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Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY
Journal article   Open access

Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY

Vibeke Strand, Namita Tundia, Alvin Wells, Maya H. Buch, Sebastiao C. Radominski, Heidi S. Camp, Alan Friedman, Jessica L. Suboticki, Kendall Dunlap, Debbie Goldschmidt, …
Rheumatology (Oxford, England), v 60(7), pp 3209-3221
01 Jul 2021
DOI: https://doi.org/10.1093/rheumatology/keaa770
PMID: 33313898
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1093/rheumatology/keaa770View
Published, Version of Record (VoR)CC BY-NC V4.0,  Open

Abstract

Life Sciences & Biomedicine Rheumatology Science & Technology
Objective. To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naive or who had an inadequate response to MTX (MTX-IR). Methods. PROs from the SELECT-EARLY and SELECT-MONOTHERAPY randomized controlled trials were evaluated at Weeks 2 and 12/14. Patients were >= 18years of age with RA symptoms for >= 6weeks (SELECT-EARLY, MTX-naive) or diagnosed RA for >= 3months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30mg) or MTX. PROs included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration/severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (SELECT-EARLY), health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey and Work Productivity and Activity Impairment (WPAI; SELECT-EARLY). Least square mean (LSM) changes and proportions of patients reporting improvements greater than or equal to the minimum clinically important differences and normative values were determined. Results. In 945 MTX-naive and 648 MTX-IR patients, UPA monotherapy (15mg, 30mg) vs MTX resulted in greater reported LSM changes from baseline at Weeks 12/14 in PtGA, pain, HAQ-DI, morning stiffness duration/severity, FACIT-F (SELECT-EARLY), HRQOL and WPAI (SELECT-EARLY). These changes were statistically significant with both doses of UPA vs MTX at Weeks 12/14 in both RCTs. Improvements were reported as early as week 2. Compared with MTX, more UPA-treated MTX-naive and MTX-IR patients reported improvements greater than or equal to the minimum clinically important differences and scores greater than or equal to normative values. Conclusion. Among MTX-naive and MTX-IR patients with active RA, UPA monotherapy at 15 or 30mg for 12/14weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone.

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17 citations in Web of Science
15 citations in Scopus

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UN Sustainable Development Goals (SDGs)

This publication has contributed to the advancement of the following goals:

#3 Good Health and Well-Being

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Collaboration types
Industry collaboration
Domestic collaboration
International collaboration
Web of Science research areas
Rheumatology
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