Evidence map›Paper›PMID 36778941›Full record

ArticleCrohn's & colitis 3602021

The Efficacy and Safety of Switching From Originator Infliximab to Single or Double Switch Biosimilar Among a Nationwide Cohort of Inflammatory Bowel Disease Patients.

Nabeel Khan, Dhruvan Patel, Tyler Pernes, Manthankumar Patel, Chinmay Trivedi, Elina Medvedeva, Dawei Xie, Yu-Xiao Yang

Abstract read
In one paragraph

Article in Crohn's & colitis 360, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Pooled it
  3. Observational
  4. Review
  5. An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024
    Article
  6. Article
  7. Article
  8. Observational
  9. 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

8 authors.

Nabeel KhanCorporal Michael J Crescenz VA Medical Center, Department of Gastroenterology, Philadelphia, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-5368-7518
Dhruvan PatelUniversity of Pennsylvania, Perelman School of Medicine, Department of Gastroenterology, Philadelphia, Pennsylvania, USA.
Tyler PernesCorporal Michael J Crescenz VA Medical Center, Department of Gastroenterology, Philadelphia, Pennsylvania, USA.
Manthankumar PatelCorporal Michael J Crescenz VA Medical Center, Department of Gastroenterology, Philadelphia, Pennsylvania, USA.
Chinmay TrivediCorporal Michael J Crescenz VA Medical Center, Department of Gastroenterology, Philadelphia, Pennsylvania, USA.
Elina MedvedevaCorporal Michael J Crescenz VA Medical Center, Department of Gastroenterology, Philadelphia, Pennsylvania, USA.
Dawei XieDepartment of Epidemiology and Biostatistics, Center of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Yu-Xiao YangCorporal Michael J Crescenz VA Medical Center, Department of Gastroenterology, Philadelphia, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Data on safety and efficacy of switching to Renflexis (SB2) from originator Infliximab (IFX) (single switch) or from originator IFX to Inflectra (CT-P13) to Renflexis (double switch) are limited. Methods: We conducted a retrospective cohort study in a nationwide cohort of patient with inflammatory bowel disease (IBD) in remission who were switched to SB2. The main exposure was the treatment course of SB2. There are 2 levels in this variable: single switch (IFX to SB2) and double switch (IFX to CT-P13 to SB2). The outcome is SB2 drug discontinuation rate and/or not being in remission after 1 year. Logistic regression was used to estimate the adjusted and unadjusted odds ratios with 95% confidence intervals to study the efficacy difference between single switch and double switch. Results: A total of 271 IBD patients were started on SB2. Among them 52 (19.2%) patients did not achieve remission at 1 year and 14 (5.1%) patients had to discontinue SB2 due to adverse events). In logistic regression analysis after controlling for covariates, there was no statistically significant difference observed in regard to efficacy or safety of the single switch versus double switch to SB2 (adjusted odds ratio for double switch compared to single switch = 1.33 (95% confidence interval 0.74-2.41, Conclusions: Among IBD patients in remission, double switch was equally effective as compared to a single switch. This will help reassure the gastroenterologists who have concerns regarding the safety and efficacy of switching between multiple biosimilars for treating IBD.

Indexed as

biosimilarsdouble switchinflammatory bowel diseaseInflectraInfliximabRenflexissingle switch

Identifiers

PMID36778941
PMCPMC9802034

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.