Safety evaluation of ustekinumab for moderate-to-severe ulcerative colitis

References

• Actis GC, Pellicano R, Fagoonee S, et al. History of inflammatory bowel diseases. J Clin Med. 2019;8(11):1970.
   PubMed Web of Science ®Google Scholar
• Del Val JH. Old-age inflammatory bowel disease onset: a different problem? World J Gastroenterol. 2011;17(22):2734–2739.
   PubMedGoogle Scholar
• Kaplan GG. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015;12(12):720–727.
   PubMed Web of Science ®Google Scholar
• Shah SC, Colombel JF, Sands BE, et al. Mucosal healing Is associated with improved long-term outcomes of patients with ulcerative colitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2016;14(9):1245–1255 e8.
   PubMed Web of Science ®Google Scholar
• Rutter M, Saunders B, Wilkinson K, et al. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology. 2004;126(2):451–459.
   PubMed Web of Science ®Google Scholar
• 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(9):1324–1338.
   PubMed Web of Science ®Google Scholar
• Turner D, Ricciuto A, Lewis A, et al. 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. 2021;160(5):1570–1583.
   PubMed Web of Science ®Google Scholar
• Atreya R, Zimmer M, Bartsch B, et al. Antibodies against tumor necrosis factor (TNF) induce T-cell apoptosis in patients with inflammatory bowel diseases via TNF receptor 2 and intestinal CD14(+) macrophages. Gastroenterology. 2011;141(6):2026–2038.
   PubMed Web of Science ®Google Scholar
• Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330(3):864–875.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723–1736.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Feagan BG, Wolf DC, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med. 2016;374(18):1754–1762.
   PubMed Web of Science ®Google Scholar
• Benson JM, Peritt D, Scallon BJ, et al. Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. MAbs. 2011;3(6):535–545.
   PubMed Web of Science ®Google Scholar
• Kashani A, Schwartz DA. The expanding role of anti-IL-12 and/or anti-IL-23 antibodies in the treatment of inflammatory bowel disease. Gastroenterol Hepatol. 2019;15(5):255–265.
   PubMedGoogle Scholar
• Benson JM, Sachs CW, Treacy G, et al. Therapeutic targeting of the IL-12/23 pathways: generation and characterization of ustekinumab. Nat Biotechnol. 2011;29(7):615–624.
   PubMed Web of Science ®Google Scholar
• Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381(13):1201–1214.
   PubMed Web of Science ®Google Scholar
• Luo J, Wu SJ, Lacy ER, et al. Structural basis for the dual recognition of IL-12 and IL-23 by ustekinumab. J Mol Biol. 2010;402(5):797–812.
   PubMed Web of Science ®Google Scholar
• Oppmann B, Lesley R, Blom B, et al. Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity. 2000;13(5):715–725.
   PubMed Web of Science ®Google Scholar
• Lupardus PJ, Garcia KC. The structure of interleukin-23 reveals the molecular basis of p40 subunit sharing with interleukin-12. J Mol Biol. 2008;382(4):931–941.
   PubMed Web of Science ®Google Scholar
• Vignali DA, Kuchroo VK. IL-12 family cytokines: immunological playmakers. Nat Immunol. 2012;13(8):722–728.
   PubMed Web of Science ®Google Scholar
• Mannon PJ, Fuss IJ, Mayer L, et al. Anti-interleukin-12 antibody for active Crohn’s disease. N Engl J Med. 2004;351(20):2069–2079.
   PubMed Web of Science ®Google Scholar
• Kamada N, Hisamatsu T, Okamoto S, et al. Unique CD14 intestinal macrophages contribute to the pathogenesis of Crohn disease via IL-23/IFN-gamma axis. J Clin Invest. 2008;118(6):2269–2280.
   PubMed Web of Science ®Google Scholar
• Kobayashi T, Okamoto S, Hisamatsu T, et al. IL23 differentially regulates the Th1/Th17 balance in ulcerative colitis and Crohn’s disease. Gut. 2008;57(12):1682–1689.
   PubMed Web of Science ®Google Scholar
• Parham C, Chirica M, Timans J, et al. A receptor for the heterodimeric cytokine IL-23 is composed of IL-12Rbeta1 and a novel cytokine receptor subunit, IL-23R. J Immunol. 2002;168(11):5699–5708.
   PubMed Web of Science ®Google Scholar
• Gaffen SL, Jain R, Garg AV, et al. The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing. Nat Rev Immunol. 2014;14(9):585–600.
