Evidence map›Paper›PMID 26316054›Full record

SynthesisDrug safety2015

Safety Profile of Certolizumab Pegol in Patients with Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis.

Alice Capogrosso Sansone, Stefania Mantarro, Marco Tuccori, Elisa Ruggiero, Sabrina Montagnani, Irma Convertino, Alessandra Marino, Matteo Fornai, Luca Antonioli, Tiberio Corona and 2 more

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
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

12 authors at 3 institutions in 1 country.

Alice Capogrosso SansoneDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Stefania MantarroDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Marco TuccoriUnit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Pisa, Italy. marco.tuccori@gmail.com.
Elisa RuggieroPharmaceutical Unit, Health District of Pisa, Pisa, Italy.
Sabrina MontagnaniDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Irma ConvertinoUnit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Pisa, Italy.
Alessandra MarinoDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Matteo FornaiDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Luca AntonioliDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Tiberio CoronaPharmaceutical Unit, Health District of Pisa, Pisa, Italy.
Danila GaribaldiPharmaceutical Unit, Health District of Lucca, Lucca, Italy.
Corrado BlandizziDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
University of Pisa · ITAzienda Ospedaliera Universitaria Pisana · ITIMT School for Advanced Studies Lucca · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCertolizumab pegol (CZP), an anti-tumor necrosis factor PEGylated Fab' fragment of a humanized monoclonal antibody, is currently approved for treatment of some immune-mediated inflammatory diseases (IMIDs). To our knowledge, no systematic review and meta-analysis evaluating the overall safety profile of CZP has been performed.

objectiveThe objective of this systematic review was to assess the adverse event (AE) patterns of CZP versus a control in patients with IMIDs.

methodsA systematic literature search was performed using PubMed/MEDLINE, EMBASE, the Cochrane Library, and the FDA database for clinical trials up to March 2014. Eligible studies were those that compared the safety profile of CZP to a control group in patients with IMIDs. The following data were extracted: number of patients experiencing AEs, serious AEs (SAEs), adverse drug reactions (ADRs), withdrawals due to AEs, fatal AEs, infectious AEs and SAEs, upper respiratory tract infections, injection-site reactions, neoplasms, and tuberculosis.

resultsA total of 2023 references were identified and 18 randomized controlled trials were included. The main pooled risk ratios of CZP-treated versus control patients were as follows: AEs 1.09 (95% confidence interval, CI 1.04-1.14), SAEs 1.50 (95% CI 1.21-1.86), ADRs 1.20 (95% CI 1.03-1.39), infectious AEs 1.28 (95% CI 1.13-1.45), infectious SAEs 2.17 (95% CI 1.36-3.47), and upper respiratory tract infections 1.34 (95% CI 1.15-1.57).

conclusionSafety data on CZP suggest an overall favorable tolerability profile, with infections being the most common AE. However, CZP-treated patients had a twofold higher risk of infectious SAEs than control patients. Large observational studies and data from national registries are needed to detect rare AEs, which might occur after long-term exposures to CZP.

Indexed as

Antibodies, Monoclonal, HumanizedCertolizumab PegolHumansInflammationRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedCertolizumab Pegol

Identifiers

PMID26316054
OpenAlexW1918972630

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.