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Australian Journal of Pharmacy : October 2006
professional pharmacy professional updates Anti-TNF alpha therapies in the treatment of Crohn’s disease By Terry Bolin, Associate Professor of Medicine, University of New South Wales T HE incidence of Crohn’s disease in Australia is increasing though the incidence of ulcerative colitis is steady. There may have been a three-fold increase in the past three decades with Crohn’s disease and it is estimated that 30,000 Australians suffer from this prob- lem. The same pattern of inflammatory bowel disease is also current within the paediatric community, so it is likely that there will be a continuing increase in Crohn’s disease in the future. While the incidence of Crohn’s disease is similar in males and females, the disease can start at any age and commonly occurs in those aged between 15 and 30 years. It is, however, increasingly commonly recognised within the paediatric popula- tion. There are genetic, racial and cultural factors that may influence susceptibility to this disease. Drug therapy is usually required for treatment and cortisone derivatives are almost always necessary for the treatment of acute attacks. Once the acute attack is under control, then maintenance treat- ment will usually involve the long-term use of aminosalicylic acid derivatives. Additional therapy requires immuno- modulatory drugs such as Azathioprine (Imuran) or Mecaptopurine with Metho- trexate usually reserved for those people who fail to respond or develop side effects with the two former drugs. Drugs that target the inflammatory cas- cade causing Crohn’s disease have been the major therapeutic advance in the last decade. Of these, arguably the most successful has been Infliximab (Remicade) which is an antibody that binds to cells producing tumour necrosis factor (TNF), resulting in its inactivation. TNF is the first chemical in the inflammatory cascade. Lack of TNF prevents activation of the next chemical in the inflammatory cas- cade and thereby interrupts the process of inflammation. Of the few anti-TNF anti- bodies available there is overwhelming evidence from published data that Inflix- imab has a very favorable benefit risk pro- file. Lack of TNF prevents activation of the next chemical in the inflammatory cascade and thereby interrupts the process of inflammation It is effective in two out of three patients and is of major value in those with peri- anal disease involving fistulae or ischiorectal abscesses. There has now been a series of studies which confirm the clinical and cost effec- tiveness of Infliximab therapy in Crohn’s disease patients. The ACCENT1 study coordinated by Infliximab played a key role in the therapy of these patients resulting in a decrease in the need for hospitalisation and surgery and improvement in their employment prospects and quality of life. A subsequent study by the same group using Infliximab maintenance after the initial induction therapy at weeks 0, 2 and 24 ? THE AUSTRALIAN JOURNAL OF PHARMACY VOL 87 OCTOBER 2006 Lichtenstein and colleagues from the Uni- versity of Pennsylvania showed that at baseline, patients had severely impaired quality of life and a high rate of unem- ployment.1 6 confirm the effect of Infliximab particu- larly in patients with fistulising Crohn’s disease significantly reducing the need for hospitalisation, surgery and cost.2 A further cost effective analysis by Der- rek Jewella’s group in the UK confirmed the cost benefit of Infliximab use because of a reduction in the need for both hospi- tal admission, length of stay and surgery.3 An additional study by Rubenstein et al examined the resource use among patients with Crohn’s disease.4 This examination of all Crohn’s disease patients managed at the University of Chicago over one year addressed hospi- talisation, hospital stay, surgery, endoscopy, radiological examinations, outpatients and emergency room visits. There was a dramatic reduction in the use of these services, particularly in terms of surgery, endoscopy, ER and outpatient visits. Patients with fistulae, in particular, had a 60 per cent decrease in hospitalisa- tion and need for surgery. This decrease in the use of healthcare resources con- firms the potential for cost savings in patients with Crohn’s disease receiving Infliximab. Long-term safety and infection compli- cations with Infliximab have been posed as potential risks. Lichtenstein’s group from the University of Pennsylvania have re-examined this question and found that the mortality rates were similar between Infliximab and non-Infliximab treated patients.5 There is therefore little doubt that anti- TNF therapies, particularly Infliximab have a key role to play in the treatment of Crohn’s disease. References available on request The increased risk for serious infection observed with Infliximab was concluded to be due to the increased dis- ease severity and steroid use.