1 Recommendations

1.1 Upadacitinib is recommended as an option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs) in adults. It is recommended only if:

tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and
the company provides upadacitinib according to the commercial arrangement.

1.2 Assess response to upadacitinib after 16 weeks of treatment. Continue treatment only if there is clear evidence of response, defined as a reduction in:

the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pretreatment value or by 2 or more units and
the spinal pain visual analogue scale (VAS) by 2 cm or more.

1.3 Take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the responses to the BASDAI and spinal pain VAS and make any adjustments needed.

1.4 If patients and their clinicians consider upadacitinib to be 1 of a range of suitable treatments (including secukinumab and ixekizumab), discuss the advantages and disadvantages of the available treatments. After that discussion, if more than 1 treatment is suitable, choose the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements.

1.5 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

Usual treatment for active non-radiographic axial spondyloarthritis in adults that is not controlled well enough with NSAIDs, and when TNF-alpha inhibitors are not suitable or do not control the condition well enough, is secukinumab or ixekizumab. These are biological treatments. Upadacitinib is another biological treatment.

Evidence from clinical trials shows that upadacitinib reduces symptoms and improves quality of life better than placebo. Indirect comparisons suggest that upadacitinib works as well as secukinumab and ixekizumab.

A cost comparison suggests upadacitinib has similar costs and overall health benefits as secukinumab and ixekizumab. So upadacitinib is recommended.