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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.

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

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