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Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial
INTRODUCTION: Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and qualit...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8850503/ https://www.ncbi.nlm.nih.gov/pubmed/35025062 http://dx.doi.org/10.1007/s13555-021-00649-y |
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author | Thaçi, Diamant Strober, Bruce Gordon, Kenneth B. Foley, Peter Gooderham, Melinda Morita, Akimichi Papp, Kim A. Puig, Lluís Menter, M. Alan Colombo, Matthew J. Elbez, Yedid Kisa, Renata M. Ye, June Napoli, Andrew A. Wei, Lan Banerjee, Subhashis Merola, Joseph F. Gottlieb, Alice B. |
author_facet | Thaçi, Diamant Strober, Bruce Gordon, Kenneth B. Foley, Peter Gooderham, Melinda Morita, Akimichi Papp, Kim A. Puig, Lluís Menter, M. Alan Colombo, Matthew J. Elbez, Yedid Kisa, Renata M. Ye, June Napoli, Andrew A. Wei, Lan Banerjee, Subhashis Merola, Joseph F. Gottlieb, Alice B. |
author_sort | Thaçi, Diamant |
collection | PubMed |
description | INTRODUCTION: Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis. METHODS: Post-hoc analysis of a 12-week Phase 2 trial was conducted for the three most efficacious dosage groups (3 mg twice daily, 6 mg twice daily, 12 mg once daily) and placebo. Investigator assessments for efficacy included Psoriasis Area and Severity Index (PASI), body surface area (BSA) involvement, and static Physician's Global Assessment; QoL was assessed using the Dermatology Life Quality Index (DLQI). Treatment responses and their associations were evaluated over time. RESULTS: Deucravacitinib elicited improvement versus placebo as early as Week 4 for most efficacy measures (including changes in absolute PASI and BSA), with efficacy trends observed from Week 2 to Week 12. Improvements in QoL, assessed by achievement of a DLQI overall score of 0/1 (no effect at all on patient’s life), followed a pattern similar to deucravacitinib-related clinical outcomes over 12 weeks. Overall, patients with greater improvements in psoriasis-related clinical signs and symptoms also reported greater improvement in QoL. However, complete skin clearance was not required for achieving DLQI 0/1. CONCLUSION: Deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and QoL in moderate to severe plaque psoriasis. Deucravacitinib has the potential to become a promising new oral therapy for this condition. TRIAL REGISTRATION: ClinicalTrials.gov identifier; NCT02931838. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-021-00649-y. |
format | Online Article Text |
id | pubmed-8850503 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-88505032022-02-23 Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial Thaçi, Diamant Strober, Bruce Gordon, Kenneth B. Foley, Peter Gooderham, Melinda Morita, Akimichi Papp, Kim A. Puig, Lluís Menter, M. Alan Colombo, Matthew J. Elbez, Yedid Kisa, Renata M. Ye, June Napoli, Andrew A. Wei, Lan Banerjee, Subhashis Merola, Joseph F. Gottlieb, Alice B. Dermatol Ther (Heidelb) Original Research INTRODUCTION: Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis. METHODS: Post-hoc analysis of a 12-week Phase 2 trial was conducted for the three most efficacious dosage groups (3 mg twice daily, 6 mg twice daily, 12 mg once daily) and placebo. Investigator assessments for efficacy included Psoriasis Area and Severity Index (PASI), body surface area (BSA) involvement, and static Physician's Global Assessment; QoL was assessed using the Dermatology Life Quality Index (DLQI). Treatment responses and their associations were evaluated over time. RESULTS: Deucravacitinib elicited improvement versus placebo as early as Week 4 for most efficacy measures (including changes in absolute PASI and BSA), with efficacy trends observed from Week 2 to Week 12. Improvements in QoL, assessed by achievement of a DLQI overall score of 0/1 (no effect at all on patient’s life), followed a pattern similar to deucravacitinib-related clinical outcomes over 12 weeks. Overall, patients with greater improvements in psoriasis-related clinical signs and symptoms also reported greater improvement in QoL. However, complete skin clearance was not required for achieving DLQI 0/1. CONCLUSION: Deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and QoL in moderate to severe plaque psoriasis. Deucravacitinib has the potential to become a promising new oral therapy for this condition. TRIAL REGISTRATION: ClinicalTrials.gov identifier; NCT02931838. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-021-00649-y. Springer Healthcare 2022-01-13 /pmc/articles/PMC8850503/ /pubmed/35025062 http://dx.doi.org/10.1007/s13555-021-00649-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open Access This 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 Thaçi, Diamant Strober, Bruce Gordon, Kenneth B. Foley, Peter Gooderham, Melinda Morita, Akimichi Papp, Kim A. Puig, Lluís Menter, M. Alan Colombo, Matthew J. Elbez, Yedid Kisa, Renata M. Ye, June Napoli, Andrew A. Wei, Lan Banerjee, Subhashis Merola, Joseph F. Gottlieb, Alice B. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial |
title | Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial |
title_full | Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial |
title_fullStr | Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial |
title_full_unstemmed | Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial |
title_short | Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial |
title_sort | deucravacitinib in moderate to severe psoriasis: clinical and quality-of-life outcomes in a phase 2 trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8850503/ https://www.ncbi.nlm.nih.gov/pubmed/35025062 http://dx.doi.org/10.1007/s13555-021-00649-y |
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