Therapeutic Drug Monitoring of Biologics for Patients with Inflammatory Bowel Diseases: How, When, and for Whom?
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During the past decade, we have entered an era of biologics for the treatment of Crohn’s disease and ulcerative colitis. The therapeutic goal of inflammatory bowel disease (IBD) management has evolved from symptom control and clinical remission to mucosal healing or even deep remission. Histological remission for ulcerative colitis and transmural healing of Crohn’s disease are potential future goals. With the adoption of the treat-to-target concept, and given the need for tight control of IBD activity, therapeutic drug monitoring (TDM) is an important element of precision medicine. TDM involves the measurement of serum biologics and anti-drug antibodies levels, to confirm whether the right drug with the right dosage was prescribed to reach the right serum levels. TDM may help clinicians adjust biologics based on objective biomarkers instead of using empirical dosage escalation or making symptom-based therapeutic adjustments. Wellestablished reactive TDM algorithms have been proposed, and emerging evidence supports the clinical application of a proactive TDM strategy to enhance the duration of effective biologics and improve clinical outcomes. Recently, the proactive TDM strategy was shown to avoid the secondary loss of response to biologics, and improve long-term clinical outcomes in IBD patients. This review summarizes data from trials, and practice guidelines, on the clinical application of proactive and reactive TDM strategies for the daily care of biologic-treated IBD patients.
Abstract
During the past decade, we have entered an era of biologics for the treatment of Crohn’s disease and ulcerative colitis. The therapeutic goal of inflammatory bowel disease (IBD) management has evolved from symptom control and clinical remission to mucosal healing or even deep remission. Histological remission for ulcerative colitis and transmural healing of Crohn’s disease are potential future goals. With the adoption of the treat-to-target concept, and given the need for tight control of IBD activity, therapeutic drug monitoring (TDM) is an important element of precision medicine. TDM involves the measurement of serum biologics and anti-drug antibodies levels, to confirm whether the right drug with the right dosage was prescribed to reach the right serum levels. TDM may help clinicians adjust biologics based on objective biomarkers instead of using empirical dosage escalation or making symptom-based therapeutic adjustments. Wellestablished reactive TDM algorithms have been proposed, and emerging evidence supports the clinical application of a proactive TDM strategy to enhance the duration of effective biologics and improve clinical outcomes. Recently, the proactive TDM strategy was shown to avoid the secondary loss of response to biologics, and improve long-term clinical outcomes in IBD patients. This review summarizes data from trials, and practice guidelines, on the clinical application of proactive and reactive TDM strategies for the daily care of biologic-treated IBD patients.
참고문헌 (57)
- Peyrin-Biroulet L, "Surgery in a populationbased cohort of Crohn's disease from Olmsted County, Minnesota(1970-2004)", Am J Gastroenterol, 107, pp.1693~1701 (2012)
- Vernier-Massouille G, "Natural history of pediatric Crohn's disease : a population-based cohort study", Gastroenterology, 135, pp.1106~1113 (2008)
- Thia KT, "Risk factors associated with progression to intestinal complications of Crohn's disease in a population-based cohort", Gastroenterology, 139, pp.1147~1155 (2010)
- Burisch J, "Natural disease course of ulcerative colitis during the first five years of follow-up in a European population-based inception cohort : an Epi-IBD study", J Crohns Colitis, 13, pp.198~208 (2019)
- Jenkinson PW, "Temporal trends in surgical resection rates and biologic prescribing in Crohn's disease : a population-based cohort study", J Crohns Colitis, 14, pp.1241~1247 (2020)
- Olivera P, "Surgical rates in the era of biological therapy : up, down or unchanged?", Curr Opin Gastroenterol, 33, pp.246~253 (2017)
