Biologics for the Management of Inflammatory Bowel Disease: A Review in Tuberculosis-Endemic Countries
2
조회
0
다운로드
5
인용
0
참고문헌
키워드
초록
The advent of biologics and biologic therapy has transformed the management of inflammatory bowel disease (IBD) with enhanced early and adequate responses to treatment, fewer hospitalizations, a reduced need for surgery, and unprecedented outcomes including complete mucosal and histologic healing. However, an important issue with the use of anti-tumor necrosis factor (anti-TNF) agents in IBD is the increased risk of tuberculosis (TB). This is compounded by the diagnostic dilemma when differentiating between Crohn’s disease and gastrointestinal TB, and the potentially serious consequences of initiating an incorrect treatment in the case of misdiagnosis. The interplay between IBD and TB is most relevant in Asia, where more than 60% of the 10.4 million new TB cases in 2016 were reported. A number of studies have reported an increased risk of TB with anti-TNF agents, including in patients who had tested negative for TB prior to treatment initiation. The limited evidence currently available regarding adhesion molecule antagonists such as vedolizumab suggests a comparatively lower risk of TB, thus making them a promising option for IBD management in TBendemic regions. This comprehensive review examines the available literature on the risk of TB with the use of biologics in the TB-endemic regions of Asia, focusing on the diagnostic dilemma, the risk of reactivation, and the optimized management algorithms for latent and active disease.
Abstract
The advent of biologics and biologic therapy has transformed the management of inflammatory bowel disease (IBD) with enhanced early and adequate responses to treatment, fewer hospitalizations, a reduced need for surgery, and unprecedented outcomes including complete mucosal and histologic healing. However, an important issue with the use of anti-tumor necrosis factor (anti-TNF) agents in IBD is the increased risk of tuberculosis (TB). This is compounded by the diagnostic dilemma when differentiating between Crohn’s disease and gastrointestinal TB, and the potentially serious consequences of initiating an incorrect treatment in the case of misdiagnosis. The interplay between IBD and TB is most relevant in Asia, where more than 60% of the 10.4 million new TB cases in 2016 were reported. A number of studies have reported an increased risk of TB with anti-TNF agents, including in patients who had tested negative for TB prior to treatment initiation. The limited evidence currently available regarding adhesion molecule antagonists such as vedolizumab suggests a comparatively lower risk of TB, thus making them a promising option for IBD management in TBendemic regions. This comprehensive review examines the available literature on the risk of TB with the use of biologics in the TB-endemic regions of Asia, focusing on the diagnostic dilemma, the risk of reactivation, and the optimized management algorithms for latent and active disease.
참고문헌 (76)
- Podolsky DK, "Inflammatory bowel disease", N Engl J Med, 347, pp.417~429 (2002)
- Bernstein CN, "World Gastroenterology Organisation Global Guidelines Inflammatory Bowel Disease : update august 2015", J Clin Gastroenterol, 50, pp.803~818 (2016)
- Ananthakrishnan AN, "Epidemiology and risk factors for IBD", Nat Rev Gastroenterol Hepatol, 12, pp.205~217 (2015)
- Silverberg MS, "Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology", Can J Gastroenterol, 19(Suppl A), pp.5A~36A (2005)
- Satsangi J, "The Montreal classification of inflammatory bowel disease : controversies, consensus, and implications", Gut, 55, pp.749~753 (2006)
- Lichtenstein GR, "Management of Crohn’s disease in adults", Am J Gastroenterol, 104, pp.465~483 (2009)
