More cheery news for sales of Schering-Plough and Johnson & Johnson’s Remicade (infliximab), after two long-term clinical trials showed the drug’s ability to heal the mucosal lining of the intestine in patients with ulcerative colitis – a serious inflammatory bowel disease.
The pooled analysis from two major clinical trials involving in excess of 700 patients – and presented for the first time at the United European Gastroenterology Week meeting in Copenhagen, Denmark, this week – showed more than 60% of those given Remicade achieved mucosal healing after eight weeks’ treatment, with 50% maintaining this at 30 weeks follow-up. Importantly, Remicade – which works by inhibiting the inflammatory mediator tumour necrosis factor-alpha – also resulted in clinical remission for many patients who had failed to respond to standard therapy with azathioprine and/or steroids. This, in turn, resulted in 50% fewer hospitalisations versus the control arm, as well as significant improvements in quality of life.
And the effects were still being witnessed at week 54 – with Remicade being associated with maintenance of clinical response, clinical remission and mucosal healing, as well as remission from steroid-use.
Currently, there are no biologic therapies approved to treat moderate to severe UC in Europe, where it affects over 700,000 people and causes inflammation and ulceration of the innermost lining of the colon, leading to bloody stools, severe diarrhoea and severe abdominal pain. If conventional treatments do not control the symptoms of the disease, many patients face surgical removal of the colon – so these latest data for Remicade could open the door to a very promising market indeed.
Schering-Plough says Remicade is the global market leader amongst the anti-TNF-alpha therapies and the only agent approved for the treatment of both rheumatoid arthritis and Crohn's disease in North America, Europe and Japan. It has just won clearance from European drug regulators for use in psoriasis patients [[07/10/05e]], and is also labelled there for treating ankylosing spondylitis and psoriatic arthritis.
But the companies are not resting on their laurels and aim to significantly expand Remicade’s potential beyond the $2 billion reaped last year: in September, J&J gained a US thumbs up for the treatment of ulcerative colitis, making it the first biologic to be cleared for the condition [[19/09/05d]]. A submission in Europe looks set to follow.