Skip to main content

Advertisement

SpringerLink
Log in

Low Rate of Drug Discontinuation, Frequent Need for Dose Adjustment, and No Association with Development of New Arthralgia in Patients Treated with Vedolizumab: Results from a Tertiary Referral IBD Center

  • Original Article
  • Published:
Digestive Diseases and Sciences Aims and scope Submit manuscript

Abstract

Background

Evaluating clinical data on the safety and efficacy of vedolizumab (VDZ) in ‘real-world’ setting is still desirable. Recent reports have raised concerns that arthralgia may be associated with VDZ.

Aims

The aim of this study is to present clinical experience with VDZ from a tertiary IBD center.

Methods

Retrospective chart reviews were performed of consecutive patients exposed to VDZ between 2015 and 2018. Clinical, biomarker, and endoscopic efficacy and safety data were evaluated.

Results

A total of 130 IBD (75CD, 55UC) patients were included. Median duration of VDZ therapy was 65 weeks. Probability of drug discontinuation was 4.9% and 9.4% at 1 and 2 years. Dose intensification was more frequent in CD compared to UC (at 1 and 2 years: 64.8/87.9% vs. 26.5/35.7%, p < 0.001). Clinical remission rates at 3-, 6- and 12 months were 44.4%, 71.4% and 77.1% in UC, and 9.1%, 26.7% and 29.2% in CD patients, respectively. Prior use of multiple biologic agents was associated with diminished efficacy of VDZ in CD. Three new cases of arthralgia were encountered during follow-up.

Conclusion

Vedolizumab (VDZ) therapy displayed good drug sustainability and clinical efficacy in a population with severe disease phenotype and high rates of previous anti-TNF failure. Frequent dose intensification was required. The safety profile was good, and no association between newly onset arthralgia and VDZ therapy was observed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. Kurina LM. Depression and anxiety in people with inflammatory bowel disease. J Epidemiol Community Health. 2001;55:716–720.

    Article  CAS  Google Scholar 

  2. Gionchetti P, Dignass A, Danese S, et al. 3rd European evidence-based consensus on the diagnosis and management of Crohn’s disease 2016: part 2: surgical management and special situations. J Crohns Colitis. 2017;11:135–149.

    Article  Google Scholar 

  3. 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;11:769–784.

    Article  Google Scholar 

  4. Ding NS, Hart A, De Cruz P. Systematic review: predicting and optimising response to anti-TNF therapy in Crohn’s disease—algorithm for practical management. Aliment Pharmacol Ther. 2016;43:30–51.

    Article  CAS  Google Scholar 

  5. Sinagra E, Perricone G, Romano C, et al. Heart failure and anti tumor necrosis factor-alpha in systemic chronic inflammatory diseases. Eur J Int Med. 2013;24:385–392.

    Article  CAS  Google Scholar 

  6. Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infection and mortality in patients with Crohn’s disease: more than 5 years of follow-up in the TREAT™ registry. Am J Gastroenterol. 2012;107:1409–1422.

    Article  CAS  Google Scholar 

  7. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369:711–721.

    Article  CAS  Google Scholar 

  8. 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.

    Article  CAS  Google Scholar 

  9. Dulai PS, Singh S, Jiang X, et al. The real-world effectiveness and safety of vedolizumab for moderate-severe Crohn’s disease: results from the US Victory Consortium. Am J Gastroenterol. 2016;111:1147–1155.

    Article  CAS  Google Scholar 

  10. Narula N, Peerani F, Meserve J, et al. Vedolizumab for ulcerative colitis: treatment outcomes from the Victory Consortium. Am J Gastroenterol. 2018;113:1345–1354.

    Article  CAS  Google Scholar 

  11. Bernstein CN, Blanchard JF, Rawsthorne P, Yu N. The prevalence of extraintestinal diseases in inflammatory bowel disease: a population-based study. Am J Gastroenterol. 2001;96:1116–1122.

