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Miguel Regueiro, M.D. Professor of Medicine Associate Chief for Education

Pro: Perioperative anti-TNF Biologics are safe and do not increase complications associated with surgery. . Miguel Regueiro, M.D. Professor of Medicine Associate Chief for Education Clinical Head and Co-Director, IBD Center University of Pittsburgh School of Medicine.

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Miguel Regueiro, M.D. Professor of Medicine Associate Chief for Education

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  1. Pro: Perioperative anti-TNF Biologics are safe and do not increase complications associated with surgery. Miguel Regueiro, M.D. Professor of Medicine Associate Chief for Education Clinical Head and Co-Director, IBD Center University of Pittsburgh School of Medicine

  2. Probability of using IMM before 1stabd surgery (n=296) Peyrin-Biroulet L et al. Gut 2011

  3. Probability of receiving at least 1 antiTNF before 1st surgery (296) Peyrin-Biroulet L et al. Gut 2011

  4. This means that most IBD patients undergoing surgery are taking an IMM and/or antiTNF If it’s an emergent surgery, we don’t have much choice on altering pre-op meds. Should the type of operation be altered? If the surgery is elective: Should we alter pre-op meds? Is starting an antiTNF in the postop setting safe?

  5. Dr Remzi will argue that peri-operative antiTNF is unsafe As you may know, there’s a bit of a rivalry between Pittsburgh and Cleveland

  6. Pittsburgh vs Cleveland

  7. Despite the intercity rivalry, I have the utmost respect for Dr Remzi and the Cleveland Clinic In reality, our hospitals and cities are quite similar

  8. UPMC and Pittsburgh on a typical summer morning

  9. Cleveland Clinic on that same, bright summer morning

  10. A Tale of Two Cities – a surgeon’s perspective on postop outcome • 27 yo CD from Youngstown OH sees Dr Regueiro in Pittsburgh on AZA/ADA • Develops SBO while in Cleveland and requires emergent surgery w Dr Remzi • Scenario 1: dc’d 4 days later, “great!” – Dr Remzi – “I am a brilliant surgeon!!” • Scenario 2: POD 2 develops an anast leak – Dr Remzi – “it’s all because of those poisons Dr Regueiro was giving you!”

  11. Three Scenarios to Consider • PRE-operative antiTNF for CROHN’S disease and POST-op complications • PRE-operative antiTNF for ULCERATIVE COLITIS disease and POST-op complications • POST-operative antiTNF for CROHN’S disease and POST-op complications

  12. PRE-operative antiTNF for CROHN’S disease and POST-op complications What are the data?

  13. 9 Crohn’s ds Postop References • Tay et al. Surgery 2003 • Marchal et al. Aliment Pharmacol Ther 2004 • Colombel et al. Am J Gastroenterol 2004 • Appau et al. J Gastrointest Surg 2008 • Indar et al. World J Surg 2009 • Canedo et al. Colorectal Dis 2011 • Nasir et al. J Gastrointest Surg 2012 • Kasparek et al. Inflamm Bowel Dis 2012 • Kopylov et al. Inflamm Bowel Dis 2012

  14. Tay – Multivariate analysis suggests improved perioperative outcome in CD pts receiving IMMs before resection • Overall, 11% Postop complications (5.6% on IMM, 25% not on IMM)

  15. Marchal – The risk of postop complications associated with IFX for CD: a controlled cohort study • 12.5% IFX vs 7.7% control: Early complication

  16. Colombel – Early postop complications are not increased in CD treated preop with IFX or IMM • Overall, 23 % postoperative complications

  17. Indar – Effect of periop IMM/TNF on early outcome in CD pts • Overall, 33% postoperative complications

  18. Canedo – Surgical resection in CD: is IMM associated with higher postop infxn rates?

  19. Nasir – Periop antiTNF does not increase the early postop complications in CD • Overall, 29% postoperative complications

  20. Kasparek – IFX does not affect postop complication rates in CD • Overall, 59% postoperative complications

  21. Appau – Use of IFX within 3 mos of IC resection IS associated with postop AEs..Dr Remzi is co-author...hmmmm…… • Overall, 72% postop complications

  22. Kopylov – AntiTNF and Postop complications in CD: Systematic Review and Meta-analysis - OR 1.7 (CI, .93-3.19) postop complications - Number Needed to Harm = 20

  23. ORs Overall Complications

  24. Risk of postop complications in CD – only one “Yes” Kopylov et al. IBD 2012

  25. PRE-operative antiTNF for ULCERATIVE COLITIS disease and POST-op complications What’s the data?

  26. UC Postop References • Selvasekar et al J Am Coll Surg 2007 • Schluender et al Dis Colon Rectum 2007 • Mor et al Dis Colon Rectum 2008 • Ferrante et al Inflamm Bowel Dis 2009 • Norgard et Aliment Pharmacol Ther 2012 • Yang et al Aliment Pharmacol Ther 2010 UC and CD Studies combined: • Kunitake et al J Gastrointest Surg 2008 • Waterman et al Gut 2012

  27. Selvasekar – Effect of IFX on short-term complications in pts undergoins operation for chronic UC – 62% complicaiton with IFX

  28. Mor – IFX in UC is associated with an increased risk of postop complications after restorative proctocolectomy • OR early complication IFX 3.54 (P = 0.004; 95% CI1.51-8.31). • OR sepsis IFX 13.8 (P = 0.011; 95% CI, 1.82-105) • OR late complication IFX 2.19 times (P = 0.08; 95% CI, 0.91-5.28)

  29. Norgard – Pre-op use of antiTNF and the risk of postop complications in pts with UC – a nationwide cohort study • 1226 UC pts – 199 IFX • Most underwent ileostomy (not IPAA) • OR reoperation 1.07 (95% CI: 0.71-1.59) • OR anastomosis leakage 0.52 (95% CI: 0.06-4.11) respectively

  30. Ferrante – Corticosteroids but not IFX increase short-term postop infectious complications in pts with UC

  31. Yang – Meta-analysis: pre-op IFX + short-term postop complications UC pts • short term infxn (NO) • 2. short term non infxn (NO) • 3. short term overall (YES)

  32. Periop antiTNF UC studies

  33. Is starting POST-op antiTNF within 1 mos of CD surgery safe? Postoperative infliximab is not associated with an increase in adverse events in Crohn's disease. Regueiro M, El-Hachem S, Kip K, et al. Dig Dis Sci. 2011 Dec;56(12):3610-5.

  34. No Difference in Adverse Events between Placebo and Infliximab (started within 4 wks of surgery)

  35. Is peri-op antiTNF Safe? Scorecard of Study Results

  36. What I do in practice?

  37. My Practice – periop management

  38. My Practice – periop management

  39. My Practice – periop management

  40. My Practice – periop management

  41. My Practice – periop management

  42. Summary Periop antiTNF • CD: antiTNF is not associated with increased risk when used in the perioperative period • UC: severity of ds is most associated with complications rather than antiTNF • 3 step IPAA being done anyway • Practically speaking: surgery should NOT be delayed because a patient is on antiTNF

  43. With that, I give you Dr Remzi

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