7,196
Views
5
CrossRef citations to date
0
Altmetric
Review

Emerging therapies for ulcerative colitis

ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon
Pages 513-524 | Received 02 Mar 2022, Accepted 20 Apr 2022, Published online: 01 May 2022

References

  • Ungaro R, Mehandru S, Allen PB, et al. Ulcerative colitis. Lancet. 2017;389:1756–1770.
  • 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;160:1570–1583.
  • Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476.
  • Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699–710.
  • Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–1736.
  • Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381:1201–1214.
  • Roda G, Jharap B, Neeraj N, et al. Loss of response to anti-TNFs: definition, epidemiology, and management. Clin Transl Gastroenterol. 2016;7:e135.
  • Singh J, Wells G, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011; CD008794. 10.1002/14651858.CD008794.pub2.
  • Sandborn WJ, Panes J, Sands BE, et al. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019;50:1068–1076.
  • Sandborn WJ, Baert F, Danese S, et al. Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis. Gastroenterology. 2020;158:562–572.
  • Schreiber S, Ben-Horin S, Leszczyszyn J, et al. Randomized controlled trial: subcutaneous vs intravenous infliximab CT-P13 maintenance in inflammatory bowel disease. Gastroenterology. 2021;160:2340–2353.
  • Bots SJ, Parker CE, Brandse JF, et al. Anti-drug antibody formation against biologic agents in inflammatory bowel disease: a systematic review and meta-analysis. BioDrugs. 2021;35:715–733.
  • 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;13:715–725.
  • Moschen AR, Tilg H, Raine T. IL-12, IL-23 and IL-17 in IBD: immunobiology and therapeutic targeting. Nat Rev Gastroenterol Hepatol. 2019;16:185–196.
  • Patel Dhavalkumar D, Kuchroo Vijay K. Th17 cell pathway in human immunity: lessons from genetics and therapeutic interventions. Immunity. 2015;43:1040–1051.
  • Fujino S, Andoh A, Bamba S, et al. Increased expression of interleukin 17 in inflammatory bowel disease. Gut. 2003;52:65–70.
  • Becker C, Dornhoff H, Neufert C, et al. Cutting edge: IL-23 cross-regulates IL-12 production in T cell-dependent experimental colitis. J Immunol. 2006;177:2760–2764.
  • O’Connor JW, Kamanaka M, Booth CJ, et al. A protective function for interleukin 17A in T cell–mediated intestinal inflammation. Nat Immunol. 2009;10:603–609.
  • Uhlig HH, McKenzie BS, Hue S, et al. Differential activity of IL-12 and IL-23 in mucosal and systemic innate immune pathology. Immunity. 2006;25:309–318.
  • Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double‐blind, phase III NAVIGATE trial. Br J Dermatol. 2018;178:114–123.
  • 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;392:650–661.
  • Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017;390:276–288.
  • Deodhar A, Helliwell PS, Boehncke W-H, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395:1115–1125.
  • Sands BE, Peyrin-Biroulet L, Kierkus J, et al. Efficacy and safety of mirikizumab in a randomized phase 2 study of patients with crohn’s disease. Gastroenterology. 2021 Epub ahead of print;160:S–37.
  • D’Haens G, Kobayashi T, Morris N, et al. OP26 efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study. J Crohn’s Colitis. 2022;16:i028–i029.
  • 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;153:77–86.
  • Dignass A, Rubin D, Bressler B, et al. OP23 the efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: phase 2b QUASAR study results through week 12. J Crohn’s Colitis. 2022;16:i025–i026.
  • Sands BE, Feagan BG, Sandborn WJ, et al. OP36 efficacy and safety of combination induction therapy with guselkumab and golimumab in participants with moderately-to-severely active ulcerative colitis: results through week 12 of a phase 2a randomized, double-blind, active-controlled, parallel-group, multicenter, proof-of-concept study. J Crohn’s Colitis. 2022;16:i042–i043.
  • Wang J, Goren I, Yang B, et al. The sphingosine 1 phosphate/sphingosine 1 phosphate receptor axis: a unique therapeutic target in inflammatory bowel disease. Aliment Pharmacol Ther. 2022;55:277–291.
  • Verstockt B, Vetrano S, Salas A, et al. Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel disease. Nat Rev Gastroenterol Hepatology. 2022; Epub ahead of print.
  • Schwab SR, Pereira JP, Matloubian M, et al. Lymphocyte sequestration through S1P lyase inhibition and disruption of S1P gradients. Science. 2005;309:1735–1739.
  • Nielsen OH, Li Y, Johansson-Lindbom B, et al. Sphingosine-1-phosphate signaling in inflammatory bowel disease. Trends Mol Med. 2017;23:362–374.
  • Sanna MG, Liao J, Jo E, et al. Sphingosine 1-phosphate (S1P) receptor subtypes S1P1 and S1P3, respectively, regulate lymphocyte recirculation and heart rate. J Biol Chem. 2004;279:13839–13848.
  • Harris S, Tran JQ, Southworth H, et al. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020;7:e839.
  • Scott FL, Clemons B, Brooks J, et al. Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1) and receptor-5 (S1P5) agonist with autoimmune disease-modifying activity. Br J Pharmacol. 2016 Jun;173(11):1778–1792.
  • Sandborn WJ, Feagan BG, D’Haens G, et al. Ozanimod as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2021;385:1280–1291.
  • Fragoso YD. Multiple sclerosis treatment with fingolimod: profile of non-cardiologic adverse events. Acta Neurol Belg. 2017;117:821–827.
  • Kappos L, Bar-Or A, Cree BAC, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018;391:1263–1273.
