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Navigating Crohn’s Disease Treatment Options: A Comparative Analysis

Explore the delicate balance between expensive high-impact drugs and affordable low-impact treatments for Crohn’s disease. Dive deep into the efficacy and safety of biological agents like Natalizumab and Infliximab and their impact on patients' quality of life. Delve into case studies highlighting treatment journeys and outcomes to guide informed decision-making.

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Navigating Crohn’s Disease Treatment Options: A Comparative Analysis

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  1. Grand Rounds10th March 2005 A/Prof Anne Duggan Director of Gastroenterology Dr Rob Gibson Gastroenterology Registrar

  2. Diseasing on the edge of the bell shaped curve Drugs, Dollars & Disappointment

  3. Crohn’s Disease

  4. Gaussian / Normal Distribution Curve

  5. Hypothesis: • Living “ on the edge” can be exciting • Diseasing “on the edge” can be dangerous • Some crohn’s patients dis-ease “on the edge” • Of QOL • Of equitable access to drugs • Of the health agenda c => b => a

  6. Crohn’s prevalence 100/100,000 Severe crohn’s

  7. PBS drug costs (end June 04)

  8. Logan 2004

  9. COST • Infliximab - $20 000/year (70kg) • CABG - $13 000 • Bowel Resection $9319 • Total Hip Replacement $8075 • Interferon/Ribavirin $10000/6mth

  10. Question Should we (DOM) target low volume expensive drugs of great benefit? OR High volume inexpensive drugs of little benefit? OR ?

  11. Monoclonal Antibodies Infliximab – Anti TNF Natiluzimab – Anti alpha4 Integrin Adalimumab – Recombinant Anti TNF Fontolizumab – Anti Interferon Gamma Anti Interleukin 12 Anti Interleukin 6 Anti Interleukin 18

  12. Other Biological Agents • Etanercept – Soluble TNF receptor • Onercept – Recombinant TNF receptor • Interleukin 10 • Interleukin 11 • GM – CSF • Pegylated Anti TNF

  13. Natalizumab • Recombinant monoclonal antibody against alpha4 integrin • Integrins are receptors involved in migration and activation of leukocytes. • Found on vascular endothelium and in extracellular matrix • Integrins are up regulated at sites of chronic inflammation

  14. Natalizumab • On the basis of 2 positive pilot studies a double blinded RCT was undertaken to examine the efficacy in moderate to severe crohns disease • Gosht et al NEJM 2003

  15. Natalizumab • Inclusion criteria • Over 18 years • Moderate to severe crohns • CDAI (220 – 450) • Azathioprine and 6-mercaptopurine in stable dose for 4 months prior

  16. Natalizumab • Exclusion criteria • Methotrexate or cyclosporine in the previous 3 months • Past Mab or investigational agent • Infectious or neoplastic disease • Obstructive symptoms • Prednisone dose over 25mg • Bowel surgery - previous 3 months

  17. Natalizumab • Endpoints at 6 weeks • Primary • Remission (CDAI<150) • Response (CDAI fall by 70) • Secondary • CRP • Quality of life

  18. Natalizumab

  19. Natalizumab • Safety • Adverse events similar across all groups • SAEs –mainly escalation of treatment • Arthralgia • Itch • Infusion reaction • Influenza type syndrome

  20. Conclusion • Efficacious in the short term • Safe • Long term therapy yet to be tested => CDP 351 Antegren trial

  21. Case Presentation 1a • Mr DL 25 years • Recently graduated from University • Now working as postman • Now in a relationship • Moved from home • Soccer coach

  22. Case Presentation 1b • Diagnosed aged 18 • Mucoid, blood stained diarrhoea 10 to12 motions daily • Generalised colicky abdominal pain • Weight loss 15kg in 2months from symptom onset • Erythema Nodosum

  23. Case Presentation 1c • Colonoscopy

  24. Case Presentation 1d • Ileoscopy

  25. Case Presentation 1e • Histology

  26. Case Presentation 1f • Treatments included • Salazopyrine • Prednisone • doses up to 75mg • Initially 8 months before weaning but rapid flare • Rarely below 12.5mg • Azathioprine

  27. Case Presentation 1g • Hospitalizations 5 in JHH in 5 years • Varied from 8 to 12 days • IV cyclosporine Seen 5 Australian Opens in Hospital

  28. Case Presentation 1h • Uncontrolled Disease • Dropped out of University • Unemployed • Depressed • Barely left the house

  29. Case Presentation 2a • Mr CR 38 years • Married • 3 children under 10 • Non smoker • Employed by Telstra • Installs and maintains Communications systems • Travels widely by car

  30. Case Presentation 2b • Presented aged 34 • Initially arthralgia and fatigue • Within days – diarrhoea, faecal urgency and associated abdominal cramps • No other extra luminal features • Stool examination – White cells only

  31. Case Presentation 2c • Colonoscopy

  32. Case Presentation 2d • Ileoscopy

  33. Case Presentation 2e • Histology

  34. Case Presentation 2f • Clinical progress • Chronic Diarrhoea (14/day) • Chronic fatigue • Weight loss ( 10kg first 5 months)

  35. Case Presentation 2g • Multiple treatments • Salazopyrine => Intolerant • Prednisone dependant for 2 years • Azathioprine => Pancreatitis • Mesalazine

  36. Case Presentation 2h • Planned his travel routes around toilets • Urgent stops by the road side • Sick leave 1 or 2 days a fortnight • Avoided hospitalization because he refused

  37. Progress on Natalizumab • All became asymptomatic within 1 to 3 months and have been so since ( all 2 to 3 years) • All on no other medication • 3 of 5 on antidepressants now off medication

  38. Infliximab morbidity and mortality in 500 patients : Serious adverse events – 8.6% Infusion reactions – 3.8% Development of drug induced lupus 1.5% Subsequent infection – 8.2% Mortality – 1%1

  39. Question Should we (DOM) target low volume expensive drugs of great benefit? OR High volume inexpensive drugs of little benefit? OR ?

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