New Data Shows DIFICLIR™ (fidaxomicin) Reduces Recurrence and Provides Cost Savings When Used First-Line for Clostridium Difficile Infection

CHERTSEY, England, May 14, 2014 /PRNewswire/ --

Recurrence has been identified by The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as the most important problem in the treatment of CDI.^[1]

New data presented at the 24^th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrates that fidaxomicin, when used first-line, is clinically effective and provides cost savings for the treatment of potentially fatal Clostridium difficile infection (CDI).^[2] Treatment with fidaxomicin led to a reduction in recurrence for patients with CDI^[2] and a saving of over £48,000 to the UK's NHS versus standard of care treatment (vancomycin or metronidazole).^[3]

The study, conducted at St George's Hospital in London, England, is the first of its kind and looks at a year's experience using fidaxomicin as a first-line treatment for all adults confirmed to have CDI, including populations not previously studied in randomised controlled Phase III trials.^[2],[4] Data collected from a total of 62 patients treated with fidaxomicin during the 12 month evaluation period were compared with those from a retrospective cohort treated with standard of care (vancomycin or metronidazole) during the previous 12 month period.^[5]

Only 6% of patients treated with fidaxomicin had a recurrence of CDI, within 28 days of end of therapy, compared with a 20% recurrence rate with vancomycin/metronidazole in the preceding year.^[5] Recurrence is a major challenge in CDI treatment, with previous studies reporting that patients who have already had one recurrence, have a 40% risk of a further episode of CDI.^[6]Importantly, in this 'real world' study, there were no second recurrences reported in those treated with fidaxomicin. Hence, the observed reduction in recurrence rates and reduced hospital stays since the introduction of fidaxomicin as first-line treatment for CDI has culminated in overall cost savings.^[5]

Commenting on the findings, Dr. Tim Planche, lead investigator and Consultant Microbiologist, St George's Hospital said: "We decided to start using fidaxomicin first-line over a year and a half ago for all cases of Clostridium difficile infection at St George's, after the exciting data reported in clinical trials showed reduction in recurrence of infection. Having looked at our data we are very pleased to see that we find the same effects occurring in our own "real world" patients. Our team have also looked at the cost-effectiveness of using fidaxomicin and we are assured of the cost benefits of continuing to use this drug. From our experience of using this drug we are very happy to continue using it first-line and that it is worth other hospitals considering as part of their strategy to treat and control Clostridium difficile infection."

Based on the findings of this landmark study, The Drugs and Therapeutics Committee for the hospital have upheld their recommendation for the use of fidaxomicin as a first-line therapy for all adult patients with CDI.^[5]

CDI is one of the most common causes of antibiotic-associated diarrhoea and severe cases can lead to bowel surgery and even death.^[7] Hospital patients with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.^[8],[9] Recurrence is a major challenge in CDI treatment, 25% of CDI patients suffer a recurrence within one month^{[10],[11],[12]}and patients who have already had one recurrence have a 40% risk of a further episode of CDI.^[6]

Commenting on the findings, Professor Oliver Cornely, University Hospital Cologne, Germany said: "One of the biggest challenges to optimal CDI management is recurrence, therefore the significant reduction in disease recurrence by fidaxomicin, compared with vancomycin, is an important step in reducing the morbidity and possibly mortality associated with CDI. The treatment for CDI had remained largely unchanged for 20 years. This real life data demonstrates a treatment advance that can improve patient outcomes and reduce the significant burden of this disease, which will hopefully lead to improved management of CDI in clinical practice."

These results represent the interim findings of a larger cohort of real world data being collected and analysed from across the UK to assess the effectiveness of fidaxomicin. Data reporting from additional study centres are expected to be presented later in the year.

NOTES TO EDITORS  

About Clostridium difficile Infection  

CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.^[13] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.^[14]  CDI is the leading cause of hospital acquired (nosocomial) diarrhoea in industrialised countries^[15] and the risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.^[16] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.^{[10],[11],[12]} The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.^[1]

About Astellas Pharma Europe Ltd.  

Astellas Pharma Europe Ltd., located in the UK, is the European Headquarters of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. As a global company, Astellas is committed to combining outstanding research and development (R&D) and marketing capabilities to continue to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. manages 21 affiliate offices located across Europe, the Middle East and Africa. In addition, the Company has an R&D site and three manufacturing plants in Europe. The company employs approximately 4,300 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu/.

References  

1. Bauer MP, et al. European Society of Clinical Microbiology and Infectious Disease (ESCMID): treatment guidance document for Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009;15:1067-79.
2. Planche T, et al. Cost-effectiveness of fidaxomicin as first-line treatment for Clostridium difficile infection. Abstract presented at ECCMID 2014.
3. Astellas Data on File DIF14036UK.
4. Cornely A, et al. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Diseases. 2012:12;281-289.
5. Astellas Data on File FDX/13/0090/EUi.
6. Kelly CP, LaMont JT. Clostridium difficile - more difficult than ever. N Engl J Med. 2008;359(18): 1932−1940.
7. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.
8. Oake N, et al. The effect of hospital-acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med. 2010;170:1804-10.
9. Hensgens MP, et al. All-Cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a Multicenter Cohort Study. Clin Infect Dis. 2013;56:1108-16.
10. Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. N Engl J Med. 2010;362;3:197-205.
11. Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycin and metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin Micro Infect. 2008;14(Suppl 7):S103-4.
12. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422-31.
13. Poutanen SM, et al. Clostridium difficile-associated diarrhoea in adults. CMAJ. 2004;171:51-8.
14. Kelly CP, et al. Clostridium difficile infection. Ann Rev Med. 1998;49:375-390.
15. Crobach MJ, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clin Micro Infect. 2009;15:1053-1066.
16. Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005;40:1591-7.