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REVIEW

Clinical Evaluation of Risankizumab in the Treatment of Adults with Moderately to Severely Active Crohn’s Disease: Patient Selection and Reported Outcomes

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Pages 273-282 | Received 29 Nov 2022, Accepted 17 Jan 2023, Published online: 31 Jan 2023

References

  • Khader SA, Thirunavukkarasu S. The Tale of IL-12 and IL-23: a paradigm shift. J Immunol. 2019;202(3):629–630. doi:10.4049/jimmunol.1801603
  • Ma C, Panaccione R, Khanna R, Feagan BG, Jairath V. IL12/23 or selective IL23 inhibition for the management of moderate-to-severe Crohn’s disease? Best Pract Res Clin Gastroenterol. 2019;38–39:101604. doi:10.1016/j.bpg.2019.02.006
  • Moschen AR, Tilg H, Raine T. IL-12, IL-23 and IL-17 in IBD: immunobiology and therapeutic targeting. Nat Rev Gastroenterol Hepatol. 2019;16(3):185–196. doi:10.1038/s41575-018-0084-8
  • Cua DJ, Sherlock J, Chen Y, et al. Interleukin-23 rather than interleukin-12 is the critical cytokine for autoimmune inflammation of the brain. Nature. 2003;421(6924):744–748. doi:10.1038/nature01355
  • Yen D, Cheung J, Scheerens H, et al. IL-23 is essential for T cell-mediated colitis and promotes inflammation via IL-17 and IL-6. J Clin Invest. 2006;116(5):1310–1316. doi:10.1172/JCI21404
  • Grossberg LB, Papamichael K, Cheifetz AS. Review article: emerging drug therapies in inflammatory bowel disease. Aliment Pharmacol Ther. 2022;55(7):789–804. doi:10.1111/apt.16785
  • Jefremow A, Neurath MF. All are equal, some are more equal: targeting IL 12 and 23 in IBD - A clinical perspective. Immunotargets Ther. 2020;9:289–297. doi:10.2147/ITT.S282466
  • 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. doi:10.1126/science.1135245
  • Liu M, Zhu W, Wang J, et al. Interleukin-23 receptor genetic polymorphisms and ulcerative colitis susceptibility: a meta-analysis. Clin Res Hepatol Gastroenterol. 2015;39(4):516–525. doi:10.1016/j.clinre.2014.10.009
  • Risankizumab Prescribing Information. Available from: https://www.rxabbvie.com/pdf/skyrizi_pi.pdf. Accessed August 23, 2022.
  • 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. doi:10.1053/j.gastro.2020.12.031
  • Sands BE, Chen J, Feagan BG, et al. Efficacy and safety of MEDI2070, an antibody against interleukin 23, in patients with moderate to severe Crohn’s disease: a phase 2a study. Gastroenterology. 2017;153(1):77–86e6. doi:10.1053/j.gastro.2017.03.049
  • D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015–2030. doi:10.1016/S0140-6736(22)00467-6
  • Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031–2046. doi:10.1016/S0140-6736(22)00466-4
  • Baert F, Atreya R, Kakuta Y, et al. DOP85 Efficacy of risankizumab rescue therapy in patients with moderately to severely active Crohn’s Disease and inadequate response to risankizumab maintenance therapy. J Crohns Colitis. 2022;16(Supplement_1):i128. doi:10.1093/ecco-jcc/jjab232.124
  • Kucharzik T, Ellul P, Greuter T, et al. ECCO guidelines on the prevention, diagnosis, and management of infections in inflammatory bowel disease. J Crohns Colitis. 2021;15(6):879–913. doi:10.1093/ecco-jcc/jjab052
  • Blauvelt A, Leonardi CL, Gooderham M, et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(6):649–658. doi:10.1001/jamadermatol.2020.0723
  • Warren RB, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a Phase III, randomized, open-label, efficacy-assessor-blinded clinical trial. Br J Dermatol. 2021;184(1):50–59. doi:10.1111/bjd.19341
  • Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650–661. doi:10.1016/S0140-6736(18)31713-6
  • Reich K, Gooderham M, Thaci D, et al. Risankizumab compared with Adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576–586. doi:10.1016/S0140-6736(19)30952-3
  • Papp KA, Lebwohl MG, Puig L, et al. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up. Br J Dermatol. 2021;185(6):1135–1145. doi:10.1111/bjd.20595
