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

Author

Rheumatology (Oxford). 2020 Dec 11;keaa770. doi: 10.1093/rheumatology/keaa770.Online ahead of print.

Vibeke Strand 1, Namita Tundia 2, Alvin Wells 3, Maya H Buch 4 5, Sebastiao C Radominski 6, Heidi S Camp 7, Alan Friedman 7, Jessica L Suboticki 8, Kendall Dunlap 8, Debbie Goldschmidt 9, Martin Bergman 10

Author Information

1 Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.

2 HEOR Immunology, AbbVie Inc., North Chicago, IL, USA.

3 Aurora Rheumatology and Immunotherapy Center, Franklin, WI, USA.

4 Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UK.

5 NIHR Manchester Biomedical Research Centre, Manchester University Foundation Trust, Manchester, UK.

6 Universidade Federal do Paraná, Curitiba, Brazil.

7 Clinical Immunology, AbbVie Inc., North Chicago, IL, USA.

8 US Medical Affairs, AbbVie Inc., North Chicago, IL, USA.

9 Analysis Group Inc., New York, NY, USA.

10 Department of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA.

Abstract

Objective: To evaluate the effect of upadacitinib (UPA) monotherapy vs MTX on patient-reported outcomes (PROs) in patients with RA who were MTX-naïve 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 ≥18 years of age with RA symptoms for ≥6 weeks (SELECT-EARLY, MTX-naïve) or diagnosed RA for ≥3 months (SELECT-MONOTHERAPY, MTX-IR) and received UPA monotherapy (15 or 30 mg) 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-naïve and 648 MTX-IR patients, UPA monotherapy (15 mg, 30 mg) 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-naïve 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-naïve and MTX-IR patients with active RA, UPA monotherapy at 15 or 30 mg for 12/14 weeks resulted in statistically significant and clinically meaningful improvements in pain, physical function, morning stiffness, HRQOL and WPAI compared with MTX alone.

Clinical trial registration number: SELECT-EARLY (NCT02706873) and SELECT-MONOTHERAPY (NCT02706951) are registered with ClinicalTrials.gov.