1 Recommendations

1.1 Ixekizumab is recommended as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy, or 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 ixekizumab according to the commercial arrangement.

1.2 Assess response to ixekizumab after 16 to 20 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.

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

1.4 These recommendations are not intended to affect treatment with ixekizumab 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

When people cannot have TNF-alpha inhibitors or they have not worked well enough the current treatment option is conventional therapy. This includes NSAIDs and physiotherapy. Secukinumab is also an option for treating radiographic disease but there is not enough data to reliably compare it with ixekizumab.

Evidence from clinical trials shows that ixekizumab is effective compared with placebo. The cost-effectiveness estimates for ixekizumab compared with conventional therapy are within what NICE usually considers cost effective. Therefore, ixekizumab is recommended.