- Magro F, "Third European evidencebased consensus on diagnosis and management of ulcerative colitis : part 1 : definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders", J Crohns Colitis, 11, pp.649~670 (2017)
- Löwenberg M, "Next-generation therapeutics for IBD", Curr Gastroenterol Rep, 17, pp.21~ (2015)
- Cheon JH, "Understanding the complications of anti-tumor necrosis factor therapy in East Asian patients with inflammatory bowel disease", J Gastroenterol Hepatol, 32, pp.769~777 (2017)
- Pithadia AB, "Treatment of inflammatory bowel disease(IBD)", Pharmacol Rep, 63, pp.629~642 (2011)
- "Crohn’s disease: management in adults, children and young people. NICE guideline (CG 152)" (2012)[URL]
- "Ulcerative colitis: management in adults, children and young people. NICE guideline (CG 166)" (2013)[URL]
- Gomollón F, "3rd European evidencebased consensus on the diagnosis and management of Crohn’s disease 2016 : part 1 : diagnosis and medical management", J Crohns Colitis, 11, pp.3~25 (2017)
- Harbord M, "Third European evidence-based consensus on diagnosis and management of ulcerative colitis : part 2 : current management", J Crohns Colitis, 11, pp.769~784 (2017)
- Devlin SM, "Evolving inflammatory bowel disease treatment paradigms : top-down versus step-up", Med Clin North Am, 94, pp.1~18 (2010)
- Rogler G, "Top-down or step-up treatment in Crohn’s disease", Dig Dis, 31, pp.83~90 (2013)
- Ungar B, "Advances in the development of new biologics in inflammatory bowel disease", Ann Gastroenterol, 29, pp.243~248 (2016)
- Zheng MK, "Insights on the use of biosimilars in the treatment of inflammatory bowel disease", World J Gastroenterol, 23, pp.1932~1943 (2017)
- "FDA approves new treatment for moderately to severely active ulcerative colitis" (2018)[URL]
- Bonovas S, "Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease : a systematic review and network meta-analysis", Clin Gastroenterol Hepatol, 14, pp.1385~1397 (2016)
- Ford AC, "Opportunistic infections with antitumor necrosis factor-α therapy in inflammatory bowel disease : meta-analysis of randomized controlled trials", Am J Gastroenterol, 108, pp.1268~1276 (2013)
- Dulai PS, "The risk of malignancy associated with the use of biological agents in patients with inflammatory bowel disease", Gastroenterol Clin North Am, 43, pp.525~541 (2014)
- Onal IK, "Tuberculosis and Crohn’s disease revisited", J Coll Physicians Surg Pak, 25, pp.443~448 (2015)
- Amarapurkar DN, "Diagnosis of Crohn’s disease in India where tuberculosis is widely prevalent", World J Gastroenterol, 14, pp.741~746 (2008)
- Meng-Tzu Weng, "Seminar Report From the 2014 Taiwan Society of Inflammatory Bowel Disease (TSIBD) Spring Forum (May 24th, 2014): Crohn’s Disease Versus Intestinal Tuberculosis Infection", Intestinal research, 13(1), pp.6~10 (2015), 대한장연구학회[DOI]
- Banerjee R, "Risk factors for diagnostic delay in Crohn’s disease and their impact on long-term complications:how do they differ in a tuberculosis endemic region?", Aliment Pharmacol Ther, 47, pp.1367~1374 (2018)
- Mack U, "LTBI : latent tuberculosis infection or lasting immune responses to M. tuberculosis? A TBNET consensus statement", Eur Respir J, 33, pp.956~973 (2009)
- "Latent tuberculosis infection: a guide for primary health care providers" (2013)[URL]
- Houben RM, "The global burden of latent tuberculosis infection : a re-estimation using mathematical modelling", PLoS Med, 13, pp.e1002152~ (2016)
- Shea KM, "Estimated rate of reactivation of latent tuberculosis infection in the United States, overall and by population subgroup", Am J Epidemiol, 179, pp.216~225 (2014)
- Murdaca G, "Infection risk associated with anti-TNF-α agents : a review", Expert Opin Drug Saf, 14, pp.571~582 (2015)
