Treatment Patterns and Effectiveness of Tofacitinib in Patients Initiating Therapy for Rheumatoid Arthritis: Results from the CorEvitas Rheumatoid Arthritis Registry.

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).