Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice

Abstract Introduction Our aim was to investigate the efficacy and safety of upadacitinib (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis (PsA) using routine clinical practice data from an observational, prospective, multicentre study. Methods This interim analysis co...

Full description

Bibliographic Details
Main Authors: Stephanie G. Werner, Xenofon Baraliakos, Sabine Reckert, Martin Bohl-Bühler, Marie-Claude Laliberté, Tanya Girard, Katharina Jeromin, Nikola Baschuk, Björn Fritz, Louis Bessette, Axel J. Hueber
Format: Article
Language:English
Published: Adis, Springer Healthcare 2023-09-01
Series:Rheumatology and Therapy
Subjects:
Online Access:https://doi.org/10.1007/s40744-023-00589-3
_version_ 1827708402780864512
author Stephanie G. Werner
Xenofon Baraliakos
Sabine Reckert
Martin Bohl-Bühler
Marie-Claude Laliberté
Tanya Girard
Katharina Jeromin
Nikola Baschuk
Björn Fritz
Louis Bessette
Axel J. Hueber
author_facet Stephanie G. Werner
Xenofon Baraliakos
Sabine Reckert
Martin Bohl-Bühler
Marie-Claude Laliberté
Tanya Girard
Katharina Jeromin
Nikola Baschuk
Björn Fritz
Louis Bessette
Axel J. Hueber
author_sort Stephanie G. Werner
collection DOAJ
description Abstract Introduction Our aim was to investigate the efficacy and safety of upadacitinib (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis (PsA) using routine clinical practice data from an observational, prospective, multicentre study. Methods This interim analysis contains upadacitinib efficacy and safety data from the UPJOINT study, collected from baseline to the week 24 visit with a focus on composite measures, clinical assessments and patient-reported outcomes, amongst others, including minimal disease activity (MDA), very low disease activity (VLDA), Disease Activity Index for Psoriatic Arthritis (DAPSA), Leeds Enthesitis Index (LEI), resolution of dactylitis and nail psoriasis and body surface area affected by skin psoriasis (BSA). Results A total of 296 patients with baseline data and 192 with completed week 24 visits were included in the analysis. The proportion of patients achieving MDA increased from 2.7% at baseline to 39.1% at week 24 (95% CI 32.1, 46.3). Similarly, the number of patients in DAPSA remission (DAPSA ≤ 4) increased from 0 at baseline to 32 (16.7%) by week 24. At that time, 59.4% of the patients were either in DAPSA remission or had low disease activity (DAPSA ≤ 14). During the 24 weeks time frame, the proportion of patients with BSA ≤ 3 increased from 80.7% to 91.1%. Furthermore, at weeks 12 and 24, 45.14% and 47.19% of affected patients showed a resolution of enthesitis. Active dactylitis and nail psoriasis at baseline were reported to affect 10.5% and 22.0%, decreasing to 2.6% and 5.7% at week 24, respectively. The safety findings are consistent with the known safety profile of upadacitinib in rheumatoid arthritis and PsA; no new safety risks were identified. Conclusion The data from this study confirm the findings of previous randomized controlled trials suggesting UPA is an effective treatment for active PsA without any new safety signals in patients from daily clinical practice. Clinical Trial Registration ClinicalTrials.gov identifier, NCT04758117.
first_indexed 2024-03-10T17:03:07Z
format Article
id doaj.art-a787fb929fe14fb9989f5c14f59ca8bb
institution Directory Open Access Journal
issn 2198-6576
2198-6584
language English
last_indexed 2024-03-10T17:03:07Z
publishDate 2023-09-01
publisher Adis, Springer Healthcare
record_format Article
series Rheumatology and Therapy
spelling doaj.art-a787fb929fe14fb9989f5c14f59ca8bb2023-11-20T10:53:24ZengAdis, Springer HealthcareRheumatology and Therapy2198-65762198-65842023-09-011061503151810.1007/s40744-023-00589-3Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical PracticeStephanie G. Werner0Xenofon Baraliakos1Sabine Reckert2Martin Bohl-Bühler3Marie-Claude Laliberté4Tanya Girard5Katharina Jeromin6Nikola Baschuk7Björn Fritz8Louis Bessette9Axel J. Hueber10RHIO (Rheumatology, Immunology and Osteology) Duesseldorf and RHIO Research InstituteRheumazentrum Ruhrgebiet, Ruhr University BochumRheumatology and Osteology PracticeRheumahaus Potsdam GbRAbbVie CanadaAbbVie CanadaAbbVie Deutschland GmbH and Co. KGAbbVie Deutschland GmbH and Co. KGAbbVie Deutschland GmbH