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Upadacitinib (UPA) is an oral, selective JAK1-selective inhibitor being developed for use in rheumatoid arthritis patients; Lancet has reported the SELECT-MONOTHERAPY trial showing that UPA is safe and effective in RA patients with an inadequate response to methotrexate (MTX).
This multicenter study randomized 648 patients, of whom 598 (92%) completed week 14.
At week 14, an ACR20 responses were:
- 41% on continued MTX
- 68% on UPA 15 mg qd
- 71% on UPA 30 mg qd (p<0·0001 for both doses vs continued methotrexate).
The week 14 DAS28(CRP) <3.2 results were:
- 19% continued MTX
- 45% UPA 15 mg
- 53% UPA 30 mg (p<0·0001 for both doses vs continued methotrexate).
Most adverse events were similar in all groups.
Herpes zoster similar on MTX and UPA 15 mg (1%) but was higher on UPA 30 mg (3%).
Whiler there were no DVT events, there was one adjudicated pulmonary embolism (<1%; upadacitinib 15 mg), and one death (<1%; upadacitinib 15 mg, haemorrhagic stroke [ruptured aneurysm]) reported.
The clinical results and safety profile in this trial is on par with that reported thus far in other upadacitinib developmental studies.