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Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study
P. Mease1, A. Setty2, K. Papp3, F. Van Den Bosch4, S. Tsuji5, M. Keiserman6, K. Carter7, Y. Li8, R. Mccaskill9, E. Mcdearmon-Blondell10, P. Wung11, W. Tillett12
- Swedish Medical Center/Providence St. Joseph Health and University of Washington, Rheumatology Research, Seattle, WA, USA. pmease@philipmease.com
- AbbVie Inc, North Chicago, IL, USA.
- Alliance Clinical Trials and Probity Medical Research, Waterloo, ON, Canada.
- Department of Internal Medicine and Paediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium.
- Department of Orthopaedics, Rheumatology and Psoriasis Center, Nippon Life Hospital, Osaka, Japan.
- Rheumatology Section, Pontifical Catholic University, School of Medicine, Porto Alegre, Brazil.
- AbbVie Inc, North Chicago, IL, USA.
- AbbVie Inc, North Chicago, IL, USA.
- AbbVie Inc, North Chicago, IL, USA.
- AbbVie Inc, North Chicago, IL, USA.
- AbbVie Inc, North Chicago, IL, USA.
- Department of Life Sciences, Centre for Therapeutic Innovation and Institute for Mathematical Innovation, University of Bath, UK.
CER16619
2023 Vol.41, N°11
PI 2286, PF 2297
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PMID: 37404160 [PubMed]
Received: 23/02/2023
Accepted : 12/06/2023
In Press: 05/07/2023
Published: 14/11/2023
Abstract
OBJECTIVES:
To assess the long-term safety and efficacy of upadacitinib in patients with psoriatic arthritis (PsA) and an inadequate response (IR) to biologic disease-modifying anti-rheumatic drugs (bDMARDs) who completed up to 152 weeks of treatment in the SELECT-PsA 2 study (ClinicalTrials.gov: NCT03104374).
METHODS:
Patients were randomised to receive blinded upadacitinib 15 or 30 mg once daily (QD), or placebo for 24 weeks followed by upadacitinib 15 or 30 mg QD. After 56 weeks, patients were eligible to enter an open-label extension (OLE) in which they continued their assigned dose of upadacitinib. Efficacy and safety were assessed through 152 weeks. A subanalysis of patients with IR to tumour necrosis factor inhibitors (TNFis) was also conducted.
RESULTS:
In total, 450 patients entered the OLE and 358 completed 152 weeks of treatment. Improvements in efficacy outcomes observed at week 56, including the proportion of patients achieving: 20/50/70% improvement in American College of Rheumatology criteria, minimal disease activity, and 75/90/100% improvement in Psoriasis Area and Severity Index, were maintained through week 152. Efficacy outcomes in the TNFi-IR subgroup were similar to those reported in the overall population. Upadacitinib was well tolerated throughout long-term treatment, with no cumulative adverse effects observed through 152 weeks.
CONCLUSIONS:
Efficacy of upadacitinib was maintained up to 152 weeks of treatment in this highly treatment-refractory population of patients with PsA. The long-term safety profile of upadacitinib 15 mg was consistent with its known safety profile across indications; no new safety signals were identified.
