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Journal of Gastroenterology

Erschienen in:

13.07.2020 | Review

The shining DIAMOND for evidence-based treatment strategies for Crohn’s disease

verfasst von: Hiroshi Nakase, Takayuki Matsumoto, Kenji Watanabe, Tadakazu Hisamatsu

Erschienen in: Journal of Gastroenterology | Ausgabe 9/2020

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Abstract

Anti-tumor necrosis factor (TNF)-α antibodies are effective therapeutic agents to treat inflammatory bowel disease (IBD). In the biologic era, the development of immunogenicity has been a critical issue for secondary loss of response. The superiority of anti-TNF therapy in combination with immunomodulators (IMs) is well-established for infliximab (IFX) but less evident for adalimumab (ADA). To clarify the contribution of thiopurines to ADA-treated patients with Crohn’s disease (CD), the deep remission of immunomodulator and adalimumab combination therapy for Crohn’s disease (DIAMOND) studies provided the first randomized comparison of efficacy between ADA monotherapy and ADA with thiopurine. The results of the DIAMOND and DIAMOND2 studies revealed the appropriate ADA therapeutic strategy for immunosuppressant-naïve patients with active CD based on therapeutic drug monitoring, endoscopic findings and clinical issues regarding the use of thiopurines.

Ben-Horin S, Chowers Y. Review article: loss of response to anti-TNF treatments in Crohn’s disease. Aliment Pharmacol Ther. 2011;33:987–95.PubMed

Billoud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn’s disease. Am J Gastroenterol. 2011;106:674–84.

Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn’s disease: a review. Am J Gastroenterol. 2009;104:760–7.PubMed

Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010;362:1383–95.PubMed

Van Schik T, Maljaars JP, Roopram RK, et al. Influence of combination therapy with immune modulation on anti-TNF trough levels and antibodies in patients with IBD. Inflamm Bowel Dis. 2014;20:2292–8.

Panaccione R, Ghosh S, Middleton S, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology. 2014;146(392–400):e3.

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;132:52–655.PubMed

Kestens C, van Oijen MG, Mulder CL, et al. Adalimumab and infliximab are equally effective for Crohn’s disease in patients not previously treated with anti-tumor necrosis factor-α agents. Clin Gastroenterol Hepatol. 2013;11:826–31.PubMed

Kopylov U, Al-Taweel T, Yaghoobi M, et al. Adalimumab monotherapy versus combination therapy with immunomodulators in patients with Crohn’s disease. A systematic review and meta-analysis. J Crohns Colitis. 2014;8:1632–41.PubMed

10.

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. 2017;45:50–62.PubMed

11.

Reenaers C, Louis E, Belaiche J, et al. Does co-treatment with immunosuppressors improve outcome in patients with Crohn’s disease treated with adalimumab? Aliment Pharmacol Ther. 2012;36:1040–8.PubMed

12.

Cosnes J, Sokol H, Bourrier A, et al. Adalimumab or infliximab as monotherapy, or in combination with an immunomodulator, in the treatment of Crohn’s disease. Aliment Pharmacol Ther. 2016;44:1102–13.PubMed

13.

Peters CP, Eshuis FJ, Toxopeus FM, et al. Adalimumab for Crohn's disease: long-term sustained benefit in a population-based cohort of 438 patients. J Crohn Colitis. 2014;8:866–75.

14.

Kiss LS, Szamosi T, Molnar T, et al. Early clinical remission and normalisation of CRP are the strongest predictors of efficacy, mucosal healing and dose escalation during the first year of adalimumab therapy in Crohn's disease. Aliment Pharmacol Ther. 2011;34:911–22.PubMed

15.

Barnes EL, Goldin A, Winter RW, et al. Sequential combination therapy versus monotherapy: a lack of benefit in time to inflammatory bowel disease-related surgery. Dig Dis Sci. 2016;61:3261–9.PubMedPubMedCentral

16.

Matsumoto T, Motoya S, Watanabe K, et al. Adalimumab monotherapy and a combination with azathioprine for Crohn's disease: a prospective, randomized trial. J Crohns Colitis. 2016;10:1259–66.PubMed

17.

Kubota T, Nishida A, Takeuchi K, et al. Frequency distribution of thiopurine S-methyltransferase activity in red blood cells of a healthy Japanese population. Ther Drug Monit. 2004;26:319–21.PubMed

18.

McLeod HL, Lin JS, Scott EP, et al. Thiopurine methyltransferase activity in American white subjects and black subjects. Clin Pharmacol Ther. 1994;55:15–20.PubMed

19.

Lowenthal A, Meyerstein N, Ben-Zvi Z. Thiopurine methyltransferase activity in the Jewish population of Israel. Eur J Clin Pharmacol. 2001;57:43–6.PubMed

20.

