Evidence map›Paper›PMID 38338289›Full record

ArticleHealthcare (Basel, Switzerland)2024

Adalimumab Biosimilar in Pediatric Inflammatory Bowel Disease: A Retrospective Study from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD).

Valeria Dipasquale, Salvatore Pellegrino, Marco Ventimiglia, Michele Citrano, Francesco Graziano, Maria Cappello, Anita Busacca, Ambrogio Orlando, Salvatore Accomando, Claudio Romano and 1 more

Open access · goldAbstract read
In one paragraph

Article in Healthcare (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
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

3 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

11 authors at 3 institutions in 1 country.

Valeria DipasqualePediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University Hospital "G. Martino", 98100 Messina, Italy.ORCID 0000-0003-3328-0734
Salvatore PellegrinoPediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University Hospital "G. Martino", 98100 Messina, Italy.
Marco VentimigliaDirectorate General of Medical Device and Pharmaceutical Service, Italian Ministry of Health, 00153 Rome, Italy.ORCID 0000-0002-3469-4720
Michele CitranoPediatric Unit, Villa Sofia Cervello Hospital, 90146 Palermo, Italy.
Francesco GrazianoPediatric Unit, Villa Sofia Cervello Hospital, 90146 Palermo, Italy.ORCID 0000-0002-4896-1842
Maria CappelloGastroenterology and Hepatology Section, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90128 Palermo, Italy.
Anita BusaccaGastroenterology and Hepatology Section, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90128 Palermo, Italy.
Ambrogio OrlandoIBD Unit, Department of Medicine, Villa Sofia Cervello Hospital, 90146 Palermo, Italy.
Salvatore AccomandoPediatric Section, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, 90128 Palermo, Italy.
Claudio RomanoPediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University Hospital "G. Martino", 98100 Messina, Italy.ORCID 0000-0001-8827-2091
Sicilian Network For Inflammatory Bowel Disease
Ospedale Vincenzo Cervello · ITUniversity of Palermo · ITMinistero della Salute · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe utilization of anti-tumor necrosis factor-α (anti-TNF-α) biosimilars in inflammatory bowel disease (IBD) is constantly increasing. However, pediatric data are limited. This study aimed to assess the effectiveness and safety of adalimumab biosimilar (ADL-BioS) in pediatric IBD patients.

methodsAll consecutive pediatric IBD patients from the Sicilian Network for Inflammatory Bowel Disease cohort treated with ADL-BioS from 2019 to 2021 were recruited. Remission at weeks 14 and 52, treatment persistence, and adverse events were the endpoints of this study. Factors associated with clinical remission and treatment persistence were examined.

resultsThere were 41 patients in total. Nine (22%) patients were switched from the reference product to ADL-BioS. Two patients had multiple switches. Eleven months was the median follow-up period. Clinical remission was attained by 70.7% and 72.0% of patients on weeks 14 and 52, respectively. Four (9.8%) adverse events occurred (10.1/100 person-year). Treatment persistence was 85.4% at 1 and 2 years. Patients with a longer duration of disease had a higher probability of stopping their treatment (

conclusionsThis is the first real-world study that particularly addresses the use of ADL-BioS in pediatric IBD. With high rates of treatment persistence and a low frequency of non-serious side effects, ADL-BioS seems to be effective.

Indexed as

ABP501biosimilareffectivenessGP2017pediatricssafety

Identifiers

PMID38338289
PMCPMC10855938
OpenAlexW4391542146

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.