Real-world clinical outcomes of patients with moderate-to-severe rheumatoid arthritis initiating upadacitinib in the United Kingdom: Final analysis from a prospective observational cohort study (ENDEAVOUR).

Objective: Upadacitinib is recommended by National Institute for Health and Care Excellence in the UK in adults with moderate-to-severe rheumatoid arthritis (RA). This observational study assessed real-world clinical outcomes and patient-reported outcomes (PROs) in patients receiving upadacitinib for 6 months in the UK.

Methods: Patients from 14 centres in whom the decision to initiate upadacitinib had already been made were enrolled. Baseline data were retrospectively collected from patient records. Clinician-reported data were collected at routine clinic visits 3 and 6 months after upadacitinib initiation. Patient-reported data were collected directly from patients using an app (electronic PROs, ePROs). The primary end-point was proportion of patients achieving clinical remission (DAS28 CRP <2.6) after 6 months of upadacitinib.

Results: Data are available for 63 patients at all three datapoints and for 53 patients for the primary end-point. At 6 months, 40% (21/53) of patients achieved clinical remission and 21% (11/53) achieved low disease activity. Response was seen at 3 months for all efficacy end-points. ePROs allowed the capture of early patient-reported data which demonstrated clinically important improvements in pain and fatigue within 10 days and other PROs within 2 months. Improvements were also seen in metrics of activity, work and quality of life (QOL).

Conclusion: Patients in ENDEAVOUR showed similar early effectiveness with upadacitinib to that observed in clinical trials. Use of ePROs demonstrated rapid onset of action and meaningful improvements in QOL providing a potential opportunity to reduce outpatient visits for early responders, thus reducing the burden on rheumatology services.