Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
2
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
The incidence and prevalence of inflammatory bowel disease (IBD), comprising Crohn’s disease and ulcerative colitis, have increased in Asia and developing countries. In the past two decades, anti-tumor necrosis factor (TNF) agents have revolutionized the treatment of IBD, in part by decreasing the rates of complications and surgery. Although anti-TNF agents have changed the course of IBD, there are unmet needs in terms of primary and secondary non-responses and side effects such as infections and malignancies. Novel biologics and small-molecule drugs have been developed for IBD, and the medical treatment options have improved. These drugs include sphingosine-1-phosphate receptor modulators and anti-integrins to block immune cell migration, and cytokine and Janus kinase inhibitors to block immune cell communications. In this review, we discuss the approved novel biologics and small-molecule drugs, including several of those in the late stages of development, for the treatment of IBD.
Abstract
The incidence and prevalence of inflammatory bowel disease (IBD), comprising Crohn’s disease and ulcerative colitis, have increased in Asia and developing countries. In the past two decades, anti-tumor necrosis factor (TNF) agents have revolutionized the treatment of IBD, in part by decreasing the rates of complications and surgery. Although anti-TNF agents have changed the course of IBD, there are unmet needs in terms of primary and secondary non-responses and side effects such as infections and malignancies. Novel biologics and small-molecule drugs have been developed for IBD, and the medical treatment options have improved. These drugs include sphingosine-1-phosphate receptor modulators and anti-integrins to block immune cell migration, and cytokine and Janus kinase inhibitors to block immune cell communications. In this review, we discuss the approved novel biologics and small-molecule drugs, including several of those in the late stages of development, for the treatment of IBD.
참고문헌 (96)
- Ng SC, "Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century : a systematic review of population-based studies", Lancet, 390, pp.2769~2778 (2017)
- Güray Can, "Epidemiologic features of ınflammatory bowel disease in Western Blacksea region of Turkey for the last 10 years: retrospective cohort study", The Korean Journal of Internal Medicine, 34(3), pp.519~529 (2019), 대한내과학회[DOI]
- Jamilya Kaibullayeva, "Prevalence and patient awareness of inflammatory bowel disease in Kazakhstan: a cross-sectional study", Intestinal research, 18(4), pp.430~437 (2020), 대한장연구학회[DOI]
- Ajit Sood, "Colitis and Crohn’s Foundation (India): a first nationwide inflammatory bowel disease registry", Intestinal research, 19(2), pp.206~216 (2021), 대한장연구학회[DOI]
- Emiko Mizoguchi, "Recent updates on the basic mechanisms and pathogenesis of inflammatory bowel diseases in experimental animal models", Intestinal research, 18(2), pp.151~167 (2020), 대한장연구학회[DOI]
- Razieh Ardali, "Pathophysiological role of Atg5 in human ulcerative colitis", Intestinal research, 18(4), pp.421~429 (2020), 대한장연구학회[DOI]
- Vulliemoz M, "TNF-alpha blockers in inflammatory bowel diseases : practical recommendations and a user’s guide : an update", Digestion, 101(Suppl 1), pp.16~26 (2020)
- Sokol H, "Complications and surgery in the inflammatory bowel diseases biological era", Curr Opin Gastroenterol, 30, pp.378~384 (2014)
- Jong Pil Im, "Changing treatment paradigms for the management of inflammatory bowel disease", The Korean Journal of Internal Medicine, 33(1), pp.28~35 (2018), 대한내과학회[DOI]
- Yoon Suk Jung, "Impact of early anti-TNF use on clinical outcomes in Crohn’s disease: a nationwide population-based study", The Korean Journal of Internal Medicine, 35(5), pp.1104~1113 (2020), 대한내과학회[DOI]
- Roda G, "Loss of response to anti-TNFs : definition, epidemiology, and management", Clin Transl Gastroenterol, 7, pp.e135~ (2016)
- Seung Wook Hong, "Comparison of loss of response between anti-tumor necrosis factor alone and combined use with immunomodulators in patients with inflammatory bowel disease", The Korean Journal of Internal Medicine, 36, pp.9~17 (2021), 대한내과학회[DOI]
