Clinical Journal of Gastroenterology

, Volume 12, Issue 1, pp 1–9 | Cite as

Golimumab in inflammatory bowel diseases: present and future scenarios

  • Gabriele DragoniEmail author
  • Marco Le Grazie
  • Beatrice Orlandini
  • Francesca Rogai
Clinical Review


Golimumab is the third anti-TNF agent approved for the treatment of ulcerative colitis. Despite initial success demonstrated by PURSUIT trials, only few real-life studies have been published evaluating its efficacy and safety in clinical practice. Its subcutaneous route and monthly administration represent an advantage in patient compliance, respectively, vs infliximab (intravenous) and adalimumab (two doses per month). The most important weakness of the molecule which often leads clinicians to choose another anti-TNF is the impossibility to dose escalate or reduce the frequency of administrations in case of secondary failure; ongoing studies are trying to solve this problem by monitoring drug levels and the eventual presence of neutralizing anti-drug antibodies. No advantage has still been demonstrated for combination therapy of golimumab with immunosuppressants and further studies are necessary to evaluate this aspect. Preliminary data also report golimumab efficacy in Crohn’s disease with higher doses than in ulcerative colitis with an acceptable safety profile. Additional studies are needed in this field to confirm the initial findings.


Anti-drug antibodies Anti-TNF Biologics Drug monitoring 



Anti-drug antibodies




Adverse events


Biologics experienced


Biologics naïve


Continuous clinical response


Crohn’s disease


European Medicines Agency


Food and Drug Administration




Inflammatory bowel diseases




Physician Global Assessment


Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment




Therapeutic drug monitoring


Tumour necrosis factor


Ulcerative colitis



We thank the anonymous reviewers for the suggestions and the editorial board for considering our manuscript for publication.



Compliance with ethical standards

Conflict of interest

Gabriele Dragoni, Marco Le Grazie, Beatrice Orlandini and Francesca Rogai declare that they have no conflict of interest.

Human/animal rights

All procedures followed have been performed in accordance with the ethical standards laid  dowm in the 1964 Declaration of Helsinki and its later amendments.

Informed consent

Informed consent was obtained from all patients for being included in the study.


