Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE.

Autor:	Strand V; Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA., Tundia N; AbbVie Inc, North Chicago, IL., Bergman M; Drexel University College of Medicine, Philadelphia, PA, USA., Ostor A; Cabrini Medical Centre, Monash University, Melbourne, Australia., Durez P; Rheumatology, Cliniques Universitaires Saint-Luc-Université Catholique de Louvain-Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium., Song IH; AbbVie Inc, North Chicago, IL., Enejosa J; AbbVie Inc, North Chicago, IL., Schlacher C; AbbVie Inc, North Chicago, IL., Song Y; Analysis Group, Inc, Boston, MA., Fleischmann R; University of Texas Southwestern Medical Center, MCRC, Dallas, TX, USA.
Jazyk:	angličtina
Zdroj:	Rheumatology (Oxford, England) [Rheumatology (Oxford)] 2021 Dec 01; Vol. 60 (12), pp. 5583-5594.
DOI:	10.1093/rheumatology/keab158
Abstrakt:	Objective: To evaluate the impact of upadacitinib vs placebo and adalimumab treatment, on patient-reported outcomes (PROs) in SELECT-COMPARE in an active RA population with inadequate responses to MTX (MTX-IR). Methods: PROs in patients receiving upadacitinib (15 mg QD), placebo, or adalimumab (40 mg EOW) while on background MTX were evaluated over 48 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA) and pain by visual analogue scale (VAS), the HAQ Disability Index (HAQ-DI), the 36-Item Short Form Survey (SF-36), morning (AM) stiffness duration and severity, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and work instability. Least squares mean (LSM) changes and proportions of patients reporting improvements ≥ minimal clinically important differences (MCIDs) and scores ≥ normative values were evaluated. Results: Upadacitinib and adalimumab resulted in greater LSM changes from baseline vs placebo across all PROs (P < 0.05) at week 12, and pain and AM stiffness severity (P < 0.05) at week 2. More upadacitinib- vs placebo-treated (P < 0.05) and similar percentages of upadacitinib- vs adalimumab-treated patients reported improvements ≥ MCID across all PROs at week 12. Upadacitinib vs adalimumab resulted in greater LSM changes from baseline in PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and the SF-36 Physical Component Summary (PCS) (all P < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients reported scores ≥ normative values in HAQ-DI and SF-36 PCS (P < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients maintained clinically meaningful improvements in PtGA, pain, HAQ-DI, FACIT-F, and AM stiffness through 48 weeks. Conclusion: In MTX-IR patients with RA, treatment with upadacitinib resulted in statistically significant and clinically meaningful improvements in PROs equivalent to or greater than with adalimumab. Trial Registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02629159. (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
Databáze:	MEDLINE
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