and Co. KGGroupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO)Department of Internal Medicine 3-Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg and Universitätsklinikum ErlangenAbstract Introduction Our aim was to investigate the efficacy and safety of upadacitinib (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis (PsA) using routine clinical practice data from an observational, prospective, multicentre study. Methods This interim analysis contains upadacitinib efficacy and safety data from the UPJOINT study, collected from baseline to the week 24 visit with a focus on composite measures, clinical assessments and patient-reported outcomes, amongst others, including minimal disease activity (MDA), very low disease activity (VLDA), Disease Activity Index for Psoriatic Arthritis (DAPSA), Leeds Enthesitis Index (LEI), resolution of dactylitis and nail psoriasis and body surface area affected by skin psoriasis (BSA). Results A total of 296 patients with baseline data and 192 with completed week 24 visits were included in the analysis. The proportion of patients achieving MDA increased from 2.7% at baseline to 39.1% at week 24 (95% CI 32.1, 46.3). Similarly, the number of patients in DAPSA remission (DAPSA ≤ 4) increased from 0 at baseline to 32 (16.7%) by week 24. At that time, 59.4% of the patients were either in DAPSA remission or had low disease activity (DAPSA ≤ 14). During the 24 weeks time frame, the proportion of patients with BSA ≤ 3 increased from 80.7% to 91.1%. Furthermore, at weeks 12 and 24, 45.14% and 47.19% of affected patients showed a resolution of enthesitis. Active dactylitis and nail psoriasis at baseline were reported to affect 10.5% and 22.0%, decreasing to 2.6% and 5.7% at week 24, respectively. The safety findings are consistent with the known safety profile of upadacitinib in rheumatoid arthritis and PsA; no new safety risks were identified. Conclusion The data from this study confirm the findings of previous randomized controlled trials suggesting UPA is an effective treatment for active PsA without any new safety signals in patients from daily clinical practice. Clinical Trial Registration ClinicalTrials.gov identifier, NCT04758117.https://doi.org/10.1007/s40744-023-00589-3UpadacitinibPsoriatic arthritisEfficacySafetyMinimal disease activityVery low disease activity
spellingShingle Stephanie G. Werner
Xenofon Baraliakos
Sabine Reckert
Martin Bohl-Bühler
Marie-Claude Laliberté
Tanya Girard
Katharina Jeromin
Nikola Baschuk
Björn Fritz
Louis Bessette
Axel J. Hueber
Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
Rheumatology and Therapy
Upadacitinib
Psoriatic arthritis
Efficacy
Safety
Minimal disease activity
Very low disease activity
title Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
title_full Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
title_fullStr Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
title_full_unstemmed Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
title_short Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
title_sort treatment with upadacitinib in active psoriatic arthritis efficacy and safety data of the first 192 patients from the upjoint study a multicentre observational study in clinical practice
topic Upadacitinib
Psoriatic arthritis
Efficacy
Safety
Minimal disease activity
Very low disease activity
url https://doi.org/10.1007/s40744-023-00589-3
work_keys_str_mv AT stephaniegwerner treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT xenofonbaraliakos treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT sabinereckert treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT martinbohlbuhler treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT marieclaudelaliberte treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT tanyagirard treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT katharinajeromin treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT nikolabaschuk treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT bjornfritz treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT louisbessette treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice
AT axeljhueber treatmentwithupadacitinibinactivepsoriaticarthritisefficacyandsafetydataofthefirst192patientsfromtheupjointstudyamulticentreobservationalstudyinclinicalpractice