CCFA. Crohns Disease vs UC: What is the best treatment for me? November

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1 CCFA Crohns Disease vs UC: What is the best treatment for me? November Ellen J. Scherl,, MD, FACP,AGAF Roberts Inflammatory Bowel Disease Center Weill Medical College Cornell University New York Presbyterian Hospital

2 Early intervention Steroids vs combo MTX vs 6MP/AZA

3 For patients with moderrate to severe CD, current ACG guidelines advocate starting with Anti tnf Prednisone Mtx Aza/6mp

4 Do you have active inflammation? Bacterial Overgrowth Bile Salt Diarrhea Overlap with Celiac/gluten sensitivity Lactose intolerance Fructose intolerance Obstructing /Non-inflammatory Crohn s stricture

5 X-RAY APPEARANCE OF ILEITIS

6

7 Is the inflammation mild? Colitis: Optimize mesalamine dose and delivery Crohns: Do not forget antibiotics What are you eating? What is the role of hydration, excersize, smoking? Are you using over the counter aspirin, NSAIDs?

8 Is your inflammation moderate or severe? Are steroids for you? What are the adverse events? What are your options?

9 Is your inflammation moderate or severe? Consider steroids? Short term vs long term Consider 6MP/AZA/MTX? When Cyclosporine? Anti TNF? Tysabri/Natalizumab? Surgery? Study?

10 Challenge your diagnosis:consider Pseudorefractory Colitis Wrong Diagnosis Left-sided Crohn s colitis /Colitis with proximal disease Ischemia Periappendiceal red patch Deep Ulcers:?CD Partially treated colitis: Patchy disease Rectal sparing in UC Common Variable Immunodeficiency (Absence of plasma cells) Concurrent Infection C difficile CMV

11 Relationship of C. difficile and IBD Altered flora, C. difficile overgrowth leads to chronic inflammation in susceptible hosts Patient with IBD has altered immune system response, susceptibility to C. difficile flare of disease Patient with IBD receives therapy, altered flora, C. difficile as a complication

12 Early Intervention: Patient selection

13 The greatest challenge for clinicians is moving from symptom-oriented(stepup)strategies to proactive prevention-oriented (early intervention) strategies.

14 Current Step-Up Approach to IBD Therapy Severe Biologicals Infliximab Others Surgery/ Bowel Rest Moderate Corticosteroids Budesonide AZA/6-MP/MTX Mild Antibiotics Aminosalicylates AZA = azathioprine; 6-MP = mercaptopurine; MTX = methotrexate.

15 Reasons for Inverting the Pyramid in the Medical Treatment of Crohn s Disease 1. 70% require surgical resection within 20 years of diagnosis 2. 50% of these require additional surgery. 3. Sulfasalazine and mesalamine are marginally effective for reducing and maintaining remission. 4. Systemic steroids are highly effective for inducing but not maintaining remission and carry significant toxicity. 5. Immunosuppressives are slow to act. 6. Infliximab may cause rapid reduction of remission and long term remission which includes mucosal healing.

16 Behavior of Crohn s Disease Over Time 100 Free of penetrating complication Cumulative Probability (%) Inflammatory Free of stricturing and/or penetrating complications Penetrating Stricturing Patients at risk: N = Months Cosnes J, et al. Inflamm Bowel Dis. 2002;8:

17 Are steroids effective in CD? Do steroids maintain remission? Immediate Outcome* (n = 74) Complete Remission 58% (n = 43) Partial Remission 26% (n = 19) No Response 16% (n = 12) 1-Year Outcome (n = 73**) Prolonged Response 32% (n = 24) Steroid Dependent 28% (n = 21) Surgery 38% (n = 28) Faubion W et al. Gastroenterology. 2001;121:255. *30 d after initiating corticosteroid therapy. **1 patient lost to follow-up.

