Therapeutic drug monitoring to improve outcome of anti-TNF drugs in pediatric inflammatory bowel disease

References

• D’Haens GR, Sartor RB, Silverberg MS, et al. Future directions in inflammatory bowel disease management. J Crohns Colitis. 2014;8(8):726–734.
   Google Scholar
• Duijvestein M, Battat R, Vande Casteele N, et al. Novel therapies and treatment strategies for patients with inflammatory bowel disease. Curr Treat Options Gastroenterol. 2018;16(1):129–146.
   Google Scholar
• Peyrin-Biroulet L, Deltenre P, de Suray N, et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn’s disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2008;6(6):644–653.
   Google Scholar
• Ns D, Hart A, De CP. Systematic review: predicting and optimising response to anti-TNF therapy in Crohn’s disease - algorithm for practical management. Aliment Pharmacol Ther. 2016;43(1):30–51.
   Google Scholar
• Ordas I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet. 2012;380(9853):1606–1619.
   Google Scholar
• Torres J, Mehandru S, Colombel JF, et al. Crohn’s disease. Lancet. 2017;389(10080):1741–1755.
   Google Scholar
• Mahid SS, Minor KS, Soto RE, et al. Smoking and inflammatory bowel disease: a meta-analysis. Mayo Clin Proc. 2006;81(11):1462–1471.
   Google Scholar
• Sakamoto N, Kono S, Wakai K, et al. Dietary risk factors for inflammatory bowel disease: a multicenter case-control study in Japan. Inflamm Bowel Dis. 2005;11(2):154–163.
   Google Scholar
• Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med. 2009;361(21):2066–2078.
   Google Scholar
• Sartor RB. Mechanisms of disease: pathogenesis of Crohn’s disease and ulcerative colitis. Nat Clin Pract Gastroenterol Hepatol. 2006;3(7):390–407.
   Google Scholar
• Jostins L, Ripke S, Weersma RK, et al. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature. 2012;491(7422):119–124.
   Google Scholar
• Liu JZ, van Sommeren S, Huang H, et al. Association analyses identify 38 susceptibility loci for inflammatory bowel disease and highlight shared genetic risk across populations. Nat Genet. 2015;47(9):979–986.
   Google Scholar
• Ng SC, Shi HY, Hamidi N, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2018;390(10114):2769–2778.
   Google Scholar
• Kappelman MD, Moore KR, Allen JK, et al. Recent trends in the prevalence of Crohn’s disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013;58(2):519–525.
   Google Scholar
• Johnston RD, Logan RF. What is the peak age for onset of IBD? Inflamm Bowel Dis. 2008;14(Suppl 2):S4–5.
   Google Scholar
• Barton JR, Gillon S, Ferguson A. Incidence of inflammatory bowel disease in Scottish children between 1968 and 1983; marginal fall in ulcerative colitis, three-fold rise in Crohn’s disease. Gut. 1989;30(5):618–622.
   Google Scholar
• Schildkraut V, Alex G, Cameron DJ, et al. Sixty-year study of incidence of childhood ulcerative colitis finds eleven-fold increase beginning in 1990s. Inflamm Bowel Dis. 2013;19(1):1–6.
   Google Scholar
• Turunen P, Kolho KL, Auvinen A, et al. Incidence of inflammatory bowel disease in Finnish children, 1987–2003. Inflamm Bowel Dis. 2006;12(8):677–683.
   Google Scholar
• Benchimol EI, Manuel DG, Guttmann A, et al. Changing age demographics of inflammatory bowel disease in Ontario, Canada: a population-based cohort study of epidemiology trends. Inflamm Bowel Dis. 2014;20(10):1761–1769.
   Google Scholar
• Pigneur B, Seksik P, Viola S, et al. Natural history of Crohn’s disease: comparison between childhood- and adult-onset disease. Inflamm Bowel Dis. 2010;16(6):953–961.