- Bruns H, "Anti-TNF immunotherapy reduces CD8+ T cell-mediated antimicrobial activity against Mycobacterium tuberculosis in humans", J Clin Invest, 119, pp.1167~1177 (2009)
- Harris J, "Tumor necrosis factor blockers influence macrophage responses to Mycobacterium tuberculosis", J Infect Dis, 198, pp.1842~1850 (2008)
- "Global tuberculosis report 2017" (2018)[URL]
- Goletti D, "Performance of the tuberculin skin test and interferon-gamma release assays : an update on the accuracy, cutoff stratification, and new potential immune-based approaches", J Rheumatol Suppl, 91, pp.24~31 (2014)
- Pai M, "Gamma interferon release assays for detection of Mycobacterium tuberculosis infection", Clin Microbiol Rev, 27, pp.3~20 (2014)
- Ndzi EN, "The pros and cons of the QuantiFERON test for the diagnosis of tuberculosis, prediction of disease progression, and treatment monitoring", Int J Mycobacteriol, 5, pp.177~184 (2016)
- Aberra FN, "Risk for active tuberculosis in inflammatory bowel disease patients", Clin Gastroenterol Hepatol, 5, pp.1070~1075 (2007)
- Jung SM, "Risk of tuberculosis in patients treated with anti-tumor necrosis factor therapy : a nationwide study in South Korea, a country with an intermediate tuberculosis burden", Int J Rheum Dis, 18, pp.323~330 (2015)
- Cantini F, "Adalimumab, etanercept, infliximab, and the risk of tuberculosis : data from clinical trials, national registries, and postmarketing surveillance", J Rheumatol Suppl, 91, pp.47~55 (2014)
- Tan BE, "Real-world clinical experience of biological disease modifying anti-rheumatic drugs in Malaysia rheumatoid arthritis patients", Rheumatol Int, 37, pp.1719~1725 (2017)
- Hong SN, "Risk of incident Mycobacterium tuberculosis infection in patients with inflammatory bowel disease : a nationwide population-based study in South Korea", Aliment Pharmacol Ther, 45, pp.253~263 (2017)
- Puri AS, "Infliximab-induced tuberculosis in patients with UC : experience from India-a country with high prevalence of tuberculosis", J Gastroenterol Hepatol, 32, pp.1191~1194 (2017)
- 변자민, "The Risk of Tuberculosis in Korean Patients with Inflammatory Bowel Disease Receiving Tumor Necrosis Factor-α Blockers", Journal of Korean Medical Science, 30(2), pp.173~179 (2015), 대한의학회
- Byun JM, "Risks for opportunistic tuberculosis infection in a cohort of 873 patients with inflammatory bowel disease receiving a tumor necrosis factor-α inhibitor", Scand J Gastroenterol, 50, pp.312~320 (2015)
- Çekiç C, "Latent tuberculosis screening tests and active tuberculosis infection rates in Turkish inflammatory bowel disease patients under anti-tumor necrosis factor therapy", Ann Gastroenterol, 28, pp.241~246 (2015)
- Chen DY, "Effectiveness of the combination of a whole-blood interferon-gamma assay and the tuberculin skin test in detecting latent tuberculosis infection in rheumatoid arthritis patients receiving adalimumab therapy", Arthritis Rheum, 59, pp.800~806 (2008)
- Takeuchi T, "Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis", Ann Rheum Dis, 67, pp.189~194 (2008)
- Seong SS, "Incidence of tuberculosis in Korean patients with rheumatoid arthritis(RA) : effects of RA itself and of tumor necrosis factor blockers", J Rheumatol, 34, pp.706~711 (2007)
- Kumar A, "Experience with anti-tumor necrosis factor-a therapy in India", APLAR J Rheumatol, 9, pp.136~141 (2006)
- Navarra SV, "Clinical experience with infliximab among Filipino patients with rheumatic diseases", APLAR J Rheumatol, 9, pp.150~156 (2006)
- Thi AA, "Challenges in screening for latent tuberculosis in inflammatory bowel disease prior to biologic treatment : a UK cohort study", Frontline Gastroenterol, 9, pp.234~240 (2018)
- Ramos GP, "Outcomes of treatment for latent tuberculosis infection in patients with inflammatory bowel disease receiving biologic therapy", Inflamm Bowel Dis, 24, pp.2272~2277 (2018)
