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Upadacitinib Monotherapy in MTX-IR Rheumatoid Arthritis

May 28, 2019 2:04 pm

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

The week 14 DAS28(CRP)

  • 19% continued MTX
  • 45% UPA 15 mg
  • 53% UPA 30 mg (p

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 (

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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