Safety Profile of Biologic Drugs in the Treatment of Inflammatory Bowel Diseases: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.

Paweł Moćko, Paweł Kawalec, Andrzej Pilc

Open access · greenAbstract readNetwork Meta-AnalysisSystematic Review

In one paragraph

Synthesis in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it

0cells of the map it votes in

5citing papers in PubMed

3.0field-weighted citation impact, top 9% 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

5 citing papers in PubMed, 18 citations in OpenAlex.

Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy alone for Crohn's perianal fistulas (PISA-II): long-term outcomes of an international, multicentre patient preference, randomised controlled trial.EClinicalMedicine · 2023
Article
Metabolomics Study of Shaoyao Plants Decoction on the Proximal and Distal Colon in Mice with Dextran Sulfate Sodium-Induced Colitis by UPLC-Q-TOF-MS.Drug design, development and therapy · 2022
Article
The Role of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease.Journal of clinical medicine · 2021
Review
Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series.Medicine and pharmacy reports · 2021
Article
Analysis of Healthcare Resource Utilization and Costs after the Initiation of Biologic Treatment in Patients with Ulcerative Colitis and Crohn's Disease.Journal of health economics and outcomes research · 2018
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

3 authors at 1 institution in 1 country.

Paweł MoćkoDrug Management Department, Faculty of Health Sciences, Institute of Public Health, Jagiellonian University, ul. Grzegórzecka 20, 31-531, Kraków, Poland.

Paweł KawalecDrug Management Department, Faculty of Health Sciences, Institute of Public Health, Jagiellonian University, ul. Grzegórzecka 20, 31-531, Kraków, Poland. pawel.kawalec@uj.edu.pl.

Andrzej PilcDrug Management Department, Faculty of Health Sciences, Institute of Public Health, Jagiellonian University, ul. Grzegórzecka 20, 31-531, Kraków, Poland.

Jagiellonian University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesBiologic drugs are used in innovative therapies for the management of inflammatory bowel diseases (IBDs). The aim of this study was to compare the safety profile of biologic drugs in patients with IBD.

methodsA systematic literature search was performed using PubMed, Embase, and CENTRAL databases, up to 22 August 2016. We included randomized, placebo-controlled, or head-to-head clinical trials that compared the safety of different biologics in patients with IBDs. Two reviewers independently conducted the search and selection of studies and rated each trial's risk of bias. The network meta-analysis (NMA) was conducted for a mid-term (20-30 weeks) and long-term (≥52 weeks) follow-up with a Bayesian hierarchical random effects model using the ADDIS

resultsSixteen randomized controlled trials were included in the systematic review with NMA. In the case of the mid-term follow-up, it was possible to conduct the NMA for assessing the relative safety profile of certolizumab pegol and infliximab, and in the case of the long-term follow-up, of infliximab, adalimumab, golimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with all analyzed biologic drugs for IBD. The analysis of probability for being the safest treatment showed that infliximab was the best option in most analyzed endpoints both in mid-term and in long-term follow-ups.

conclusionsWe showed no significant differences in the relative safety profile of the analyzed biologic drugs. Further studies are needed to confirm our findings, including head-to-head comparisons between these drugs.

Indexed as

Biological ProductsInflammatory Bowel DiseasesAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBayes TheoremHumansInfliximabRandomized Controlled Trials as TopicAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiological ProductsgolimumabInfliximabvedolizumab

Identifiers

PMID27599485

DOI10.1007/s40261-016-0459-y

OpenAlexW2519251061

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.