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.

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.