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Upadacitinib Monotherapy in MTX-IR Rheumatoid Arthritis

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.

The author has received compensation as an advisor or consultant on this subject

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