- Su Jin Choi, "Liver enzyme elevation in patients with ankylosing spondylitis treated with tumor necrosis factor inhibitors: a single-center historical cohort study", The Korean Journal of Internal Medicine, 35(3), pp.723~731 (2020), 대한내과학회[DOI]
- Hyo Sun Lee, "Novel treatments for inflammatory bowel disease", The Korean Journal of Internal Medicine, 33(1), pp.20~27 (2018), 대한내과학회[DOI]
- Samanen JC, "Introduction to Biological and Small Molecule Drug Research and Development", pp.161~203 (2013), Elsevier
- Soo-Young Na, "Perspectives on Current and Novel Treatments for Inflammatory Bowel Disease", Gut and Liver, 13(6), pp.604~616 (2019), 거트앤리버 소화기연관학회협의회[DOI]
- 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)
- Jovani M, "Vedolizumab for the treatment of IBD : a selective therapeutic approach targeting pathogenic a4b7cells", Curr Drug Targets, 14, pp.1433~1443 (2013)
- Mullershausen F, "Persistent signaling induced by FTY720-phosphate is mediated by internalized S1P1 receptors", Nat Chem Biol, 5, pp.428~434 (2009)
- O’Sullivan C, "The structure and function of the S1P1receptor", Trends Pharmacol Sci, 34, pp.401~412 (2013)
- Sanchez T, "Structural and functional characteristics of S1P receptors", J Cell Biochem, 92, pp.913~922 (2004)
- Lobaton T, "Review article : anti-adhesion therapies for inflammatory bowel disease", Aliment Pharmacol Ther, 39, pp.579~594 (2014)
- Scott FL, "Ozanimod(RPC1063)is a potent sphingosine-1-phosphate receptor-1(S1P1)and receptor-5(S1P5)agonist with autoimmune disease-modifying activity", Br J Pharmacol, 173, pp.1778~1792 (2016)
- Sandborn WJ, "Ozanimod induction and maintenance treatment for ulcerative colitis", N Engl J Med, 374, pp.1754~1762 (2016)
- Sandborn WJ, "Long-term efficacy and safety of ozanimod in moderately to severely active ulcerative colitis : results from the open-label extension of the randomized, phase 2 TOUCHSTONE Study", J Crohns Colitis, 15, pp.1120~1129 (2021)
- Sandborn WJ, "Ozanimod as induction and maintenance therapy for ulcerative colitis", N Engl J Med, 385, pp.1280~1291 (2021)
- Brossard P, "Pharmacokinetics and pharmacodynamics of ponesimod, a selective S1P1 receptor modulator, in the first-inhuman study", Br J Clin Pharmacol, 76, pp.888~896 (2013)
- Feagan BG, "Ozanimod induction therapy for patients with moderate to severe Crohn’s disease : a single-arm, phase 2, prospective observer-blinded endpoint study", Lancet Gastroenterol Hepatol, 5, pp.819~828 (2020)
- Sandborn WJ, "Natalizumab induction and maintenance therapy for Crohn’s disease", N Engl J Med, 353, pp.1912~1925 (2005)
- Targan SR, "Natalizumab for the treatment of active Crohn’s disease : results of the ENCORE Trial", Gastroenterology, 132, pp.1672~1683 (2007)
- del Pilar Martin M, "Decrease in the numbers of dendritic cells and CD4+ T cells in cerebral perivascular spaces due to natalizumab", Arch Neurol, 65, pp.1596~1603 (2008)
- Kleinschmidt-DeMasters BK, "Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis", N Engl J Med, 353, pp.369~374 (2005)
- Langer-Gould A, "Progressive multifocal leukoencephalopathy in a patient treated with natalizumab", N Engl J Med, 353, pp.375~381 (2005)
- Feagan BG, "Vedolizumab as induction and maintenance therapy for ulcerative colitis", N Engl J Med, 369, pp.699~710 (2013)
- Sandborn WJ, "Vedolizumab as induction and maintenance therapy for Crohn’s disease", N Engl J Med, 369, pp.711~721 (2013)
- Choon Jin Ooi, "Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study", Intestinal research, 19(1), pp.71~82 (2021), 대한장연구학회[DOI]
- Rupa Banerjee, "Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study", Intestinal research, 19(1), pp.83~94 (2021), 대한장연구학회[DOI]
- Hiroyuki Okamoto, "Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn’s disease", Intestinal research, 19(1), pp.95~105 (2021), 대한장연구학회[DOI]
- Feagan BG, "Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists", Clin Gastroenterol Hepatol, 15, pp.229~239 (2017)
- Sands BE, "Vedolizumab as induction and maintenance therapy for Crohn’s disease in patients naive to or who have failed tumor necrosis factor antagonist therapy", Inflamm Bowel Dis, 23, pp.97~106 (2017)
- Sands BE, "Effects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failed", Gastroenterology, 147, pp.618~627 (2014)
- Kim J, "Clinical outcomes and response predictors of vedolizumab induction treatment for Korean patients with inflammatory bowel diseases who failed anti-TNF therapy : a KASID prospective multicenter cohort study", Inflamm Bowel Dis, 27, pp.1931~1941 (2021)
