Upadacitinib Provides Marked Improvements in Rheumatoid Arthritis Datapoints

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The results show improvements in RAPID3, pain, fatigue, and morning stiffness at weeks 8 and 12 among patients treated with upadacitinib.

Upadacitinib results in a number of improvements for patients with rheumatoid arthritis, including pain, fatigue, and morning stiffness.

A team, led by Leslie Harrold, CorEviitas, evaluated the impact of upadacitinib on patient-reported outcomes in patients with rheumatoid arthritis during the first 12 weeks of treatment using a mobile health application.

The data presented during the 2022 American College of Rheumatology (ACR) Convergence Meeting in Philadelphia.


There is not much known about how upadacitinib impacts rheumatoid arthritis during the initial weeks of therapy in real-world clinical practice.

In the study, participating rheumatologists from the CorEvitas RA Registry recruited patients across 17 sites between July 2020 and October 2021. Each patient initiated upadacitinib treatment during the study period.

The team used a modified version of the ArthritisPower app to collect patient-reported outcomes, including RAPID3, PROMIS Fatigue-7a Short Form, and duration of morning joint stiffness data at baseline and weeks 1-4, 8, and 12.

They also summarized patient-reported outcomes as mean change from baseline for continuous outcomes (RAPID3 including pain, PROMIS Fatigue, duration of morning stiffness) and as proportion of patients achieving response RAPID3 low disease activity [LDA; defined as RAPID3 ≤ 6) for binary outcomes.

The team also assessed the treatment satisfaction questionnaire for medication TSQM-9; range: 0-100 for effectiveness, convenience, and overall satisfaction subscales) and compliance questionnaire for rheumatology (CQR; range: 0-20) were at weeks 8 and 12. The data was summarized as mean.

The investigators also assessed RAPID3 responses over time using Kaplan-Meier estimation to determine the proportion of patients achieving disease activity improvement defined as a reduction of at least 1 RAPID3 disease activity category and minimally clinically important difference, defined as a MCID decrease of ≥3.8.

The results were analyzed for all patients initiating upadacitinib treatment and for a subsample of TNF inhibitor (TNFi)-experienced patients with moderate to severe disease at baseline, defined as RAPID3 > 6.

The Patient Population

The study included 103 patients with rheumatoid arthritis initiating upadacitinib, 62.1% of which were TNFi-experienced. The mean age of the patient population at initiation was 59.9 years and 81.6% were female.

The mean RAPID3 was 14.9. Overall, 51.4% (n = 53) of the patient population completed the study and provided PRO data.

The results show improvements in RAPID3, pain, fatigue, and morning stiffness at weeks 8 and 12 among patients treated with upadacitinib.

Then at week 12, 37.5% of patients achieved RAPID3 LDA.

There were also improvements in RAPID3 disease activity and achievement of MCID starting at week 1, with approximately 50% of patients achieving these outcomes by week 4 and 60% achieving them by week 12.

They observed similar or slightly attenuated results in patients with prior TNFi experience.

Finally, the mean responses at week 12 for SQM-9 for the effectiveness subscale was 66.8, for convenience 83.6, and for overall satisfaction 68.5 for all patients treated with upadacitinib. The mean CQR at week 12 for all patients was 17.5.

“In this real-world cohort of RA patients, treatment with UPA was associated with improvement in RAPID3, pain, fatigue, and morning stiffness regardless of prior TNFi experience,” the authors wrote. “Improvement in RAPID3 patient-reported disease activity was observed as early as week 1, with continued improvement reported through week 12.”

The study, “Early Real-World Effectiveness of Upadacitinib in Rheumatoid Arthritis Using Patient-Reported Outcomes Collected via Mobile Application,” was published online by ACR Convergence.