- Turner D, "STRIDE-II : an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease(STRIDE)initiative of the International Organization for the Study of IBD(IOIBD). Determining therapeutic goals for treat-to-target strategies in IBD", Gastroenterology, 160, pp.1570~1583 (2021)
- Bouguen G, "Treat to target : a proposed new paradigm for the management of Crohn's disease", Clin Gastroenterol Hepatol, 13, pp.1042~1050 (2015)
- Colombel JF, "Effect of tight control management on Crohn's disease(CALM) : a multicentre, randomised, controlled phase 3 trial", Lancet, 390, pp.2779~2789 (2017)
- Feuerstein JD, "American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease", Gastroenterology, 153, pp.827~834 (2017)
- Papamichael K, "Appropriate therapeutic drug monitoring of biologic agents for patients with inflammatory bowel diseases", Clin Gastroenterol Hepatol, 17, pp.1655~1668 (2019)
- Shukla R, "Therapeutic drug monitoring of non-anti-tumor necrosis factor biologics", Clin Gastroenterol Hepatol, 19, pp.1108~1110 (2021)
- Kennedy NA, "Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn's disease : a prospective, multicentre, cohort study", Lancet Gastroenterol Hepatol, 4, pp.341~353 (2019)
- Feagan BG, "Vedolizumab as induction and maintenance therapy for ulcerative colitis", N Engl J Med, 369, pp.699~710 (2013)
- Adedokun OJ, "Pharmacokinetics and exposure response relationships of ustekinumab in patients with Crohn's disease", Gastroenterology, 154, pp.1660~1671 (2018)
- Vande Casteele N, "American Gastroenterological Association Institute technical review on the role of therapeutic drug monitoring in the management of inflammatory bowel diseases", Gastroenterology, 153, pp.835~857 (2017)
- Colombel JF, "Infliximab, azathioprine, or combination therapy for Crohn's disease", N Engl J Med, 362, pp.1383~1395 (2010)
- Seow CH, "Trough serum infliximab : a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis", Gut, 59, pp.49~54 (2010)
- Maser EA, "Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease", Clin Gastroenterol Hepatol, 4, pp.1248~1254 (2006)
- Adedokun OJ, "Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis", Gastroenterology, 147, pp.1296~1307 (2014)
- Cornillie F, "Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab : a retrospective analysis of the ACCENT I trial", Gut, 63, pp.1721~1727 (2014)
- Papamichael K, "Role for therapeutic drug monitoring during induction therapy with TNF antagonists in IBD : evolution in the definition and management of primary nonresponse", Inflamm Bowel Dis, 21, pp.182~197 (2015)
- 최소윤, "Serum Infliximab Cutoff trough Level Values for Maintaining Hematological Remission in Pediatric Inflammatory Bowel Disease", Gut and Liver, 13(5), pp.541~548 (2019), 거트앤리버 소화기연관학회협의회[DOI]
- Vande Casteele N, "Infliximab exposure-response relationship and thresholds associated with endoscopic healing in patients with ulcerative colitis", Clin Gastroenterol Hepatol, 17, pp.1814~1821 (2019)
- Dreesen E, "Infliximab exposure predicts superior endoscopic outcomes in patients with active Crohn’s disease : pharmacokinetic-pharmacodynamic analysis of TAILORIX", J Crohn’s Colitis, 12(Suppl 1), pp.S063~S064 (2018)
- Vande Casteele N, "Adequate infliximab exposure during the induction phase is associated with early complete fistula response in patients with fistulizing Crohn’s disease : a post-hoc analysis of the ACCENT-2 trial", J Crohn’s Colitis, 13(Suppl 1), pp.S053~S054 (2019)
- Chiu YL, "Serum adalimumab concentration and clinical remission in patients with Crohn's disease", Inflamm Bowel Dis, 19, pp.1112~1122 (2013)
- Roblin X, "Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases", Clin Gastroenterol Hepatol, 12, pp.80~84 (2014)
- Ungar B, "Optimizing anti-TNF-αtherapy : serum levels of infliximab and adalimumab are associated with mucosal healing in patients with inflammatory bowel diseases", Clin Gastroenterol Hepatol, 14, pp.550~557 (2016)
- Colombel JF, "Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease", Clin Gastroenterol Hepatol, 12, pp.423~431 (2014)
- Vande Casteele N, "Exposureresponse relationship of certolizumab pegol induction and maintenance therapy in patients with Crohn's disease", Aliment Pharmacol Ther, 47, pp.229~237 (2018)
- Adedokun OJ, "Pharmacokinetics and exposure-response relationship of golimumab in patients with moderately-to-severely active ulcerative colitis : results from Phase 2", 3 PURSUIT Induction and Maintenance Studies, 2017, pp.11, 35~46
