Upadacitinib monotherapy versus methotrexate monotherapy in methotrexate-naïve Japanese patients with rheumatoid arthritis: Long-term efficacy and safety through 5 years in the SELECT-EARLY study.

Abstract

Objective: To evaluate the long-term (5-year) efficacy and safety of upadacitinib monotherapy compared with methotrexate (MTX) monotherapy in Japanese patients with rheumatoid arthritis who were included in the Phase 3 SELECT-EARLY study.

Methods: Japanese patients were randomised 2:1:1:1 to upadacitinib 7.5, 15, or 30 mg daily, or MTX 7.5 mg/week (titrated to ≤15 mg/week). Efficacy assessments through Week 260 are reported as observed for patients receiving continuous upadacitinib or MTX, and by randomised group using non-responder imputation. Treatment-emergent adverse events were collected over 5 years and reported as events per 100 patient-years.

Results: Of the 138 Japanese patients treated, 123 (89%) completed Week 48, and 121 (88%) entered the long-term extension on the study drug. Patients receiving upadacitinib had better overall long-term efficacy outcomes compared with patients receiving MTX. Similarly, treatment with upadacitinib resulted in numerically greater inhibition of structural joint progression through 5 years, relative to MTX. Higher treatment-emergent adverse event rates were observed in the 30 mg upadacitinib group compared with all other treatment groups, and no new safety signals were identified overall.

Conclusion: This subanalysis of the SELECT-EARLY Japanese population corroborates findings from the global study population on the long-term clinical efficacy and safety of upadacitinib.