D'Haens GR. Top-down therapy for IBD: rationale and requisite evidence. Nat Rev Gastroenterol Hepatol. 2010;7:86–92.PubMed

21.

Nakase H, Motoya S, Matsumoto T, et al. Significance of measurement of serum trough level and anti-drug antibody of adalimumab as personalised pharmacokinetics in patients with Crohn's disease: a subanalysis of the DIAMOND trial. Aliment Pharmacol Ther. 2017;46:873–82.PubMedPubMedCentral

22.

Ward MG, Warner B, Unsworth N, et al. Infliximab and adalimumab drug levels in Crohn’s disease: contrasting associations with disease activity and influencing factors. Aliment Pharmacol Ther. 2017;46:150–61.PubMed

23.

Yarur AJ, Kubiliun MJ, Czul F, et al. Concentrations of 6-thioguanine nucleotide correlate with trough levels of infliximab in patients with inflammatory bowel disease on combination therapy. Clin Gastroenterol Hepatol. 2015;13(1118–1124):e3.

24.

Mazor Y, Almog R, Kopylov U, et al. Adalimumab drug and antibody as predictors of clinical and laboratory response in patients with Crohn’s disease. Aliment Pharmacol Ther. 2014;40:620–8.PubMed

25.

Wolf DC, Scott H, Lockton S, et al. Mechanisms of loss of response to adalimumab in Crohn’s disease. Gastroenterology. 2013;144(Suppl 1):s775.

26.

Qiu Y, Mao R, Chen BL, et al. Effects of combination therapy with immunomodulators on trough levels and antibodies against tumor necrosis factor antagonists in patients with inflammatory bowel diseases: A meta-analysis. Clinical Clin Gastroenterol Hepatol. 2017;15(1359–1372):e6.

27.

Strik AS, van den Brink GR, Ponsioen C, et al. Suppression of anti-drug antibodies to infliximab or adalimumab with the addition of an immunomodulatory in patients with inflammatory disease. Aliment Pharmacol Ther. 2017;45:1128–34.PubMed

28.

Kariyawasam VC, Ward MG, Blaker PA, et al. Thiopurines dosed to a therapeutic 6-thioguanine level in combination with adalimumab are more effective than subtherapeutic thiopurine-based combination therapy or adalimumab monotherapy during induction and maintenance in patients with long-standing Crohn's disease. Inflamm Bowel Dis. 2017;23:1555–65.PubMed

29.

Chalhoub JM, Rimmani HH, Gumaste VV, et al. Systematic review and meta-analysis: adalimumab monotherapy versus combination therapy with immunomodulators for induction and maintenance of remission and response in patients with Crohn's disease. Inflamm Bowel Dis. 2017;23:1316–27.PubMed

30.

Ungar B, Kopylov U, Engel T, et al. Addition of an immunomodulator can reverse antibody formation and loss of response in patients treated with adalimumab. Aliment Pharmacol Ther. 2017;45:276–82.PubMed

31.

Bultman E, de Haar C, van Liere-Baron A, et al. Predictor of dose escalation of adalimumab in a prospective cohort of Crohn’s disease patients. Aliment Pharmacol Ther. 2012;35:335–41.PubMed

32.

Bond A, Asher R, Jackson R, et al. Comparative analysis of the influence of clinical factors including BMI on adalimumab and infliximab trough levels. Eur J Gastroenterol Hepatol. 2016;28:271–6.PubMed

33.

Baert F, Vande Casteele N, Tops S, et al. Prior response to infliximab and early serum drug concentrations predict effects of adalimumab in ulcerative colitis. Aliment Pharmacol Ther. 2014;40:1324–32.PubMed

34.

Lie MR, Kreijne JE, van der Woude CJ. Sex is associated with adalimumab side effects and drug survival in patients with Crohn's disease. Inflamm Bowel Dis. 2017;23:75–81.

35.

Watanabe K, Matsumoto T, Hisamatsu T, et al. Clinical and pharmacokinetic factors associated with adalimumab-induced mucosal healing in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2018;16(542–549):e1.

36.

Papamichael K, Cheifetz AS. Therapeutic drug monitoring in IBD: the new standard-of-care for anti-TNF therapy. Am J Gastroenterol. 2017;112:673–6.PubMed

37.

Hazlewood GS, Rezaie A, Borman M, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis. Gastroenterology. 2015;148(344–54):e5.

38.

Chaparro M, Barreiro-de Acosta M, Echarri A, et al. Correlation between anti-TNF serum levels and endoscopic inflammation in inflammatory bowel disease patients. Dig Dis Sci. 2019;64:846–54.PubMed

39.

