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Review

Optimization of biologic therapy in Crohn’s disease

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Pages 263-272 | Received 18 Aug 2017, Accepted 23 Nov 2017, Published online: 30 Nov 2017

References

  • Rogler G, Vavricka S, Schoepfer A, et al. Mucosal healing and deep remission: what does it mean? World J Gastroenterol. 2013;19(43):7552–7560.
  • Peyrin-Biroulet L, Fiorino G, Buisson A, et al. First-line therapy in adult Crohn’s disease: who should receive anti-TNF agents? Nat Rev Gastroenterol Hepatol. 2013;10(6):345–351.
  • O’Toole A, Moss AC. Optimizing biologic agents in ulcerative colitis and Crohn’s disease. Curr Gastroenterol Rep. 2015;17(8):32,015–0453-1.
  • Schreiber S, Reinisch W, Colombel JF, et al. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn’s disease. J Crohns Colitis. 2013;7(3):213–221.
  • Schreiber S, Colombel J-F, Bloomfield R, et al. Increased response and remission rates in short-duration Crohn’s disease with subcutaneous certolizumab pegol: an analysis of PRECiSE 2 randomized maintenance trial data. Am J Gastroenterol. 2010;105(7):1574–1582.
  • Ding NS, Hart A, De Cruz P. 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.
  • 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.
  • Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007;132:52–65.
  • Ford AC, Sandborn WJ, Khan KJ, et al. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):644–659; quiz 660.
  • Ainsworth MA, Bendtzen K, Brynskov J. Tumor necrosis factor-alpha binding capacity and anti-infliximab antibodies measured by fluid-phase radioimmunoassays as predictors of clinical efficacy of infliximab in Crohn’s disease. Am J Gastroenterol. 2008;103(4):944–948.
  • Gisbert JP, Marín AC, McNicholl AG, et al. Systematic review with meta-analysis: the efficacy of a second anti-TNF in patients with inflammatory bowel disease whose previous anti-TNF treatment has failed. Aliment Pharmacol Ther. 2015;41(7):613–623.
  • Hanauer SB, Wagner CL, Bala M, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn’s disease. Clin Gastroenterol Hepatol. 2004;2(7):542–553.
  • O’Meara S, Nanda KS, Moss AC. Antibodies to infliximab and risk of infusion reactions in patients with inflammatory bowel disease: a systematic review and meta-analysis. Inflamm Bowel Dis. 2014;20(1):1–6.
  • Afif W, Loftus EV Jr, Faubion WA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010;105(5):1133–1139.
  • Bendtzen K, Ainsworth M, Steenholdt C, et al. Individual medicine in inflammatory bowel disease: monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumor necrosis factor-alpha antibodies. Scand J Gastroenterol. 2009;44(7):774–781.
  • Steenholdt C, Bendtzen K, Brynskov J, et al. Optimizing treatment with TNF inhibitors in inflammatory bowel disease by monitoring drug levels and antidrug antibodies. Inflamm Bowel Dis. 2016;22(8):1999–2015.
  • Mosli MH, Sandborn WJ, Kim RB, et al. Toward a personalized medicine approach to the management of inflammatory bowel disease. Am J Gastroenterol. 2014;109(7):994–1004.
  • Bendtzen K. Personalized medicine: theranostics (therapeutics diagnostics) essential for rational use of tumor necrosis factor-alpha antagonists. Discov Med. 2013;15(83):201–211.
  • Svenson M, Geborek P, Saxne T, et al. Monitoring patients treated with anti-TNF-alpha biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology (Oxford). 2007;46(12):1828–1834.
  • Wang S-L, 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.
  • Lallemand C, Kavrochorianou N, Steenholdt C, et al. Reporter gene assay for the quantification of the activity and neutralizing antibody response to TNF alpha antagonists. J Immunol Methods. 2011;373(1–2):229–239.
  • 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.
  • Steenholdt C, Brynskov J, Thomsen O, et al. 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. 2013;63:919–927.
  • De Cruz P, Kamm MA, Prideaux L, et al. Mucosal healing in Crohn’s disease: a systematic review. Inflamm Bowel Dis. 2013;19(2):429–444.
  • 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.
  • Colombel JF, Panaccione R, Bossuyt P, et al. Superior endoscopic and deep remission outcomes in adults with moderate to severe Crohn’s disease managed with treat to target approach versus clinical symptoms: data from calm. Gastroenterology. 2017;152(5):S155.
  • Roblin X, Marotte H, Rinaudo M, et al. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2014;12(1):80,84.e2.
  • Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010;363:1086–1088.
  • Colombel JF, Reinisch W, Mantzaris G, et al. Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn’s disease - a SONIC post hoc analysis. Aliment Pharmacol Ther. 2015;41:734–746.
  • Colombel JF, Jharap B, Sandborn WJ, et al. Effects of concomitant immunomodulators on the pharmacokinetics, efficacy and safety of adalimumab in patients with Crohn’s disease or ulcerative colitis who had failed conventional therapy. Aliment Pharmacol Ther. 2016;45:50–62.
  • Colombel JF, Adedokun OJ, Gasink C, et al. Higher levels of infliximab may alleviate the need of azathioprine comedication in the treatment of patients with Crohn’s disease: a SONIC post hoc analysis. Gastroenterology. 2017;152(5):S37–S38.
  • Bortlik M, Duricova D, Machkova N, et al. Discontinuation of anti-tumor necrosis factor therapy in inflammatory bowel disease patients: a prospective observation. Scand J Gastroenterol. 2015;51(2):196–202.
