Patients with Crohn disease (CD) should be seen by a gastroenterologist on a routine basis to monitor for complications and flares of the disease and adjust treatment accordingly. Patients with uncomplicated cases of CD need follow-up visits every 6 months, while those on azathioprine or mercaptopurine require visits on a 3-month basis. Telemedicine has also been shown to be a safe method of follow-up, which may minimize need for outpatient visits and help reduce hospital admissions.[308]de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, et al. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-68.
http://www.ncbi.nlm.nih.gov/pubmed/28716313?tool=bestpractice.com
[309]Gordon M, Sinopoulou V, Lakunina S, et al. Remote care through telehealth for people with inflammatory bowel disease. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014821.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD014821.pub2/full
http://www.ncbi.nlm.nih.gov/pubmed/37140025?tool=bestpractice.com
To minimize the risk of iatrogenic complications, guidelines recommend baseline blood-test screening prior to initiation of all non-nutritional treatments and regular monitoring, to exclude sepsis and pre-existing renal or liver impairment.[110]Torres J, Bonovas S, Doherty G, et al. ECCO guidelines on therapeutics in Crohn's disease: medical treatment. J Crohns Colitis. 2020 Jan 1;14(1):4-22.
https://academic.oup.com/ecco-jcc/article/14/1/4/5620479
http://www.ncbi.nlm.nih.gov/pubmed/31711158?tool=bestpractice.com
Drugs can cause nephrotoxicity or hepatotoxicity.
Particular mention should be made of immunomodulators (azathioprine, mercaptopurine, methotrexate, and tumor necrosis factor [TNF]-alpha inhibitors), which can produce life-threatening consequences if started without due caution.
Monitoring for patients treated with immunomodulators
Immunomodulators should never be started if there is any indication of sepsis. Before commencing azathioprine or mercaptopurine, it is advisable to measure the patient's blood thiopurine S-methyltransferase level to assess susceptibility to toxicity. Blood counts and liver function tests require close monitoring during treatment. Previous exposure to common viruses, such as varicella zoster (chickenpox), may be checked by antibody testing prior to initiation of azathioprine.[116]Bermejo F, Aguas M, Chaparro M, et al; en representación de GETECCU. Recommendations of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) on the use of thiopurines in inflammatory bowel disease. Gastroenterol Hepatol. 2018 Mar;41(3):205-21.
https://www.elsevier.es/en-revista-gastroenterologia-hepatologia-english-edition--382-articulo-recommendations-spanish-working-group-on-S2444382418300361
http://www.ncbi.nlm.nih.gov/pubmed/29357999?tool=bestpractice.com
Before commencing methotrexate, it is important to measure complete blood count and renal and liver function, and these should be monitored regularly while on treatment.
In patients who relapse on thiopurine maintenance therapy, thiopurine metabolite testing (6-thioguanine nucleotide [6-TGN] and 6-methylmercaptopurine [6-MMP]) can guide dose optimization and likelihood of side effects.[229]European Crohn's and Colitis Organisation. Thiopurines [internet publication].
http://www.e-guide.ecco-ibd.eu/interventions-therapeutic/thiopurines
Thiopurine metabolites can also be used to:[230]Lelay-Taha MN, Reveillaud I, Sri-Widada J, et al. RNA-protein organization of U1, U5 and U4-U6 small nuclear ribonucleoproteins in HeLa cells. J Mol Biol. 1986 Jun 5;189(3):519-32.
http://www.ncbi.nlm.nih.gov/pubmed/2946870?tool=bestpractice.com
Assess compliance to therapy
Detect sub/supra therapeutic dosing
Identify resistance to thiopurines or the need to add allopurinol (in patients who are hypermethylators of thiopurines), or
Investigate possible thiopurine side effects
The British Society of Gastroenterology suggests checking metabolites in patients with newly abnormal liver function tests or myelotoxicity, and using results to alter dosing (or stop the drug) as necessary.[70]Lamb CA, Kennedy NA, Raine T, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019 Dec;68(suppl 3):s1-106.
