The SELECT‐EARLY trial studied the effect of Upadacitinib ( Rinvoq ), an oral, reversible, JAK inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who are naïve or have limited exposure to Methotrexate.
Patients were randomized ( n=947, 1:1:1 ) to once‐daily Upadacitinib ( 15mg or 30mg ) or weekly Methotrexate ( 7.5–20 mg/week ) for 24 weeks.
The primary endpoints were: proportions of patients achieving 50%or more response in the American College of Rheumatology ( ACR ) criteria at week 12, and proportions achieving a 28‐joint Disease Activity Score including C‐reactive protein ( DAS28[ CRP ] ) of less than 2.6 at week 24.
Data were presented through week 24.
At baseline, median disease duration was 0.5 years ( range 0–44 years ). 840 ( 89% ) patients completed 24 weeks of treatment.
The study met both primary endpoints for Upadacitinib 15mg and 30mg versus Methotrexate ( ACR50 at week 12: 52% and 56% versus 28%, P less than 0.001; DAS28( CRP ) less than 2.6 at week 24: 48% and 50% versus 19%, P less than 0.001 ).
Statistically significant and clinically meaningful improvements in multiple patient‐reported outcomes were recorded with both Upadacitinib doses versus Methotrexate.
Overall, 88% and 89% of Upadacitinib 15mg and 30mg patients had no radiographic progression ( mTSS less than or equal to 0; Methotrexate: 78%; at least P less than 0.01 ).
Through week 24, the frequency of treatment‐emergent adverse events was similar between the Methotrexate ( 65% ) and Upadacitinib 15mg arms ( 64% ), but slightly higher in the Upadacitinib 30mg arm ( 71% ).
Six deaths were reported ( Upadacitinib 15mg: 2, Upadacitinib 30mg: 3, Methotrexate: 1 ).
In conclusion, both doses of Upadacitinib monotherapy demonstrated significant improvements in clinical, radiographic, and patient‐reported outcomes versus Methotrexate. ( Xagena )
van Vollenhoven R et al, Arthritis Rheumatol 2020; Online ahead of print