1 Recommendations

1.1 Upadacitinib is recommended as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy in adults, 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 If patients and their clinicians consider upadacitinib to be one of a range of suitable treatments (including secukinumab and ixekizumab), choose the least expensive treatment, taking into account administration costs, dosage, price per dose and commercial arrangements.

1.3 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 pre-treatment value or by 2 or more units and
a reduction in the spinal pain visual analogue scale (VAS) by 2 cm or more.

1.4 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.

1.5 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 ankylosing spondylitis in adults that is not controlled well enough with conventional therapy, and when TNF-alpha inhibitors are not suitable or do not control the condition well enough, is secukinumab or ixekizumab. Upadacitinib is another treatment that works in a similar way.

Evidence from clinical trials shows that upadacitinib is more effective than placebo. Indirect comparisons of upadacitinib with secukinumab and ixekizumab suggest they have similar clinical effectiveness.

A cost comparison suggests upadacitinib has similar costs and overall health benefits as secukinumab and ixekizumab. So upadacitinib is recommended for treating active ankylosing spondylitis in adults if it is used in the same population as secukinumab and ixekizumab.