- Sands BE, "Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis", N Engl J Med, 381, pp.1215~1226 (2019)
- Feagan BG, "Rapid response to vedolizumab therapy in biologic-naive patients with inflammatory bowel diseases", Clin Gastroenterol Hepatol, 17, pp.130~138 (2019)
- Schwartz DA, "Efficacy and safety of 2 vedolizumab intravenous regimens for perianal fistulizing Crohn’s disease : ENTERPRISE Study", Clin Gastroenterol Hepatol, 20, pp.1059~1067 (2022)
- Fares Ayoub,, "Vedolizumab for perianal fistulizing Crohn’s disease: systematic review and meta-analysis", Intestinal research, 20(2), pp.240~250 (2022), 대한장연구학회[DOI]
- Colombel JF, "The safety of vedolizumab for ulcerative colitis and Crohn’s disease", Gut, 66, pp.839~851 (2017)
- Milch C, "Vedolizumab, a monoclonal antibody to the gut homing α4β7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype", J Neuroimmunol, 264, pp.123~126 (2013)
- Loftus EV Jr, "Long-term safety of vedolizumab for inflammatory bowel disease", Aliment Pharmacol Ther, 52, pp.1353~1365 (2020)
- 나수영, "고령에서 염증성 장질환의 치료 – 무엇이 다르고 무엇을 알아야 하는가?", 대한소화기학회지, 77(5), pp.231~240 (2021), 대한소화기학회[DOI]
- Vitaliy Y. Poylin, "Vedolizumab does not increase perioperative surgical complications in patients with inflammatory bowel disease, cohort study", Intestinal research, 20(1), pp.72~77 (2022), 대한장연구학회[DOI]
- Benson JM, "Discovery and mechanism of ustekinumab : a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders", MAbs, 3, pp.535~545 (2011)
- Shuai K, "Regulation of JAK-STAT signalling in the immune system", Nat Rev Immunol, 3, pp.900~911 (2003)
- Murray PJ, "The JAK-STAT signaling pathway : input and output integration", J Immunol, 178, pp.2623~2629 (2007)
- Ghoreschi K, "Janus kinases in immune cell signaling", Immunol Rev, 228, pp.273~287 (2009)
- Wittig BM, "Drug evaluation : CNTO-1275, a mAb against IL-12", IL-23p40 for the potential treatment of inflammatory diseases, 2007, pp.8, 947~954
- Feagan BG, "Ustekinumab as induction and maintenance therapy for Crohn’s disease", N Engl J Med, 375, pp.1946~1960 (2016)
- Toshifumi Hibi, "Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn’s disease: a subpopulation analysis of phase 3 induction and maintenance studies", Intestinal research, 15(4), pp.475~486 (2017), 대한장연구학회
- Sadik Saman, "Ustekinumab is effective in biological refractory Crohn’s disease patients–regardless of approval study selection criteria", Intestinal research, 17(3), pp.340~348 (2019), 대한장연구학회[DOI]
- Alexandra Cohen, "Ustekinumab for the treatment of refractory pediatric Crohn’s disease: a single-center experience", Intestinal research, 19(2), pp.217~224 (2021), 대한장연구학회[DOI]
- Sands BE, "Ustekinumab as induction and maintenance therapy for ulcerative colitis", N Engl J Med, 381, pp.1201~1214 (2019)
- Tadakazu Hisamatsu, "Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)", Intestinal research, 19(4), pp.386~397 (2021), 대한장연구학회[DOI]
- Sandborn WJ, "Long-term efficacy and safety of ustekinumab for Crohn’s disease through the second year of therapy", Aliment Pharmacol Ther, 48, pp.65~77 (2018)
- Papp K, "Safety surveillance for ustekinumab and other Psoriasis Treatments from the Psoriasis Longitudinal Assessment and Registry(PSOLAR)", J Drugs Dermatol, 14, pp.706~714 (2015)
- Menter A, "Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis : results from the Psoriasis Longitudinal Assessment and Registry(PSOLAR)", J Eur Acad Dermatol Venereol, 30, pp.1148~1158 (2016)
- Olivera P, "Next generation of small molecules in inflammatory bowel disease", Gut, 66, pp.199~209 (2017)
- Sandborn WJ, "Tofacitinib as induction and maintenance therapy for ulcerative colitis", N Engl J Med, 376, pp.1723~1736 (2017)
- Sandborn WJ, "Efficacy and safety of extended induction with tofacitinib for the treatment of ulcerative colitis", Clin Gastroenterol Hepatol, 20, pp.1821~1830 (2022)
- Satoshi Motoya, "Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies", Intestinal research, 16(2), pp.233~245 (2018), 대한장연구학회
- Panes J, "Tofacitinib for induction and maintenance therapy of Crohn’s disease : results of two phase IIb randomised placebo-controlled trials", Gut, 66, pp.1049~1059 (2017)
