Cargando…

Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis

INTRODUCTION: The aim of this study was to evaluate guselkumab efficacy on regional psoriasis in a subset of psoriasis patients with a self-reported psoriatic arthritis (PsA) diagnosis. METHODS: In the phase 3 VOYAGE-1 and -2 studies, at week (W)0, patients with moderate-to-severe psoriasis were ran...

Descripción completa

Detalles Bibliográficos
Autores principales: Orbai, Ana-Maria, Chakravarty, Soumya D., You, Yin, Shawi, May, Yang, Ya-Wen, Merola, Joseph F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10613182/
https://www.ncbi.nlm.nih.gov/pubmed/37713133
http://dx.doi.org/10.1007/s13555-023-01012-z
_version_ 1785128774146195456
author Orbai, Ana-Maria
Chakravarty, Soumya D.
You, Yin
Shawi, May
Yang, Ya-Wen
Merola, Joseph F.
author_facet Orbai, Ana-Maria
Chakravarty, Soumya D.
You, Yin
Shawi, May
Yang, Ya-Wen
Merola, Joseph F.
author_sort Orbai, Ana-Maria
collection PubMed
description INTRODUCTION: The aim of this study was to evaluate guselkumab efficacy on regional psoriasis in a subset of psoriasis patients with a self-reported psoriatic arthritis (PsA) diagnosis. METHODS: In the phase 3 VOYAGE-1 and -2 studies, at week (W)0, patients with moderate-to-severe psoriasis were randomized to guselkumab 100 mg, placebo → guselkumab 100 mg at W16 through W44, or adalimumab 80 mg then 40 mg at W1 through W48 (VOYAGE-1) or W24 (VOYAGE-2). Pooled efficacy outcomes, including scalp-specific Investigator’s Global Assessment (ss-IGA), hands and/or feet Physician’s Global Assessment (hf-PGA), fingernail PGA (f-PGA), Nail Psoriasis Area and Severity Index (NAPSI), and Dermatology Life Quality Index (DLQI), were compared (nominal p-values) through W24 in patients with self-reported PsA diagnosis. Response rates/percentage improvement from baseline were determined, employing treatment failure rules and non-response/no improvement data imputation. RESULTS: A total of 76, 153, and 106 psoriasis patients with self-reported PsA were randomized to the placebo, guselkumab, or adalimumab groups, respectively; the baseline characteristics of patients in all three arms were comparable. At W16, a greater proportion of guselkumab- versus placebo-treated patients achieved ss-IGA 0/1 (80.6% vs. 22.7%, p < 0.001), hf-PGA 0/1 (68.9% vs. 14.8%, p < 0.001), f-PGA 0/1 (47.6% vs. 17.0%, p < 0.001), and DLQI 0/1 (45.6% vs. 2.7%, p < 0.001) responses; mean percentage NAPSI improvement was also greater with guselkumab (39.5% vs. 6.5%, p < 0.001). At W24, patients receiving guselkumab had higher ss-IGA 0/1 (77.5% vs. 58.5%, p = 0.003) and DLQI 0/1 (47.7% vs. 34.3%, p = 0.024) response rates versus those receiving adalimumab. Response rates/mean percentage improvements at W48 (VOYAGE-1) were numerically greater with guselkumab than adalimumab (e.g., NAPSI improvement: 75.6% vs. 60.9%). CONCLUSIONS: Guselkumab-treated patients with psoriasis and self-reported PsA showed meaningful improvements in nail, scalp, and palmoplantar psoriasis. TRIAL REGISTRATION: VOYAGE-1 (ClinicalTrials.gov Identifier: NCT02207231) and VOYAGE-2 (ClinicalTrials.gov Identifier: NCT02207244). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-023-01012-z.
format Online
Article
Text
id pubmed-10613182