  • Sriwastava S, Chaudhary D, Srivastava S, et al. Progressive multifocal leukoencephalopathy and sphingosine 1-phosphate receptor modulators used in multiple sclerosis: an updated review of literature. J Neurol. 2022;269(3): 1678–1687.
  • Selmaj KW, Cohen JA, Comi G, et al. Ozanimod in relapsing multiple sclerosis: pooled safety results from the clinical development program. Mult Scler Relat Disord. 2021;51:102844.
  • Zeposia (Ozanimod) - summary of product characteristics. European Medicines Agency 2021.https://www.ema.europa.eu/en/documents/product-information/zeposia-epar-product-information_en.pdf
  • Sandborn WJ, Peyrin-Biroulet L, Zhang J, et al. Efficacy and safety of etrasimod in a phase 2 randomized trial of patients with ulcerative colitis. Gastroenterology. 2020;158:550–561.
  • Danese S, Argollo M, Le Berre C, et al. JAK selectivity for inflammatory bowel disease treatment: does it clinically matter? Gut. 2019;68:1893–1899.
  • Salas A, Hernandez-Rocha C, Duijvestein M, et al. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020;17:323–337.
  • De Vries LCS, Wildenberg ME, De Jonge WJ, et al. The future of janus kinase inhibitors in inflammatory bowel disease. J Crohn’s Colitis. 2017;11:885–893.
  • Choy EH. Clinical significance of janus kinase inhibitor selectivity. Rheumatology (Oxford). 2019;58(6):953–962.
  • Olivera PA, Lasa JS, Bonovas S, et al. Safety of janus kinase inhibitors in patients with inflammatory bowel diseases or other immune-mediated diseases: a systematic review and meta-analysis. Gastroenterology. 2020;158:1554–1573.
  • Vermeire S, Schreiber S, Petryka R, et al. 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. 2017;389:266–275.
  • Feagan BG, Danese S, Loftus EV, et al. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet. 2021;397:2372–2384.
  • Kavanaugh A, Westhovens RR, Winthrop KL, et al. Safety and efficacy of filgotinib: up to 4-year results from an open-label extension study of phase II rheumatoid arthritis programs. J Rheumatol. 2021;48:1230–1238.
  • Jyseleca (Filgotinib) summary of product characteristics. European Medicines Agency. 2020.https://www.ema.europa.eu/en/documents/product-information/jyseleca-epar-product-information_en.pdf
  • 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. Food and Drug Administration. 2021.https://www.fda.gov/media/151936/download
  • Sandborn WJ, Feagan BG, Loftus EV Jr., et al. Efficacy and safety of upadacitinib in a randomized trial of patients with crohn’s disease. Gastroenterology. 2020;158:2123–2138.
  • Vermeire S, Danese S, Zhou W, et al. OP23 efficacy and safety of upadacitinib as induction therapy in patients with moderately to severely active ulcerative colitis: results from phase 3 U-ACCOMPLISH study. J Crohn’s Colitis. 2021;15:S021–S022.
  • Danese S, Vermeire S, Zhou W, et al. OP24 efficacy and safety of upadacitinib induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 U-ACHIEVE study. J Crohn’s Colitis. 2021;15:S022–S024.
  • Panaccione R, Hebuterne X, Lindsay J, et al. Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active ulcerative colitis: results from a randomized phase 3 study. United European Gastroenterol J. 2021;9:1207–1209.
  • Vermeire S, Tanida S, Renwei H, et al. Efficacy of upadacitinib induction therapy in patients with moderately to severely active ulcerative colitis by biologic inadequate responder status: results from two randomized phase 3 studies. United European Gastroenterol J. 2021;9:17–18.
  • Sands BE, Peyrin-Biroulet L, Loftus EV, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med. 2019;381:1215–1226.
  • Lasa JS, Olivera PA, Danese S, et al. Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021;7:161–170. Epub ahead of print
  • Burr NE, Gracie DJ, Black CJ, et al. Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis. Gut. 2021;gutjnl-2021–326390. Epub ahead of print. DOI:10.1136/gutjnl-2021-326390.
  • Dalal RS, Mitri J, Goodrick H, et al. Real-world comparison of tofacitinib vs ustekinumab among bio-exposed patients with ulcerative colitis: a propensity score analysis. Inflamm Bowel Dis. 2021;27:1694–1697.
  • Hupe M, Riviere P, Nancey S, et al. Comparative efficacy and safety of vedolizumab and infliximab in ulcerative colitis after failure of a first subcutaneous anti-TNF agent: a multicentre cohort study. Aliment Pharmacol Ther. 2020;51:852–860.
  • Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386:316–326.
  • Papp KA, Blauvelt A, Bukhalo M, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med. 2017;376:1551–1560.
  • Sandborn W, Chan D, Johanns J, et al. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study. Gastroenterology. 2022;8 [Epub ahead of print].
  • Yang E, Panaccione N, Whitmire N, et al. Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn’s disease. Aliment Pharmacol Ther. 2020;51:1031–1038.
  • Kwapisz L, Raffals LE, Bruining DH, et al. Combination biologic therapy in inflammatory bowel disease: experience from a tertiary care center. Clin Gastroenterol Hepatol. 2021;19:616–617.
  • Goessens L, Colombel JF, Outtier A, et al. Safety and efficacy of combining biologics or small molecules for inflammatory bowel disease or immune-mediated inflammatory diseases: a European retrospective observational study. United European Gastroenterol J. 2021;9:1136–1147.
  • Boleto G, Kanagaratnam L, Drame M, et al. Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: a systematic review and meta-analysis. Semin Arthritis Rheum. 2019;49:35–42.