https://gut.bmj.com/content/68/Suppl_3/s1.long
http://www.ncbi.nlm.nih.gov/pubmed/31562236?tool=bestpractice.com
However, routine measurement of metabolites has not been shown to be beneficial, due to wide variations in levels reported.[231]Wright S, Sanders DS, Lobo AJ, et al. Clinical significance of azathioprine active metabolite concentrations in inflammatory bowel disease. Gut. 2004 Aug;53(8):1123-8.
https://gut.bmj.com/content/53/8/1123.long
http://www.ncbi.nlm.nih.gov/pubmed/15247179?tool=bestpractice.com
Prospective studies show a lack of clinical benefit.[232]González-Lama Y, Bermejo F, López-Sanromán A, et al. Thiopurine methyl-transferase activity and azathioprine metabolite concentrations do not predict clinical outcome in thiopurine-treated inflammatory bowel disease patients. Aliment Pharmacol Ther. 2011 Sep;34(5):544-54.
https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2011.04756.x
http://www.ncbi.nlm.nih.gov/pubmed/21722149?tool=bestpractice.com
[233]Reinshagen M, Schütz E, Armstrong VW, et al. 6-thioguanine nucleotide-adapted azathioprine therapy does not lead to higher remission rates than standard therapy in chronic active crohn disease: results from a randomized, controlled, open trial. Clin Chem. 2007 Jul;53(7):1306-14.
https://academic.oup.com/clinchem/article/53/7/1306/5627529
http://www.ncbi.nlm.nih.gov/pubmed/17495015?tool=bestpractice.com
[234]Dassopoulos T, Dubinsky MC, Bentsen JL, et al. Randomised clinical trial: individualised vs. weight-based dosing of azathioprine in Crohn's disease. Aliment Pharmacol Ther. 2014 Jan;39(2):163-75.
https://onlinelibrary.wiley.com/doi/10.1111/apt.12555
http://www.ncbi.nlm.nih.gov/pubmed/24237037?tool=bestpractice.com
Monitoring for patients treated with TNF-alpha inhibitors
TNF-alpha inhibitor agents are associated with an increased risk of developing tuberculosis (TB).[117]Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001 Oct 11;345(15):1098-104.
https://www.nejm.org/doi/full/10.1056/NEJMoa011110
http://www.ncbi.nlm.nih.gov/pubmed/11596589?tool=bestpractice.com
[310]Cao BL, Qasem A, Sharp RC, et al. Systematic review and meta-analysis on the association of tuberculosis in Crohn's disease patients treated with tumor necrosis factor-α inhibitors (Anti-TNFα). World J Gastroenterol. 2018 Jul 7;24(25):2764-75.
https://www.wjgnet.com/1007-9327/full/v24/i25/2764.htm
http://www.ncbi.nlm.nih.gov/pubmed/29991880?tool=bestpractice.com
Patients should be screened with a combination of history-taking, chest x-rays, an interferon-gamma release assay blood test, and/or a tuberculin skin test if deemed high risk. Reactivation of hepatitis B has been reported, with a theoretical risk of reactivation of hepatitis C; patients with CD should be tested for serologic markers of hepatitis B and hepatitis C before treatment is initiated.[120]Esteve M, Saro C, González-Huix F, et al. Chronic hepatitis B reactivation following infliximab therapy in Crohn’s disease patients: need for primary prophylaxis. Gut. 2004 Sep;53(9):1363-5.
https://gut.bmj.com/content/53/9/1363.long
http://www.ncbi.nlm.nih.gov/pubmed/15306601?tool=bestpractice.com
[121]Huang M, Huang L. Reactivation of hepatitis C viral infection after treatment with infliximab. J Clin Gastroenterol. 2014 Feb;48(2):189-90.
http://www.ncbi.nlm.nih.gov/pubmed/24247815?tool=bestpractice.com
In clinical practice, the same TB precautions are taken for those starting newer biologic agents as those starting TNF-alpha inhibitor therapies. This is despite the fact that data suggest that biologics have favorable safety profiles with low risk of adverse events.[110]Torres J, Bonovas S, Doherty G, et al. ECCO guidelines on therapeutics in Crohn's disease: medical treatment. J Crohns Colitis. 2020 Jan 1;14(1):4-22.
