treated patients. Safety profiles were similar between the treatment groups, and no patients discontinued the study drug owing to adverse events. CONCLUSION: Risankizumab was efficacious and well tolerated in patients with moderate to severe plaque psoriasis in the Russian Federation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03518047. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-022-00776-0. Springer Healthcare 2022-08-02 /pmc/articles/PMC9464287/ /pubmed/35917057 http://dx.doi.org/10.1007/s13555-022-00776-0 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Odnopozova, Liudmila Edin, Anton Sukharev, Alexey Wu, Tianshuang Aydin, Kerstin Kelly, Maureen Khotko, Alkes Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation |
title | Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation |
title_full | Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation |
title_fullStr | Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation |
title_full_unstemmed | Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation |
title_short | Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation |
title_sort | risankizumab for the treatment of moderate to severe plaque psoriasis in the russian federation |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9464287/ https://www.ncbi.nlm.nih.gov/pubmed/35917057 http://dx.doi.org/10.1007/s13555-022-00776-0 |
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