Inflammatory Bowel Disease New Clinics-New Treatments

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IBD -Size of problem. IncidenceCrohns Disease 7/100,000 per annumUlcerative colitis 6/100,000 per annumDisease affects young people so high prevalenceAffects people of working age so burden on society highAetiology Unknown. Type/Distribution of Disease. Crohn`s disease(anywhere in

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Inflammatory Bowel Disease New Clinics-New Treatments

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1. Inflammatory Bowel Disease New Clinics-New Treatments Dr John Linehan

2. IBD -Size of problem Incidence Crohns Disease 7/100,000 per annum Ulcerative colitis 6/100,000 per annum Disease affects young people so high prevalence Affects people of working age so burden on society high Aetiology Unknown

3. Type/Distribution of Disease Crohn`s disease (anywhere in gut) IBD Ulcerative Colitis (varying amounts of colon) Distribution will dictate how to most effectively deliver drug therapy If only rectal involvement then can get extremely good steroid therapy with suppositories thereby minimising systemic side effectsDistribution will dictate how to most effectively deliver drug therapy If only rectal involvement then can get extremely good steroid therapy with suppositories thereby minimising systemic side effects

4. IBD Aims of Medical treatment Induction of remission Traditionally Steroids Prevent relapse Traditionally 5 Aminosalicylates Prevent long term complications Limit side effects

5. 5 ASAs Used for prevention of relapse Also used for induction of remission in mild disease Often used in sub-therapeutic doses in remission

6. 5ASAs (ASCEND TRIAL) Moderate disease e.g. >4 bowel movements per day. No fever, no tachcardia 4.8g/day quicker remission than 2.4g/day More likely to go into remission

7. 5 ASA Modern formulations of mesalazine much lower side effects than Sulphasalazine Proven benefit in UC. Possibly helpful in Crohn’s colitis Possible role in reducing risk of neoplasia in patients with extensive UC by 75% Compliance of oral medication often poor (up to 40% poor compliance) Patients who take >80% of prescribed dose are 5x less likely to relapse

8. 5ASA Remember local therapy for left sided disease More effective than local steroid therapy Can be used as maintenance therapy locally e.g. foam enema twice per week

9. PODIUM Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission A multi-centre investigator-blinded randomised controlled study in 362 patients Primary objective– To compare the 12 month maintenance of remission rate in patients with quiescent UC between two dosing schemes 2g mesalazine once daily vs 1g mesalazine twice daily Langholz et al

10. PODIUM results 362 UC patients Remission 73.8% (2g once/day) vs 63.6% (1g bd)

11. PINCE Study Enema plus tablets vs just enema in extensive colitis Most symptoms due to distal disease

12. PINCE Results

13. Steroids Prednisolone mainstay of treatment in induction of remission Multiple side effects in long-term & short- term e.g. osteoporosis etc 30 % of patients with UC require systemic steroids. 54% achieve complete remission 16% of oral steroid treated patients do not respond

14. Steroids If use then have to use properly Use proper doses. Use for proper length of time Less effective than mesalazine in treating local disease

15. Azathioprine

19. Azathioprine in Clinic Patients properly consented and have TPMT measured Treatment ideally initiated after TPMT result Patients have blood tests done in strict protocol. Patients are rung if blood tests are not OK. Also patients “reminded” if miss blood tests Dedicated answer phone for patients to ring if they are having problems New shared care agreement

20. Methotrexate Similar idea to Azathioprine Only proven effect in Crohn’s disease Only trial evidence of effect with weekly im injection Needs regular monitoring Logistically more difficult ?May need liver biopsy after 4g

21. Chronic IBD clinic Again run by Vanessa Cambridge Patients with stable IBD Run alongside Consultant Gastroenterologist Frees up space in consultant clinic Protocols for monitoring blood tests, Screening colonoscopy etc High degree of patient satisfaction

23. Inflammatory Bowel Disease- Modern Treatments Dr John Linehan Royal United Hospital Bath

24. Tumour Necrosis Factor Produced by stimulated immune cells Found in raised quantities in Crohns Disease & UC Necrosis of tumours Essential for defense against intracellular pathogens Pro inflammatory- produces shock and tissue damage if over produced

25. Infliximab IgG1 antibody Chimera Humanised Antigenic

31. ACCENT 1 study, Hanauer, Lancet 2002 Long term use of Infliximab Relapse after single dose ~19 weeks 0,2,6,week induction, 8 week maintenance

33. Long term use of Infliximab ACCENT 1

34. Long term use of Infliximab PROBLEMS Antibodies Infusion reactions Side effects Cost Long term results

35. Antibodies (Baert, 2003) on demand treatment

36. Immune suppression reduces anti-Infliximab antibody formation (Baert NEJM 2003)

37. Prevention of infusion reactions 32% , reduces to 8% on steroids and immunosuppressants Paracetamol / Diphenhydramine H1 and H2 antagonists Prednisolone 40mg 3 days before infusion Hydrocortisone100mg IV before infusion Maintenance, not on relapse

38. COST Induction + maintenance 1 year (5mg/Kg dose) Ł10,000 UK 16,000 Euros $16,000

39. New kids on the block Adalumibab (anti TNF) Certolizumab (PEG Anti TNF) Natalizumab Basiliximab Fontolizumab Tocilizumab, Visilizumab, daclizumab etc

40. Adalimumab Fully humanised Therefore less antibodies Maybe more effective for longer ~50% effective in patients Injections can be done at home. Recently NICE approved Originally used in patients who have responded to infliximab initially but then side effects or lack of effect Slightly cheaper

41. Conclusions: New Immunological Therapies Now lots of patients treated Only tried in difficult patient groups Good success in treatment of difficult conditions e.g. Crohn's fistulae Mechanisms better understood Expensive

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