https://academic.oup.com/ecco-jcc/article/14/1/4/5620479
http://www.ncbi.nlm.nih.gov/pubmed/31711158?tool=bestpractice.com
Antibodies to TNF-alpha inhibitor therapies are a potential concern as they may lead to loss of clinical response and lower serum levels.[163]Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013 Jan;108(1):40-7.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3561464
http://www.ncbi.nlm.nih.gov/pubmed/23147525?tool=bestpractice.com
[164]Nielsen OH, Bjerrum JT, Seidelin JB, et al. Biological treatment of Crohn's disease. Dig Dis. 2012;30(suppl 3):121-33.
http://www.ncbi.nlm.nih.gov/pubmed/23295703?tool=bestpractice.com
Therapeutic monitoring of TNF-alpha inhibitors can be done by testing the serum level of circulating drug (trough level, taken before the next dose is due). This may allow dose adjustment if levels are too high. If levels are too low, additional testing for anti-TNF antibody levels can be done, where their presence may render any dose escalation futile and inadvisable and may encourage a switch to an alternative agent. This can be done in two groups of patients, those who lose response to TNF-alpha inhibitor treatment, and those who are maintained on treatment and could benefit from sustained treatment.
Guidelines do not recommend proactive therapeutic drug monitoring in those in clinical remission or for those who have lost response to a TNF-alpha agent.[110]Torres J, Bonovas S, Doherty G, et al. ECCO guidelines on therapeutics in Crohn's disease: medical treatment. J Crohns Colitis. 2020 Jan 1;14(1):4-22.
https://academic.oup.com/ecco-jcc/article/14/1/4/5620479
http://www.ncbi.nlm.nih.gov/pubmed/31711158?tool=bestpractice.com
[246]Feuerstein JD, Nguyen GC, Kupfer SS, et al. American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease. Gastroenterology. 2017 Sep;153(3):827-34.
https://www.gastrojournal.org/article/S0016-5085(17)35963-2/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/28780013?tool=bestpractice.com
Further research is required regarding the best method to measure TNF-alpha inhibitor levels, the reference standards, the accuracy for predicting clinical state, and clinically meaningful thresholds.[247]National Institute for Health and Care Excellence (UK). Therapeutic monitoring of TNF-alpha inhibitors in Crohn’s disease (LISA-TRACKER ELISA kits, IDKmonitor ELISA kits, and Promonitor ELISA kits). Feb 2016 [internet publication].
https://www.nice.org.uk/guidance/dg22
One trial compared proactive therapeutic drug monitoring (individualized, scheduled monitoring of serum drug levels) with standard infliximab therapy in patients with immune-mediated inflammatory diseases, including CD. Patients who received therapeutic drug monitoring were more likely to sustain disease remission compared with patients who received standard care (73.6% vs. 55.9%).[248]Syversen SW, Jørgensen KK, Goll GL, et al. Effect of therapeutic drug monitoring vs standard therapy during maintenance infliximab therapy on disease control in patients with immune-mediated inflammatory diseases: a randomized clinical trial. JAMA. 2021 Dec 21;326(23):2375-84.
https://jamanetwork.com/journals/jama/fullarticle/2787318
http://www.ncbi.nlm.nih.gov/pubmed/34932077?tool=bestpractice.com
The National Institute for Health and Care Excellence in the UK has evaluated a commercially available enzyme-linked immunosorbent assay (ELISA) as a technology for this purpose for centers where TNF levels and antibody levels are performed.[249]National Institute for Health and Care Excellence (UK). RIDASCREEN tests for monitoring infliximab in inflammatory bowel disease. Jun 2017 [internet publication].
