• Vibeke Strand, Namita Tundia, Martin Bergman, Andrew Ostor, Patrick Durez, In-Ho Song, Jeffrey Enejosa, Casey Schlacher, Yan Song, and Roy Fleischmann.
• Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
• Rheumatology (Oxford). 2021 Feb 16.

ObjectiveTo 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 methotrexate (MTX-IR).MethodsPROs in patients receiving upadacitinib (15 mg QD), placebo, or adalimumab (40 mg EOW) while on background MTX were evaluated over 48 weeks. PROs included PtGA and pain by VAS, HAQ-DI, 36-Item Short Form Survey (SF-36), morning (AM) stiffness duration and severity, FACIT-F, and work instability. Least squares mean (LSM) changes and proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) and scores ≥ normative values were evaluated.ResultsUpadacitinib 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 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.ConclusionIn 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.© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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