714
Views
9
CrossRef citations to date
0
Altmetric
Review

The biologics of ulcerative colitis

, , &
Pages 175-184 | Received 28 Jun 2016, Accepted 09 Dec 2016, Published online: 21 Dec 2016

References

  • Torres J, Billioud V, Sachar DB, et al. Ulcerative colitis as a progressive disease: the forgotten evidence. Inflamm Bowel Dis. 2012;18:1356–1363.
  • Hoivik ML, Moum B, Solberg IC, et al.; IBSEN Group. Work disability in inflammatory bowel disease patients 10 years after disease onset: results from the IBSEN study. Gut. 2013;62:368–375.
  • Burger D, Travis S. Conventional medical management of inflammatory bowel disease. Gastroenterology. 2011;140:1827–1837.
  • Peyrin-Biroulet L. Disease-modifying anti-inflammatory bowel disease drugs (DMAIDs): the missing term in the literature. Am J Gastroenterol. 2013;108:859–860.
  • Bressler B, Marshall JK, Bernstein CN, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015;148:1035–1058.
  • Annese V, Duricova D, Gower-Rousseau C, et al. Impact of new treatments on hospitalisation, surgery, infection, and mortality in IBD: a focus paper by the epidemiology committee of ECCO. J Crohns Colitis. 2016;10:216–225.
  • Jakobsen C, Paerregaard A, Munkholm P, et al. Pediatric inflammatory bowel disease: increasing incidence, decreasing surgery rate, and compromised nutritional status: a prospective population-based cohort study 2007–2009. Inflamm Bowel Dis. 2011;17:2541–2550.
  • Vind I, Riis L, Jess T, et al.; DCCD Study Group. Increasing incidences of inflammatory bowel disease and decreasing surgery rates in Copenhagen City and County, 2003–2005: a population-based study from the Danish Crohn colitis database. Am J Gastroenterol. 2006;101:1274–1282.
  • Vester-Andersen MK, Prosberg MV, Jess T, et al. Disease course and surgery rates in inflammatory bowel disease: a population-based, 7-year follow-up study in the era of immunomodulating therapy. Am J Gastroenterol. 2014;109:705–714.
  • Singh S, Al-Darmaki A, Frolkis AD, et al. Postoperative mortality among patients with inflammatory bowel diseases: a systematic review and meta-analysis of population-based studies. Gastroenterology. 2015;149:928–937.
  • Burisch J, Pedersen N, Čuković-Čavka S, et al.; EpiCom Group. East-west gradient in the incidence of inflammatory bowel disease in Europe: the ECCO-EpiCom inception cohort. Gut. 2014;63:588–597.
  • Sjöberg D, Holmström T, Larsson M, et al. Incidence and clinical course of Crohn’s disease during the first year – results from the IBD Cohort of the Uppsala Region (ICURE) of Sweden 2005–2009. J Crohns Colitis. 2014;8:215–222.
  • Petkau JM, Eksteen B. Selective biologics for ulcerative colitis and Crohn’s disease – clinical utility of vedolizumab. Biologics. 2016;10:33–52.
  • Harbord M, Annese V, Vavricka SR, et al.; European Crohn’s and Colitis Organisation. The first European evidence-based consensus on extra-intestinal manifestations in inflammatory bowel disease. J Crohns Colitis. 2016;10:239–254.
  • Bernstein CN, Shanahan F. Disorders of a modern lifestyle: reconciling the epidemiology of inflammatory bowel diseases. Gut. 2008;57:1185–1191.
  • Vegh Z, Burisch J, Pedersen N, et al.; EpiCom group. Treatment steps, surgery, and hospitalization rates during the first year of follow-up in patients with inflammatory bowel diseases from the 2011 ECCO-Epicom Inception Cohort. J Crohns Colitis. 2015;9:747–753.
  • Bernstein CN, Fried M, Krabshuis JH, et al. World Gastroenterology Organization practice guidelines for the diagnosis and management of IBD in 2010. Inflamm Bowel Dis. 2010;16:112–124.
  • 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.
  • Armuzzi A, Pugliese D, Danese S, et al. Long-term combination therapy with infliximab plus azathioprine predicts sustained steroid-free clinical benefit in steroid-dependent ulcerative colitis. Inflamm Bowel Dis. 2014;20:1368–1374.
  • Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006;3:CD005112.
  • Hyams J, Damaraju L, Blank M, et al. Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol. 2012;10:391–399.
  • Järnerot 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;128:1805–1811.
  • Gustavsson A, Järnerot 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;32:984–989.
  • Lees CW, Heys D, Ho GT, et al. A retrospective analysis of the efficacy and safety of infliximab as rescue therapy in acute severe ulcerative colitis. Aliment Pharmacol Ther. 2007;26:411–419.
  • Regueiro M, Curtis J, Plevy S. Infliximab for hospitalized patients with severe ulcerative colitis. J Clin Gastroenterol. 2006;40:476–481.
  • Jakobovits SL, Jewell DP, Travis SP. Infliximab for the treatment of ulcerative colitis: outcomes in Oxford from 2000 to 2006. Aliment Pharmacol Ther. 2007;25:1055–1060.
