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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...

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Autores principales: Odnopozova, Liudmila, Edin, Anton, Sukharev, Alexey, Wu, Tianshuang, Aydin, Kerstin, Kelly, Maureen, Khotko, Alkes
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
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.
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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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