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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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1 Recommendations

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1 Recommendations

1.1 Upadacitinib with or without methotrexate is not recommended, within its marketing authorisation, for treating moderate active rheumatoid arthritis (a disease activity score [DAS28] of 3.2 to 5.1) in adults who cannot tolerate, or whose disease has responded inadequately to, 1 or more conventional disease-modifying antirheumatic drugs (DMARDs).

1.2 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.

1.3 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. But the evidence may not reflect clinical practice, and it does not include people who could not tolerate methotrexate.

The cost-effectiveness results are uncertain. But they are likely to be higher than what NICE considers a cost-effective use of NHS resources. So upadacitinib, with or without methotrexate, is not recommended.