PMID- 35751108 OWN - NLM STAT- MEDLINE DCOM- 20220628 LR - 20221104 IS - 1478-6362 (Electronic) IS - 1478-6354 (Print) IS - 1478-6354 (Linking) VI - 24 IP - 1 DP - 2022 Jun 24 TI - Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial. PG - 155 LID - 10.1186/s13075-022-02813-x [doi] LID - 155 AB - BACKGROUND: In previous clinical trials, patients with active rheumatoid arthritis (RA) treated with upadacitinib (UPA) have improved patient-reported outcomes (PROs). This post hoc analysis of SELECT-CHOICE, a phase 3 clinical trial, evaluated the impact of UPA vs abatacept (ABA) with background conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on PROs in patients with RA with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARD-IR). METHODS: Patients in SELECT-CHOICE received UPA (oral 15 mg/day) or ABA (intravenous). PROs evaluated included Patient Global Assessment of Disease Activity (PtGA) by visual analog scale (VAS), patient's assessment of pain by VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), morning stiffness duration and severity, 36-Item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Impairment (WPAI), and EQ-5D 5-Level (EQ-5D-5L) index score. Least squares mean (LSM) changes from baseline to weeks 12 and 24 were based on an analysis of covariance model. Proportions of patients reporting improvements >/= minimal clinically important differences (MCID) were compared using chi-square tests. RESULTS: Data from 612 patients were analyzed (UPA, n=303; ABA, n=309). Mean age was 56 years and mean disease duration was 12 years. One-third received >/=2 prior bDMARDs and 72% received concomitant methotrexate at baseline. At week 12, UPA- vs ABA-treated patients had significantly greater improvements in PtGA, pain, HAQ-DI, morning stiffness severity, EQ-5D-5L, 2/4 WPAI domains, and 3/8 SF-36 domains and Physical Component Summary (PCS) scores (P<0.05); significant differences persisted at week 24 for HAQ-DI, morning stiffness severity, SF-36 PCS and bodily pain domain, and WPAI activity impairment domain. At week 12, significantly more UPA- vs ABA-treated patients reported improvements >/=MCID in HAQ-DI (74% vs 64%) and SF-36 PCS (79% vs 66%) and 4/8 domain scores (P<0.05). CONCLUSIONS: At week 12, UPA vs ABA treatment elicited greater improvements in key domains of physical functioning, pain, and general health and earlier improvements in HAQ-DI. Overall, more UPA- vs ABA-treated patients achieved >/=MCID in most PROs at all timepoints; however, not all differences were statistically significant. These data, however, highlight the faster response to UPA treatment. TRIAL REGISTRATION: NCT03086343 , March 22, 2017. CI - (c) 2022. The Author(s). FAU - Bergman, Martin AU - Bergman M AD - Drexel University College of Medicine, Philadelphia, PA, USA. FAU - Tundia, Namita AU - Tundia N AD - AbbVie Inc., North Chicago, IL, USA. FAU - Martin, Naomi AU - Martin N AD - AbbVie Inc., North Chicago, IL, USA. FAU - Suboticki, Jessica L AU - Suboticki JL AD - AbbVie Inc., North Chicago, IL, USA. FAU - Patel, Jayeshkumar AU - Patel J AD - AbbVie Inc., North Chicago, IL, USA. FAU - Goldschmidt, Debbie AU - Goldschmidt D AD - Analysis Group, Inc., Boston, MA, USA. FAU - Song, Yan AU - Song Y AD - Analysis Group, Inc., Boston, MA, USA. Yan.Song@analysisgroup.com. FAU - Wright, Grace C AU - Wright GC AD - Grace C Wright MD PC; Association of Women in Rheumatology; United Rheumatology, New York, NY, USA. LA - eng SI - ClinicalTrials.gov/NCT03086343 PT - Clinical Trial, Phase III PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220624 PL - England TA - Arthritis Res Ther JT - Arthritis research & therapy JID - 101154438 RN - 0 (Antirheumatic Agents) RN - 0 (Biological Products) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 4RA0KN46E0 (upadacitinib) RN - 7D0YB67S97 (Abatacept) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM EIN - Arthritis Res Ther. 2022 Nov 3;24(1):248. PMID: 36329507 MH - Abatacept/therapeutic use MH - *Antirheumatic Agents MH - *Arthritis, Rheumatoid/complications/drug therapy MH - *Biological Products/therapeutic use MH - Double-Blind Method MH - Heterocyclic Compounds, 3-Ring MH - Humans MH - Methotrexate/therapeutic use MH - Middle Aged MH - Pain/drug therapy MH - Patient Reported Outcome Measures MH - Quality of Life MH - Treatment Outcome PMC - PMC9229430 OTO - NOTNLM OT - JAK inhibitors OT - Patient-reported outcomes OT - Rheumatoid arthritis OT - Targeted synthetic DMARDs OT - Upadacitinib COIS- MB is a consultant/speaker for AbbVie, Amgen, BMS, Genentech/Roche, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz, and Sanofi/Regeneron; and shareholder of Johnson & Johnson (parent company of Janssen). GCW has received speaker and consulting fees from AbbVie and BMS. NM, JLS, and JP are employees and stockholders of AbbVie. NT is a former employee of AbbVie and may hold stock. DG and YS are employees of Analysis Group, Inc., which received consulting fees from AbbVie for this study. EDAT- 2022/06/25 06:00 MHDA- 2022/06/29 06:00 PMCR- 2022/06/24 CRDT- 2022/06/24 23:41 PHST- 2021/07/19 00:00 [received] PHST- 2022/05/13 00:00 [accepted] PHST- 2022/06/24 23:41 [entrez] PHST- 2022/06/25 06:00 [pubmed] PHST- 2022/06/29 06:00 [medline] PHST- 2022/06/24 00:00 [pmc-release] AID - 10.1186/s13075-022-02813-x [pii] AID - 2813 [pii] AID - 10.1186/s13075-022-02813-x [doi] PST - epublish SO - Arthritis Res Ther. 2022 Jun 24;24(1):155. doi: 10.1186/s13075-022-02813-x.