    Article  CAS  Google Scholar 

  12. Thiebault H, Boyard-Lasselin P, Guignant C, et al. Paradoxical articular manifestations in patients with inflammatory bowel diseases treated with infliximab. Eur J Gastroenterol Hepatol. 2016;28:876–881.

    Article  CAS  Google Scholar 

  13. Varkas G, Thevissen K, De Brabanter G, et al. An induction or flare of arthritis and/or sacroiliitis by vedolizumab in inflammatory bowel disease: a case series. Ann Rheum Dis. 2017;76:878–881.

    Article  CAS  Google Scholar 

  14. Cai T, Lin T-C, Bond A, et al. The association between arthralgia and vedolizumab using natural language processing. Inflamm Bowel Dis. 2018;24:2242–2246.

    Article  Google Scholar 

  15. Feagan BG, Sandborn WJ, Colombel J-F, et al. Incidence of arthritis/arthralgia in inflammatory bowel disease with long-term vedolizumab treatment: post hoc analyses of the GEMINI trials. J Crohns Colitis. 2019;13:50–57.

    Article  Google Scholar 

  16. Tadbiri S, Peyrin-Biroulet L, Serrero M, et al. Impact of vedolizumab therapy on extra-intestinal manifestations in patients with inflammatory bowel disease: a multicentre cohort study nested in the OBSERV-IBD cohort. Aliment Pharmacol Ther. 2018;47:485–493.

    Article  CAS  Google Scholar 

  17. Elewaut D, De Keyser F, Van Den Bosch F, et al. Enrichment of T cells carrying beta7 integrins in inflamed synovial tissue from patients with early spondyloarthropathy, compared to rheumatoid arthritis. J Rheumatol. 1998;25:1932–1937.

    CAS  PubMed  Google Scholar 

  18. Lewis JD, Chuai S, Nessel L, et al. Use of the noninvasive components of the mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008;14:1660–1666.

    Article  Google Scholar 

  19. Vermeire S, Schreiber S, Sandborn WJ, et al. Correlation between the Crohn’s disease activity and Harvey–Bradshaw indices in assessing Crohn’s disease severity. Clin Gastroenterol Hepatol. 2010;8:357–363.

    Article  Google Scholar 

  20. Ferrante M, Colombel J, Sandborn WJ, et al. Validation of endoscopic activity scores in patients with Crohn’s disease based on a post hoc analysis of data from SONIC. Gastroenterology. 2013;145:978–986.

    Article  Google Scholar 

  21. Engel T, Ungar B, Yung DE, et al. Vedolizumab in IBD-lessons from real-world experience; A systematic review and pooled analysis. J Crohns Colitis. 2018;12:245–257.

    Article  Google Scholar 

  22. Amiot A, Grimaud JC, Peyrin-Biroulet L, et al. Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2016;14:1593–1601.

    Article  CAS  Google Scholar 

  23. Amiot A, Serrero M, Peyrin-Biroulet L, et al. One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multicentre cohort study. Aliment Pharmacol Ther. 2017;46:310–321.

    Article  CAS  Google Scholar 

  24. Kotze PG, Ma C, Almutairdi A, et al. Real-world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease. Aliment Pharmacol Ther. 2018;48:626–637.

    Article  CAS  Google Scholar 

  25. Eriksson C, Marsal J, Bergemalm D, et al. Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG). Scand J Gastroenterol. 2017;52:722–729.

    Article  CAS  Google Scholar 

  26. Rosario M, French JL, Dirks NL, et al. Exposure–efficacy relationships for vedolizumab induction therapy in patients with ulcerative colitis or Crohn’s disease. J Crohns Colitis. 2017;11:921–929.

    Article  Google Scholar 

  27. Feagan BG, Lasch K, Lissoos T, et al. Rapid response to vedolizumab therapy in biologic-naive patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2019;17:130–138.

    Article  CAS  Google Scholar 

  28. Peyrin-Biroulet L, Danese S, Argollo M, et al. Loss of response to vedolizumab and ability of dose intensification to restore response in patients with Crohn’s disease or ulcerative colitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2019;17:838–846.