   Google Scholar
• Van Limbergen J, Russell RK, Drummond HE, et al. Definition of phenotypic characteristics of childhood-onset inflammatory bowel disease. Gastroenterology. 2008;135(4):1114–1122.
   Google Scholar
• Lichtenstein GR. New ACG Guideline for the Management of Crohn’s Disease. Gastroenterol Hepatol. 2018;14(8):451.
   Google Scholar
• Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of crohn’s disease in adults. Am J Gastroenterol. 2018;113(4):481–517.
   Google Scholar
• Jovani M, Danese S. Vedolizumab for the treatment of IBD: a selective therapeutic approach targeting pathogenic a4b7 cells. Curr Drug Targets. 2013;14(12):1433–1443.
   Google Scholar
• Teng MW, Bowman EP, McElwee JJ, et al. IL-12 and IL-23 cytokines: from discovery to targeted therapies for immune-mediated inflammatory diseases. Nat Med. 2015;21(7):719–729.
   Google Scholar
• Turner D, Ruemmele FM, Orlanski-Meyer E, et al. Management of paediatric ulcerative colitis, part 1: ambulatory care-an evidence-based guideline from European Crohn’s and Colitis organization and European society of paediatric gastroenterology, hepatology and nutrition. J Pediatr Gastroenterol Nutr. 2018;67(2):257–291.
   Google Scholar
• Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002;359(9317):1541–1549.
   Google Scholar
• Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010;362(15):1383–1395.
   Google Scholar
• Hebuterne X, Lemann M, Bouhnik Y, et al. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn’s disease following treatment with certolizumab pegol. Gut. 2013;62(2):201–208.
   Google Scholar
• Colombel JF, Rutgeerts P, Reinisch W, et al. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology. 2011;141(4):1194–1201.
   Google Scholar
• Beutler B, Cerami A. The biology of cachectin/TNF–a primary mediator of the host response. Annu Rev Immunol. 1989;7:625–655.
   Google Scholar
• Feldmann M, Maini RN. Anti-TNF alpha therapy of rheumatoid arthritis: what have we learned?. Annu Rev Immunol. 2001;19:163–196.
   Google Scholar
• Quetglas EG, Mujagic Z, Wigge S, et al. Update on pathogenesis and predictors of response of therapeutic strategies used in inflammatory bowel disease. World J Gastroenterol. 2015;21(44):12519–12543.
   Google Scholar
• Billmeier U, Dieterich W, Neurath MF, et al. Molecular mechanism of action of anti-tumor necrosis factor antibodies in inflammatory bowel diseases. World J Gastroenterol. 2016;22(42):9300–9313.
   Google Scholar
• Guo Y, Lu N, Bai A. Clinical use and mechanisms of infliximab treatment on inflammatory bowel disease: a recent update. Biomed Res Int. 2013;2013:581631.
   Google Scholar
• Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology. 2006;130(2):323–333. quiz 591.
   Google Scholar
• Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trial. Gut. 2007;56(9):1232–1239.
   Google Scholar
• Ben-Horin S, Kopylov U, Chowers Y. Optimizing anti-TNF treatments in inflammatory bowel disease. Autoimmun Rev. 2014;13(1):24–30.
   Google Scholar
• McLean LP, Cross RK. Adverse events in IBD: to stop or continue immune suppressant and biologic treatment. Expert Rev Gastroenterol Hepatol. 2014;8(3):223–240.
   Google Scholar
• Wheat CL, Ko CW, Clark-Snustad K, et al. Inflammatory Bowel Disease (IBD) pharmacotherapy and the risk of serious infection: a systematic review and network meta-analysis. BMC Gastroenterol. 2017;17(1):52.
   Google Scholar
• Cheifetz A, Smedley M, Martin S, et al. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol. 2003;98(6):1315–1324.
   Google Scholar
• Vultaggio A, Matucci A, Nencini F, et al. Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy. 2010;65(5):657–661.
   Google Scholar
• Cheifetz A, Mayer L. Monoclonal antibodies, immunogenicity, and associated infusion reactions. Mt Sinai J Med. 2005;72(4):250–256.
