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Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs

Author

Strand V1, Schiff M2, Tundia N3, Friedman A4, Meerwein S5, Pangan A4, Ganguli A4, Fuldeore M4, Song Y6, Pope J7. Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.

Author Information

1 Stanford University, 306 Ramona Road, Portola Valley, CA, 94028, USA.

2 University of Colorado School of Medicine, Denver, CO, 80045, USA.

3 AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. namita.tundia@abbvie.com.

4 AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.

5 AbbVie Deutschland GmbH & Co., KG, Mainzer Strasse 81, 65189, Wiesbaden, Germany.

6 Analysis Group Inc., 14th Floor, 111 Huntington Avenue, Boston, MA, 02199, USA.

7 University of Western Ontario, St. Joseph's Health Care, 268 Grosvenor Street, London, ON, N6A 4V2, Canada.

Abstract

BACKGROUND: 

Patient-reported outcomes (PROs) are important when evaluating treatment benefits in rheumatoid arthritis (RA). We compared upadacitinib, an oral, selective JAK-1 inhibitor, with placebo to assess clinically meaningful improvements in PROs in patients with RA who have had inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARD-IR).

METHODS: 

PRO responses between upadacitinib 15 mg or 30 mg and placebo were evaluated at week 12 from the SELECT-BEYOND trial. Improvement was determined by measuring Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), duration and severity of morning (AM) stiffness, and Insomnia Severity Index (ISI). Least squares mean changes and percentage of patients reporting improvements ≥ minimum clinically important differences (MCID) and scores greater than or equal to normative values were determined. The number needed to treat (NNT) to achieve clinically meaningful improvements was calculated.

RESULTS: 

In 498 patients, both upadacitinib doses resulted in statistically significant changes from baseline versus placebo in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 7 of 8 SF-36 domains (15 mg), 6 of 8 SF-36 domains (30 mg), and AM stiffness duration and severity. Compared with placebo, more upadacitinib-treated patients reported improvements ≥ MCID in PtGA, pain, HAQ-DI, SF-36 PCS, 7 of 8 SF-36 domains (15 mg), 5 of 8 SF-36 domains (30 mg), AM stiffness duration and severity, and ISI (30 mg) and scores ≥ normative values in HAQ-DI and SF-36 domains. Across most PROs, NNTs to achieve MCID with upadacitinib ranged from 4 to 7 patients.

CONCLUSIONS: 

In bDMARD-IR RA patients, upadacitinib (15 mg or 30 mg) improved multiple aspects of quality of life, and more patients reached clinically meaningful improvements approaching normative values compared with placebo.

TRIAL REGISTRATION: 

The trial is registered with ClinicalTrials.gov (NCT02706847), registered 6 March 2016.