Real-World Use and Effectiveness Outcomes in Patients with Rheumatoid Arthritis Treated with Upadacitinib: An Analysis from the CorEvitas Registry

Abstract

Introduction: Data assessing longer-term real-world effectiveness and treatment patterns with upadacitinib (UPA), a Janus kinase inhibitor, in rheumatoid arthritis (RA) are lacking. We assessed improvement in clinical and patient-reported outcomes and treatment patterns for up to 12 months among adult patients with RA initiating UPA.

Methods: Data were collected from the CorEvitas^® RA Registry (08/2019-04/2022). Eligible patients had moderate to severe RA (Clinical Disease Activity Index [CDAI] > 10) and follow-up visits at 6 or 12 months after UPA initiation. Outcomes were mean change from baseline, percentage achieving minimal clinically important differences (MCID) in clinical and patient-reported outcomes, and disease activity at follow-up. We evaluated clinical outcomes and therapy changes among patients with tumor necrosis factor inhibitor (TNFi) experience and among those receiving UPA as first-line therapy, as well as those receiving UPA as monotherapy versus as part of combination therapy. We further evaluated whether outcomes were similar among those that remained on therapy.

Results: Patients treated with UPA (6-month cohort, N = 469; 12-month cohort, N = 263) had statistically significant improvements (p < 0.001) in mean CDAI, tender/swollen joint counts, pain, and fatigue at follow-up. At 12 months, 46.0% achieved MCID in CDAI and 40.0% achieved low disease activity/remission. Overall, 43.0% discontinued UPA at 12 months; of those receiving combination treatment (N = 90) with conventional therapies and UPA, 42.2% (N = 38) discontinued conventional therapy. Findings were similar in the 6-month cohort and among subgroups. Changes from baseline and proportions of patients achieving MCID or clinical outcomes tended to be numerically lower among patients with TNFi experience and numerically higher among those receiving UPA as first-line therapy.

Conclusions: UPA initiation was associated with improvements in clinical and patient-reported outcomes, with meaningful clinical improvements regardless of prior TNFi experience, line of therapy, or concomitant use of conventional therapies. Further research is needed to better understand sustained response of UPA over longer treatment periods.

Keywords: Patient-reported outcomes; Real-world evidence; Registry; Rheumatoid arthritis; Upadacitinib.

Fig. 1

Rates of achieving minimum clinically important differences^a in clinical and patient-reported outcomes at a 6-month and b 12-month follow-up. ^aMCID for CDAI was based on baseline CDAI score. For baseline CDAI > 10 and ≤ 22, MCID = > 6-point decrease; and baseline CDAI > 22, MCID = > 12-point decrease. MCID for HAQ-DI was ≥ 0.22-point decrease. For assessments measured on a 100-point VAS scale, MCID was set at ≥ 10-point decrease. “Much Better Improvement” in patient-reported pain was defined as a 20-point decrease and a ≥ 33% decrease in scores from initiation (Salaffi F, et al. Eur J Pain. 2004;8(4):283–91). Error bars represent 95% confidence intervals of the mean response rate. CDAI Clinical Disease Activity Index, HAQ-DI Health Assessment Questionnaire – Disability Index, MCID minimal clinically important difference, TNFi tumor necrosis factor inhibitor, VAS visual analog scale, UPA upadacitinib

Fig. 2

Disease activity at a 6-month and b 12-month follow-up as measured by CDAI. CDAI Clinical Disease Activity Index, HDA high disease activity, LDA low disease activity, MDA moderate disease activity, TNFi tumor necrosis factor inhibitor, UPA upadacitinib