UK regulatory body recommends golimumab for ankylosing spondylitis


The UK’s National Institute for Health and Clinical Excellence (NICE), which provides guidance on the cost effectiveness of treatments, now recommends golimumab (Simponi, MSD) for the management of the spinal disorder ankylosing spondylitis — but only in specific circumstances.

NICE states that the drug can now be used to treat patients with severe active ankylosing spondylitis, an inflammatory disease of unknown cause that leads to inflammation of the sacroiliac joint at the base of the spine and along the spine, in the same way that it recommends two other tumour necrosis factor (TNF) inhibitor treatments, adalimumab (Humira, Abbott) and etanercept (Enbrel, Pfizer), are used to treat the condition. Therefore it can be used if the patient has active spinal disease, as assessed on two separate occasions 12 weeks apart, and conventional treatment (at least two non-steroidal anitinflammatory drugs taken sequentially at the maximum tolerated or recommended dose) has failed.


NICE also advises that treatment with any TNF inhibitor should be supervised by a specialist in the diagnosis and management of anklosing spondylitis, and outlines how response to treatment with these drugs should be monitored.


As well as advising that doctors prescribing golimumab should follow the recommendations for adalimumab and etanercept, NICE also states that its manufacturer should provide the 100mg dose of the treatment at the same price as it provides the 50mg dose.


Carole Longson, health technology evaluation centre director at NICE, said, “The evidence for golimumab demonstrated comparable clinical and cost effectiveness to the two drugs that we already recommend for this condition. This meant that we were able to complete the appraisal faster. It is good news for people with this disabling condition that golimumab now joins adalimumab and etanercept as NICE-recommended treatment options for ankylosing spondylitis.”