Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

Mease, Philip J.; Lertratanakul, Apinya; Papp, Kim; Bosch, Filip E Van den; Tsuji, Shigeyoshi; Dokoupilová, Eva; Keiserman, Mauro Waldemar; Bu, X.; Chen, Liang; Mccaskill, R.; Zueger, Patrick; Mcdearmon-Blondell, E.; Pangan, Aileen L.; Tillett, William

doi:10.1007/s40744-021-00305-z

Cited by 49 publications

(60 citation statements)

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“…The safety and efficacy of upadacitinib for these indications were established in five pivotal clinical trials in RA [ 8 – 12 ], two in PsA [ 13 , 14 ], and one in ankylosing spondylitis [ 15 ]. Improvements in PsA disease activity and safety were demonstrated with upadacitinib through 56 weeks in the phase 3 SELECT-PsA 1 [ 16 ] and SELECT-PsA 2 trials [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

et al. 2021

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Introduction This integrated analysis describes the safety profile of upadacitinib, an oral Janus kinase inhibitor, at 15 and 30 mg once daily for up to 3 years of exposure in patients with active psoriatic arthritis (PsA) who had a prior inadequate response or intolerance to ≥ 1 non-biologic or biologic disease-modifying antirheumatic drug. Methods Safety data were pooled and analyzed from two randomized, placebo-controlled phase 3 trials. Both trials evaluated upadacitinib 15 mg and 30 mg once daily, and one trial also evaluated adalimumab 40 mg every other week. Treatment-emergent adverse events (TEAEs) and laboratory data were summarized for four groups: pooled placebo, pooled upadacitinib 15 mg, pooled upadacitinib 30 mg, and adalimumab. TEAEs were reported as exposure-adjusted event rates (events per 100 patient-years [E/100 PY]) up to a data cut-off of June 29, 2020. Results A total of 2257 patients received ≥ 1 dose of upadacitinib 15 mg ( N = 907) or 30 mg ( N = 921) for 2504.6 PY of exposure or adalimumab ( N = 429) for 549.7 PY of exposure. Upper respiratory tract infection, nasopharyngitis, and increased creatine phosphokinase (CPK) were the most common TEAEs with upadacitinib. Rates of malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs), and deaths were similar across treatment groups. Rates of herpes zoster (HZ) and opportunistic infections (OI; excluding tuberculosis, HZ, and oral candidiasis) were higher with upadacitinib versus adalimumab. Serious infection, anemia, and CPK elevations were most frequent with upadacitinib 30 mg. Potentially clinically significant laboratory abnormalities were uncommon. Conclusions Upadacitinib 15 mg and adalimumab had similar safety profiles with the exception of HZ and OIs, consistent with what was observed in rheumatoid arthritis. Rates of malignancies, MACEs, VTEs, and deaths were comparable among patients receiving upadacitinib and adalimumab. No new safety risks emerged with longer-term exposure to upadacitinib. Trial Registration Numbers SELECT-PsA 1: NCT03104400; SELECT-PsA 2: NCT03104374. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00410-z.

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Section: Introductionmentioning

confidence: 99%

Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

et al. 2021

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“…48 And finally, when patients respond poorly or are intolerant to all classes of biologicals, the switch to a targeted synthetic DMARD may be justified based on promising data reported for the JAK inhibitor upadacitinib. 48,65,66…”

Section: Treatmentmentioning

confidence: 99%

Psoriatic Spondylitis: A Disease Manifestation in Debate

Zeidler¹

2022

J Clin Rheumatol

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With the advent of classification criteria for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), patients with axial manifestations associated with psoriasis, initially described in the l950s as a specific entity termed psoriatic spondylitis (PS), are now categorized within PsA, ankylosing spondylitis (AS), and axSpA. Thus, different terms are used to describe axial disease in patients with PsA including PS, axial psoriatic arthritis (axPsA), and psoriatic spondyloarthritis. Patients with PS may present with inflammatory and/or mechanical back pain, but also may display axial disease on imaging despite not complaining of back pain. Cervical spondylitis has been reported in 35% to 75% of patients with PsA. Axial disease is silent in 20% and 25% of patients with axial PsA and PsA, respectively. The majority of axPsA patients have peripheral arthritis alongside the axial involvement, whereas only 2% to 5% of PsA patients have solely axial arthritis with no peripheral arthritis.A debate is currently underway as to whether inflammatory axial disease and psoriasis represent axSpA with psoriasis or a subset of PsA named axPsA. Studies have recognized that axial disease in PsA patients seems to be different demographically, genetically, clinically, and radiographically when compared with AS with or without psoriasis. This narrative review summarizes current knowledge regarding axial involvement of PsA in terms of history, terminology, classification, epidemiology, clinical presentation, imaging, diagnosis, and treatment, with the aim of providing advice for management of PS in clinical evidence-based practice. Data-driven studies are needed to develop clear, nonoverlapping classification criteria for spinal involvement in PsA.

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“…Upadacitinib (15 mg or 30 mg administered once daily [QD]) is being investigated for the treatment of patients with PsA and an inadequate response or intolerance to non-biologic and biologic disease-modifying antirheumatic drugs (nb/bDMARDs) in the phase 3 SELECT-PsA 1 and SELECT-PsA 2 studies, respectively. In both of these studies, upadacitinib was effective in improving the signs and symptoms of PsA, with responses maintained over 56 weeks of treatment [ 5 – 8 ]. In SELECT-PsA 1, upadacitinib 15 mg and 30 mg achieved non-inferiority versus adalimumab for American College of Rheumatology 20% response criteria at week 12 [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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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.

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Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

Cited by 49 publications

References 38 publications

Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

Psoriatic Spondylitis: A Disease Manifestation in Debate

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

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