The Crohn’s Disease-Ulcerative Colitis Clinical AppraisalPart II

Academic Content

Publication Overview Introduction Navigating this Publication See Part I

Step 1 -

Rationale and Definition

Step 2 -

International Clinician Survey Results

Step 3 -

Data Review and Faculty Summary

Step 4 -

International and Faculty Survey Comparison and Faculty Discussion

Step 5 -

Dr. Peyrin-Biroulet’s Observed Future Directions and References

Faculty Presentations

Statement 1 Statement 2 Statements
3a and 3b Statement 4 Statement 5 Statement 6 Statement 7 Statement 8

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Clinical Gastroentrology and Hepatology

Dr. Peyrin-Biroulet’s Observed Future Directions

A large, statistically powered, prospective, cross-sectional, observational cohort addressing the issues presented is needed. The IBD CAncer and seRious infections in Europe (ICARE) project²⁰ is a European prospective observational multicenter cohort study that will enroll an estimated 17,600 IBD patients to prospectively assess the presence and extent of safety concerns (cancers; specifically, lymphoma, and serious infections) associated with anti-TNF monotherapy or combination therapy with anti-TNF agents and thiopurines. The first IBD patient was enrolled into the ICARE prospective cohort study in September 2015.

References

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[2]

Dulai PS, Siegel CA. The risk of malignancy associated with the use of biological agents in patients with inflammatory bowel disease. Gastroenterol Clin North Am. 2014;43:525-541.

[3]

Toruner M, Loftus EV, Jr., Harmsen WS, et al. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology 2008;134:929-936.

[4]

Fidder H, Schnitzler F, Ferrante M, et al. Long-term safety of infliximab for the treatment of inflammatory bowel disease: A single-centre cohort study. Gut 2009;58:501-508.

[5]

Jones J, Kaplan GG, Peyrin-Biroulet L, et al. Impact of concomitant immunomodulator treatment on efficacy and safety of anti-TNF therapy in Crohn's disease: A meta-analysis of placebo controlled trials with individual patient-level data. Gastroenterology 2013;144(5 Suppl 1):S-179. Abstract 979.

[6]

Jones JL, Kaplan GG, Peyrin-Biroulet L, et al. Effects of concomitant immunomodulator therapy on efficacy and safety of anti-tumor necrosis factor therapy for Crohn's disease: A meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2015;13:2233-2240.

[7]

Lichtenstein GR, Diamond RH, Wagner CL, et al. Clinical trial: Benefits and risks of immunomodulators and maintenance infliximab for IBD-subgroup analyses across four randomized trials. Aliment Pharmacol Ther. 2009;30:210-226.

[8]

Lichtenstein GR, Rutgeerts P, Sandborn WJ, et al. A pooled analysis of infections, malignancy, and mortality in infliximab- and immunomodulator-treated adult patients with inflammatory bowel disease. Am J Gastroenterol. 2012;107:1051-1063.

[9]

Marehbian J, Arrighi HM, Hass S, et al. Adverse events associated with common therapy regimens for moderate-to-severe Crohn's disease. Am J Gastroenterol. 2009;104:2524-2533.

[10]

Deepak P, Stobaugh DJ, Ehrenpreis ED. Infectious complications of TNF-alpha inhibitor monotherapy versus combination therapy with immunomodulators in inflammatory bowel disease: Analysis of the Food and Drug Administration Adverse Event Reporting System. J Gastrointestin Liver Dis. 2013;22:269-276.

[11]

Beaugerie L, Brousse N, Bouvier AM, et al; CESAME Study Group. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet 2009;374:1617-1625.

[12]

Peyrin-Biroulet L, Khosrotehrani K, Carrat F, et al. Increased risk for nonmelanoma skin cancers in patients who receive thiopurines for inflammatory bowel disease. Gastroenterology 2011;141:1621-1628.

[13]

Siegel CA, Marden SM, Persing SM, et al. Risk of lymphoma associated with combination anti-tumor necrosis factor and immunomodulator therapy for the treatment of Crohn's disease: A meta-analysis. Clin Gastroenterol Hepatol. 2009;7:874-881.

[14]

Lichtenstein GR, Feagan BG, Cohen RD, et al. Drug therapies and the risk of malignancy in Crohn's disease: results from the TREAT™ Registry. Am J Gastroenterol. 2014;109:212-223.

[15]

Osterman MT, Sandborn WJ, Colombel JF, et al. Increased risk of malignancy with adalimumab combination therapy, compared with monotherapy, for Crohn's disease. Gastroenterology 2014;146:941-949.

[16]

Deepak P, Sifuentes H, Sherid M, et al. T-cell non-Hodgkin's lymphomas reported to the FDA AERS with tumor necrosis factor-alpha (TNF-alpha) inhibitors: results of the REFURBISH study. Am J Gastroenterol. 2013;108:99-105.

[17]

Long MD, Martin CF, Pipkin CA, et al. Risk of melanoma and nonmelanoma skin cancer among patients with inflammatory bowel disease. Gastroenterology 2012;143:390-399.

[18]

McKenna MR, Stobaugh DJ, Deepak P. Melanoma and non-melanoma skin cancer in inflammatory bowel disease patients following tumor necrosis factor-alpha inhibitor monotherapy and in combination with thiopurines: Analysis of the Food and Drug Administration Adverse Event Reporting System. J Gastrointestin Liver Dis. 2014;23:267-271.

[19]

Magro F, Peyrin-Biroulet L, Sokol H, et al. Extra-intestinal malignancies in inflammatory bowel disease: results of the 3rd ECCO Pathogenesis Scientific Workshop (III). J Crohns Colitis 2014;8:31-44.

[20]

ClinicalTrials.gov IBD Cancer and Serious Infection in Europe (I-CARE). NCT02377258. Last updated April 26, 2015. Available at https://clinicaltrials.gov/ct2/show/NCT02377258. Accessed March 4, 2016.

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