Imaeda H, Bamba S, Takahashi K, et al. Relationship between serum infliximab trough levels and endoscopic activities in patients with Crohn's disease under scheduled maintenance treatment. J Gastroenterol. 2014;49:674–82.PubMed

40.

Barnes EL, Allegretti JR. Are anti-tumor necrosis factor trough levels predictive of mucosal healing in patients with inflammatory bowel disease?: a systematic review and meta-analysis. J Clin Gastroenterol. 2016;50:733–41.PubMed

41.

Hisamatsu T, Matsumoto T, Watanabe K, et al. Concerns and side effects of azathioprine during adalimumab induction and maintenance therapy for Japanese patients with Crohn's disease: a subanalysis of a prospective randomised clinical trial [DIAMOND study]. J Crohns Colitis. 2019;13:1097–104.PubMed

42.

Yang SK, Hong M, Baek J, et al. A common missense variant in NUDT15 confers susceptibility to thiopurine-induced leukopenia. Nat Genet. 2014;46:1017–20.PubMedPubMedCentral

43.

Kakuta Y, Kawai Y, Okamoto D, et al. NUDT15 codon 139 is the best pharmacogenetic marker for predicting thiopurine-induced severe adverse events in Japanese patients with inflammatory bowel disease: a multicenter study. J Gastroenterol. 2018;53:1065–78.PubMedPubMedCentral

44.

Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT™ registry. Am J Gastroenterol. 2012;107:1409–22.PubMedPubMedCentral

45.

Beaugerie L, Brousse N, Bouvier AM, et al. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet. 2009;374(9701):1617–25.PubMed

46.

Abbas AM, Almukhtar RM, Loftus EV Jr, et al. Risk of melanoma and non-melanoma skin cancer in ulcerative colitis patients treated with thiopurines: a nationwide retrospective cohort. Am J Gastroenterol. 2014;109:1781–93.PubMed

47.

Osterman MT, Sandborn WJ, Colombel JF, et al. Crohn's disease activity and concomitant immunosuppressants affect the risk of serious and opportunistic infections in patients treated with adalimumab. Am J Gastroenterol. 2016;111:1806–15.PubMed

48.

D’Haens G, Reinisch W, Panaccione R, et al. Lymphoma risk and overall safety profile of adalimumab in patients with Crohn's disease with up to 6 years of follow-up in the Pyramid registry. Am J Gastroenterol. 2018;113:872–82.PubMed

49.

Singh S, Facciorusso A, Dulai PS, et al. Comparative risk of serious infections with biologic and/or immunosuppressive therapy in patients with inflammatory bowel diseases: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2020;18:69–81.PubMed

50.

Van Assche G, Magdelaine-Beuzelin C, D'Haens G, et al. Withdrawal of immunosuppression in Crohn's disease treated with scheduled infliximab maintenance: a randomized trial. Gastroenterology. 2008;134:1861–8.PubMed

51.

Hisamatsu T, Kato S, Kunisaki R, et al. Withdrawal of thiopurines in Crohn's disease treated with scheduled adalimumab maintenance: a prospective randomised clinical trial (DIAMOND2). J Gastroenterol. 2019;54:860–70.PubMed

52.

Adedokun OJ, Xu Z, Marano CW, et al. 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. J Crohns Colitis. 2017;11:35–46.PubMed

53.

Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357:239–50.PubMed

54.

Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007;357:228–38.PubMed

55.

Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013;369:711–21.PubMed

56.

Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699–710.PubMed

57.

Sandborn WJ, Fegan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146(96–109):e1.

58.

Sandborn WJ, Fegan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:85–95 quiz e14–5.PubMed

59.

Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2016;375:1946–60.PubMed

60.

Mitrev N, Vande Casteele N, Seow CH, et al. Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases aliment. Pharmacol Ther. 2017;46:1037–53.

61.

Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting therapeutic targets in inflammatory bowel disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol. 2015;110:1324–38.PubMed

62.

Fiorino G, Danese S. Adalimumab and azathioprine combination therapy for Crohn's disease: a shining DIAMOND? J Crohns Colitis. 2016;10:1257–8.PubMed

Titel: The shining DIAMOND for evidence-based treatment strategies for Crohn’s disease
verfasst von: Hiroshi Nakase
Takayuki Matsumoto
Kenji Watanabe
Tadakazu Hisamatsu
Publikationsdatum: 13.07.2020
Verlag: Springer Singapore
Erschienen in: Journal of Gastroenterology / Ausgabe 9/2020
Print ISSN: 0944-1174
Elektronische ISSN: 1435-5922
DOI: https://doi.org/10.1007/s00535-020-01702-x

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