Certain patients with Crohn's disease have gained the potential to access a new treatment option in Europe with the expanded approval of Janssen's psoriasis blockbuster Stelara.
European regulators have cleared use of the biologic as an option for adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Crohn's disease is a chronic inflammatory bowel disease that affects the lining of the digestive tract at any point, affecting around 115,000 people in the UK. The exact cause of the condition is unknown, but it is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or other environmental factor.
There is no known cure for the disease, so current treatment aims focus on stopping the inflammatory process, relieving symptoms and the avoidance of surgery wherever possible. Stelara (ustekinumab) is the first biologic therapy for Crohn's disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses, Janssen noted.
Approval of Stelara (ustekinumab) came after clinical studies showed that between 34 percent (UNITI-1 study) and 56 percent (UNITI-2 study) of patients experienced relief from their Crohn's disease symptoms in just six weeks after receiving the one-time intravenous infusion of the drug.
"Clinicians in the UK treating Crohn's disease are routinely faced with the challenge of managing patients who have disease refractory to standard treatments. To have a new licensed biologic agent in Crohn's disease is exciting, and in the coming years we look forward to seeing the role this agent plays in clinical practice," noted Dr Stuart Bloom, consultant gastroenterologist, University College London Hospitals.
The drug, which was approved by US regulators back in September, has now been launched for Crohn's in the UK.