  1. 1.
    Magro F, Gionchetti P, Eliakim R, et al. European Crohn’s and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders. J Crohns Colitis. 2017;11:649–70.CrossRefGoogle Scholar
  2. 2.
    Ordás I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet. 2012;380:1606–19.CrossRefGoogle Scholar
  3. 3.
    Tracey D, Klareskog L, Sasso EH, et al. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117:244–79.CrossRefGoogle Scholar
  4. 4.
    Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–76.CrossRefGoogle Scholar
  5. 5.
    Ben-Horin S, Kopylov U, Chowers Y. Optimizing anti-TNF treatments in inflammatory bowel disease. Autoimmun Rev. 2014;13:24–30.CrossRefGoogle Scholar
  6. 6.
    Kay J, Matteson EL, Dasgupta B, et al. GLMimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008;58:964–75.CrossRefGoogle Scholar
  7. 7.
    Inman RD, Davis JC Jr, Dv H, et al. Efficacy and safety of GLMimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebocontrolled, phase III trial. Arthritis Rheum. 2008;58:3402–12.CrossRefGoogle Scholar
  8. 8.
    Kavanaugh A, McInnes I, Mease P, et al. GLMimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60:976–86.CrossRefGoogle Scholar
  9. 9.
    Sandborn WJ, Feagan BG, Marano C, PURSUIT-SC Study Group, et al. Subcutaneous GLMimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:85–95.CrossRefGoogle Scholar
  10. 10.
    Sandborn WJ, Feagan BG, Marano C, PURSUIT-Maintenance Study Group, et al. Subcutaneous GLMimumab maintains clinical response in patients with moderate-tosevere ulcerative colitis. Gastroenterology. 2014;146:96–109.CrossRefGoogle Scholar
  11. 11.
    Martin PL, Oneda S, Treacy G. Effects of an anti-TNF-α monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system. Am J Reprod Immunol. 2007;58:138–49.CrossRefGoogle Scholar
  12. 12.
    Shealy DJ, Cai A, Staquet K, et al. Characterization of GLMimumab, a human monoclonal antibody specific for human tumor necrosis factor α. MAbs. 2010;2:428–39.CrossRefGoogle Scholar
  13. 13.
    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;8:443–68.CrossRefGoogle Scholar
  14. 14.
    Rutgeerts P, Feagan BG, Marano CW, PURSUIT-IV study group, et al. Randomised clinical trial: a placebo-controlled study of intravenous GLMimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015;42:504–14.CrossRefGoogle Scholar
  15. 15.
    Peyrin-Biroulet L, Van Assche G, Armuzzi A, et al. Implementing the concept of continuous clinical response into clinical practice for ulcerative colitis. Clin Gastroenterol Hepatol. 2017;15:1154–61.CrossRefGoogle Scholar
  16. 16.
    Gibson PR, Feagan BG, Sandborn WJ, et al. Maintenance of efficacy and continuing safety of GLMimumab for active ulcerative colitis: PURSUIT-SC maintenance study extension through 1 year. Clin Transl Gastroenterol. 2016;28:7:e168.CrossRefGoogle Scholar
  17. 17.
    Hibi T, Imai Y, Senoo A, et al. Efficacy and safety of GLMimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study). J Gastroenterol. 2017;52:1101–11.CrossRefGoogle Scholar
  18. 18.
    Castro-Laria L, Argüelles-Arias F, García-Sánchez V, et al. Initial experience with GLMimumab in clinical practice for ulcerative colitis. Rev Esp Enferm Dig. 2016;108:129–32.Google Scholar
  19. 19.
    Detrez I, Dreesen E, Van Stappen T, et al. Variability in GLMimumab exposure: a ‘real-life’ observational study in active ulcerative colitis. J Crohns Colitis. 2016;10:575–81.CrossRefGoogle Scholar
  20. 20.
    Bosca-Watts MM, Cortes X, Iborra M, et al. Short-term effectiveness of GLMimumab for ulcerative colitis: Observational multicenter study. World J Gastroenterol. 2016;21:22:10432–9.CrossRefGoogle Scholar
  21. 21.
    Tursi A, Allegretta L, Buccianti N, et al. Effectiveness and safety of GLMimumab in treating outpatient ulcerative colitis: a real-life prospective, multicentre, observational study in primary inflammatory bowel diseases centers. J Gastrointestin Liver Dis. 2017;26:239–44.Google Scholar
  22. 22.
    Taxonera C, Rodríguez C, Bertoletti F, et al. Clinical outcomes of GLMimumab as first, second or third anti-TNF agent in patients with moderate-to-severe ulcerative colitis. Inflamm Bowel Dis. 2017;23:1394–402.CrossRefGoogle Scholar
  23. 23.
    Smolen JS, Kay J, Doyle MK, et al. GO-AFTER study investigators. GLMimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374:210–21.CrossRefGoogle Scholar
  24. 24.
