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Published on 24 August 2011

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NICE approves golimumab for ankylosing spondylitis

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The National Institute for Health and Clinical Excellence (NICE) has today issued final guidance to the National Health Service (NHS) recommending golimumab (Simponi) as an option for treating ankylosing spondylitis in specific circumstances.

Golimumab is now a NICE-recommended option for the treatment of severe, active ankylosing spondylitis in adults when used as described for other tumour necrosis factor (TNF) inhibitor treatments – adalimumab and etanercept –  and the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose.

“We are pleased to recommend golimumab for treating ankylosing spondylitis, providing another treatment option for this progressive and irreversible condition,” said Professor Carole Longson, Health Technology Evaluation Centre Director at NICE.

“Ankylosing spondylitis causes a great deal of pain and discomfort for individuals, impacting significantly on day-to-day life. The evidence for golimumab demonstrated comparable clinical and cost effectiveness to the two drugs that we had already recommended for this condition.

“This meant that we were able to complete the appraisal faster. It’s good news for people with this disabling condition that golimumab now joins adalimumab and etanercept as NICE-recommended treatment options for ankylosing spondylitis.”

Golimumab is recommended for treatment only if all of the specified clinical criteria are fulfilled, including:

– having active spinal disease as assessed on two separate occasions 12 weeks apart

– failure of conventional treatment with at least two non-steroidal anti-inflammatory drugs taken sequentially at maximum tolerated or recommended dosage to control symptoms.

It is also recommended that only specialist physicians, who are experienced in the diagnosis and management of ankylosing spondylitis, should supervise treatment.

People currently receiving golimumab for the treatment of severe, active ankylosing spondylitis who do not fulfil the criteria for treatment with adalimumab and etanercept should have the option to continue golimumab until they and their clinician consider it appropriate to stop.

NICE



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