PMID- 31791386 OWN - NLM STAT- MEDLINE DCOM- 20200909 LR - 20231020 IS - 1478-6362 (Electronic) IS - 1478-6354 (Print) IS - 1478-6354 (Linking) VI - 21 IP - 1 DP - 2019 Dec 2 TI - 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. PG - 263 LID - 10.1186/s13075-019-2059-8 [doi] LID - 263 AB - 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. FAU - Strand, Vibeke AU - Strand V AD - Stanford University, 306 Ramona Road, Portola Valley, CA, 94028, USA. FAU - Schiff, Michael AU - Schiff M AD - University of Colorado School of Medicine, Denver, CO, 80045, USA. FAU - Tundia, Namita AU - Tundia N AD - AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. namita.tundia@abbvie.com. FAU - Friedman, Alan AU - Friedman A AD - AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. FAU - Meerwein, Sebastian AU - Meerwein S AD - AbbVie Deutschland GmbH & Co., KG, Mainzer Strasse 81, 65189, Wiesbaden, Germany. FAU - Pangan, Aileen AU - Pangan A AD - AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. FAU - Ganguli, Arijit AU - Ganguli A AD - AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. FAU - Fuldeore, Mahesh AU - Fuldeore M AD - AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. FAU - Song, Yan AU - Song Y AD - Analysis Group Inc., 14th Floor, 111 Huntington Avenue, Boston, MA, 02199, USA. FAU - Pope, Janet AU - Pope J AD - University of Western Ontario, St. Joseph's Health Care, 268 Grosvenor Street, London, ON, N6A 4V2, Canada. LA - eng SI - ClinicalTrials.gov/NCT02706847 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20191202 PL - England TA - Arthritis Res Ther JT - Arthritis research & therapy JID - 101154438 RN - 0 (Antirheumatic Agents) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 4RA0KN46E0 (upadacitinib) SB - IM MH - Aged MH - Antirheumatic Agents/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Female MH - Heterocyclic Compounds, 3-Ring/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Patient Reported Outcome Measures MH - Quality of Life MH - Treatment Outcome PMC - PMC6889334 OTO - NOTNLM OT - Fatigue OT - HAQ OT - JAK inhibitor OT - MCID OT - Pain OT - Patient-reported outcome measures OT - Quality of life OT - Rheumatoid arthritis OT - SF-36 OT - Treatment outcomes OT - Upadacitinib COIS- VS is a consultant for AbbVie, Amgen, AstraZeneca, BMS, Celgene, Genentech, GSK, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB, and is involved in advisory boards for AbbVie, Amgen, AstraZeneca, BMS, Celgene, Genentech, GSK, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB. MS is a consultant for AbbVie, BMS, Eli Lilly, JNJ, and UCB, and is a member of the speaker bureau for AbbVie and BMS. JP is a consultant for AbbVie, Amgen, BMS, Celltrion, GSK, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Sandoz, and UCB. NT, AF, SM, AP, and MF are employees of AbbVie and may own AbbVie stock or stock options. AG is a former employee of AbbVie and may own AbbVie stock or stock options. YS is an employee of Analysis Group Inc., which received consulting fees from AbbVie for this study. EDAT- 2019/12/04 06:00 MHDA- 2020/09/10 06:00 PMCR- 2019/12/02 CRDT- 2019/12/04 06:00 PHST- 2019/05/17 00:00 [received] PHST- 2019/11/08 00:00 [accepted] PHST- 2019/12/04 06:00 [entrez] PHST- 2019/12/04 06:00 [pubmed] PHST- 2020/09/10 06:00 [medline] PHST- 2019/12/02 00:00 [pmc-release] AID - 10.1186/s13075-019-2059-8 [pii] AID - 2059 [pii] AID - 10.1186/s13075-019-2059-8 [doi] PST - epublish SO - Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.