    Adedokun O, Xu Z, Marano C, et al. Pharmacokinetics and exposure-response relationship of GLMimumab in patients with moderately-to-severely active ulcerative colitis: results from Phase 2/3 PURSUIT Induction and Maintenance Studies. J Crohns Colitis. 2017;11:35–46.CrossRefGoogle Scholar
  25. 25.
    Rosas J, Llinares-Tello F, Martín S, et al. Evaluation of serum level of golimumab and antibodies antigolimumab in patients with rheumatic diseases: results from a local registry. Ann Rheum Dis 2014;73:Abstract 935.CrossRefGoogle Scholar
  26. 26.
    Chen D, Chen Y, Hung W, et al. Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment. Ann Rheum Dis. 2015;74:2261–4.CrossRefGoogle Scholar
  27. 27.
    Viazis N, Giakoumis M, Bamias G, et al. Predictors of tissue healing in ulcerative colitis patients treated with anti-TNF. Dig Liver Dis. 2017;49:29–33.CrossRefGoogle Scholar
  28. 28.
    Keystone EC, Genovese MC, Klareskog L, et al. GO-FORWARD Study. GLMimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2009;68:789–96.CrossRefGoogle Scholar
  29. 29.
    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;142:257–65.CrossRefGoogle Scholar
  30. 30.
    Weber-Schoendorfer C, Oppermann M, Wacker E, et al. Pregnancy outcome after TNF-alpha inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol. 2015;80:727–39.CrossRefGoogle Scholar
  31. 31.
    Bröms 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;14:234–41 (e1–5).CrossRefGoogle Scholar
  32. 32.
    Poturoglu S, Ormeci AC, Duman AE. Treatment of pregnant women with a diagnosis of inflammatory bowel disease. World J Gastrointest Pharmacol Ther. 2016;7: 490–502.CrossRefGoogle Scholar
  33. 33.
    Hyams JS, Chan D, Adedokun OJ, et al. Subcutaneous golimumab in pediatric ulcerative colitis: pharmacokinetics and clinical benefit. Inflamm Bowel Dis. 2017;23:2227–37.CrossRefGoogle Scholar
  34. 34.
    Greener T, Boland K, Steinhart AH, et al. The unfinished symphony: GLMimumab therapy for anti-TNF refractory Crohn’s disease. J Crohns Colitis. 2018;12:458–464.CrossRefGoogle Scholar
  35. 35.
    Martineau C, Flourié B, Wils P, et al. Efficacy and safety of GLMimumab in Crohn’s disease: a French national retrospective study. Aliment Pharmacol Ther. 2017;46:1077–84.CrossRefGoogle Scholar
  36. 36.
    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;160:704–11.CrossRefGoogle Scholar
  37. 37.
    Stidham RW, Lee TC, Higgins PD, et al. Systematic review with network metaanalysis: the efficacy of anti-tumour necrosis factor-alpha agents for the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2014;39:660–71.CrossRefGoogle Scholar
  38. 38.
    Galván-Banqueri M, Vega-Coca MD, Castillo-Muñoz MA, et al. Indirect comparison for Anti-TNF drugs in moderate to severe ulcerative colitis. Farm Hosp. 2015;39:80–91.Google Scholar
  39. 39.
    Thorlund K, Druyts E, Toor K, et al. Comparative efficacy of GLMimumab, infliximab and adalimumab for moderately to severely active ulcerative colitis: a network metaanalysis accounting for differences in trial designs. Expert Rev Gastroenterol Hepatol. 2015;9:693–700.CrossRefGoogle Scholar
  40. 40.
    Mei WQ, Hu HZ, Liu Y, et al. Infliximab is superior to other biological agents for treatment of active ulcerative colitis: a meta-analysis. World J Gastroenterol. 2015;21:6044–51.CrossRefGoogle Scholar
  41. 41.
    Toor K, Druyts E, Jansen JP, et al. Cost per remission and cost per response with infliximab, adalimumab, and GLMimumab for the treatment of moderately-to-severely active ulcerative colitis. J Med Econ 2015;6:437–446.CrossRefGoogle Scholar
  42. 42.
    Trigo-Vicente C, Gimeno-Ballester V, Montoiro-Allué R, et al. Cost-effectiveness analysis of infliximab, adalimumab, GLMimumab and vedolizumab for moderate to severe ulcerative colitis in Spain. Expert Rev Pharmacoecon Outcomes Res. 2017;2:1–9.Google Scholar
  43. 43.
    Sheridan J, Coe CA, Doran P, et al. Protocol for a multicentred randomised controlled trial investigating theuse of personalised golimumab dosing tailored to inflammatory load in ulcerative colitis: the GOAL-ARC study (GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis) led by the INITIAtive group (NCT0268772). BMJ Open Gastroenterol. 2018;5:e000174.CrossRefGoogle Scholar

Copyright information

© Japanese Society of Gastroenterology 2018

Authors and Affiliations

  1. 1.IBD Unit, Gastroenterology Department, Careggi HospitalUniversity of FlorenceFlorenceItaly

Personalised recommendations