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-106131822023-10-30 Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis Orbai, Ana-Maria Chakravarty, Soumya D. You, Yin Shawi, May Yang, Ya-Wen Merola, Joseph F. Dermatol Ther (Heidelb) Brief Report INTRODUCTION: The aim of this study was to evaluate guselkumab efficacy on regional psoriasis in a subset of psoriasis patients with a self-reported psoriatic arthritis (PsA) diagnosis. METHODS: In the phase 3 VOYAGE-1 and -2 studies, at week (W)0, patients with moderate-to-severe psoriasis were randomized to guselkumab 100 mg, placebo → guselkumab 100 mg at W16 through W44, or adalimumab 80 mg then 40 mg at W1 through W48 (VOYAGE-1) or W24 (VOYAGE-2). Pooled efficacy outcomes, including scalp-specific Investigator’s Global Assessment (ss-IGA), hands and/or feet Physician’s Global Assessment (hf-PGA), fingernail PGA (f-PGA), Nail Psoriasis Area and Severity Index (NAPSI), and Dermatology Life Quality Index (DLQI), were compared (nominal p-values) through W24 in patients with self-reported PsA diagnosis. Response rates/percentage improvement from baseline were determined, employing treatment failure rules and non-response/no improvement data imputation. RESULTS: A total of 76, 153, and 106 psoriasis patients with self-reported PsA were randomized to the placebo, guselkumab, or adalimumab groups, respectively; the baseline characteristics of patients in all three arms were comparable. At W16, a greater proportion of guselkumab- versus placebo-treated patients achieved ss-IGA 0/1 (80.6% vs. 22.7%, p < 0.001), hf-PGA 0/1 (68.9% vs. 14.8%, p < 0.001), f-PGA 0/1 (47.6% vs. 17.0%, p < 0.001), and DLQI 0/1 (45.6% vs. 2.7%, p < 0.001) responses; mean percentage NAPSI improvement was also greater with guselkumab (39.5% vs. 6.5%, p < 0.001). At W24, patients receiving guselkumab had higher ss-IGA 0/1 (77.5% vs. 58.5%, p = 0.003) and DLQI 0/1 (47.7% vs. 34.3%, p = 0.024) response rates versus those receiving adalimumab. Response rates/mean percentage improvements at W48 (VOYAGE-1) were numerically greater with guselkumab than adalimumab (e.g., NAPSI improvement: 75.6% vs. 60.9%). CONCLUSIONS: Guselkumab-treated patients with psoriasis and self-reported PsA showed meaningful improvements in nail, scalp, and palmoplantar psoriasis. TRIAL REGISTRATION: VOYAGE-1 (ClinicalTrials.gov Identifier: NCT02207231) and VOYAGE-2 (ClinicalTrials.gov Identifier: NCT02207244). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-023-01012-z. Springer Healthcare 2023-09-15 /pmc/articles/PMC10613182/ /pubmed/37713133 http://dx.doi.org/10.1007/s13555-023-01012-z Text en © The Author(s) 2023 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 Brief Report
Orbai, Ana-Maria
Chakravarty, Soumya D.
You, Yin
Shawi, May
Yang, Ya-Wen
Merola, Joseph F.
Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis
title Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis
title_full Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis
title_fullStr Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis
title_full_unstemmed Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis
title_short Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis
title_sort efficacy of guselkumab in treating nails, scalp, hands, and feet in patients with psoriasis and self-reported psoriatic arthritis
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10613182/
https://www.ncbi.nlm.nih.gov/pubmed/37713133
http://dx.doi.org/10.1007/s13555-023-01012-z
work_keys_str_mv AT orbaianamaria efficacyofguselkumabintreatingnailsscalphandsandfeetinpatientswithpsoriasisandselfreportedpsoriaticarthritis
AT chakravartysoumyad efficacyofguselkumabintreatingnailsscalphandsandfeetinpatientswithpsoriasisandselfreportedpsoriaticarthritis
AT youyin efficacyofguselkumabintreatingnailsscalphandsandfeetinpatientswithpsoriasisandselfreportedpsoriaticarthritis
AT shawimay efficacyofguselkumabintreatingnailsscalphandsandfeetinpatientswithpsoriasisandselfreportedpsoriaticarthritis
AT yangyawen efficacyofguselkumabintreatingnailsscalphandsandfeetinpatientswithpsoriasisandselfreportedpsoriaticarthritis
AT merolajosephf efficacyofguselkumabintreatingnailsscalphandsandfeetinpatientswithpsoriasisandselfreportedpsoriaticarthritis