Upadacitinib for treating moderate rheumatoid arthritis

1.1 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:

1.2 Upadacitinib can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the criteria in section 1.1 are met.

1.3 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.

1.4 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.

1.5 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.

1.6 These recommendations are not intended to affect treatment with upadacitinib that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Clinical trial evidence suggests that upadacitinib plus conventional DMARDs (including methotrexate) is more effective than placebo plus conventional DMARDs for treating moderate disease that has not responded well enough to conventional DMARDs. Evidence also suggests that upadacitinib alone is more effective than methotrexate for the same population.

Using methods accepted in NICE technology appraisal guidance 375 and NICE technology appraisal guidance 715, the cost-effectiveness estimate was within what NICE normally considers an acceptable use of NHS resources, although these methods may have to be reconsidered in future appraisals. So upadacitinib, alone or with methotrexate, is recommended for people with moderate rheumatoid arthritis whose disease has responded inadequately to intensive therapy with 2 or more conventional DMARDs.