  • Torres J, Boyapati R, Kennedy N, et al. Systematic review of effects of withdrawal of immunomodulators or biologic agents from patients with inflammatory bowel disease. Gastroenterology. 2015;149:1716–1730.
  • Louis E, Mary J, Vernier–Massouille G, et al. Maintenance of remission among patients with Crohn’s disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 2012;142:63–70.e5.
  • Pariente B, Laharie D. Review article: why, when and how to de-escalate therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2014;40:338–353.
  • Drobne D, Bossuyt P, Breynaert C, et al. Withdrawal of immunomodulators after co-treatment does not reduce trough level of infliximab in patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2015;13:514–521.e4.
  • Vande Casteele N, Ferrante M, Van Assche G, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015;148:1320–1329.e3.
  • Van Stappen T, Vande Casteele N, Van Assche G, et al. Clinical relevance of detecting anti-infliximab antibodies with a drug-tolerant assay: post hoc analysis of the TAXIT trial. Gut. 2017. DOI:10.1136/gutjnl-2016-313071.
  • D’Haens G, Vermeire S, Lambrecht G, et al. Drug-level based dosing versus symptom-based dose adaptation in patients with Crohn’s disease: a prospective, randomized multicenter study (TAILORIX). Gastroenterology. 2016;150:S143.
  • Rubin D, Panaccione R, Chao J, et al. A practical, evidence-based guide to the use of adalimumab in Crohn’s disease. Curr Med Res Opin. 2011;27:1803–1813.
  • Sandborn WJ, Hanauer S, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trial. Gut. 2007;56:1232–1239.
  • Sandborn WJ, Colombel JF, Schreiber S, et al. Dosage adjustment during long-term adalimumab treatment for Crohnʼs disease: clinical efficacy and pharmacoeconomics. Inflamm Bowel Dis. 2011;17:141–151.
  • Zittan E, Kabakchiev B, Milgrom R, et al. Higher adalimumab drug levels are associated with mucosal healing in patients with Crohn’s disease. J Crohns Colitis. 2016;10:510–515.
  • Paul S, Moreau A, Del Tedesco E, et al. Pharmacokinetics of adalimumab in inflammatory bowel diseases: a systematic review and meta-analysis. Inflamm Bowel Dis. 2014;20:1288–1295.
  • Feuerstein JD, Nguyen GC, Kupfer SS, et al. American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease. Gastroenterology. 2017;153:827–834.
  • Schreiber S. Certolizumab pegol for the treatment of Crohn’s disease. Ther Adv Gastroenterol. 2011;4(6):375–389.
  • Colombel J-F, Sandborn WJ, Allez M, et al. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2014;12:423–431.e1.
  • Sandborn WJ, Wolf DC, Kosutic G, et al. Effects of transient and persistent anti-drug antibodies to certolizumab pegol. Inflamm Bowel Dis. 2017;23:1047–1056.
  • Vande Casteele N, Mould D, Kosutic G, et al. Refinement of population pharmacokinetic model of certolizumab pegol in Crohnʼs disease patients to account for time varying nature of covariates. Inflamm Bowel Dis. 2016;22:S42.
  • Williet N, Boschetti G, Fovet M, et al. Association between low trough levels of vedolizumab during induction therapy for inflammatory bowel diseases and need for additional doses within 6 months. Clin Gastroenterol Hepatol. 2017. DOI:10.1016/j.cgh.2016.11.023.
  • Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369:711–721.
  • Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375:1946–1960.
  • Battat R, Kopylov U, Bessissow T, et al. Association among ustekinumab trough concentrations and clinical, biomarker, and endoscopic outcomes in patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2017. DOI:10.1016/j.cgh.2017.03.032.
  • Steenholdt C, Brynskov J, Thomsen O, et al. Individualized therapy is a long-term cost-effective method compared to dose intensification in Crohn’s disease patients failing infliximab. Dig Dis Sci. 2015;60:2762–2770.
  • Freeman K, Connock M, Auguste P, et al. Clinical effectiveness and cost-effectiveness of use of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [LISA-TRACKER® enzyme-linked immunosorbent assay (ELISA) kits, TNF-α-Blocker ELISA kits and Promonitor® ELISA kits] versus standard care in patients with Crohn’s disease: systematic reviews and economic modelling. Health Technol Assess. 2016;20:1–288.
  • Davidov Y, Ungar B, Bar-Yoseph H, et al. Association of induction infliximab levels with clinical response in perianal Crohn’s disease. J Crohns Colitis. 2016.
  • Ungar B, Haj-Natour O, Kopylov U, et al. Ashkenazi Jewish origin protects against formation of antibodies to infliximab and therapy failure. Medicine. 2015;94(18):e673.
  • Subramaniam K, D’Rozario J, Pavli P. Lymphoma and other lymphoproliferative disorders in inflammatory bowel disease: a review. J Gastroenterol Hepatol. 2012;28:24–30.
  • Papamichael K, Mantzaris G, Peyrin-Biroulet L. A safety assessment of anti-tumor necrosis factor alpha therapy for treatment of Crohn’s disease. Expert Opin Drug Saf. 2016;15:493–501.
  • Brandse JF, Vos LM, Jansen J, et al. Serum concentration of anti-TNF antibodies, adverse effects and quality of life in patients with inflammatory bowel disease in remission on maintenance treatment. J Crohns Colitis. 2015;9(11):973–981.
  • Denadai R, Teixeira F, Steinwurz F, et al. Induction or exacerbation of psoriatic lesions during anti-TNF-α therapy for inflammatory bowel disease: a systematic literature review based on 222 cases. J Crohns Colitis. 2013;7:517–524.
  • Yarur AJ, Jain A, Sussman DA, et al. The association of tissue anti-TNF drug levels with serological and endoscopic disease activity in inflammatory bowel disease: the ATLAS study. Gut. 2016;65:249–255.

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