  • Gordon KB, Lebwohl M, Papp KA, et al. Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2022;186(3):466–475. doi:10.1111/bjd.20818
  • Papp KA, Blauvelt A, Bukhalo M, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med. 2017;376(16):1551–1560. doi:10.1056/NEJMoa1607017
  • Strober B, Menter A, Leonardi C, et al. Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa-1 and UltIMMa-2 studies. J Eur Acad Dermatol Venereol. 2020;34(12):2830–2838. doi:10.1111/jdv.16521
  • Ferrante M, Peyrin-Biroulet L, Dignass A, et al. Clinical and Endoscopic Improvements with risankizumab induction and maintenance dosing versus placebo are observed irrespective of number of prior failed biologics. United Eur Gastroenterol J. 2022;10(S8):9–184. doi:10.1002/ueg2.12293
  • ClinicalTrials.gov. Clinical Trial information; 2022. Available from: https://clinicaltrialsgov/ct2/show/NCT04524611. Accessed January 18, 2023
  • Singh S, Murad MH, Fumery M, et al. Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn’s disease: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021;6(12):1002–1014. doi:10.1016/S2468-1253(21)00312-5
  • Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn’s disease. N Engl J Med. 2004;350(9):876–885. doi:10.1056/NEJMoa030815
  • Colombel JF, Schwartz DA, Sandborn WJ, et al. Adalimumab for the treatment of fistulas in patients with Crohn’s disease. Gut. 2009;58(7):940–948. doi:10.1136/gut.2008.159251
  • Regueiro M, Kip KE, Baidoo L, Swoger JM, Schraut W. Postoperative therapy with infliximab prevents long-term Crohn’s disease recurrence. Clin Gastroenterol Hepatol. 2014;12(9):1494–502 e1. doi:10.1016/j.cgh.2013.12.035
  • Battat R, Lukin D, Scherl EJ, et al. Immunogenicity of tumor necrosis factor antagonists and effect of dose escalation on anti-drug antibodies and serum drug concentrations in inflammatory bowel disease. Inflamm Bowel Dis. 2021;27(9):1443–1451. doi:10.1093/ibd/izaa313
  • 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. doi:10.1016/S2468-1253(19)30012-3
  • 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. doi:10.1056/NEJMoa0904492
  • Solitano V, Facciorusso A, Jess T, et al. Comparative risk of serious infections with biologic agents and oral small molecules in inflammatory bowel diseases: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2022. doi:10.1016/j.cgh.2022.07.032
  • Sandborn WJ, Rebuck R, Wang Y, et al. Five-year efficacy and safety of ustekinumab treatment in crohn’s disease: the IM-UNITI trial. Clin Gastroenterol Hepatol. 2022;20(3):578–590 e4. doi:10.1016/j.cgh.2021.02.025
  • Papp K, Gottlieb AB, Naldi L, et al. Safety surveillance for ustekinumab and other psoriasis treatments from the psoriasis longitudinal assessment and registry (PSOLAR). J Drugs Dermatol. 2015;14(7):706–714.
  • Sands BE, Irving PM, Hoops T, et al. Ustekinumab versus Adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn’s disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022;399(10342):2200–2211. doi:10.1016/S0140-6736(22)00688-2
  • Lamb CA, Kennedy NA, Raine T, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019;68(Suppl 3):s1–s106. doi:10.1136/gutjnl-2019-318484
  • Mahadevan U, Long MD, Kane SV, et al. Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease. Gastroenterology. 2021;160(4):1131–1139. doi:10.1053/j.gastro.2020.11.038
  • Broms G, Granath F, Ekbom A, et al. Low risk of birth defects for infants whose mothers are treated with anti-tumor necrosis factor agents during pregnancy. Clin Gastroenterol Hepatol. 2016;14(2):234–41e1–5. doi:10.1016/j.cgh.2015.08.039
  • Luu M, Benzenine E, Doret M, et al. Continuous anti-tnfalpha use throughout pregnancy: possible complications for the mother but not for the fetus. A retrospective cohort on the French national health insurance database (EVASION). Am J Gastroenterol. 2018;113(11):1669–1677. doi:10.1038/s41395-018-0176-7
  • Moens A, van der Woude CJ, Julsgaard M, et al. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Aliment Pharmacol Ther. 2020;51(1):129–138. doi:10.1111/apt.15539