Evidence of Crohn s Disease. Case Presentation

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1 Witt Wait to Treat tutiled Until Endoscopic Evidence of Crohn s Disease Raymond Cross, MD, MS, AGAF Associate Professor of Medicine Director, IBD Program University of Maryland School of Medicine Co-Director, Digestive Health Center University of Maryland Medical Center Case Presentation 17 year old woman with obstructing ileal CD with upper tract t involvement thas been hospitalized twice for treatment of partial SBO Treated with oral 5-ASA and three courses of steroids Imaging demonstrates 5 cm stricture with wall enhancement, mesenteric adenopathy and proximal dilation 1

2 Both you and the patient agree to pursue surgery instead of medical therapy Rationale: 1. Proximal dilation suggests more severe fibrosis 2. Medical therapy unlikely to result in durable response 3. Anti-TNF therapy is associated with postoperative complications 4. Stricture is short 2

3 Long-Term Evolution of Crohn's Disease is Structural Damage Cumulative probability (%) Penetrating Inflammatory Stricturing Patients at risk: n= Cosnes et al, Inflamm Bowel Dis 2002 Months Probability of Surgery for Crohn s Disease Patients (%) Years After Diagnosis No Surgery 1 Surgery 2 Surgeries Munkholm, P, et al. Gastroenterology

4 What is the natural history of CD after ileocolonic resection and primary anastomosis? Natural History of CD After Surgery Prob bability of Recurrence Years Survival without endoscopic lesions Survival without symptoms Survival without surgery Rutgeerts P, et al. Gastroenterology

5 How Do We Manage CD Patients After Surgery? Can we predict who is more likely to have recurrence? How should patients be followed? When should colonoscopy be performed? Which if any medications should be given? How should endoscopic recurrence be managed? Risk Factors Associated with Postoperative CD Recurrence Patient Related Smoking Younger age at diagnosis Disease-Related Perforating > fibrostenotic Disease duration < 10 years Ileocolitis> liti ileitis iti > colitis Disease refractory to medical therapy Surgery-Related Ileocolonic anastomosis > ileal > ileostomy Kirsner s Inflammatory Bowel Diseases 6 th edition

6 Endoscopic Score Rutgeert s Endoscopic Score Description i0 No lesions i1 <5 aphthous lesions i2 >= 5 aphthous lesions with normal intervening mucosa or skip areas of larger lesions or lesions confined to the IC anastomosis (<1 cm in length) i3 diffuse aphthous hh ileitis ii with ihdiffusely inflamed mucosa i4 diffuse inflammation with already larger ulcers, nodules, and/or narrowing Rutgeerts P, et al. Gastroenterology 1990 Rutgeert s Endoscopic Score i0 i1 i2 i3 i4 6

7 Symptomatic Recurrence Based on Degree of Endoscopic Activity 1.2 Prob bability of Recurrence i0+i1 i2 i3 i Years Rutgeerts P, et al. Gastroenterology 1990 Summary of Postop RCTs 5-ASA, Nitroimidazoles, AZA/6-MP Postoperative Prevention RCTs Clinical Recurrence Endoscopic recurrence Placebo 25% 77% 53% - 79% 5 ASA 24% - 58% 63% - 66% Budesonide 19% - 32% 52% - 57% Nitroimidazole 7% - 8% 52% - 54% AZA/6MP 34% 50% 42 44% Regueiro M. Inflamm Bowel Dis

8 IFX Reduces Post-operative Recurrence after Intestinal Resection Endoscop pic Recurrence Rate Regueiro M, et al. Gastroenterology 2009 Endoscopic Recurrence: endoscopic scores of i2, i3, or i4 Endoscopic Recurrence: endoscopic scores of i2, i3, or i4 Placebo IFX % patients Endoscopic Grade by Individual Scores Infliximab (n=11) Placebo (n=13) Endoscopic grade 1 year after surgery 8

9 Risk of Post-Op Recurrence Low Moderate High No Meds Colonoscopy 6-12 months post-op 6MP or AZA ± metronidazoleole Anti-TNF Colonoscopy 6-12 months post-op No Recurrence Recurrence No Recurrence Recurrence Colonoscopy every 1-3 yrs Immunomodulator or anti-tnf Colonoscopy every 1-3 yrs anti-tnf or biologics Regueiro M. Inflamm Bowel Dis 2009 Long-standing <10yrs CD, Penetrating Stricture CD, 1 st disease, >=10 surgery, cm > or Stricture 2 inflammatory surgeries <10 cmcd Is treating patients with postoperative anti-tnf cost effective? 9

10 Early Postoperative IFX Treatment is More Effective AND Costly Decision analytic model comparing 5 strategies No treatment AZA Antibiotics Early IFX IFX for severe recurrence 1 year time frame Ananthakrishnan AN, et al. (2011) Am J Gastroenterol Tailored IFX for Patients with ER is More Cost Effective Ananthakrishnan AN, et al. (2011) Am J Gastroenterol 10

