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Indian Journal of Gastroenterology

, Volume 38, Issue 1, pp 44–54 | Cite as

Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: A multicenter study

  • Nagesh Kamat
  • Saurabh Kedia
  • Uday C. Ghoshal
  • Abhimanyu Nehra
  • Govind Makharia
  • Ajit Sood
  • Vandana Midha
  • Varun Gupta
  • Gourdas Choudhuri
  • Vineet AhujaEmail author
Original Article

Abstract

Background

Adalimumab has emerged as a useful drug for treating patients with Crohn’s disease (CD) and ulcerative colitis (UC), not responding to conventional therapy. There is limited data on effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease (IBD).

Methods

Patients with IBD who received at least one dose of adalimumab biosimilar from October 2015 to February 2018 were retrospectively included in this multicenter data analysis. Its effectiveness in inducing and maintaining clinical remission at 8, 26, and 52 weeks for CD and UC and safety profile of the drug was studied.

Results

Seventy patients (49 CD; 21 UC) with a median age of 39 (range 13–73) years, male predominance (64.3%), and median (IQR) disease duration of 72 (33–104) months were included. Adalimumab biosimilar was effective in inducing remission (at 8 weeks) in 46.9% and 52.4% patients with CD and UC, respectively, of whom  32.7% and 33.3% (three fourths of remitters) maintained remission over 1 year, respectively. Twenty (28.6%) patients experienced adverse events; seven (10%) were serious of whom  three had developed tuberculosis.

Conclusions

Adalimumab biosimilar in usual clinical practice is safe and effective in inducing and maintaining remission in Indian patients with IBD. Steroid-free clinical remission was observed in one third of patients with UC and CD at 1 year of therapy.

Graphical Abstract

Keywords

Adalimumab Biosimilar Efficacy Inflammatory bowel disease Safety 

Notes

Compliance with ethical standards

Conflict of interest

NK, SK, UCG, AN, GM, AS, VM, VG, GC and VA declare that they have no conflict of interest.

Ethics statement

The study was performed in a manner to conform with the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights. The study protocol was approved by the institutional review board and ethics committee of the coordinating center.

Disclaimer

The authors are solely responsible for the data and the content of the paper. In no way the Honorary Editor-in-Chief, Editorial Board Members, or the printer/publishers are responsible for the results/findings and content of this article.

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Copyright information

© Indian Society of Gastroenterology 2019

Authors and Affiliations

  • Nagesh Kamat
    • 1
  • Saurabh Kedia
    • 1
  • Uday C. Ghoshal
    • 2
  • Abhimanyu Nehra
    • 2
  • Govind Makharia
    • 1
  • Ajit Sood
    • 3
  • Vandana Midha
    • 3
  • Varun Gupta
    • 4
  • Gourdas Choudhuri
    • 4
  • Vineet Ahuja
    • 1
    Email author
  1. 1.Department of GastroenterologyAll India Institute of Medical SciencesNew DelhiIndia
  2. 2.Department of GastroenterologySanjay Gandhi Postgraduate Institute of Medical SciencesLucknowIndia
  3. 3.Department of GastroenterologyDayanand Medical College and HospitalLudhianaIndia
  4. 4.Department of GastroenterologyFortis Memorial Research InstituteGurugramIndia

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