   Google Scholar
• Crandall WV, Mackner LM. Infusion reactions to infliximab in children and adolescents: frequency, outcome and a predictive model. Aliment Pharmacol Ther. 2003;17(1):75–84.
   Google Scholar
• Mocci G, Marzo M, Papa A, et al. Dermatological adverse reactions during anti-TNF treatments: focus on inflammatory bowel disease. J Crohns Colitis. 2013;7(10):769–779.
   Google Scholar
• Weinblatt ME, Fleischmann R, Huizinga TW, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012;51(12):2204–2214.
   Google Scholar
• Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013;65(1):28–38.
   Google Scholar
• Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2009;68(6):789–796.
   Google Scholar
• Urquhart L. Market watch: top drugs and companies by sales in 2017. Nat Rev Drug Discov. 2018;17(4):232.
   Google Scholar
• Pentek M, Lakatos PL, Oorsprong T, et al. Access to biologicals in Crohn’s disease in ten European countries. World J Gastroenterol. 2017;23(34):6294–6305.
   Google Scholar
• Church PC, Hyams J, Ruemmele F, et al. The continental divide: anti-TNF use in pediatric IBD is different in North America compared to other parts of the world. Can J Gastroenterol Hepatol. 2018;2018:3190548.
   Google Scholar
• Gonczi L, Vegh Z, Golovics PA, et al. Prediction of short- and medium-term efficacy of biosimilar infliximab therapy. Do trough levels and antidrug antibody levels or clinical and biochemical markers play the more important role? J Crohns Colitis. 2017;11(6):697–705.
   Google Scholar
• Yanai H, Lichtenstein L, Assa A, et al. Levels of drug and antidrug antibodies are associated with outcome of interventions after loss of response to infliximab or adalimumab. Clin Gastroenterol Hepatol. 2015;13(3):522–530 e2.
   Google Scholar
• Vermeire S, Gils A, Accossato P, et al. Immunogenicity of biologics in inflammatory bowel disease. Therap Adv Gastroenterol. 2018;11:1756283X17750355.
   Google Scholar
• van Schie KA, Hart MH, de Groot ER, et al. The antibody response against human and chimeric anti-TNF therapeutic antibodies primarily targets the TNF binding region. Ann Rheum Dis. 2015;74(1):311–314.
   Google Scholar
• Chirmule N, Jawa V, Meibohm B. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy. Aaps J. 2012;14(2):296–302.
   Google Scholar
• 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;108(1):40–47. quiz 48.
   Google Scholar
• Roblin X, Marotte H, Leclerc M, et al. Combination of C-reactive protein, infliximab trough levels, and stable but not transient antibodies to infliximab are associated with loss of response to infliximab in inflammatory bowel disease. J Crohns Colitis. 2015;9(7):525–531.
   Google Scholar
• Ordas I, Feagan BG, Sandborn WJ. Therapeutic drug monitoring of tumor necrosis factor antagonists in inflammatory bowel disease. Clin Gastroenterol Hepatol. 2012;10(10):1079–1087. quiz e85–6.
   Google Scholar
• Liefferinckx C, Minsart C, Toubeau JF, et al. Infliximab trough levels at induction to predict treatment failure during maintenance. Inflamm Bowel Dis. 2017;23(8):1371–1381.
   Google Scholar
• Vande Casteele N, Gils A, Singh S, et al. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol. 2013;108(6):962–971.
   Google Scholar
• Bond A, Dodd S, Fisher G, et al. Concurrent immunomodulator therapy is associated with higher adalimumab trough levels during scheduled maintenance therapy. Scand J Gastroenterol. 2017;52(2):204–208.
   Google Scholar
• Ben-Horin S, Waterman M, Kopylov U, et al. 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. 2013;11(4):444–447.
   Google Scholar
• Ruemmele FM, Veres G, Kolho KL, et al. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn’s disease. J Crohns Colitis. 2014;8(10):1179–1207.
