Dr David Epstein Vincent Pallotti Hospital and University of Cape Town

Transcription

1 Inflammatory Bowel Disease Management in South Africa in 2016 Pharmaceutical Care Management Association Dr David Epstein Vincent Pallotti Hospital and University of Cape Town

2 Inflammatory Bowel Disease 1. IBD What do we know about IBD in SA? 3. Challenges Treating Crohn s disease in Monitoring patients on treatment 5. Crohn s treatment in SA. Are we getting it right?

3 What is inflammatory bowel disease or IBD? Inflammation of the gastrointestinal tract Affects young people Cause unknown 2 overlapping conditions Crohn s disease and ulcerative colitis

4 Only affects the colon or large intestine Ulcerative causes ulcers Colitis inflammation of the colon which is superficial Always involves the rectum or lowest part of the colon Can involve the whole colon Ulcerative colitis

5 Crohn s disease Crohn s after Dr. Burill Crohn Can affect any part of the digestive system from mouth to anus and this can be patchy. Often involves the last part of the small intestine. Has the tendency to burrow outside the intestine or colon causing an abscess or fistula. Terminal ileum and caecum

6 Symptoms of IBD Gradual onset and symptoms may wax and wane Abdominal pain / cramps Diarrhoea (or Constipation) Blood or mucus in the stool Loss of weight Fatigue

7 Inflammatory Bowel Disease (IBD) vs. Irritable Bowel Syndrome (IBS) Irritable Bowel Syndrome Common in young people Functional problem Some symptoms may be similar NO inflammation present NO surgery required Benign condition Do not confuse Inflammatory Bowel Disease (IBD) with Irritable Bowel Syndrome (IBS)

8 What causes Inflammatory bowel disease? Genetic makeup Bacteria in our colon and intestines Overactive and misdirected immune system Lifestyle and environment

9 Inflammatory Bowel Disease under the microscope Digested food and Bacteria Intestine or Colon Lining Happy Immune Cells

10 Normal Colon and Intestine Colon Intestine

11 Inflammatory Bowel Disease under the microscope Digested food and Bacteria Intestine or Colon Lining Tumour necrosis factor α Angry Immune Cells

12 Inflammation Ulcerative Colitis Crohn s Disease

13 Extra-Intestinal Manifestations of IBD Anaemia and iron deficiency Osteoporosis Arthritis Liver problems Other autoimmune conditions

14 Complications after years of disease Ulcerative Colitis Colon Cancer Crohn s disease Fistula or abscess Primary sclerosing cholangitis Osteoporosis Strictures Narrowing in the intestine due to inflammation or scarring blockage

15 Diagnosing IBD Think about IBD! Stool tests Calprotectin Exclude infections Blood tests Anaemia (Haemoglobin) High levels of inflammation (CRP & ESR) Endoscopy Colonoscopy with biopsies Radiology X-rays of the abdomen CT scan of the abdomen MRI scans of the intestine

16 2. What do we know about IBD in South Africa?

17 Epidemiology of IBD in Cape Town Was considered a disease of affluence in South Africa Groote Schuur Hospital UC patients 60% white Crohn s patients 72% white Wright J et al S Afr Med J Feb 12;63(7):226-9

18 New IBD Cases Diagnosed Annually Groote Schuur Hospital + 5 private practice audits

19 New IBD Cases Diagnosed Annually: (Groote Schuur Hospital & 5 private practice audits) UC CD 10 0

20 IBD in Children and Adolescents Age At Diagnosis September Diagnosis < 30 years Diagnosis < 17 years Diagnosis < 10 years % CD 1.0% 5.7% UC 0.9%

21 Gender Differences vs. Ethnicity n = 2,981 January % of IBD patients are Coloured Coloured women are largest IBD demographic at 24% UC CD UC CD UC CD UC CD Coloured White Black Asian * Cape Coloureds are subjects of mixed-ancestry. The term which is non-derogatory refers to a heterogeneous ethnic group of which genome analysis has now identified South Asian, European, Indonesian and isixhosa sub-saharan blacks as the four predominant genetic contributors. 4

22 IBD Epidemiology in SA Increasing IBD Affecting all communities in SA Opportunity to study SA regional and ethnic differences Genetics Environment Southern Africa

23 3. Challenges in Treating Crohn s Disease in South Africa in 2016 Delay in diagnosis Treatment goals have changed Choosing the right drug, for the right patient at the right time Monitoring, Monitoring, Monitoring Who is responsible for successful treatment outcome? Doctor Patient Funder Pharmaceutical industry

24 Five years of symptoms at diagnosis Symptoms controlled with intermittent steroids Long stricture after 6 years Large abscess 6 years after last operation Well after surgery, no treatment for 4 years

25 Medication Used in IBD 1. Antibiotics Ciprofloxacin Metronidazole 2. Steroids Prednisone, Meticorten Entocort Hydrocortisone 3. Aminosalicylates Salazapyrine, Asacol, Pentasa Mezvant, Salofalk Granules 4. Immunomodulators Azapress, Azamun Imuran Puri-Nethol Methotrexate 5. Biological Drugs Revellex Humira Entyvio Biosimilars 6. Exclusive enteral nutrition Modulen IBD Not funded