    Article  CAS  Google Scholar 

  29. Williet N, Boschetti G, Fovet M, et al. Association between low trough levels of vedolizumab during induction therapy for inflammatory bowel diseases and need for additional doses within 6 months. Clin Gastroenterol Hepatol. 2017;15:1750–1757.

    Article  CAS  Google Scholar 

  30. Stallmach A, Langbein C, Atreya R, et al. Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease—a prospective multicenter observational study. Aliment Pharmacol Ther. 2016;44:1199–1212.

    Article  CAS  Google Scholar 

  31. Baumgart DC, Bokemeyer B, Drabik A, et al. Vedolizumab induction therapy for inflammatory bowel disease in clinical practice—a nationwide consecutive German cohort study. Aliment Pharmacol Ther. 2016;43:1090–1102.

    Article  CAS  Google Scholar 

  32. Kopylov U, Avni-Biron I, Ron Y, et al. Effectiveness and safety of vedolizumab for maintenance treatment in inflammatory bowel disease—the Israeli real world experience. Dig Liver Dis. 2019;51:68–74.

    Article  CAS  Google Scholar 

Download references

Acknowledgments

JR and LG were responsible for data analysis, literature overview and drafting the manuscript. CV, TB, WA, GW, ES, and AB contributed to the data collection and the final analysis and conducted critical review of the manuscript. PLL was leader of research planning and result interpretation; also he contributed to the statistical planning and data analysis, supervised the manuscript preparation, and is acting as guarantor of submission. All authors read and approved the final manuscript including the authorship list.

Funding

Not applicable.

Author information

Author notes

  1. Jason Reinglas and Lorant Gonczi have contributed equally to this work.

Authors and Affiliations

  1. Division of Gastroenterology, McGill University Health Centre (MUHC), Montreal General Hospital, 1650 Ave. Cedar, D16.173.1, Montreal, QC, H3G 1A4, Canada

    Jason Reinglas MD, Christine Verdon MD, Talat Bessissow MD, PhD, Waqqas Afif MD, PhD, Gary Wild MD, PhD, Ernest Seidman MD, PhD, Alain Bitton MD, PhD & Peter L. Lakatos MD, PhD

  2. 1st Department of Medicine, Semmelweis University, Budapest, Hungary

    Lorant Gonczi MD & Peter L. Lakatos MD, PhD

Authors
  1. Jason Reinglas MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lorant Gonczi MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Christine Verdon MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Talat Bessissow MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Waqqas Afif MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Gary Wild MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Ernest Seidman MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Alain Bitton MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Peter L. Lakatos MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Peter L. Lakatos MD, PhD.

Ethics declarations

Conflict of interest

JR, LG, and CV declare no conflict of interest. GW has been a speaker and/or advisory board member for AbbVie, Janssen, Pfizer, Shire, and Takeda. ES has received unrestricted research grants from AbbVie and Janssen. AB has been a member of Advisory Boards—Abbvie, Pfizer, Takeda, Janssen, Merck; Speaker’s bureau—Abbvie, Janssen, Takeda, Pfizer. TB has been a peaker or advisory board member for Takeda, Janssen, Abbvie, Merck, Pfizer, Pendopharm, Ferring, Shire. WA has been a speaker for Janssen, Prometheus, Dynacare, Takeda, AbbVie Theradiag. PLL has been a speaker and/or advisory board member for AbbVie, Falk Pharma GmbH, Ferring, Genetech, Janssen, Kyowa Hakko Kirin Pharma, Mitsubishi Tanabe Pharma Corporation, MSD, Pfizer, Roche, Shire, and Takeda and has received unrestricted research grants from AbbVie, MSD, and Pfizer.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Reinglas, J., Gonczi, L., Verdon, C. et al. Low Rate of Drug Discontinuation, Frequent Need for Dose Adjustment, and No Association with Development of New Arthralgia in Patients Treated with Vedolizumab: Results from a Tertiary Referral IBD Center. Dig Dis Sci 65, 2046–2053 (2020). https://doi.org/10.1007/s10620-019-05982-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10620-019-05982-z

Keywords

Search

Navigation