Cargando…

Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials

INTRODUCTION: Low disease activity (LDA)/remission is the target of treatment in patients with psoriatic arthritis (PsA). We assessed the proportions of patients with PsA receiving upadacitinib who achieved LDA/remission over 1 year. METHODS: This was a post hoc analysis of the double-blind, placebo...

Descripción completa

Detalles Bibliográficos
Autores principales: Mease, Philip, Kavanaugh, Arthur, Gladman, Dafna, FitzGerald, Oliver, Soriano, Enrique R., Nash, Peter, Feng, Dai, Lertratanakul, Apinya, Douglas, Kevin, Lippe, Ralph, Gossec, Laure
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314475/
https://www.ncbi.nlm.nih.gov/pubmed/35606663
http://dx.doi.org/10.1007/s40744-022-00449-6
_version_ 1784754328111677440
author Mease, Philip
Kavanaugh, Arthur
Gladman, Dafna
FitzGerald, Oliver
Soriano, Enrique R.
Nash, Peter
Feng, Dai
Lertratanakul, Apinya
Douglas, Kevin
Lippe, Ralph
Gossec, Laure
author_facet Mease, Philip
Kavanaugh, Arthur
Gladman, Dafna
FitzGerald, Oliver
Soriano, Enrique R.
Nash, Peter
Feng, Dai
Lertratanakul, Apinya
Douglas, Kevin
Lippe, Ralph
Gossec, Laure
author_sort Mease, Philip
collection PubMed
description INTRODUCTION: Low disease activity (LDA)/remission is the target of treatment in patients with psoriatic arthritis (PsA). We assessed the proportions of patients with PsA receiving upadacitinib who achieved LDA/remission over 1 year. METHODS: This was a post hoc analysis of the double-blind, placebo-controlled SELECT-PsA 1 (also adalimumab-controlled) and SELECT-PsA 2 trials. Treatment targets assessed included LDA/remission defined by Disease Activity in Psoriatic Arthritis (≤ 14/ ≤ 4) and Psoriatic Arthritis Disease Activity Scores (≤ 3.2/ ≤ 1.9), as well as minimal disease activity (MDA)/very low disease activity (VLDA) states (5/7 and 7/7 components, respectively, of MDA criteria). Targets were assessed at 24 and 56 weeks. For binary outcomes, non-responder imputation was used for missing data. Data from patients receiving upadacitinib 30 mg was not included in the analysis. RESULTS: Overall, 1386 patients were analyzed. Disease control (i.e., LDA/MDA) was achieved at 24 weeks in upadacitinib 15 mg-treated patients across both studies: LDA/MDA was achieved by 25–48% of patients receiving upadacitinib 15 mg versus 2–16% of patients receiving placebo, and remission/VLDA rates were 7–14% with upadacitinib 15 mg versus 0–4% with placebo. The proportions of patients achieving treatment targets were numerically similar to upadacitinib 15 mg and adalimumab. All responses were sustained at 56 weeks. CONCLUSIONS: Remission and LDA are feasible targets with upadacitinib treatment in patients with PsA. TRIAL REGISTRATION: ClinicalTrial.gov identifiers NCT03104400 (SELECT-PsA 1) and NCT03104374 (SELECT-PsA 2). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00449-6.
format Online
Article
Text
id pubmed-9314475
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-93144752022-07-27 Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials Mease, Philip Kavanaugh, Arthur Gladman, Dafna FitzGerald, Oliver Soriano, Enrique R. Nash, Peter Feng, Dai Lertratanakul, Apinya Douglas, Kevin Lippe, Ralph Gossec, Laure Rheumatol Ther Brief Report INTRODUCTION: Low disease activity (LDA)/remission is the target of treatment in patients with psoriatic arthritis (PsA). We assessed the proportions of patients with PsA receiving upadacitinib who achieved LDA/remission over 1 year. METHODS: This was a post hoc analysis of the double-blind, placebo-controlled SELECT-PsA 1 (also adalimumab-controlled) and SELECT-PsA 2 trials. Treatment targets assessed included LDA/remission defined by Disease Activity in Psoriatic Arthritis (≤ 14/ ≤ 4) and Psoriatic Arthritis Disease Activity Scores (≤ 3.2/ ≤ 1.9), as well as minimal disease activity (MDA)/very low disease activity (VLDA) states (5/7 and 7/7 components, respectively, of MDA criteria). Targets were assessed at 24 and 56 weeks. For binary outcomes, non-responder imputation was used for missing data. Data from patients receiving upadacitinib 30 mg was not included in the analysis. RESULTS: Overall, 1386 patients were analyzed. Disease control (i.e., LDA/MDA) was achieved at 24 weeks in upadacitinib 15 mg-treated patients across both studies: LDA/MDA was achieved by 25–48% of patients receiving upadacitinib 15 mg versus 2–16% of patients receiving placebo, and remission/VLDA rates were 7–14% with upadacitinib 15 mg versus 0–4% with placebo. The proportions of patients achieving treatment targets were numerically similar to upadacitinib 15 mg and adalimumab. All responses were sustained at 56 weeks. CONCLUSIONS: Remission and LDA are feasible targets with upadacitinib treatment in patients with PsA. TRIAL REGISTRATION: ClinicalTrial.gov identifiers NCT03104400 (SELECT-PsA 1) and NCT03104374 (SELECT-PsA 2). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00449-6. Springer Healthcare 2022-05-23 /pmc/articles/PMC9314475/ /pubmed/35606663 http://dx.doi.org/10.1007/s40744-022-00449-6 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 Brief Report
Mease, Philip
Kavanaugh, Arthur
Gladman, Dafna
FitzGerald, Oliver
Soriano, Enrique R.
Nash, Peter
Feng, Dai
Lertratanakul, Apinya
Douglas, Kevin
Lippe, Ralph
Gossec, Laure
Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
title Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
title_full Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
title_fullStr Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
title_full_unstemmed Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
title_short Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
title_sort disease control with upadacitinib in patients with psoriatic arthritis: a post hoc analysis of the randomized, placebo-controlled select-psa 1 and 2 phase 3 trials
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314475/
https://www.ncbi.nlm.nih.gov/pubmed/35606663
http://dx.doi.org/10.1007/s40744-022-00449-6
work_keys_str_mv AT measephilip diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT kavanaugharthur diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT gladmandafna diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT fitzgeraldoliver diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT sorianoenriquer diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT nashpeter diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT fengdai diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT lertratanakulapinya diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT douglaskevin diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT lipperalph diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials
AT gosseclaure diseasecontrolwithupadacitinibinpatientswithpsoriaticarthritisaposthocanalysisoftherandomizedplacebocontrolledselectpsa1and2phase3trials