Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2

Autor:	A. Lertratanakul, R. Lippe, Roberto Ranza, P. Zueger, Christopher D. Saffore, Filip Van den Bosch, Ying Ying Leung, Peter Nash, Vibeke Strand, Edit Drescher
Rok vydání:	2021
Předmět:	Quality of life Work productivity medicine.medical_specialty PHASE-3 MULTICENTER Pain IMPROVEMENT Disease Physical function PROFILE Placebo RECOMMENDATIONS law.invention DOUBLE-BLIND Psoriatic arthritis Rheumatology Randomized controlled trial law Internal medicine Psoriasis Medicine and Health Sciences medicine Immunology and Allergy Biologic disease-modifying anti-rheumatic drugs Original Research Patient-reported outcomes business.industry Minimal clinically important difference Biology and Life Sciences medicine.disease humanities Activity NORMATIVE VALUES Upadacitinib HEALTH-ASSESSMENT QUESTIONNAIRE TRIAL BURDEN business
Zdroj:	RHEUMATOLOGY AND THERAPY Rheumatology and Therapy
ISSN:	2198-6584 2198-6576
Popis:	Introduction Psoriatic arthritis (PsA) has a major impact on health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), important components in the assessment of therapeutic efficacy. We evaluated the impact of upadacitinib on PROs in PsA patients with inadequate responses or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARD-IR). Methods Patients enrolled in the phase 3 SELECT-PsA 2 randomized controlled trial (RCT) received 56 weeks of oral upadacitinib 15 mg QD, upadacitinib 30 mg QD, or placebo switched to either dose of upadacitinib at week 24. PROs included patient global assessment of disease activity (PtGA), pain, physical function (HAQ-DI), health-related quality of life (SF-36 physical (PCS) and mental (MCS) component summary and domain scores), fatigue (FACIT-F), psoriasis symptom severity (SAPS), and work productivity (WPAI). Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values, and maintenance of improvements were assessed. Results At weeks 12 and 24, patients treated with either upadacitinib dose reported statistically and nominally significant improvements from baseline across all PROs versus placebo (p ≤ 0.05), except the WPAI absenteeism domain, which were maintained or further improved to week 56. A significantly greater proportion of patients receiving either upadacitinib dose reported improvements ≥ MCID and scores ≥ normative values versus placebo (nominal p ≤ 0.01) in most PROs at weeks 12 and 24, with clinically meaningful improvements continuing to week 56. Improvements ≥ MCID were reported as early as week 2 in PtGA, pain, and HAQ-DI. Conclusions Upadacitinib provides rapid, clinically meaningful, and sustained improvements in PROs reported by bDMARD-IR PsA patients. SELECT-PsA 2 ClinicalTrials.gov number, NCT03104374. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00377-x.
Databáze:	OpenAIRE
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