Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec;10(6):1519-1533.
doi: 10.1007/s40744-023-00594-6. Epub 2023 Sep 20.

A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis

Leslie R Harrold  1   2 , Patrick Zueger  3 , W Benjamin Nowell  4 , Taylor Blachley  5 , Amy Schrader  5 , Paul R Lakin  5 , David Curtis  4 , Laura Stradford  4 , Shilpa Venkatachalam  4 , Namita Tundia  3 , Pankaj A Patel  3
Affiliations

A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis

Leslie R Harrold et al. Rheumatol Ther. 2023 Dec.

Abstract

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® 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.

Keywords: CorEvitas; Digital health; Janus kinase (JAK) inhibitor; Observational; Patient-reported outcomes; Prospective; Real-world effectiveness; Rheumatoid arthritis; Routine Assessment of Patient Index Data 3 (RAPID3); Upadacitinib.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Patient disposition. TNFi tumor necrosis factor inhibitor
Fig. 2
Fig. 2
RAPID3 in all patients and TNFi-experienced patients treated with upadacitinib over time. A Mean change from baseline in RAPID3 (0–30). B Mean change from baseline in pain (VAS 0–10). C Proportion of patients achieving RAPID3 LDA (defined as RAPID3 ≤ 6) among patients with moderate-to-high disease (RAPID3 > 6) at baseline. For all figures, patients with data available at each respective timepoint are shown. *P < 0.05 for all patients, and #P < 0.05 for TNFi-experienced patients, indicates a statistically significant difference between baseline and follow-up values based on paired t test for continuous outcomes. CI confidence interval, LDA low disease activity, RAPID3 Routine Assessment of Patient Index Data 3, TNFi tumor necrosis factor inhibitor, VAS visual analogue scale
Fig. 3
Fig. 3
Morning stiffness and fatigue in all patients and TNFi-experienced patients treated with upadacitinib over time. A Mean change from baseline in morning stiffness duration (hours) was calculated among patients reporting morning stiffness at baseline. B Mean change from baseline in PROMIS-Fatigue 7a SF (29.4–83.2), where higher scores indicate greater fatigue. For both figures, patients with data available at each respective timepoint are shown. *P < 0.05 for all patients, and #P < 0.05 for TNFi-experienced patients, indicates a statistically significant difference between baseline and follow-up values based on paired t test for continuous outcomes. CI confidence interval, PROMIS-Fatigue 7a SF Patient-Reported Outcomes Measurement Information System–Fatigue 7a Short Form, TNFi tumor necrosis factor inhibitor
Fig. 4
Fig. 4
Kaplan–Meier estimation of RAPID3 responses in all patients and TNFi-experienced patients treated with upadacitinib over time. A Proportion of patients achieving RAPID3 improvement in disease category (defined as a reduction of at least one category). B Proportion of patients achieving RAPID3 MCID (defined as a decrease in RAPID3 ≥ 3.8). For both figures, patients were censored if they withdrew from the study without achieving improvement in disease activity category or MCID, or they completed the 12-week study without achieving improvement. Patients were censored at the time of their last follow-up encounter. CI confidence interval, MCID minimal clinically important difference, RAPID3 Routine Assessment of Patient Index Data 3, TNFi tumor necrosis factor inhibitor
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Harrold L, Zueger P, Nowell WB, Blachley T, Lakin P, Curtis D, et al. Early real-world effectiveness of upadacitinib in rheumatoid arthritis using patient-reported outcomes collected via mobile application [abstract]. Arthritis Rheumatol. 2022;74(suppl 9):2656–58.
    1. Burmester GR, Pope JE. Novel treatment strategies in rheumatoid arthritis. Lancet. 2017;389:2338–2348. doi: 10.1016/S0140-6736(17)31491-5. - DOI - PubMed
    1. Curtis JR, Singh JA. Use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther. 2011;33:679–707. doi: 10.1016/j.clinthera.2011.05.044. - DOI - PMC - PubMed
    1. Lin YJ, Anzaghe M, Schulke S. Update on the pathomechanism, diagnosis, and treatment options for rheumatoid arthritis. Cells. 2020;9:880. doi: 10.3390/cells9040880. - DOI - PMC - PubMed
    1. Kalden JR, Schulze-Koops H. Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment. Nat Rev Rheumatol. 2017;13:707–718. doi: 10.1038/nrrheum.2017.187. - DOI - PubMed

LinkOut - more resources