adalimumab 40mg pre-filled syringe (Humira)

following a full submission:

adalimumab (Humira®) is accepted for restricted use within NHS Scotland for the treatment of adults with severe active ankylosing spondylitis who have an inadequate response to conventional therapy. It is restricted to use in accordance with the British Society for Rheumatology (BSR) guidelines of July 2004.

Adalimumab improves signs, symptoms, physical function and quality of life in patients with severe active ankylosing spondylitis. It reduces spinal inflammation, but there is no radiological evidence that it decreases joint damage.

An economic evaluation demonstrated that it is a cost-effective treatment option when used in tumour necrosis factor (TNF)- antagonist naïve patients in accordance with the BSR guidelines and where clear and rigorous stopping rules are applied