Cargando…
Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies
BACKGROUND: Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of av...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8380608/ https://www.ncbi.nlm.nih.gov/pubmed/34218429 http://dx.doi.org/10.1007/s40744-021-00337-5 |
_version_ | 1783741231492235264 |
---|---|
author | Orbai, Ana-Maria Husni, M. Elaine Gladman, Dafna D. Leung, Ying Ying Siebert, Stefan Tillett, William Vis, Marijn Chambenoit, Olivier Meng, Xiangyi Mease, Philip J. |
author_facet | Orbai, Ana-Maria Husni, M. Elaine Gladman, Dafna D. Leung, Ying Ying Siebert, Stefan Tillett, William Vis, Marijn Chambenoit, Olivier Meng, Xiangyi Mease, Philip J. |
author_sort | Orbai, Ana-Maria |
collection | PubMed |
description | BACKGROUND: Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains. METHODS: Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2–5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts. RESULTS: Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P < 0.05 vs placebo) and 18.6% and 9.0% of TNF-IR patients (nonsignificant vs placebo) experienced resolution in 66 swollen and 68 tender joint counts, respectively; additionally, 37.2% of TNFi-naive patients and 24.2% of TNF-IR patients achieved complete resolution of psoriasis at week 16 (all P < 0.05 vs placebo). Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains. CONCLUSIONS: Secukinumab demonstrated efficacy vs placebo across GRAPPA-OMERACT PsA core domains. Higher responses among TNFi-naive vs TNF-IR patients suggest that secukinumab should be considered for first-line use in PsA. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-021-00337-5. |
format | Online Article Text |
id | pubmed-8380608 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-83806082021-09-08 Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies Orbai, Ana-Maria Husni, M. Elaine Gladman, Dafna D. Leung, Ying Ying Siebert, Stefan Tillett, William Vis, Marijn Chambenoit, Olivier Meng, Xiangyi Mease, Philip J. Rheumatol Ther Original Research BACKGROUND: Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains. METHODS: Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2–5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts. RESULTS: Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P < 0.05 vs placebo) and 18.6% and 9.0% of TNF-IR patients (nonsignificant vs placebo) experienced resolution in 66 swollen and 68 tender joint counts, respectively; additionally, 37.2% of TNFi-naive patients and 24.2% of TNF-IR patients achieved complete resolution of psoriasis at week 16 (all P < 0.05 vs placebo). Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains. CONCLUSIONS: Secukinumab demonstrated efficacy vs placebo across GRAPPA-OMERACT PsA core domains. Higher responses among TNFi-naive vs TNF-IR patients suggest that secukinumab should be considered for first-line use in PsA. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-021-00337-5. Springer Healthcare 2021-07-03 /pmc/articles/PMC8380608/ /pubmed/34218429 http://dx.doi.org/10.1007/s40744-021-00337-5 Text en © The Author(s) 2021 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 Orbai, Ana-Maria Husni, M. Elaine Gladman, Dafna D. Leung, Ying Ying Siebert, Stefan Tillett, William Vis, Marijn Chambenoit, Olivier Meng, Xiangyi Mease, Philip J. Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies |
title | Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies |
title_full | Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies |
title_fullStr | Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies |
title_full_unstemmed | Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies |
title_short | Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies |
title_sort | secukinumab efficacy on psoriatic arthritis grappa-omeract core domains in patients with or without prior tumor necrosis factor inhibitor use: pooled analysis of four phase 3 studies |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8380608/ https://www.ncbi.nlm.nih.gov/pubmed/34218429 http://dx.doi.org/10.1007/s40744-021-00337-5 |
work_keys_str_mv | AT orbaianamaria secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT husnimelaine secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT gladmandafnad secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT leungyingying secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT siebertstefan secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT tillettwilliam secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT vismarijn secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT chambenoitolivier secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT mengxiangyi secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies AT measephilipj secukinumabefficacyonpsoriaticarthritisgrappaomeractcoredomainsinpatientswithorwithoutpriortumornecrosisfactorinhibitorusepooledanalysisoffourphase3studies |