18 Increasing Use of Immunomodulators Patients Receiving an Immunomodulator* (%) *Azathioprine or methotrexate. Cosnes J, et al. Gut. 2005;54: (n=34) (n=46) (n=102) (n=176) (n=207) Months After Diagnosis P<0.0001

19 Intestinal Resection Rate in Crohn s Disease Remained Stable Over 25 Years Number of Intestinal Resections/100 Patients Surgery <3 months after diagnosis Surgery >3 months after diagnosis No significant change over time Numbers above bars represent number of patients at risk for intestinal resection at beginning of the year. Cosnes J, et al. Gut. 2005;54:

20 Combination vs Monotherapy Although the combination of an imm with antitnf reduces immunogenicity and increases serum concentrations, the risk benefit of combination therapy in light of recent reports of HST-cell Lymphomas in young males receiving combination therapy has led to re-evaluation of recommendations for concurrent immunomodulatory therapy with anti-tnfs. ACG Practice Guidelines Feb 2009

21 One Year Data from the SONIC Study: A Randomized, Double-Blind Trial Comparing Infliximab and Infliximab plus Azathioprine to Azathioprine in Patients with Crohn s Disease Naive to Immunomodulators and Biologic Therapy 21 William Sandborn, MD; Paul Rutgeerts, MD; Walter Reinisch, MD; Gerassimos Mantzaris, MD; Asher Kornbluth, MD; Daniel Rachmilewitz, MD; Simon Lichtiger, MD; Geert D Haens, MD; C Janneke van der Woude, MD; Robert Diamond, MD; Delma Broussard, MD; Ronald Hegedus; Jean Frederic Colombel, MD Gastroenterology. 2009; 136 (5): Suppl 1. A-116.

22 SONIC Study Design 22 Main Extension Visits Week 0* Week 2 Week 6 Week 10 Week 14 Week 18 Week 22 Week 26* Week 30 Week 34 Week 38 Week 42 Week 46 Week 50 Week 54 Randomization of patients Azathioprine 2.5 mg/kg Infliximab 5 mg/kg Infliximab 5 mg/kg + placebo + Azathioprine + placebo capsules infusions 2.5 mg/kg Primary Endpoint (Corticosteroid-free Remission at Week 26) * Endoscopy performed at Weeks 0 & 26 Secondary Endpoint (Week 50) Sandborn, WJ et al. Gastroenterology. 2009; 136 (5): Suppl 1. A-116.

23 SONIC 23 Clinical Remission Without Corticosteroids at Week 26 Primary Endpoint 100 p<0.001 Proportion of Patients (%) p= p= /170 75/169 96/169 AZA + placebo IFX + placebo IFX+ AZA Sandborn, WJ et al. Gastroenterology. 2009; 136 (5): Suppl 1. A-116.

24 SONIC 24 Corticosteroid-Free Clinical Remission at Week 26 by Baseline CRP 100 Proportion of Patients (%) p=0.121 p<0.001 p=0.503 p=0.314 p=0.004 p= /71 27/67 35/69 27/98 48/101 61/96 CRP < 0.8 mg/dl (n=207) CRP >= 0.8 mg/dl (n=295) AZA+ placebo IFX + placebo IFX + AZA Sandborn, WJ et al. ACG 2008.

25 SONIC Complete Mucosal Healing at Week Proportion of Patients (%) p=0.023 p< p= /109 28/93 47/107 AZA + placebo IFX + placebo IFX+ AZA Sandborn, WJ et al. DDW 2009.

26 SONIC Summary of Adverse Events Through Week 50 All Randomized Patients 26 AZA + placebo (n=161) IFX + placebo (n=163) IFX + AZA (n=179) Pts with 1 AE, n (%) 144 (89.4%) 145 (89.0%) 161 (89.9%) Pts with 1 SAE, n (%) 43 (26.7%) 39 (23.9%) 27 (15.1%) Serious infections 9 (5.6%) 8 (4.9%) 7 (3.9%) Sandborn, WJ et al. Gastroenterology. 2009; 136 (5): Suppl 1. A-116.

27 SONIC 27 Conclusions Week 50 results were similar to what was observed at Week 26 Infliximab monotherapy was superior to azathioprine monotherapy Infliximab/AZA combination therapy, when started together in naïve patients, was superior to AZA and infliximab monotherapy Patients with clear evidence of active inflammation had a particularly strong benefit from an infliximab-based regimen The safety profile was similar between patients treated with AZA, IFX, and the combination AZA/IFX regimen Sandborn, WJ et al. Gastroenterology. 2009; 136 (5): Suppl 1. A-116.