   Google Scholar
• McConnell J, Parvulescu-Codrea S, Behm B, et al. Accelerated infliximab infusions for inflammatory bowel disease improve effectiveness. World J Gastrointest Pharmacol Ther. 2012;3(5):74–82.
   Google Scholar
• Clare DF, Alexander FC, Mike S, et al. Accelerated infliximab infusions are safe and well tolerated in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2009;21(1):71–75.
   Google Scholar
• Ordas I, Mould DR, Feagan BG, et al. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther. 2012;91(4):635–646.
   Google Scholar
• Lichtenstein GR, Panaccione R, Mallarkey G. Efficacy and safety of adalimumab in Crohn’s disease. Therap Adv Gastroenterol. 2008;1(1):43–50.
   Google Scholar
• Vande Casteele N, Baert F, Bian S, et al. subcutaneous absorption contributes to observed interindividual variability in adalimumab serum concentrations in Crohn’s disease: a prospective multicentre study. J Crohns Colitis. 2019.
   Google Scholar
• Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(1):85–95. quiz e14–5.
   Google Scholar
• Ryman JT, Meibohm B. Pharmacokinetics of monoclonal antibodies. CPT Pharmacometrics Syst Pharmacol. 2017;6(9):576–588.
   Google Scholar
• Klotz U, Teml A, Schwab M. Clinical pharmacokinetics and use of infliximab. Clin Pharmacokinet. 2007;46(8):645–660.
   Google Scholar
• Fasanmade AA, Adedokun OJ, Blank M, et al. Pharmacokinetic properties of infliximab in children and adults with Crohn’s disease: a retrospective analysis of data from 2 phase III clinical trials. Clin Ther. 2011;33(7):946–964.
   Google Scholar
• Xu Y, Adedokun OJ, Chan D, et al. Population pharmacokinetics and exposure-response modeling analyses of golimumab in children with moderately to severely active ulcerative colitis. J Clin Pharmacol. 2019;59(4):590–604.
   Google Scholar
• Patel KR, Roberts JT, Barb AW. Multiple variables at the leukocyte cell surface impact Fc gamma receptor-dependent mechanisms. Front Immunol. 2019;10:223.
   Google Scholar
• Mould DR, Sweeney KR. The pharmacokinetics and pharmacodynamics of monoclonal antibodies–mechanistic modeling applied to drug development. Curr Opin Drug Discovery Dev. 2007;10(1):84–96.
   Google Scholar
• Ternant D, Ducourau E, Perdriger A, et al. Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis. Br J Clin Pharmacol. 2014;78(1):118–128.
   Google Scholar
• Brandse JF, van Den Brink GR, Wildenberg ME, et al. Loss of infliximab into feces is associated with lack of response to therapy in patients with severe ulcerative colitis. Gastroenterology. 2015;149(2):350–5 e2.
   Google Scholar
• Lopetuso LR, Gerardi V, Papa V, et al. Can we predict the efficacy of Anti-TNF-alpha agents? Int J Mol Sci. 2017;18:9.
   Google Scholar
• Naviglio S, Giuffrida P, Stocco G, et al. How to predict response to anti-tumour necrosis factor agents in inflammatory bowel disease. Expert Rev Gastroenterol Hepatol. 2018;12(8):797–810.
   Google Scholar
• Carman N, Mack DR, Benchimol EI. Therapeutic drug monitoring in pediatric inflammatory bowel disease. Curr Gastroenterol Rep. 2018;20(5):18.
   Google Scholar
• Kang JS, Lee MH. Overview of therapeutic drug monitoring. Korean J Intern Med. 2009;24(1):1–10.
   Google Scholar
• Dubinsky MC, Lamothe S, Yang HY, et al. Pharmacogenomics and metabolite measurement for 6-mercaptopurine therapy in inflammatory bowel disease. Gastroenterology. 2000;118(4):705–713.
