Evidence map›Paper›PMID 28612180›Full record

SynthesisBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2017

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

Vibeke Strand, Alejandro Balsa, Jamal Al-Saleh, Leonor Barile-Fabris, Takahiko Horiuchi, Tsutomu Takeuchi, Sadiq Lula, Charles Hawes, Blerina Kola, Lisa Marshall

Registry-linked trialOpen access · hybridAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04731831 (Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.), which is not on this map. Cited by 172 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
172citing papers in PubMed, 6 pooled it
25.8field-weighted citation impact, top 1% 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.

NCT04731831 unknown statusnot on this mapstarted 2020, after this paper: background citation

Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.

TypeobservationalSponsorAalborg University HospitalRan2020 to 2025Enrolled120ConditionsArthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
3 · Its place in the literature

Who cites it

172 citing papers in PubMed, 6 syntheses or guidelines pooled it, 344 citations in OpenAlex.

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112 more citing papers are in PubMed but not listed here.

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

10 authors at 8 institutions in 6 countries.

Vibeke StrandDivision of Immunology/Rheumatology, Stanford University School of Medicine, 306 Ramona Road, Portola Valley, CA, 94028, USA. vibekestrand@me.com.ORCID http://orcid.org/0000-0003-4978-4072
Alejandro BalsaRheumatology Unit, Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain.
Jamal Al-SalehRheumatology Section, Dubai Hospital, Dubai, United Arab Emirates.
Leonor Barile-FabrisHospital de Especialidades Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, México City, Mexico.
Takahiko HoriuchiDepartment of Internal Medicine, Kyushu University Beppu Hospital, Beppu, Japan.
Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Sadiq LulaMarket Access Solutions, Envision Pharma Group, London, UK.
Charles HawesPfizer Ltd, Surrey, UK.
Blerina KolaPfizer Ltd, Surrey, UK.
Lisa MarshallMedical Affairs, Pfizer, Collegeville, PA, USA.
Pfizer (United Kingdom) · GBDubai Hospital · AEHospital Universitario La Paz · ESKeio University · JPKyushu University Beppu Hospital · JPMexican Social Security Institute · MXPfizer (United States) · USStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesA systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety.

methodsLiterature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis.

resultsOf >21,000 screened publications, 443 were included. Anti-drug antibody (ADAb) rates varied widely among biologics across diseases (and are not directly comparable because of immunoassay heterogeneity); the highest overall rates were reported with infliximab (0-83%), adalimumab (0-54%), and infliximab biosimilar CT-P13 (21-52%), and the lowest with secukinumab (0-1%), ustekinumab (1-11%), etanercept (0-13%), and golimumab (0-19%). Most ADAbs were neutralizing, except those to abatacept and etanercept. ADAb+ versus ADAb- patients had lower rates of clinical response to adalimumab (RA, PsA, JIA, AS, Ps), golimumab (RA), infliximab (RA, PsA, AS, Ps), rituximab (RA), ustekinumab (Ps), and CT-P13 (RA, AS). Higher rates of infusion-related reactions were reported in infliximab- and CT-P13-treated ADAb+ patients. Background immunosuppressives/anti-proliferatives reduced biologic immunogenicity across diseases.

conclusionsBased on reviewed reports, biologic/biosimilar immunogenicity differs among agents, with the highest rates observed with infliximab and adalimumab. As ADAb formation in biologic-/biosimilar-treated patients may increase the risk of lost response, the immunogenicity of these agents is an important (albeit not the only) consideration in the treatment decision-making process.

Indexed as

AbataceptAntibodies, MonoclonalAnti-Inflammatory Agents, Non-SteroidalAntirheumatic AgentsArthritis, JuvenileArthritis, PsoriaticArthritis, RheumatoidBiosimilar PharmaceuticalsColitis, UlcerativeCrohn DiseaseEtanerceptHumansInfliximabSpondylitis, AnkylosingUstekinumabAbataceptAntibodies, MonoclonalAnti-Inflammatory Agents, Non-SteroidalAntirheumatic AgentsBiosimilar PharmaceuticalsEtanerceptgolimumabInfliximabUstekinumab

Identifiers

PMID28612180
PMCPMC5548814
OpenAlexW2624671969

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

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.