11 Cost-Effectiveness Analysis One Year After Surgery Strategy Costs Incr Cost QALY Change in QALYs $/QALY ICER No Rx $1, $2,321-5-ASA $5,904 $3, $6,921 - AZA $6,692 $ $7,792 $299,188 IFX $25,127 $18, $28,918 $1,831,912 Doherty GA, et al. (2012) Inflamm Bowel Dis Cost-Effectiveness Analysis 5 Years After Surgery Strategy Costs Incr Cost QALY Change in QALYs $/QALY ICER No Rx $6, $1,713-5-ASA $24,639 $18, $6,795 $244,177 AZA $43,709 $19, $12,182 (Dominated) IFX $112,165 $87, $306,131 $2,303,318 Doherty GA, et al. (2012) Inflamm Bowel Dis 11

12 For patients at very high risk for clinical recurrence, ABX, AZA, and tailored IFX use all dominated No Treatment. At this recurrence rate, the ICER associated with upfront IFX was $135,580 / QALY, which was still greater than the accepted WTP threshold, suggesting that upfront IFX in all patients is unlikely to be cost effective within the time horizon of our model even in high-risk patients. Why not wait until endoscopic or even en clinical recurrence until beginning treatment with an anti-tnf agent? 12

13 Rates of Mucosal Healing Based on Timing of Anti-TNF Treatment Sorrentino Regueiro Yoshida Fernandez-Blanco Mantzaris Yamamoto Regueiro2 Mantzaris2 Sorrentino2 SONIC ACCENT 1 MUSIC EXTEND of Patients with osal Healing Proportion Muco Impact of IFX on Early Endoscopic Lesions after Surgery Twenty six patients in clinical remission on mesalamine 3 g/day after resection with ER in the neoterminal ileum ( i2) 10 continued mesalamine 8 treated with AZA 50 mg/day 8 treated with IFX 5 mg/kg every 8 weeks Colonoscopy repeated 6 months later Yamamoto T, et al. (2009) Inflamm Bowel Dis 13

14 Clinical and Endoscopic Disease Activity 6 Months after Change in Rx Variable Mesalamine (n=10) AZA (n=8) IFX (n=8) P Clinical Recurrence Improvement in Endoscopic Inflammation Complete Mucosal Healing 7 (70%) 3 (38%) 0 (0%) (0%) 3 (38%) 6 (75%) (0%) 1 (13%) 3 (38%) 0.10 Yamamoto T, et al. (2009) Inflamm Bowel Dis Subsequent Analysis of Regueiro Study Only 22% of colonoscopies in patient taking IFX had endoscopic recurrence Regueiro M, et al. (2014) Clin Gastroenterol Hepatol 14

15 Long Term Rates of Surgery Do Not Differ Between IFX and Placebo 5 of 11 (46%) of IFX assigned patients underwent surgery compared to 6 of 13 (46%) placebo assigned patients Time to surgery was decreased in placebo treated patients (1058+/-529 vs /-359 days) Regueiro M, et al. (2014) Clin Gastroenterol Hepatol ADA for the Prevention and/or RX of Recurrent CD after Surgery Prospective, single center, open label study (n=23) Group I: ADA immediately after surgery Group II: ADA 6 months after surgery despite treatment with 5-ASA (n=2), AZA (n=10), or IFX (n=3) Ileocolonoscopy 6 and 24 months after surgery Papamichael K, et al. (2012) J Crohns Colitis 15

16 ADA Induces Endoscopic and Clinical Remission Post-Operatively 6 months after starting ADA 3 patients had a score of i0/i1, 10 had a score of i2, and 2 had a score of i3 24 months after starting ADA 9 patients (60%) had a score of i0 (n=3) or i1 (n=6) 6 patients (40%) had persistent disease (i2=5 and i3=1) 5 out of 9 patients with clinical disease activity achieved remission on ADA 2 required surgery Papamichael K, et al. (2012) J Crohns Colitis IFX is more Effective than 5-ASA for Treatment of Recurrence Prospective, open-label, multicenter study (n=43) Colonoscopy 6 months after resection Endoscopic recurrence (Rutgeert s score 2) Patients with recurrence received either mesalamine 800 mg TID or IFX 5 mg/kg q 8 weeks Colonoscopy repeated after 54 weeks therapy Sorrentino D, et al. (2012) Dig Dis Sci 16

17 Sorrentino D, et al. (2012) Dig Dis Sci Summary As personalized medicine evolves, risk/stratification of patients with CD after surgery will be more precise and drug selection will be vastly improved Decision about best approach after surgery should be individualized (shared decision making) Reserve anti-tnf agents for those at highest risk for recurrence Monitor anastomosis after surgery Initiate anti-tnf agent or other highly effective treatment for severe recurrence 17

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