NICE guidance - upadacitinib for treating moderate rheumatoid arthritis

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Upadacitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs), only if:

  • disease is moderate (a disease activity score [DAS28] of 3.2 to 5.1) and

  • the company provides upadacitinib according to the commercial arrangement

Upadacitinib can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the criteria above are met.

If more than 1 treatment is suitable, start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose). This may vary because of differences in how the drugs are used and treatment schedules.

Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. If this initial response is not maintained, stop treatment.

Take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DAS28 and make any appropriate adjustments.

Upadacitinib is a Janus kinase (JAK) inhibitor which has been studied across a spectrum of patients with moderately to severely active rheumatoid arthritis (RA) (2)

Upadacitinib is a JAKi engineered for increased selectivity for JAK1 over JAK2, JAK3 and tyrosine kinase 2

JAK inhibitors have been associated with several safety risks, including herpes zoster, serious and opportunistic infections, thromboembolic events and changes in laboratory parameters (2)

Upadacitinib 15 mg once daily had a similar safety profile to that of adalimumab for rates of serious infections, malignancies, major adverse cardiovascular events and venous thromboembolic events but higher rates of herpes zoster and creatine phosphokinase elevations (2)


  • (1) NICE (November 2021). Upadacitinib for treating moderate rheumatoid arthritis
  • (2) Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme [published online ahead of print, 2020 Oct 28] [published correction appears in Ann Rheum Dis. 2021 May;80(5):e83]. Ann Rheum Dis. 2020;80(3):304-311. doi:10.1136/annrheumdis-2020-218510

Last edited 11/2021 and last reviewed 11/2021