National Institute for Health and Care Excellence experts have supported the use of Janssen’s biologic Stelara.
The substance is utilised in order to treat adult patients with Crohn’s disease, with Stelara able to deal with some of the more severe cases.
A Final Appraisal Determination has already been issued recommending the drug in line with its licensed indication.
Stelara will be used when patients fail to respond to conventional therapy or an anti-TNF-alpha therapy.
Crohn’s is known to affect around 115,000 people in the UK, although the precise cause of the disease has yet to be located.
It is however associated with abnormalities of the immune system, with genetics playing a major role in its development.
Current treatment is focused on halting the inflammatory process, as no know cure is available.
However, only around half of Crohn’s patients maintain relief from their symptoms for more than a year with currently available therapies or no appropriate treatment.
Thus, the fact that Stelara (ustekinumab) offers a different form of treatment from other licensed therapies is considered particularly valuable.
It has been established as the first human monoclonal antibody for Crohn’s disease to target the interleukin (IL)-12 and IL-23 cytokines.
While the causes of Crohn’s are unknown, it is understood that the (IL)-12 and IL-23 cytokines play a central role in inflammatory and immune responses related to the condition.
Clinical studies related to the drug indicated that between 34 and 56% of patients had a positive response, reporting some relief from their Crohn’s disease symptoms within six weeks.
NICE’s preliminary guidelines indicate that cost must be taken into consideration when choosing treatments for Crohn’s.
“The choice of treatment between ustekinumab or another biological therapy should be made on an individual basis after discussion between the patient and their clinician about the advantages and disadvantages of the treatments available. If more than one treatment is suitable, the least expensive should be chosen (taking into account administration costs, dosage and price per dose),” NICE documentations states.
Dr Peter Irving, consultant gastroenterologist, Guy’s and St Thomas’ NHS Foundation Trust, suggested that the decision over Stelara would be hugely beneficial for patients in the NHS system.
“The promising results seen in the clinical trials suggest that the possibility of treating patients with a new drug employing a novel mode of action will reap real benefits for patients with a disease that can have enormous impact on their lives.”
Sarah Berry, Health Policy & Public Affairs Officer from Crohn’s and Colitis UK, also welcomed the move, suggesting that it could have a major and positive impact on those suffering with the condition in Britain.
“Crohn’s can be profoundly debilitating and current treatment options simply do not work for everyone. This ruling gives access to a desperately needed additional treatment option to those who may otherwise have been condemned to living with unmanageable disease progression with devastating impact on their quality of life.”