- Sandborn WJ, "Vedolizumab as induction and maintenance therapy for Crohn's disease", N Engl J Med, 369, pp.711~721 (2013)
- Guidi L, "Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease", United European Gastroenterol J, 7, pp.1189~1197 (2019)
- Dreesen E, "Evidence to support monitoring of vedolizumab trough concentrations in patients with inflammatory bowel diseases", Clin Gastroenterol Hepatol, 16, pp.1937~1946 (2018)
- Sandborn WJ, "Ustekinumab induction and maintenance therapy in refractory Crohn's disease", N Engl J Med, 367, pp.1519~1528 (2012)
- Feagan BG, "Ustekinumab as induction and maintenance therapy for Crohn's disease", N Engl J Med, 375, pp.1946~1960 (2016)
- Sands BE, "Ustekinumab as induction and maintenance therapy for ulcerative colitis", N Engl J Med, 381, pp.1201~1214 (2019)
- Verstockt B, "Ustekinumab exposure-outcome analysis in Crohn's disease only in part explains limited endoscopic remission rates", J Crohns Colitis, 13, pp.864~872 (2019)
- van Rheenen PF, "The medical management of paediatric Crohn's disease : an ECCO-ESPGHAN guideline update", J Crohns Colitis, 15, pp.171~194 (2021)
- Ben-Horin S, "Addition of an immunomodulator to infliximab therapy eliminates antidrug antibodies in serum and restores clinical response of patients with inflammatory bowel disease", Clin Gastroenterol Hepatol, 11, pp.444~447 (2013)
- Sazonovs A, "HLADQA1*05 carriage associated with development of anti-drug antibodies to infliximab and adalimumab in patients with Crohn's disease", Gastroenterology, 158, pp.189~199 (2020)
- Baert F, "Antibodies to adalimumab are associated with future inflammation in Crohn's patients receiving maintenance adalimumab therapy : a post hoc analysis of the Karmiris trial", Gut, 65, pp.1126~1131 (2016)
- Bian S, "Antibodies toward vedolizumab appear from the first infusion onward and disappear over time", Inflamm Bowel Dis, 23, pp.2202~2208 (2017)
- Chiu HY, "The association between clinical response to ustekinumab and immunogenicity to ustekinumab and prior adalimumab", PLoS One, 10, pp.e0142930~ (2015)
- Paul S, "Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease : a prospective study", Inflamm Bowel Dis, 19, pp.2568~2576 (2013)
- Choon Jin Ooi, "Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia", Intestinal research, 17(3), pp.285~310 (2019), 대한장연구학회[DOI]
- Yanai H, "Levels of drug and antidrug antibodies are associated with outcome of interventions after loss of response to infliximab or adalimumab", Clin Gastroenterol Hepatol, 13, pp.522~530 (2015)
- Steenholdt C, "Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment : a randomised, controlled trial", Gut, 63, pp.919~927 (2014)
- Vaughn BP, "Proactive therapeutic concentration monitoring of infliximab may improve outcomes for patients with inflammatory bowel disease : results from a pilot observational study", Inflamm Bowel Dis, 20, pp.1996~2003 (2014)
- Papamichael K, "Improved long-term outcomes of patients with inflammatory bowel disease receiving proactive compared with reactive monitoring of serum concentrations of infliximab", Clin Gastroenterol Hepatol, 15, pp.1580~1588 (2017)
- Papamichael K, "Proactive therapeutic drug monitoring of adalimumab is associated with better long-term outcomes compared with standard of care in patients with inflammatory bowel disease", J Crohns Colitis, 13, pp.976~981 (2019)
- Vande Casteele N, "Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease", Gastroenterology, 148, pp.1320~1329 (2015)
- Assa A, "Proactive monitoring of adalimumab trough concentration associated with increased clinical remission in children with Crohn's disease compared with reactive monitoring", Gastroenterology, 157, pp.985~996 (2019)
- Lamb CA, "British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults", Gut, 68(Suppl 3), pp.s1~s106 (2019)
- Mahadevan U, "Inflammatory bowel disease in pregnancy clinical care pathway : a report from the American Gastroenterological Association IBD Parenthood Project Working Group", Gastroenterology, 156, pp.1508~1524 (2019)
- Sparrow MP, "Therapeutic drug monitoring of biologics during induction to prevent primary non-response", J Crohns Colitis, 14, pp.542~556 (2020)
