1 Recommendations

1.1 Tofacitinib 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 tofacitinib according to the commercial arrangement.

1.2 If people with the condition and their clinicians consider tofacitinib to be 1 of a range of suitable treatments (including secukinumab and ixekizumab), after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements.

1.3 Assess response to tofacitinib 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 make any adjustments needed.

1.5 These recommendations are not intended to affect treatment with tofacitinib 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

People with active ankylosing spondylitis that is not controlled well enough with conventional therapy are usually offered TNF-alpha inhibitors. If TNF-alpha inhibitors are not suitable or do not control the condition well enough, people are usually offered secukinumab or ixekizumab. Tofacitinib is an alternative to secukinumab or ixekizumab, but it might not be as safe for some people with ankylosing spondylitis, for example, people who are over 65 or who smoke.

Clinical trial evidence shows that tofacitinib is more effective than placebo for treating active ankylosing spondylitis. Tofacitinib has not been compared directly with secukinumab or ixekizumab, but an indirect treatment comparison suggests that it is as effective.

A cost comparison with secukinumab, which is most likely to be used after TNF-alpha inhibitors or when they are not suitable, suggests that tofacitinib has similar or lower costs. So, tofacitinib is recommended if it is used in the same population as secukinumab and ixekizumab.