   PubMed Web of Science ®Google Scholar
• Langrish CL, Chen Y, Blumenschein WM, et al. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation. J Exp Med. 2005;201(2):233–240.
   PubMed Web of Science ®Google Scholar
• Duerr RH, Taylor KD, Brant SR, et al. A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science. 2006;314(5804):1461–1463.
   PubMed Web of Science ®Google Scholar
• Oliver J, Rueda B, Lopez-Nevot MA, et al. Replication of an association between IL23R gene polymorphism with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2007;5(8):977–981, 81 e1–2.
   PubMed Web of Science ®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.
   PubMed Web of Science ®Google Scholar
• Sivanesan D, Beauchamp C, Quinou C, et al. IL23R (interleukin 23 receptor) variants protective against inflammatory bowel diseases (IBD) display loss of function due to impaired protein stability and intracellular trafficking. J Biol Chem. 2016;291(16):8673–8685.
   PubMed Web of Science ®Google Scholar
• Zhou L, Chong MM, Littman DR. Plasticity of CD4+ T cell lineage differentiation. Immunity. 2009;30(5):646–655.
   PubMed Web of Science ®Google Scholar
• Curtsinger JM, Mescher MF. Inflammatory cytokines as a third signal for T cell activation. Curr Opin Immunol. 2010;22(3):333–340.
   PubMed Web of Science ®Google Scholar
• Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008;84(5):548–558.
   PubMed Web of Science ®Google Scholar
• Adedokun OJ, Xu Z, Marano C, et al. Ustekinumab pharmacokinetics and exposure response in a phase 3 randomized trial of patients with ulcerative colitis. Clin Gastroenterol Hepatol. 2020;18(10):2244–2255 e9.
   PubMed Web of Science ®Google Scholar
• Panaccione R, Danese S, Sandborn WJ, et al. Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy. Aliment Pharmacol Ther. 2020;52(11–12):1658–1675.
   PubMed Web of Science ®Google Scholar
• Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946–1960.
   PubMed Web of Science ®Google Scholar
• Li K, Marano C, Zhang H, et al. Relationship between combined histologic and endoscopic endpoints and efficacy of ustekinumab treatment in patients with ulcerative colitis. Gastroenterology. 2020;159(6):2052–2064.
   PubMed Web of Science ®Google Scholar
• Amiot A, Filippi J, Abitbol V, et al. Effectiveness and safety of ustekinumab induction therapy for 103 patients with ulcerative colitis: a GETAID multicentre real-world cohort study. Aliment Pharmacol Ther. 2020;51(11):1039–1046.
   PubMed Web of Science ®Google Scholar
• Chaparro M, Garre A, Iborra M, et al. Effectiveness and safety of ustekinumab in ulcerative colitis: real-world evidence from the ENEIDA registry. J Crohns Colitis. 2021 Apr 16:jjab070. doi:https://doi.org/10.1093/ecco-jcc/jjab070. Epub ahead of print. PMID: 33860795; PMCID: PMC8083263.
   Google Scholar
• Singh S, Murad MH, Fumery M, et al. First- and second-line pharmacotherapies for patients with moderate to severely active ulcerative colitis: an updated network meta-analysis. Clin Gastroenterol Hepatol. 2020;18(10):2179–2191 e6.
   PubMed Web of Science ®Google Scholar
• Honap S, Meade S, Ibraheim H, et al. Effectiveness and safety of ustekinumab in inflammatory bowel disease: a systematic review and meta-analysis. Dig Dis Sci. 2021 Mar 16. doi:https://doi.org/10.1007/s10620-021-06932-4.
   Google Scholar
• Rolston VS, Kimmel J, Popov V, et al. Ustekinumab does not increase risk of adverse events: a meta-analysis of randomized controlled trials. Dig Dis Sci. 2021;66(5):1631–1638.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Feagan BG, Fedorak RN, et al. A randomized trial of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn’s disease. Gastroenterology. 2008;135(4):1130–1141.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Gasink C, Gao LL, et al. Ustekinumab induction and maintenance therapy in refractory Crohn’s disease. N Engl J Med. 2012;367(16):1519–1528.
   PubMed Web of Science ®Google Scholar
• Dhaliwal J, McKay HE, Deslandres C, et al. One-year outcomes with ustekinumab therapy in infliximab-refractory paediatric ulcerative colitis: a multicentre prospective study. Aliment Pharmacol Ther. 2021;53(12):1300-1308.
