Patients in the UK with Crohn’s disease have been given a new hope following the launch of Abbott’s Humira, which, the company says, is the first fully-human tumour necrosis factor antagonist to be approved for the condition.
Humira (adalimumab) is the second anti-TNF licensed for Crohn’s disease in Europe after Schering-Plough’s offering Remicade (infliximab), but it is the first to offer adult patients the convenience of self-injection at home, compared to the latter's two-hour infusion in hospital.
Furthermore, as a spokeswoman for the company told PharmaTimes UK News, the annual cost of Humira is well under that of Remicade, at £9,653 versus £15,778, respectively.
Humira works by specifically blocking the activity of TNF, which is a key component of the inflammatory process associated with Crohn’s disease, and its approval in Europe was based on the results of three-randomised, double-blind, placebo-controlled, multi-centre trials – CLASSIC 1, CHARM and GAIN – which demonstrated the agent’s safety and efficacy.
Key findings of these trials were that: Humira induced a treatment response from as early as week one; three times as many patients who continued therapy maintained clinical remission at one year compared with placebo; and 29% of patients taking Humira in clinical remission at one year were able stop taking corticosteroids compared with only 6% on placebo, according to Abbott.
“Currently, there is no cure for Crohn’s disease, which reinforces the need for effective treatment options that will help maintain control of the disease. Adalimumab represents an important advance in managing this serious and debilitating condition,” commented Professor Ghosh, a gastroenterologist at Hammersmith Hospital, London.
A NICE review
The UK’s cost-effectiveness body – the National Institute for Health and Clinical Excellence – is currently assessing the use of anti-TNF therapies for the control of Crohn’s disease, and its decision is expected in July next year.
Two other anti-TNF therapies that may be included in the review are UCB’s Cimzia (certolizumab pegol) and Elan/Biogen Idec’s Tysabri (natalizumab), provided they get the green light in time. But Cimzia is facing a long delay in the US after regulators issued a request for more information on the drug, and so its European approval may also experience a similar obstacle.