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

• Published in: Arthritis research & therapy Vol. 21; no. 1; pp. 263 - 10
• Main Authors: Strand, Vibeke, Schiff, Michael, Tundia, Namita, Friedman, Alan, Meerwein, Sebastian, Pangan, Aileen, Ganguli, Arijit, Fuldeore, Mahesh, Song, Yan, Pope, Janet
• Format: Journal Article
• Language: English
• Published: England BioMed Central 02.12.2019; BMC
• Subjects: Arthritis; Health surveys; Insomnia; JAK inhibitor; Mental health; Pain; Patient-reported outcome measures; Patients; Population; Quality of life; Questionnaires; Rheumatoid arthritis; Treatment outcomes; Upadacitinib; Values; United States > US; Pain; MCID; Patient-reported outcome measures; Rheumatoid arthritis; Treatment outcomes; Fatigue; HAQ; JAK inhibitor; Upadacitinib; Quality of life; SF-36
• ISSN: 1478-6362; 1478-6354; 1478-6362
• DOI: 10.1186/s13075-019-2059-8

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