PMID- 37728861 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240516 IS - 2198-6576 (Print) IS - 2198-6584 (Electronic) IS - 2198-6576 (Linking) VI - 10 IP - 6 DP - 2023 Dec TI - A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis. PG - 1519-1533 LID - 10.1007/s40744-023-00594-6 [doi] AB - INTRODUCTION: The impact of upadacitinib on rheumatoid arthritis (RA) symptoms was evaluated during the first 12 weeks of treatment via patient-reported outcomes (PROs) using a mobile health application (app). METHODS: Participating rheumatologists from the CorEvitas RA Registry (prospective, observational cohort) recruited patients with RA initiating upadacitinib treatment. A modified version of the ArthritisPower(R) app was used to collect PROs, including the Routine Assessment of Patient Index Data 3 (RAPID3), duration of morning joint stiffness, and the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue 7a Short Form at baseline and weeks 1-4, 8, and 12. RAPID3 responses over time were assessed using Kaplan-Meier estimation to determine the proportion of patients achieving disease activity improvement and minimal clinically important difference (MCID). Results were analyzed for all patients initiating upadacitinib and a subsample of TNF inhibitor (TNFi)-experienced patients with moderate to severe disease at baseline. RESULTS: A total of 103 patients with RA initiating upadacitinib (62.1% TNFi-experienced) were included. At week 12, 53 patients (51.4%) completed the study and provided PRO data via the app. Among all patients, improvements in RAPID3, pain, morning stiffness, and fatigue were observed at week 1 and were maintained or further improved through week 12. At week 12, 37.5% of patients achieved RAPID3 low disease activity. Starting at week 1, improvements in RAPID3 disease activity category (19.4% of patients) and achievement of MCID (16.3%) were reported, with nearly 50% of patients achieving these outcomes by week 4 (RAPID3 category: 48.8%; MCID: 49.2%) and 60% by week 12 (RAPID3 category: 59.6%; MCID: 59.8%). TNFi-experienced patients generally reported similar outcomes. Patient-reported medication convenience and compliance were generally high. CONCLUSIONS: In this real-world cohort of patients with RA, treatment with upadacitinib was associated with early and significant improvement in RAPID3, pain, morning stiffness, and fatigue regardless of prior TNFi experience. Clinically meaningful improvement in RAPID3 patient-reported disease activity was observed as early as week 1, with continued improvement reported through week 12. CI - (c) 2023. The Author(s). FAU - Harrold, Leslie R AU - Harrold LR AUID- ORCID: 0000-0002-0170-2747 AD - CorEvitas, LLC, 300 5th Avenue, Waltham, MA, 02451, USA. lharrold@corevitas.com. AD - University of Massachusetts Medical School, Worcester, MA, USA. lharrold@corevitas.com. FAU - Zueger, Patrick AU - Zueger P AD - AbbVie Inc., North Chicago, IL, USA. FAU - Nowell, W Benjamin AU - Nowell WB AD - Global Healthy Living Foundation, Upper Nyack, NY, USA. FAU - Blachley, Taylor AU - Blachley T AD - CorEvitas, LLC, 300 5th Avenue, Waltham, MA, 02451, USA. FAU - Schrader, Amy AU - Schrader A AD - CorEvitas, LLC, 300 5th Avenue, Waltham, MA, 02451, USA. FAU - Lakin, Paul R AU - Lakin PR AD - CorEvitas, LLC, 300 5th Avenue, Waltham, MA, 02451, USA. FAU - Curtis, David AU - Curtis D AD - Global Healthy Living Foundation, Upper Nyack, NY, USA. FAU - Stradford, Laura AU - Stradford L AD - Global Healthy Living Foundation, Upper Nyack, NY, USA. FAU - Venkatachalam, Shilpa AU - Venkatachalam S AD - Global Healthy Living Foundation, Upper Nyack, NY, USA. FAU - Tundia, Namita AU - Tundia N AD - AbbVie Inc., North Chicago, IL, USA. FAU - Patel, Pankaj A AU - Patel PA AD - AbbVie Inc., North Chicago, IL, USA. LA - eng PT - Journal Article DEP - 20230920 PL - England TA - Rheumatol Ther JT - Rheumatology and therapy JID - 101674543 PMC - PMC10654297 OTO - NOTNLM OT - CorEvitas OT - Digital health OT - Janus kinase (JAK) inhibitor OT - Observational OT - Patient-reported outcomes OT - Prospective OT - Real-world effectiveness OT - Rheumatoid arthritis OT - Routine Assessment of Patient Index Data 3 (RAPID3) OT - Upadacitinib COIS- Financial arrangements of the authors with companies whose products may be related to the present manuscript are listed, as declared by the authors. Leslie R. Harrold: Employee and shareholder of CorEvitas, consultant to AbbVie, Bristol Myers Squibb, and Roche, speaker's bureau for Bristol Myers Squibb. Patrick Zueger: Employee of AbbVie and may hold stock or stock options. W. Benjamin Nowell: Employee of Global Healthy Living Foundation, an independent nonprofit research organization, principal investigator for studies with grant support from AbbVie, Amgen, Janssen, and Scipher Medicine. Taylor Blachley: Former employee of CorEvitas; current employee of Syneos Health. Amy Schrader: Employee of CorEvitas. Paul R. Lakin: Employee of CorEvitas. David Curtis: Employee of Global Healthy Living Foundation, an independent nonprofit research organization. Laura Stradford: Employee of Global Healthy Living Foundation, an independent nonprofit research organization. Shilpa Venkatachalam: Employee of Global Healthy Living Foundation, an independent nonprofit research organization. Namita Tundia: Former employee of AbbVie and may hold stock or stock options; current employee of EMD Serono. Pankaj A. Patel: Employee of AbbVie and may hold stock or stock options. EDAT- 2023/09/20 12:51 MHDA- 2023/09/20 12:52 PMCR- 2023/09/20 CRDT- 2023/09/20 11:34 PHST- 2023/06/21 00:00 [received] PHST- 2023/08/18 00:00 [accepted] PHST- 2023/09/20 12:52 [medline] PHST- 2023/09/20 12:51 [pubmed] PHST- 2023/09/20 11:34 [entrez] PHST- 2023/09/20 00:00 [pmc-release] AID - 10.1007/s40744-023-00594-6 [pii] AID - 594 [pii] AID - 10.1007/s40744-023-00594-6 [doi] PST - ppublish SO - Rheumatol Ther. 2023 Dec;10(6):1519-1533. doi: 10.1007/s40744-023-00594-6. Epub 2023 Sep 20.