   Google Scholar
• Lega S, Bramuzzo M, Dubinsky MC. Therapeutic drug monitoring in pediatric IBD: current application and future perspectives. Curr Med Chem. 2018;25(24):2840–2854.
   Google Scholar
• Batchelor HK, Marriott JF. Paediatric pharmacokinetics: key considerations. Br J Clin Pharmacol. 2015;79(3):395–404.
   Google Scholar
• Hamalainen A, Sipponen T, Kolho KL. Serum infliximab concentrations in pediatric inflammatory bowel disease. Scand J Gastroenterol. 2013;48(1):35–41.
   Google Scholar
• Naviglio S, Lacorte D, Lucafo M, et al. Causes of treatment failure in children with inflammatory bowel disease treated with infliximab: a pharmacokinetic study. J Pediatr Gastroenterol Nutr. 2019;68(1):37–44.
   Google Scholar
• Singh N, Rosenthal CJ, Melmed GY, et al. Early infliximab trough levels are associated with persistent remission in pediatric patients with inflammatory bowel disease. Inflamm Bowel Dis. 2014;20(10):1708–1713.
   Google Scholar
• van Hoeve K, Dreesen E, Hoffman I, et al. Adequate infliximab exposure during induction predicts remission in paediatric patients with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2019; 68(6):847-853.
   Google Scholar
• Ungar B, Glidai Y, Yavzori M, et al. Association between infliximab drug and antibody levels and therapy outcome in pediatric inflammatory bowel diseases. J Pediatr Gastroenterol Nutr. 2018;67(4):507–512.
   Google Scholar
• Lega S, Phan BL, Rosenthal CJ, et al. Proactively optimized infliximab monotherapy is as effective as combination therapy in IBD. Inflamm Bowel Dis. 2019;25(1):134–141.
   Google Scholar
• Kennedy NA, Heap GA, Green HD, et al. 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. 2019;4(5):341-353.
   Google Scholar
• Brandse JF, Mould D, Smeekes O, et al. A real-life population pharmacokinetic study reveals factors associated with clearance and immunogenicity of infliximab in inflammatory bowel disease. Inflamm Bowel Dis. 2017;23(4):650–660.
   Google Scholar
• Dotan I, Ron Y, Yanai H, et al. Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease: a population pharmacokinetic study. Inflamm Bowel Dis. 2014;20(12):2247–2259.
   Google Scholar
• Fasanmade AA, Adedokun OJ, Olson A, et al. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Ther. 2010;48(5):297–308.
   Google Scholar
• Detrez I, Dreesen E, Van Stappen T, et al. Variability in golimumab exposure: a ‘Real-Life’ observational study in active ulcerative colitis. J Crohns Colitis. 2016;10(5):575–581.
   Google Scholar
• Hoekman DR, Brandse JF, de Meij TG, et al. The association of infliximab trough levels with disease activity in pediatric inflammatory bowel disease. Scand J Gastroenterol. 2015;50(9):1110–1117.
   Google Scholar
• Choi SY, Kang B, Lee JH, et al. Clinical use of measuring trough levels and antibodies against infliximab in patients with pediatric inflammatory bowel disease. Gut Liver. 2017;11(1):55–61.
   Google Scholar
• van Hoeve K, Dreesen E, Hoffman I, et al. Higher infliximab trough levels are associated with better outcome in paediatric patients with inflammatory bowel disease. J Crohns Colitis. 2018;12(11):1316–1325.
   Google Scholar
• Kang B, Choi SY, Choi YO, et al. Infliximab trough levels are associated with mucosal healing during maintenance treatment with infliximab in paediatric Crohn’s disease. J Crohns Colitis. 2019;13(2):189–197.
   Google Scholar
• Ungar B, Levy I, Yavne Y, et al. Optimizing anti-TNF-alpha therapy: serum levels of infliximab and adalimumab are associated with mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2016;14(4):550–557 e2.
