Abstract
Objective This real-world analysis assessed baseline demographics/characteristics and treatment patterns/effectiveness in patients with rheumatoid arthritis (RA) initiating tofacitinib in the United States (US) CorEvitas RA Registry.
Methods The primary analysis of this study (NCT04721808) included patients with RA initiating tofacitinib with a 12-month follow-up visit from November 2012–January 2021. Outcomes included baseline demographics/characteristics and tofacitinib initiation/discontinuation reasons, treatment patterns, and effectiveness (disease activity and patient-reported outcomes at 12 months); primary effectiveness outcome: Clinical Disease Activity Index low disease activity (CDAI LDA). All data, analyzed descriptively, were stratified by tofacitinib regimen (monotherapy vs combination therapy), line of therapy (2nd–4th line), time of initiation (2012–2014/2015–2017/2018–2020), and dose (5 mg twice daily vs 11 mg once daily).
Results Of 2,874 patients with RA who initiated tofacitinib, 1,298 had a qualifying 12-month follow-up visit: of these, 43.1% as monotherapy; 66.5% as 4th-line therapy. Overall, tumor necrosis factor inhibitors (40.8%) were the most common treatment immediately prior to tofacitinib initiation; the most common reason for tofacitinib initiation (among those with a reason) was lack/loss of efficacy of prior treatment (67.7%). Overall, at 12 months, 31.9%/10.1% achieved CDAI LDA/remission, 22.4%/10.4%/5.0% achieved ≥ 20%/ ≥ 50%/ ≥ 70% improvement in modified American College of Rheumatology core set measures, and improvements in patient-reported outcomes were observed. Effectiveness was generally similar across tofacitinib stratifications.
Conclusion Tofacitinib effectiveness (CDAI LDA) was observed in a US real-world setting of patients with RA regardless of tofacitinib regimen, line of therapy, time of initiation, and dose. (ClinicalTrials.gov: NCT04721808)