- Carpio D, "Tuberculosis in anti-tumour necrosis factor-treated inflammatory bowel disease patients after the implementation of preventive measures : compliance with recommendations and safety of retreatment", J Crohns Colitis, 10, pp.1186~1193 (2016)
- Abitbol Y, "Negative screening does not rule out the risk of tuberculosis in patients with inflammatory bowel disease undergoing anti-TNF treatment : a descriptive study on the GETAID cohort", J Crohns Colitis, 10, pp.1179~1185 (2016)
- Jauregui-Amezaga A, "Risk of developing tuberculosis under anti-TNF treatment despite latent infection screening", J Crohns Colitis, 7, pp.208~212 (2013)
- Mañosa M, "Current incidence of active tuberculosis in IBD patients treated with anti-TNF agents : still room for improvement", J Crohns Colitis, 7, pp.e499~e500 (2013)
- Luthra P, "Systematic review and metaanalysis : opportunistic infections and malignancies during treatment with anti-integrin antibodies in inflammatory bowel disease", Aliment Pharmacol Ther, 41, pp.1227~1236 (2015)
- Ng SC, "Low frequency of opportunistic infections in patients receiving vedolizumab in clinical trials and post-marketing setting", Inflamm Bowel Dis, 24, pp.2431~2441 (2018)
- Colombel JF, "The safety of vedolizumab for ulcerative colitis and Crohn’s disease", Gut, 66, pp.839~851 (2017)
- Bye WA, "Systematic review : the safety of vedolizumab for the treatment of inflammatory bowel disease", Aliment Pharmacol Ther, 46, pp.3~15 (2017)
- Amiot A, "Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease", Clin Gastroenterol Hepatol, 14, pp.1593~1601 (2016)
- Cantini F, "Risk of tuberculosis reactivation in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis receiving non-anti-TNF-targeted biologics", Mediators Inflamm, 2017, pp.8909834~ (2017)
- Winthrop KL, "Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis", Ann Rheum Dis, 75, pp.1133~1138 (2016)
- Cohen S, "Worldwide, 3-year, postmarketing surveillance experience with tofacitinib in rheumatoid arthritis", Rheumatol Ther, 5, pp.283~291 (2018)
- Rahier JF, "Second European evidencebased consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease", J Crohns Colitis, 8, pp.443~468 (2014)
- British Thoracic Society Standards of Care Committee, "BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment", Thorax, 60, pp.800~805 (2005)
- Shu-Chen Wei, "Management of Crohn’s disease in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease", Intestinal research, 15(3), pp.285~310 (2017), 대한장연구학회
- Shu-Chen Wei, "Management of ulcerative colitis in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease", Intestinal research, 15(3), pp.266~284 (2017), 대한장연구학회
- Dong Il Park, "Asian Organization for Crohn’s and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: risk assessment", Intestinal research, 16(1), pp.4~16 (2018), 대한장연구학회
- Dong Il Park, "Asian Organization for Crohn’s and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 2: management", Intestinal research, 16(1), pp.17~25 (2018), 대한장연구학회
- Lis K, "Tumor necrosis factor inhibitors : state of knowledge", Arch Med Sci, 10, pp.1175~1185 (2014)
- Yoon KH, "Epidemic obesity and type 2 diabetes in Asia", Lancet, 368, pp.1681~1688 (2006)
- Singh S, "Obesity and response to anti-tumor necrosis factor-α agents in patients with select immune-mediated inflammatory diseases : a systematic review and meta-analysis", PLoS One, 13, pp.e0195123~ (2018)
- Vande Casteele N, "Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease", Gastroenterology, 148, pp.1320~1329 (2015)
- Brandse JF, "Loss of infliximab into feces is associated with lack of response to therapy in patients with severe ulcerative colitis", Gastroenterology, 149, pp.350~355 (2015)