   Google Scholar
• Papamichael K, Rakowsky S, Rivera C, et al. Infliximab trough concentrations during maintenance therapy are associated with endoscopic and histologic healing in ulcerative colitis. Aliment Pharmacol Ther. 2018;47(4):478–484.
   Google Scholar
• Vande Casteele N, Ferrante M, Van Assche G, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015;148(7):1320–9 e3.
   Google Scholar
• Ungar B, Ben-Shatach Z, Ben-Haim G, et al. Infliximab therapy intensification upon loss of response: is there an optimal trough level? Dig Liver Dis. 2019;S1590-8658(19)30099-4.
   Google Scholar
• Ma C, Battat R, Jairath V, et al. Advances in therapeutic drug monitoring for small-molecule and biologic therapies in inflammatory bowel disease. Curr Treat Options Gastroenterol. 2019;17(1):127–145.
   Google Scholar
• Vande Casteele N. Assays for measurement of TNF antagonists in practice. Frontline Gastroenterol. 2017;8(4):236–242.
   Google Scholar
• Jani M, Isaacs JD, Morgan AW, et al. Detection of anti-drug antibodies using a bridging ELISA compared with radioimmunoassay in adalimumab-treated rheumatoid arthritis patients with random drug levels. Rheumatology (Oxford). 2016;55(11):2050–2055.
   Google Scholar
• Wadhwa M, Knezevic I, Kang HN, et al. Immunogenicity assessment of biotherapeutic products: an overview of assays and their utility. Biologicals. 2015;43(5):298–306.
   Google Scholar
• Wang SL, Ohrmund L, Hauenstein S, et al. Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum. J Immunol Methods. 2012;382(1–2):177–188.
   Google Scholar
• Lallemand C, Kavrochorianou N, Steenholdt C, et al. Reporter gene assay for the quantification of the activity and neutralizing antibody response to TNFalpha antagonists. J Immunol Methods. 2011;373(1–2):229–239.
   Google Scholar
• Gils A, Vande Casteele N, Poppe R, et al. Development of a universal anti-adalimumab antibody standard for interlaboratory harmonization. Ther Drug Monit. 2014;36(5):669–673.
   Google Scholar
• Steenholdt C, Bendtzen K, Brynskov J, et al. Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn’s disease: post hoc analysis of a randomized controlled trial. Am J Gastroenterol. 2014;109(7):1055–1064.
   Google Scholar
• Lu J, Van Stappen T, Spasic D, et al. Fiber optic-SPR platform for fast and sensitive infliximab detection in serum of inflammatory bowel disease patients. Biosens Bioelectron. 2016;79:173–179.
   Google Scholar
• Beeg M, Nobili A, Orsini B, et al. A surface plasmon resonance-based assay to measure serum concentrations of therapeutic antibodies and anti-drug antibodies. Sci Rep. 2019;9(1):2064.
   Google Scholar
• Curci D, Lucafo M, Cifu A, et al. Determination of serum infliximab concentration by point-of-care devices in children with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2019; May 28, epub ahead of print.
   Google Scholar
• Danhof M, de Lange EC, Della Pasqua OE, et al. Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research. Trends Pharmacol Sci. 2008;29(4):186–191.
   Google Scholar
• Ramsey LB, Mizuno T, Vinks AA, et al. Learning health systems as facilitators of precision medicine. Clin Pharmacol Ther. 2017;101(3):359–367.
   Google Scholar
• Krishna M, Nadler SG. Immunogenicity to biotherapeutics - the role of anti-drug immune complexes. Front Immunol. 2016;7:21.
   Google Scholar
• Ferguson BS, Hoggarth DA, Maliniak D, et al. Real-time, aptamer-based tracking of circulating therapeutic agents in living animals. Sci Transl Med. 2013;5(213):213ra165.
   Google Scholar
• Lucafo M, Franca R, Selvestrel D, et al. Pharmacogenetics of treatments for inflammatory bowel disease. Expert Opin Drug Metab Toxicol. 2018;14(12):1209–1223.
   Google Scholar