Evidence map›Paper›PMID 33301077›Full record

SynthesisBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2021

Systematic Review and Principal Components Analysis of the Immunogenicity of Adalimumab.

Rodrigo Borrega, Carlos Araújo, Nádia Aguiam, Fernando Magro, João Eurico Fonseca, Silvio Danese, João Lopes, Joao Goncalves

Abstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.2field-weighted citation impact, top 50% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Observational
  2. Review
  3. Article
  4. Observational
  5. Article
  6. Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    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

8 authors at 3 institutions in 2 countries.

Rodrigo BorregaiMED.ULisboa, Research Institute for Medicines, Faculty of Pharmacy, University of Lisbon, Avenida Gama Pinto, 1640-019, Lisbon, Portugal.ORCID http://orcid.org/0000-0001-7627-7223
Carlos AraújoiMED.ULisboa, Research Institute for Medicines, Faculty of Pharmacy, University of Lisbon, Avenida Gama Pinto, 1640-019, Lisbon, Portugal.ORCID http://orcid.org/0000-0001-5202-6091
Nádia AguiamiMED.ULisboa, Research Institute for Medicines, Faculty of Pharmacy, University of Lisbon, Avenida Gama Pinto, 1640-019, Lisbon, Portugal.
Fernando MagroUnit of Pharmacology and Therapeutics, Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal.ORCID http://orcid.org/0000-0003-2634-9668
João Eurico FonsecaRheumatology and Metabolic Bone Diseases Unit, Santa Maria University Hospital, North Lisbon Centre, Lisbon, Portugal.ORCID http://orcid.org/0000-0003-1432-3671
Silvio DaneseHumanitas Clinical and Research Center-IRCCS, Rozzano, Italy.ORCID http://orcid.org/0000-0001-7341-1351
João LopesiMED.ULisboa, Research Institute for Medicines, Faculty of Pharmacy, University of Lisbon, Avenida Gama Pinto, 1640-019, Lisbon, Portugal.ORCID http://orcid.org/0000-0002-1657-344X
Joao GoncalvesiMED.ULisboa, Research Institute for Medicines, Faculty of Pharmacy, University of Lisbon, Avenida Gama Pinto, 1640-019, Lisbon, Portugal. joao.goncalves@ff.ul.pt.ORCID http://orcid.org/0000-0002-1245-3715
University of Lisbon · PTHumanitas University · ITUniversidade do Porto · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe reported immunogenicity rates of adalimumab differ significantly between studies because of a wide variety of factors related to the disease, patients, study design, and products.

objectiveThe objective of this study was to characterize this variability and identify the major factors that contribute to these fluctuations.

methodsA systematic literature review was conducted using the MEDLINE, Clinicaltrials.gov, and Cochrane Library databases. Studies that reported the immunogenicity rates of adalimumab were selected, and data pertaining to publication details, study characteristics, characteristics of the cohort at baseline, and immunogenicity were extracted. Records were sorted according to the immunogenicity assay type, and mean immunogenicity values for each assay type were calculated. Normalised immunogenicity was calculated for each report by subtracting the appropriate mean immunogenicity value. Collected data were subjected to statistical analysis, namely analysis of variance (ANOVA) and principal component analysis, to unveil immunogenicity rate patterns across studies from a multivariate perspective.

resultsIn total, 130 publications were identified, from which 165 data records were extracted and included in the analysis. The immunogenicity rates of adalimumab averaged 24.9% across studies and varied significantly over time, ranging between 0 and 87%. An increase across time in the reported immunogenicity rates was detected, and the assay used to detect anti-adalimumab antibodies was a significant (but not exclusive) contributor to this trend. Furthermore, the principal components analysis revealed that the type of study and the exposure time were associated with the assay-normalised immunogenicity rates of adalimumab. Nonetheless, neither these nor the remaining factors included in this analysis seem to contribute to the temporal increase in reported immunogenicity rates.

conclusionsFuture studies that evaluate the patient-, product-, and disease-related factors behind the immunogenicity of adalimumab are required because the evidence published so far does not completely explain the temporal increase in immunogenicity rates detected in this analysis.

Indexed as

AdalimumabHumansInfliximabPrincipal Component AnalysisAdalimumabInfliximab

Identifiers

PMID33301077
OpenAlexW3111383052

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.