   PubMed Web of Science ®Google Scholar
• Wils P, Seksik P, Stefanescu C, et al. Safety of ustekinumab or vedolizumab in pregnant inflammatory bowel disease patients: a multicentre cohort study. Aliment Pharmacol Ther. 2021;53(4):460–470.
   PubMed Web of Science ®Google Scholar
• SECURE-IBD DATABASE. [Internet]. Surveillance epidemiology of coronavirus (COVID-19) under research exclusion. [cited 2021 May 14]. Available from: https://covidibd.org/current-data/
   Google Scholar
• Lukin DJ, Kumar A, Hajifathalian K, et al. Baseline disease activity and steroid therapy stratify risk of COVID-19 in patients with inflammatory bowel disease. Gastroenterology. 2020;159(4):1541–1544 e2.
   PubMed Web of Science ®Google Scholar
• Brenner EJ, Ungaro RC, Gearry RB, et al. Corticosteroids, but not TNF antagonists, are associated with adverse COVID-19 outcomes in patients with Inflammatory bowel diseases: results from an international registry. Gastroenterology. 2020;159(2):481–491 e3.
   PubMed Web of Science ®Google Scholar
• Ungaro RC, Brenner EJ, Gearry RB, et al. Effect of IBD medications on COVID-19 outcomes: results from an international registry. Gut. 2021;70(4):725–732.
   PubMed Web of Science ®Google Scholar
• Bossa F, Carparelli S, Latiano A, et al. Impact of the COVID-19 outbreak and the serum prevalence of SARS-CoV-2 antibodies in patients with inflammatory bowel disease treated with biologic drugs. Dig Liver Dis. 2021;53(3):277–282.
   PubMedGoogle Scholar
• Siegel CA, Melmed GY, McGovern DP, et al. SARS-CoV-2 vaccination for patients with inflammatory bowel diseases: recommendations from an international consensus meeting. Gut. 2021;70(4):635–640.
   PubMed Web of Science ®Google Scholar
• Wong SY, Dixon R, Pazos VM, et al. Serological response to mRNA COVID-19 vaccines in IBD patients receiving biological therapies. Gastroenterology. 2021;161(2):715–718.e4.
   PubMed Web of Science ®Google Scholar
• Kennedy NA, Lin S, Goodhand JR, et al. Infliximab is associated with attenuated immunogenicity to BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 vaccines in patients with IBD. Gut. 2021;70(10):1884-1893.
   Web of Science ®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.
   PubMed Web of Science ®Google Scholar
• 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(2):392–400 e3.
   PubMed Web of Science ®Google Scholar
• Siegel CA, Marden SM, Persing SM, et al. Risk of lymphoma associated with combination anti-tumor necrosis factor and immunomodulator therapy for the treatment of Crohn’s disease: a meta-analysis. Clin Gastroenterol Hepatol. 2009;7(8):874–881.
   PubMed Web of Science ®Google Scholar
• Kirchgesner J, Lemaitre M, Carrat F, et al. Risk of serious and opportunistic infections associated with treatment of inflammatory bowel diseases. Gastroenterology. 2018;155(2):337–346 e10.
   PubMed Web of Science ®Google Scholar
• Park S, Abdi T, Gentry M, et al. Histological disease activity as a predictor of clinical relapse among patients with ulcerative colitis: systematic review and meta-analysis. Am J Gastroenterol. 2016;111(12):1692–1701.
   PubMed Web of Science ®Google Scholar
• Haider SA, Yadav A, Perry C, et al. Ustekinumab dose escalation improves clinical responses in refractory Crohn’s disease. Therap Adv Gastroenterol. 2020;13:1756284820959245.
   Web of Science ®Google Scholar
• Fumery M, Peyrin-Biroulet L, Nancey S, et al. Effectiveness and safety of ustekinumab intensification at 90 mg every four weeks In Crohn’s disease: a multicenter study. J Crohns Colitis. 2020;jjaa177. doi:https://doi.org/10.1093/ecco-jcc/jjaa177. Epub ahead of print. PMID: 32898232.
   Google Scholar
• Ollech JE, Normatov I, Peleg N, et al. Effectiveness of ustekinumab dose escalation in patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2021;19(1):104–110.
   PubMed Web of Science ®Google Scholar
• Sedano R, Guizzetti L, McDonald C, et al. Intravenous ustekinumab reinduction is effective in prior biologic failure Crohn’s disease patients already on every-4-week dosing. Clin Gastroenterol Hepatol. 2021;19(7):1497–1498.e1.
   PubMed Web of Science ®Google Scholar