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)

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. 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 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). 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. The ENDEAVOUR study looked at the impact of treatment with upadacitinib in people with moderate-to-severe rheumatoid arthritis (RA) in the UK. The study enrolled people for whom the decision to start treatment with upadacitinib had already been made. It assessed the impact of upadacitinib at the start of treatment (using medical records) and at routine outpatient hospital visits, 3 and 6 months after the start of treatment (using information reported by their doctor). Doctors used the 28-joint Disease Activity Score (DAS28) which takes into consideration the number of tender and swollen joints, patient global assessment of RA and markers of inflammation to define response to treatment, with a score of