Rheumatol Ther. 2026 Apr 13. doi: 10.1007/s40744-026-00854-1. Online ahead of print.
ABSTRACT
INTRODUCTION: We present the final results of the CANadian TOfacitinib for Rheumatoid Arthritis observationaL (CANTORAL) study, which investigated tofacitinib effectiveness, safety, and persistence to month (M) 36 in patients with rheumatoid arthritis (RA).
METHODS: Patients with RA initiating tofacitinib in Canada (October 2017-June 2022) were enrolled in a multicenter, prospective, observational study. Coprimary effectiveness outcomes were Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA) and remission at M6. Secondary and additional outcomes included Disease Activity Score in 28 joints using erythrocyte sedimentation rate/C-reactive protein (DAS28-4[ESR/CRP])-defined LDA and remission, and change from baseline (CFB) in Health Assessment Questionnaire Disability Index (HAQ-DI). Safety was evaluated to M36.
RESULTS: Overall, 505 and 507 patients were included in the effectiveness and safety analysis sets, respectively; 59.2% were biologic disease-modifying antirheumatic drug-naïve, 79.2% were ≥ 50 years, 38.6% were ≥ 65 years, and 56.0% were current/former smokers. 59.6% discontinued the study. LDA/remission rates at M36 were: CDAI, 71.0% (n/N = 66/93)/35.5% (n/N = 33/93); DAS28-4(ESR), 69.6% (n/N = 32/46)/52.2% (n/N = 24/46); DAS28-4(CRP), 79.7% (n/N = 47/59)/66.1% (n/N = 39/59); 66.1% (n/N = 82/124) patients had HAQ-DI CFB ≥ 0.22. Treatment-emergent adverse events (TEAEs), TEAEs of special interest, and deaths were reported in 69.8% (n/N = 354/507), 46.5% (n/N = 236/507), and 1.2% (n/N = 6/507) of patients, respectively. For patients with major adverse cardiovascular events and malignancies (excluding nonmelanoma skin cancer), proportions of current/former smokers and patients ≥ 65 years were higher than in the whole population.
CONCLUSIONS: Tofacitinib provided early and sustained improvement of disease signs and symptoms in patients with RA in Canada. Safety was consistent with the RA clinical program and the established tofacitinib clinical profile. Results were consistent with the interim analysis.
PMID:41973390 | DOI:10.1007/s40744-026-00854-1