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ArticleIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2019

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 Ahuja

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trends in the use of biologic agents and their persistence rates in inflammatory bowel disease in India.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Efficacy and safety of biosimilar versus originator infliximab in patients with inflammatory bowel disease: A real-world cohort analysis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2022
    Article
  9. Review
  10. Observational
  11. Review
  12. Article
  13. Article
  14. Article
  15. Relapse rate following withdrawal of anti-TNF therapy in patients with inflammatory bowel disease: A real-life cohort from northern India.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2020
    Article
  16. Article
  17. Colonic Mucormycosis in Fistulizing Crohn's Disease.Journal of emergencies, trauma, and shock
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Nagesh KamatDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, 110 029, India.
Saurabh KediaDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, 110 029, India.
Uday C GhoshalDepartment of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India.
Abhimanyu NehraDepartment of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India.
Govind MakhariaDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, 110 029, India.
Ajit SoodDepartment of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India.
Vandana MidhaDepartment of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India.
Varun GuptaDepartment of Gastroenterology, Fortis Memorial Research Institute, Gurugram, 122 002, India.
Gourdas ChoudhuriDepartment of Gastroenterology, Fortis Memorial Research Institute, Gurugram, 122 002, India.
Vineet AhujaDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, 110 029, India. vineet.aiims@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdalimumab 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).

methodsPatients 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.

resultsSeventy 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.

conclusionsAdalimumab 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.

Indexed as

AdalimumabAdolescentAdultAgedAnti-Inflammatory AgentsFemaleHumansIndiaInflammatory Bowel DiseasesMaintenance ChemotherapyMaleMiddle AgedRemission InductionRetrospective StudiesTime FactorsTreatment OutcomeAdalimumabAnti-Inflammatory AgentsAdalimumabBiosimilarEfficacyInflammatory bowel diseaseSafety

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.