28 Stratifying Responders Before you treat with biologic (monotherapy or combination) make sure there is inflammation: CRP Endoscopic evidence Biomarker of inflammation: Fecal Calprotectin

29 AGA Medical Position Statement for IBD Mild to Moderate Mesalamine Topical budesonide or hydrocortisone for distal colonic inflammation Moderate to Severe Oral corticosteroids if failure to respond to mesalamine and other first line therapies for CD or UC AZA or 6-MP should be considered for pts with a severe flare of disease requiring one or more courses of corticosteroids for CD or UC Infliximab for pts who do not respond to conventional therapy for UC and CD Severe and Fulminant Parenteral corticosteroids for severe UC and CD IV cyclosporine to avoid surgery in patients with severe, corticosteroidrefractory UC Oral cyclosporine in steroid refractory UC pts, but requires AZA and 6-MP for maintenance of remission Lichtenstein G et al, Gastroenterol. 2006;130:

30 What if I have Ulcerative Colitis?

31 Reasons for Inverting the Pyramid in the Medical Treatment of Crohn s Disease 1. 70% require surgical resection within 20 years of diagnosis 2. 50% of these require additional surgery. 3. Sulfasalazine and mesalamine are marginally effective for reducing and maintaining remission. 4. Systemic steroids are highly effective for inducing but not maintaining remission and carry significant toxicity. 5. Immunosuppressives are slow to act. 6. Infliximab may cause rapid reduction of remission and long term remission which includes mucosal healing.

32 UC Disease Severity: Copenhagen County, 1962 to 1987 Patients With UC (N = 1,161) 100% 80% 60% 40% 20% 0% Fulminant Disease (9%) Moderate to Higher Activity (71%) Low Activity (20%) Disease Activity Langholz EP, et al. Scand J Gastroenterol. 1991;26:

33 UC: Natural History* Percent of Patients 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Years After Diagnosis Colectomy Disease activity Remission * Percent of patients with disease activity, in remission, or having colectomy performed each year after diagnosis Langholz E, et al. Gastroenterology. 1994;107:3.

34 Natural Course of UC Proctitis Left-Sided Pancolitis Regression Progression Surgery a Langholz, et al. Scand J Gastroenterol. 1996;31:260.

35 IBD Treatment Pyramid

36 32 yo man with 15 yr hx of Crohn s stricturing ileitis. C/o continued intermittent RLQ pain bloating nausea and inability to gain weight despite current meds Vit B12 Deficincy on AZA and budesonide. No response to Pentasa SBS: Short segment stricturing Crohn s ileitis Reluctant to consider antitnf or surgery

37 X-RAY APPEARANCE OF ILEITIS

38 Nutrition and IBD Nutrition Consultation reveals: Patient is afraid to eat during day because of pain. When he returns from work he eats a large meal,then goes to sleep he is typically awakened from sleep with abd pain (4 AM) He is advised to eat small meals and nothing 2-3 hrs before bed. Improves, gains weight, avoids surgery

39 AGA Medical Position Statement for IBD Mild to Moderate Mesalamine Topical budesonide or hydrocortisone for distal colonic inflammation Moderate to Severe Oral corticosteroids if failure to respond to mesalamine and other first line therapies for CD or UC AZA or 6-MP should be considered for pts with a severe flare of disease requiring one or more courses of corticosteroids for CD or UC Infliximab for pts who do not respond to conventional therapy for UC and CD Severe and Fulminant Parenteral corticosteroids for severe UC and CD IV cyclosporine to avoid surgery in patients with severe, corticosteroidrefractory UC Oral cyclosporine in steroid refractory UC pts, but requires AZA and 6-MP for maintenance of remission Lichtenstein G et al, Gastroenterol. 2006;130:

40 IBD Treatment Pyramid

41 Functional Short Gut

42 Early Intervention: Patient selection

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