https://www.nice.org.uk/advice/mib109
Monitoring for patients treated with immunosuppressants and corticosteroids
Patients on immunosuppressants and corticosteroids should receive routine evaluation and testing with regard to drug levels and complications of the treatment. Bone mineral densitometry scanning (dual energy x-ray absorptiometry) should be considered in all patients with CD, due to the higher risk of osteoporosis. Patients at particularly high risk fall into two groups as follows:
Patients ages <65 years, receiving prolonged courses of corticosteroids (>3 months per year)
Patients who have continuing active disease, are underweight (body mass index <20 kg/m²), ages >75 years, or with weight loss >10% from baseline
Monitoring for malabsorption
Patients should be monitored for evidence of malabsorption, with diet adjustments and supplementations given accordingly. Serum B12 levels should be monitored in patients with ileal CD and in those with ileal resection.
Cancer surveillance
Patients with CD have more than twofold increased risk of developing colon cancer.[280]Gordon H, Biancone L, Fiorino G, et al. ECCO guidelines on inflammatory bowel disease and malignancies. J Crohns Colitis. 2023 Jun 16;17(6):827-54.
https://academic.oup.com/ecco-jcc/article/17/6/827/6931718
Patients who have had the disease for more than 8 years, or who have predominantly colonic disease, are at greater risk. Surveillance colonoscopy screening is recommended for patients with CD; those with colonic disease are likely to benefit most from surveillance.[311]Farraye FA, Odze RD, Eaden J, et al. AGA medical position statement on the diagnosis and management of colorectal neoplasia in inflammatory bowel disease. Gastroenterology. 2010 Feb;138(2):738-45.
http://www.gastrojournal.org/article/S0016-5085(09)02202-1/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/20141808?tool=bestpractice.com
[312]von Roon AC, Reese G, Teare J, et al. The risk of cancer in patients with Crohn's disease. Dis Colon Rectum. 2007 Jun;50(6):839-55.
http://www.ncbi.nlm.nih.gov/pubmed/17308939?tool=bestpractice.com
[313]Bye WA, Nguyen TM, Parker CE, et al. Strategies for detecting colon cancer in patients with inflammatory bowel disease. Cochrane Database Syst Rev. 2017 Sep 18;(9):CD000279.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000279.pub4/full
http://www.ncbi.nlm.nih.gov/pubmed/28922695?tool=bestpractice.com
[314]Maykel JA, Hagerman G, Mellgren AF, et al. Crohn's colitis: the incidence of dysplasia and adenocarcinoma in surgical patients. Dis Colon Rectum. 2006 Jul;49(7):950-7.
http://www.ncbi.nlm.nih.gov/pubmed/16729218?tool=bestpractice.com
[
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How does surveillance compare with no surveillance for detecting colon cancer in people with ulcerative colitis or inflammatory bowel disease?/cca.html?targetUrl=https://cochranelibrary.com/cca/doi/10.1002/cca.1965/fullShow me the answer Patients with CD are also at higher risk of developing squamous cell carcinoma of the anus, duodenal neoplasia, and lymphoma. There is some evidence to say that patients with perianal CD are at increased risk for developing colorectal and anal cancer.[315]Johansen MP, Wewer MD, Nordholm-Carstensen A, et al. Perianal Crohn's disease and the development of colorectal and anal cancer: a systematic review and meta-analysis. J Crohns Colitis. 2023 Apr 3;17(3):361-8.
https://academic.oup.com/ecco-jcc/article/17/3/361/6706844
http://www.ncbi.nlm.nih.gov/pubmed/36130090?tool=bestpractice.com
Where dysplasia (precancerous change) is found in a patient with inflammatory bowel disease, management options include enhanced surveillance, endoscopic resection or prophylactic surgery depending on the individual situation.[316]Kabir M, Thomas-Gibson S, Tozer PJ, et al. DECIDE: Delphi Expert Consensus Statement on inflammatory bowel disease dysplasia shared management decision-making. J Crohns Colitis. 2023 Nov 8;17(10):1652-71.
https://academic.oup.com/ecco-jcc/article/17/10/1652/7160823
http://www.ncbi.nlm.nih.gov/pubmed/37171140?tool=bestpractice.com