  • Ferrante M, Vermeire S, Katsanos KH, et al. Predictors of early response to infliximab in patients with ulcerative colitis. Inflamm Bowel Dis. 2007;13:123–128.
  • Laharie D, Bourreille A, Branche J, et al. Groupe d‘Etudes Thérapeutiques des affections inflammatoires digestives. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet. 2012;380:1909–1915.
  • Chang KH, Burke JP, Coffey JC. Infliximab versus cyclosporine as rescue therapy in acute severe steroid-refractory ulcerative colitis: a systematic review and meta-analysis. Int J Colorectal Dis. 2013;28:287–293.
  • Laharie D, Filippi J, Roblin X, et al. Impact of mucosal healing on long term outcomes in ulcerative colitis treated with infliximab: a multicenter experience. Aliment Pharmacol Ther. 2013;37:998–1004.
  • Farkas K, Lakatos PL, Szűcs M, et al. Frequency and prognostic role of mucosal healing in patients with Crohn‘s disease and ulcerative colitis after one-year of biological therapy. World J Gastroenterol. 2014;20:2995–3001.
  • McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405–417.
  • Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605–1612.
  • Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613–1620.
  • Papamichael K, Van Stappen T, Jairath V, et al. Review article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases. Aliment Pharmacol Ther. 2015;42:1158–1169.
  • Gecse K, Farkas K, Lovasz BD, et al. Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. Gastroenterology. 2015;148:S-865–6.
  • Jung YS, Park DI, Kim YH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;30:1705–1712.
  • Molnar T, Farkas K, Rutka M, et al. Efficacy of the new infliximab biomarker CTP13 induction therapy on mucosal healing in ulcerative colitis patients. J Crohns Colitis. 2015;9:S382.
  • Murphy C, Sugrue K, Mohamad J, et al. Biosimilar but not the same. J Crohns Colitis. 2015;9(Suppl 1):S331–S332.
  • Sieczkowska J, Jarzebicka D, Banaszkiewicz A, et al. Switching between infliximab originator and biosimilar in pediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10:127–132.
  • Ben-Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognize the biosimilar Remsima. Gut. 2016;65:1132–1138.
  • Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomized controlled trial. Gut. 2011;60:780–787.
  • 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;142:257–265.
  • Colombel JF, Sandborn WJ, Ghosh S, et al. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014;109:1771–1780.
  • 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;19:1700–1709.
  • McDermott E, Murphy S, Keegan D, et al. Efficacy of adalimumab as a long term maintenance therapy in ulcerative colitis. J Crohns Colitis. 2013;7:150–153.
  • Ferrante M, Karmiris K, Compernolle G, et al. Efficacy of adalimumab in patients with ulcerative colitis: restoration of serum levels after dose escalation results in a better long-term outcome. Gut. 2011;60(Suppl 3):A72.
  • García-Bosch O, Gisbert JP, Canas-Ventura A, et al. Observational study on the efficacy of adalimumab for the treatment of ulcerative colitis and predictors of outcome. J Crohns Colitis. 2013;7:717–722.
  • Armuzzi A, Biancone L, Daperno M, et al. Adalimumab in active ulcerative colitis: a “real life” observational study. Dig Liver Dis. 2013;45:738–743.
  • Lippert E, Müller M, Ott C. Golimumab in unresponsive ulcerative colitis. Biologics. 2014;8:207–210.
  • Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:85–95.
  • Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:96–109.
  • Renna S, Orlando E, Macaluso FS, et al. A prospective real life comparison of the efficacy of adalimumab versus golimumab in moderate to severe ulcerative colitis. Aliment Pharmacol Ther. 2016;44:310–311.
  • Available from http://www.fda.gov/Drugs/DrugSafety/ucm270849.html
  • Gisbert JP, González-Lama Y, Maté J. Systematic review: infliximab therapy in ulcerative colitis. Aliment Pharmacol Ther. 2007;25:19–37.
  • Orlando A, Armuzzi A, Papi C, et al.; Italian Society of Gastroenterology; Italian Group for the study of Inflammatory Bowel Disease. The Italian Society of Gastroenterology (SIGE) and the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) clinical practice guidelines: the use of tumor necrosis factor-alpha antagonist therapy in inflammatory bowel disease. Dig Liver Dis. 2011;43:1–20.
  • Rahier JF, Magro F, Abreu C, et al. Second European evidence-based consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease. J Crohns Colitis. 2014;8:443–468.
  • Cottone M, Kohn A, Daperno M, et al. Advanced age is an independent risk factor for severe infections and mortality in patients given anti-tumor necrosis factor therapy for inflammatory bowel disease. Clin Gastroenterol Hepatol. 2011;9:30–35.
  • Biancone L, Calabrese E, Petruzziello C, et al. Treatment with biologic therapies and the risk of cancer in patients with IBD. Nat Clin Pract Gastroenterol Hepatol. 2007;4:78–91.
