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Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2
- Source :
- RHEUMATOLOGY AND THERAPY, Rheumatology and Therapy
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- ISSN :
- 21986584 and 21986576
- Volume :
- 8
- Database :
- OpenAIRE
- Journal :
- Rheumatology and Therapy
- Accession number :
- edsair.doi.dedup.....dd062b55d6c7a3b39e42d5fd87734598