NICE Draft Guidance Recommends Upadacitinib for Moderate Rheumatoid Arthritis

Pavankumar Kamat

October 08, 2021

The National Institute for Health and Care Excellence (NICE) has recommended updacitinib (Rinvoq, AbbVie) in combination with methotrexate for the treatment of adults with moderate active rheumatoid arthritis in a draft guidance published recently. With this, updacitinib joins adalimumab, etanercept, filgotinib and infliximab (all with methotrexate) as a further treatment option for the indication.

Updacitinib is recommended for the treatment of active rheumatoid arthritis in adults, if the following conditions are fulfilled:

  • Moderate disease (disease activity score [DAS28], 3.2-5.1).

  • Disease has not adequately responded to intensive therapy with two or more conventional disease-modifying antirheumatic drugs (DMARDs).

Upadacitinib can be considered as monotherapy if there is a contraindication or intolerance to methotrexate, given that the above criteria are met.

Treatment with upadacitinib should be stopped if an adequate therapeutic response as per the European League Against Rheumatism (EULAR) criteria is not achieved after 6 months. Appropriate clinical adjustments should be made after accounting for the possible influence of physical, psychological, sensory or learning disabilities, or communication difficulties on the DAS28.

The recommended dose of upadacitinib is 15 mg administered once daily orally.

Clinical trial evidence showed upadacitinib in combination with conventional DMARDs (including methotrexate) to be more effective than placebo plus conventional DMARDs for the treatment of moderate disease that has inadequately responded to conventional DMARDs. Upadacitinib monotherapy appears to be more effective than methotrexate for the same population.

The drug is to be used only when provided by the company in agreement with the commercial arrangement. The recommendations should not affect patients whose treatment with the drug was started before publication of the final guidance, which is expected in November 2021.


This article originally appeared on Univadis, part of the Medscape Professional Network.


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