  • Lichtenstein GR, Rutgeerts P, Sandborn WJ, et al. A pooled analysis of infections, malignancy, and mortality in infliximab- and immunomodulator-treated adult patients with inflammatory bowel disease. Am J Gastroenterol. 2012;107:1051–1063.
  • Cleynen I, Vermeire S. Paradoxical inflammation induced by anti-TNF agents in patients with IBD. Nat Rev Gastroenterol Hepatol. 2012;9:496–503.
  • Denadai R, Teixeira FV, Steinwurz F, et al. Induction or exacerbation of psoriatic lesions during anti-TNF-α therapy for inflammatory bowel disease: a systematic literature review based on 222 cases. J Crohns Colitis. 2013;7:517–524.
  • Vermeire S, Noman M, van Assche G, et al. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn’s disease. Gut. 2007;56:1226–1231.
  • Rutgeerts P, Feagan BG, Lichtenstein GR, et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease. Gastroenterology. 2004;126:402–413.
  • Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007;146:829–838.
  • Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn’s disease. N Engl J Med. 2003;348:601–608.
  • Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009;137:1628–1640.
  • Hanauer SB, Wagner CL, Bala M, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn’s disease. Clin Gastroenterol Hepatol. 2004;2:542–553.
  • Adedokun OJ, Sandborn WJ, Feagan BG, et al. Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis. Gastroenterology. 2014;147:1296–1307.
  • Seow CH, Newman A, Irwin SP, et al. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010;59:49–54.
  • Sandborn WJ. Tailoring treatment to the individual patient: drug monitoring. Dig Dis. 2014;32(Suppl 1):88–91.
  • 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;146:392–400.
  • Peyrin-Biroulet L, Salleron J, Filippi J, et al. Anti-TNF monotherapy for Crohn’s disease: a 13-year multicentre experience. J Crohns Colitis. 2016;10:516–524.
  • Orlando A, Renna S, Rizzuto G, et al. Selective use of combination therapy in patients with infliximab-resistant inflammatory bowel disease: data from a tertiary referral center. Clin Gastroenterol Hepatol. 2016;14:914.
  • Agace W. Generation of gut-homing T cells and their localization to the small intestinal mucosa. Immunol Lett. 2010;128:21–23.
  • Jaensson E, Uronen-Hansson H, Pabst O, et al. Small intestinal CD103+ dendritic cells display unique functional properties that are conserved between mice and humans. J Exp Med. 2008;205:2139–2149.
  • Iwata M, Hirakiyama A, Eshima Y, et al. Retinoic acid imprints gut-homing specificity on T cells. Immunity. 2004;21:527–538.
  • Agace W. T-cell recruitment to the intestinal mucosa. Trends Immunol. 2008;29:514–522.
  • Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2005;353:1912–1925.
  • Monaco MC, Major EO. The link between VLA-4 and JC virus reactivation. Expert Rev Clin Immunol. 2012;8:63–72.
  • Armuzzi A, Gionchetti P, Daperno M, et al.; GIVI (Gruppo Italiano su Vedolizumab nelle IBD) Group. Expert consensus paper on the use of vedolizumab for the management of patients with moderate-to-severe inflammatory bowel disease. Dig Liver Dis. 2016;48:360–370.
  • Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699–710.
  • Wang MC, Zhang LY, Han W, et al. PRISMA – efficacy and safety of vedolizumab for inflammatory bowel diseases: a systematic review and meta-analysis of randomized controlled trials. Medicine. 2014;93:e326.
  • Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. Gut. 2016 Feb 18. pii: gutjnl-2015-311079. [Epub ahead of print]
  • Ho GT, Chiam P, Drummond H, et al. The efficacy of corticosteroid therapy in inflammatory bowel disease: analysis of a 5-year UK inception cohort. Aliment Pharmacol Ther. 2006;24:319–330.
  • Zenlea T, Peppercorn MA. Immunosuppressive therapies for inflammatory bowel disease. World J Gastroenterol. 2014;20:3146–52.7.
  • Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006;19:CD005112.
  • 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;160:704–711.
  • Renna S, Cottone M, Orlando A. Optimization of the treatment with immunosuppressants and biologics in inflammatory bowel disease. World J Gastroenterol. 2014;20:9675–9690.
  • Ljung T, Karlén P, Schmidt D, et al. Infliximab in inflammatory bowel disease: clinical outcome in a population based cohort from Stockholm County. Gut. 2004;53:849–853.
  • Ben-Horin S, Chowers Y. Review article: loss of response to anti-TNF treatments in Crohn’s disease. Aliment Pharmacol Ther. 2011;33:987–995.
  • Rogler G, Bernstein CN, Sood A, et al. Role of biological therapy for inflammatory bowel disease in developing countries. Gut. 2012;61:706–712.
  • Archer R, Tappenden P, Ren S, et al. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model. Health Technol Assess. 2016;20:1–326.
  • Macaluso FS, Cottone M, Orlando A. The selective use of combination therapy in patients with inflammatory bowel disease resistant to anti-TNF: to whom, how and how long? J Crohns Colitis. 2016; 10:1451.
  • Ha C, Ullman TA, Siegel CA, et al. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol. 2012;10:1002–1007.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.