High Wycombe, UK, 14 November 2016 - The launch today of STELARA® (ustekinumab) in the UK presents a new treatment 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.[i] With no known cure, the aim of treatment for Crohn’s disease is to stop the inflammatory process, relieve symptoms (induce and maintain remission) and avoid surgery wherever possible.[ii] 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.1
“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,” commented Dr Stuart Bloom, Consultant Gastroenterologist, University College London Hospitals.
Crohn’s disease is a chronic inflammatory bowel disease that affects the lining of the digestive tract at any point.2 It affects approximately 115,000 people in the UK and although the exact cause is unknown it is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or other environmental factors.2 Though anyone can be affected by Crohn’s disease at any age, it most often impacts those between the ages of 16 to 30 in both men and women2 and can affect people in many ways, for example, by potentially causing fatigue, weight loss, abdominal pain and cramping, diarrhoea, depression, stress, anaemia and colorectal cancer.2,[iii],[iv],[v],[vi]
A comprehensive Phase 3 clinical development programme, comprising of UNITI-1 and UNITI-2 (induction to week 8), and IM-UNITI (maintenance up to 52 weeks) studies, demonstrated significantly greater rates of clinical remission in patients who had either failed on TNFα antagonist therapies or previously failed conventional therapy, compared to placebo (UNITI-1 ∼6 mg/kg p=0.003, 130mg p=0.002; UNITI-2 ∼6 mg/kg p<0.001, 130mg p=0.009; IM-UNITI 8 week injection p=0.005, 12 week injection p=0.040).[vii],[viii],[ix],[x] In the placebo-controlled IM-UNITI maintenance study (8-week induction and 44-week maintenance phases, representing 1-year total of therapy) adverse events were reported in similar proportions across ustekinumab and placebo treatment groups, the majority of which were related to gastrointestinal disorders, such as abdominal pain and diarrhoea, and infections/infestations, of which, nasopharyngitis and upper respiratory infection were the most common.[xi],[xii] Reported serious adverse events were similar in the ustekinumab groups compared to placebo and no deaths or major adverse cardiovascular events were reported.10
“Janssen is committed to delivering medicines for use in a variety of immunological conditions. The treatment options available in Crohn’s disease are currently limited and we are very pleased to announce the launch of ustekinumab in the UK, which offers an alternative mechanism of action for the treatment of those with this condition. The potential to offer sustained remission in Crohn’s disease indicates a step forward in the management of this chronic and debilitating illness,” commented Dr Rozlyn Bekker, Medical Director of Janssen UK & Ireland.Editor's Details
Last updated on: 15/11/2016
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