Positioning ustekinumab in moderate-to-severe ulcerative colitis: new kid on the block

References

• Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet. 2012;380(9853):1590–1605.
   PubMed Web of Science ®Google Scholar
• Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011;365(18):1713–1725.
   PubMed Web of Science ®Google Scholar
• Geremia A, Biancheri P, Allan P, et al. Innate and adaptive immunity in inflammatory bowel disease. Autoimmun Rev. 2014;13(1):3–10.
   PubMed Web of Science ®Google Scholar
• Neurath MF. Cytokines in inflammatory bowel disease. Nat Rev Immunol. 2014;14:329.
   PubMed Web of Science ®Google Scholar
• Danese S, Fiorino G, Peyrin-Biroulet L, et al. Biological agents for moderately to severely active ulcerative colitis: a systematic review and network meta-analysis. Ann Intern Med. 2014;160(10):704–711.
   PubMed Web of Science ®Google Scholar
• Bonovas S, Pantavou K, Evripidou D, et al. Safety of biological therapies in ulcerative colitis: an umbrella review of meta-analyses. Best Pract Res Clin Gastroenterol. 2018;32–33:43–47.
   PubMed Web of Science ®Google Scholar
• Bonovas S, Lytras T, Nikolopoulos G, et al. Systematic review with network meta-analysis: comparative assessment of tofacitinib and biological therapies for moderate-to-severe ulcerative colitis. Aliment Pharmacol Ther. 2018;47(4):454–465.
   PubMed Web of Science ®Google Scholar
• Gustavsson A, Jarnerot G, Hertervig E, et al. Clinical trial: colectomy after rescue therapy in ulcerative colitis - 3-year follow-up of the Swedish-Danish controlled infliximab study. Aliment Pharmacol Ther. 2010;32(8):984–989.
   PubMed Web of Science ®Google Scholar
• Danese S, Fiorino G. Reinisch W Review article: causative factors and the clinical management of patients with Crohn’s disease who lose response to anti-TNF-alpha therapy. Aliment Pharmacol Ther. 2011;34(1):1–10.
   PubMed Web of Science ®Google Scholar
• Allocca M, Furfaro F, Fiorino G, et al. Can IL-23 be a good target for ulcerative colitis? Best Pract Res Clin Gastroenterol. 2018;32–33:95–102.
   PubMed Web of Science ®Google Scholar
• Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353(23):2462–2476.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142(2):257-65e1-3.
   Web of Science ®Google Scholar
• Reinisch W, Sandborn WJ, Panaccione R, et al. 52-week efficacy of adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunosuppressants. Inflamm Bowel Dis. 2013;19(8):1700–1709.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Colombel JF, D’Haens G, et al. One-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab: subgroup analyses from ULTRA 2. Aliment Pharmacol Ther. 2013;37(2):204–213.
   PubMed Web of Science ®Google Scholar
• 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.
   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
• A SPECIAL MEETING REVIEW EDITION: CCFA/Advances in Inflammatory Bowel Diseases 2015: Highlights in Ulcerative Colitis and Crohn’s Disease: A Review of Selected Presentations From the CCFA/Advances in Inflammatory Bowel Diseases 2015 Clinical and Research Conference * December 10–12,2015 * Orlando, FloridaSpecial Reporting on:* New and Future Adhesion Molecule-Based Therapies in IBD* Efficacy and Safety of Vedolizumab for Inflammatory Bowel Disease in Clinical Practice* A Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Ustekinumab, a Human IL-12/23p40 Monoclonal Antibody, in Moderate-Severe Crohn’s Disease Refractory to Anti-TNFalpha: UNITI-1* Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease* Does Vedolizumab Affect Postoperative Outcomes in Patients Undergoing Abdominal Operations for Inflammatory Bowel Disease? PLUS Meeting Abstract Summaries With Expert Commentary by: Gary R. Lichtenstein, MDProfessor of MedicineDirector, Center for Inflammatory Bowel DiseaseUniversity of Pennsylvania Health SystemHospital of the University of Pennsylvania Philadelphia, Pennsylvania Gastroenterol Hepatol (N Y). 2016; 12(2 Suppl 1), 1–20.
   Google Scholar
• Abraham C, Cho J. Interleukin-23/Th17 Pathways and Inflammatory Bowel Disease. Inflamm Bowel Dis. 2009;15(7):1090–1100.
   PubMed Web of Science ®Google Scholar
• Galvez J. Role of Th17 Cells in the Pathogenesis of Human IBD. ISRN Inflamm. 2014;2014:928461.
   PubMedGoogle 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
• Teng MWL, Bowman EP, McElwee JJ, et al. IL-12 and IL-23 cytokines: from discovery to targeted therapies for immune-mediated inflammatory diseases. Nat Med. 2015;21:719.
   PubMed Web of Science ®Google Scholar
• Jauregui-Amezaga A, Somers M, De Schepper H, et al. Next generation of biologics for the treatment of Crohn’s disease: an evidence-based review on ustekinumab. Clin Exp Gastroenterol. 2017;10:293–301.
   PubMed Web of Science ®Google Scholar
• Hueber W, Sands BE, Lewitzky S, et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012;61(12):1693–1700.
   PubMed Web of Science ®Google Scholar
• Fobelo Lozano MJ, Serrano Giménez R. Castro Fernández M Emergence of Inflammatory Bowel Disease During Treatment With Secukinumab. J Crohn’s Colitis. 2018;12(9):1131–1133.
   Google Scholar
• European Medicine Agency Stelara - Summary of Product Characteristics. [ cited 2019 Feb 28]. Available from: https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf
   Google Scholar
• Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665–1674.
   PubMed Web of Science ®Google Scholar
• Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675–1684.
   PubMed Web of Science ®Google Scholar
• McInnes IB, Kavanaugh A, Gottlieb AB, et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780–789.
   PubMed Web of Science ®Google Scholar
• Ritchlin C, Rahman P, Kavanaugh A, et al. Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990–999.
   PubMed Web of Science ®Google Scholar
• Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease New England. J Med. 2016;375(20):1946–1960.
   Google Scholar
• Dayan JR, Dolinger M, Benkov K, et al. Real World Experience With Ustekinumab in Children and Young Adults at a Tertiary Care Pediatric Inflammatory Bowel Disease Center. J Pediatr Gastroenterol Nutr. 2019;69(1):61–67.
   PubMed Web of Science ®Google Scholar
• Scherl E, Jacobstein D, Murphy C, et al. A109 Pregnancy outcomes in women exposed to ustekinumab in the Crohn’s disease clinical development program. J Can Assoc Gastroenterol. 2018;1(suppl_2):166.
   Google Scholar
• Mahadevan U, Robinson C, Bernasko N, et al. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019;156(5):1508–1524.
   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
• Sands BE, Peyrin-Biroulet L, Marano CW, et al. 833a – efficacy in Biologic-Failure and Nonbiologic-Failure Populations in a Phase 3 Study of Ustekinumab in Moderate severe Ulcerative Colitis: unifi. Gastroenterology. 2019;156(6,Supplement 1):S-181-S-182.
   Web of Science ®Google Scholar
• Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: current Management. J Crohns Colitis. 2017;11(7):769–784.
   PubMed Web of Science ®Google Scholar
• Jarnerot G, Hertervig E, Friis-Liby I, et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005;128(7):1805–1811.
   PubMed Web of Science ®Google Scholar
• Laharie D, Bourreille A, Branche J, et al. Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab. Gut. 2018;67(2):237–243.
   PubMed Web of Science ®Google Scholar