EU Clear Use of Janssen’s Treatment for Crohn’s Disease
With expanded approval of Janssen’s psoriasis blockbuster Stelara, individual patients in the EU with Crohn’s disease have gained possible access a new treatment option.
Regulators in Europe have approved use of the biologic as an alternative 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 conventional therapy or a TNFα antagonist or may have medical contraindications to such therapies.
Crohn’s disease is a chronic inflammatory bowel disease that affects the lining of the digestive tract. The disease is estimated to be affecting around 115,000 people in the UK, although the exact cause of the condition is unknown, it is associated with abnormalities of the immune system that could be caused by a genetic predisposition or other environmental factors.
Whilst there is no known cure for the disease, current treatment aims focus on stopping the inflammatory process, relieving symptoms and the avoidance of surgery wherever possible. Stelara is the first biologic therapy for Crohn’s disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a vital role in inflammatory and immune responses, Janssen noted.
Approval of Stelara 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.