Things are looking good for Schering-Plough/Johnson & Johnson’s Remicade and Abbott Laboratories' Humira after preliminary recommendations by the National Institute for Health and Clinical Excellence have favoured their use in the treatment of Crohn’s disease on the National Health Service.

Crohn’s disease - a chronic inflammatory condition affecting the gastrointestinal tract that can cause diarrhoea, abdominal pain, weight loss, malaise, lethargy, anorexia, nausea, vomiting and fever - is estimated to affect around 60,000 people in the UK. Relapses of the disease can seriously disrupt normal daily activities and therefore substantially affect quality of life.

As there is no cure for Crohn’s disease treatment strategies are currently focused on reducing the symptoms of the illness and extending periods of remission, and clinical trials of Humira and Remicade – both anti-TNF therapies – have demonstrated their ability to first induce remission in patients with active disease and then also prevent relapse in those who have responded to an induction regimen.

Now, after considering all the available evidence, an appraisal committee for the cost watchdog has endorsed the use of Humira (adalimumab) as an option for induction and maintenance therapy in adults with severe active non-fistulising Crohn’s disease - defined as very poor general health with weight loss and sometimes fever, severe abdominal pain and frequent diarrhoea - after deeming the drug a cost-effective use of NHS resources.

In addition, the committee has also given the thumbs up to Remicade (infliximab) as an induction and maintenance therapy, but only in one or more of the following circumstances: the patient is intolerant to Humira; the patient is a child; or the Crohn’s disease is fistulising - abnormal connections between areas of the intestine or adjacent organs.

Difference in cost
These stipulations stem from the fact that, as clinical specialists consider both medicines to be equally effective treatments for the condition and there is no head-to-head trial data to prove otherwise, the only differentiation between the two drugs is their cost, and Remicade is more expensive.

Regular maintenance treatment with Remicade costs around £12,584 a year while the price of Humira comes in at about £9,295, and therefore the committee has concluded that, based on the available evidence, Humira compared with standard care is more cost effective in this setting than Remicade.

It was also stressed that maintenance therapy for both drugs should be restricted to up to 12 months, at which point the patient should be reassessed and treatment if there is “clear evidence” the disease is active. This is in response to specialists’ concerns over the longer-term effectiveness and safety of TNF-alpha inhibitors, the committee noted.

Just last month regulators on the other side of the Atlantic told manufacturers of drugs in this class – including Humira and Remicade – that stronger warning labels must be put on these products, in particular regarding a higher risk of cancer to younger patients.