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1 Recommendations

1.1

Upadacitinib should not be used to treat giant cell arteritis in adults.

1.2

This recommendation is not intended to affect treatment with upadacitinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

Upadacitinib is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to show upadacitinib offers benefit or is value for money in this population.

Why the committee made these recommendations

Usual treatment for giant cell arteritis is corticosteroids, which are gradually reduced over time. Tocilizumab or methotrexate (off-label use) may be added when the condition relapses.

Evidence from a clinical trial shows that, compared with placebo, upadacitinib results in:

  • an increase in the number of people with sustained or complete remission of giant cell arteritis

  • people being able to reduce corticosteroid use.

How effective it is compared with placebo after 1 year is unknown. Also, it has not been directly compared with tocilizumab or methotrexate. The results of an indirect comparison with tocilizumab suggest that they may be similarly effective, but this is very uncertain.

There are uncertainties in the economic model, including the modelling of:

  • a 2‑year treatment stopping rule

  • sequencing of treatments after relapse

  • time to a first flare in people with new-onset giant cell arteritis

  • giant cell arteritis flare-related complications

  • corticosteroid-related complications.

Because of the uncertainties in the clinical evidence and economic model, it is not possible to determine the most likely cost-effectiveness estimates for upadacitinib. So, it should not be used.