- Hanauer S, "Tofacitinib induction therapy reduces symptoms within 3 days for patients with ulcerative colitis", Clin Gastroenterol Hepatol, 17, pp.139~147 (2019)
- Uzzan M, "Tofacitinib as salvage therapy for 55 patients hospitalised with refractory severe ulcerative colitis : a GETAID cohort", Aliment Pharmacol Ther, 54, pp.312~319 (2021)
- Hiromichi Shimizu, "Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis", Intestinal research, 19(1), pp.115~118 (2021), 대한장연구학회[DOI]
- Sandborn WJ, "Safety of tofacitinib for treatment of ulcerative colitis, based on 4. 4 years of data from Global Clinical Trials", Clin Gastroenterol Hepatol, 17, pp.1541~1550 (2019)
- Desai RJ, "Risk of venous thromboembolism associated with tofacitinib in patients with rheumatoid arthritis: a population-based cohort study", Rheumatology(Oxford), 61, pp.121~130 (2021)
- Ytterberg SR, "Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis", N Engl J Med, 386, pp.316~326 (2022)
- "FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions" (2021)[URL]
- Sandborn WJ, "Efficacy of upadacitinib in a randomized trial of patients with active ulcerative colitis", Gastroenterology, 158, pp.2139~2149 (2020)
- Sandborn WJ, "Efficacy and safety of upadacitinib in a randomized trial of patients with Crohn’s disease", Gastroenterology, 158, pp.2123~2138 (2020)
- D’Haens G, "Upadacitinib was efficacious and well-tolerated over 30 months in patients with Crohn’s disease in the CELEST Extension Study", Clin Gastroenterol Hepatol (2021)[DOI]
- Sands BE, "Efficacy and safety of MEDI2070, an antibody against interleukin 23, in patients with moderate to severe Crohn’s disease : a phase 2a study", Gastroenterology, 153, pp.77~86 (2017)
- Feagan BG, "Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn’s disease : a randomised, double-blind, placebo-controlled phase 2 study", Lancet, 389, pp.1699~1709 (2017)
- Sandborn WJ, "Efficacy and safety of mirikizumab in a randomized phase 2 study of patients with ulcerative colitis", Gastroenterology, 158, pp.537~549 (2020)
- Sandborn WJ, "Efficacy and safety of continued treatment with mirikizumab in a phase 2 trial of patients with ulcerative colitis", Clin Gastroenterol Hepatol, 20, pp.105~115 (2022)
- Sands BE, "Efficacy and safety of mirikizumab in a randomized phase 2 study of patients with Crohn’s disease", Gastroenterology, 162, pp.495~508 (2022)
- Feagan BG, "Filgotinib as induction and maintenance therapy for ulcerative colitis(SELECTION) : a phase 2b", 3 double-blind, randomised, placebo-controlled trial, 2021, pp.397, 2372~2384
- Vermeire S, "Clinical remission in patients with moderate-to-severe Crohn’s disease treated with filgotinib(the FITZROY study) : results from a phase 2, double-blind, randomised, placebo-controlled trial", Lancet, 389, pp.266~275 (2017)
- D’Amico F, "Positioning filgotinib in the treatment algorithm of moderate to severe ulcerative colitis", J Crohns Colitis, 16, pp.835~844 (2022)
- Tang MT, "Review article : nonclinical and clinical pharmacology, pharmacokinetics and pharmacodynamics of etrolizumab, an anti-β7 integrin therapy for inflammatory bowel disease", Aliment Pharmacol Ther, 47, pp.1440~1452 (2018)
- Peyrin-Biroulet L, "Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors(HICKORY) : a phase 3, randomised, controlled trial", Lancet Gastroenterol Hepatol, 7, pp.128~140 (2022)
- Vermeire S, "Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis(LAUREL) : a randomised, placebo-controlled, double-blind, phase 3 study", Lancet Gastroenterol Hepatol, 7, pp.28~37 (2022)
- Rubin DT, "Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis(HIBISCUS) : two phase 3randomised, controlled trials", Lancet Gastroenterol Hepatol, 7, pp.17~27 (2022)
- Danese S, "Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis(GARDENIA) : a randomised, double-blind, double-dummy, phase 3 study", Lancet Gastroenterol Hepatol, 7, pp.118~127 (2022)
- Sandborn WJ, "Efficacy and safety of etrasimod in a phase 2 randomized trial of patients with ulcerative colitis", Gastroenterology, 158, pp.550~561 (2020)
- Vermeire S, "Long-term safety and efficacy of etrasimod for ulcerative colitis : results from the Open-label Extension of the OASIS Study", J Crohns Colitis, 15, pp.950~959 (2021)
- 송은미, "Natural history of inflammatory bowel disease: a comparison between the East and the West", Intestinal research, 20(4), pp.418~430 (2022), 대한장연구학회[DOI]