26 Diagnosis Delay in IBD 1 gastroenterologist per 602,045 population Surgeons Physicians GPs 2008 Endoscopy unit audit Western Cape Health Dept. 5.8 million people 75% rely on public health services 89 endoscopes Procedure waiting time 8 to 9 weeks Watermeyer GA et al S Afr J Surg 2008

27 Symptom duration in months Duration of Symptoms at Diagnosis April years Delayed diagnosis associated with complicated disease course and high rates of surgery * years 5 CD UC CD UC 0 Mean Median * Schoepfer et al Am J Gastroenterol 2013

28 Duration of Symptoms at Diagnosis vs Surgery in Crohn s Disease No of patients per symptom group No of patients requiring surgery Early Diagnosis Delayed Diagnosis 21% 16% 25%% <3 3 to 6 6 to 12 > 12 34% Duration of Symptoms in Months

29 The goals of treatment in IBD have evolved in recent years Symptomatic benefit Steroid-free remission Mucosal healing Reduced hospitalisation and surgery Prevention of disability

30 Choosing the right drug for the right patient at the right time Identify Crohn s patient who will have aggressive, disabling disease Young age at diagnosis Weight loss Require steroids Extensive disease (colon and small intestine) Upper gastrointestinal tract disease Penetrating disease i.e fistulas and abscesses Smokers Research: genetics, inflammatory profile, etc etc

31 Choosing the right drug, for the right patient at the right time

32 Choosing the right drug in Crohn s Disease One size fits all Step Up Approach Most Effective Treatment risks Expensive Low efficacy Low toxicity Cheap Surgery Biological Rx as last resort Immuno-modulators only after repeated flares Steroids with flares of disease Regular Aminosalicylates Antibiotics Treatment level according to patient symptoms

33 Digestive damage Cumulative Irreversible Damage Over Time After 20 years 88% of Crohn s patients will have permanent damage to their colon/ intestine Stricture Surgery Stricture Fistula/abscess Inflammatory activity (CDAI, CDEIS, CRP) Disease onset Pre-clinical Diagnosis Early disease Clinical Pariente B, et al. Inflammatory Bowel Diseases 2011;17:

34 Paradigm Shift: Top Down Identify patients for a aggressive treatment at diagnosis to prevent damage and disability Biologicals alone or in combination with immuno-modulators Cost Steroids Salicylates Antibiotics

35 Paradigm Shift: Top Down Rapid remission with healing of the intestine/ colon lining preventing permanent damage Avoid steroids side effects and complications Salicylates & Antibiotics not required

36 Choosing the right drug, for the right patient at the right time

37 Remission at 1 year (%) Start anti-tnfs early in appropriate patients anti-tnf therapy is most effective in early disease SUTD REACH SONIC Treating patients early with biological drugs results in better treatment outcomes 40 CHARM CHARM ACCENT I CHARM subanalysis Disease duration (years) D Haens G, et al. Lancet 2008;371:660 67; Hyams et al. Gastroenterology 2007;132(3):863 73; Sandborn WJ, N Engl J Med ;15; Hanauer S, et al. Lancet 2002;359: ; Schreiber S, et al. Gastroenterol 2007;132(4 Suppl 2):A-147; Colombel JF, et al. Gastroenterology 2007;132:52 65.

38 Monitoring, Monitoring, Monitoring Crohn s Flare Patient Sick Mucosal damage Smoldering Crohn s Patient may be well Mucosal damage Symptoms Blood tests Drug levels Stool tests = Calprotectin Colonoscopy + Scans Mucosal Healing Patient well

39 Treatment Data from the SA IBD Registry

40 Immune Suppression in CD n = 1129 patients May *Healing intestine & colon *Steroid sparing *Prevent damage 42% Total CD 8% AZA / MTX Anti-TNF

41 Why so few patients on biological therapy? Gastroenterologists 88 gastroenterologists South Africa 35 have prescribed a biological Industry - 15 regular prescribers Funding Issues Limited availability in public sector Limited funding by medical schemes Other reasons????

42 Is biological therapy cost effective? Biological therapy Drug costs $$$$ Reduced admissions Reduced surgery Quality of life good Productive member of society No biological therapy Drug costs $ Frequent admissions $$$ Surgery required $$$$ Poor quality of life Disability

43 Inflammatory Bowel Disease Inflammation of the gut Young people Chronic illness The face of IBD is changing in SA More patients every year Affecting all communities Affecting all ethnic groups Conclusions Treatment Diagnose early Early, aggressive & expensive therapy in appropriate patients Monitor response to treatment and put out that smoldering fire Challenges Limited use of drugs which have the greatest impact on the disease Reasons multifactorial

44 The way forward Doctors Treatment of patients we need to do better Need to use guidelines, locally relevant, financially sustainable Cost containment Funders Understanding of the disease Support evidenced based therapies Work with clinicians to achieve common goals IBD patients with well controlled disease, free of complications and enjoying good quality of life

45 I don t need treatment, I m coping fine

46 Thank You