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
| Autor: | Namita Tundia, Arijit Ganguli, Aileen L. Pangan, Michael Schiff, Mahesh Fuldeore, Janet E. Pope, Sebastian Meerwein, Yan Song, Vibeke Strand, Alan Friedman |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Quality of life medicine.medical_specialty lcsh:Diseases of the musculoskeletal system SF-36 Pain Placebo MCID law.invention Arthritis Rheumatoid Randomized controlled trial law Internal medicine medicine Humans Patient Reported Outcome Measures Rheumatoid arthritis Fatigue Aged business.industry Minimal clinically important difference Treatment outcomes Middle Aged HAQ medicine.disease Rheumatology humanities Treatment Outcome JAK inhibitor Antirheumatic Agents Patient-reported outcome measures Upadacitinib Number needed to treat Female lcsh:RC925-935 business Heterocyclic Compounds 3-Ring Research Article |
| Zdroj: | Arthritis Research & Therapy, Vol 21, Iss 1, Pp 1-10 (2019) Arthritis Research & Therapy |
| ISSN: | 1478-6362 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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