Roche/Chugai’s RoActemra has now won the backing of the National Institute of Health and Care Excellence for the treatment of eligible patients with giant cell arteritis (GCA).
The drug was initially rejected in draft guidelines published in November, after the appraisal committee highlighted “substantial uncertainties” in the evidence on how long patients would have to take the treatment and what the long-term benefits are.
Almost 15,000 UK patients develop GCA – a potentially life-threatening form of vasculitis that results in inflammation of blood vessels – every year.
The condition, which is also known temporal arteritis (TA), can be difficult to diagnose because of its wide range of symptoms, which include severe headaches, scalp tenderness, jaw pain and visual symptoms.
If left untreated it can lead to blindness, aortic aneurysm or stroke. To date, management of GCA has been limited to long-term high-dose steroids, but this can cause skin problems and weight gain, as well as diabetes and osteoporosis in the long-term. There have been no treatment advances for GCA for nearly 60 years.
As such, NICE’s endorsement of RoActemra (tocilizumab) “offers new hope for patients, with better disease control and quality of life, and fewer side effects compared to steroids,” said Professor Bhaskar Dasgupta, consultant rheumatologist, Southend University Hospital.
“The GiACTA clinical trial showed that tocilizumab (in combination with a rapidly tapered dose of steroids) improved long-term disease control, reduced and delayed the risk of disease flare, and substantially reduced the total dose of steroids compared to steroids alone.”
The cost watchdog is recommended funding for one year of RoActemra for those patients who suffer flares of their GCA or may not respond fully to steroids, as their disease is most difficult to control.
Final guidance is expected towards the end of the month.
RoActemra is an anti-IL-6 receptor licensed for the treatment of adult patients with moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children two years of age and older, and for the treatment of GCA in adult.