ArticleTherapeutic advances in neurological disorders2016
Incidence, characterization, and clinical impact analysis of peginterferon beta1a immunogenicity in patients with multiple sclerosis in the ADVANCE trial.
Article in Therapeutic advances in neurological disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
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.
Who cites it
16 citing papers in PubMed, 29 citations in OpenAlex.
- Outcome of pediatric patients with acute lymphoblastic leukemia/lymphoblastic lymphoma with hypersensitivity to pegaspargase treated with PEGylated Erwinia asparaginase, pegcrisantaspase: A report from the Children's Oncology Group.Pediatric blood & cancer · 2018Trial
- Immunogenicity Management Strategies for PEGylated Drug Delivery Systems.International journal of nanomedicine · 2026Review
- Detection of PEG-specific antibodies in SARS-CoV-2 positive and negative sera with implications for autoimmune reactivity.Scientific reports · 2025Article
- Interferons and Multiple Sclerosis: Lessons from 25 Years of Clinical and Real-World Experience with Intramuscular Interferon Beta-1a (Avonex).CNS drugs · 2021Review
- Opportunities and challenges for the clinical translation of structured DNA assemblies as gene therapeutic delivery and vaccine vectors.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2021Review
- Immunogenicity Risk Assessment for PEGylated Therapeutics.The AAPS journal · 2020Review
- Subchronic and chronic toxicity evaluation of inorganic nanoparticles for delivery applications.Advanced drug delivery reviews · 2019Review
- Immunological Aspects of Approved MS Therapeutics.Frontiers in immunology · 2019Review
- Elimination half-lives of interleukin-6 and cytokine-induced neutrophil chemoattractant-1 synthesized in response to inflammatory stimulation in rats.Laboratory animal research · 2018Article
- Anti-Interferon Alpha Antibodies in Patients with High-Risk BCR/ABL-Negative Myeloproliferative Neoplasms Treated with Recombinant Human Interferon-α.Medical science monitor : international medical journal of experimental and clinical research · 2018Article
- Long-term outcomes of peginterferon beta-1a in multiple sclerosis: results from the ADVANCE extension study, ATTAIN.Therapeutic advances in neurological disorders · 2018Article
- Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development.The AAPS journal · 2017Article
- Advances in the treatment of relapsing-remitting multiple sclerosis: the role of pegylated interferon β-1a.Degenerative neurological and neuromuscular disease · 2017Review
- Anti-PEG antibodies in the clinic: Current issues and beyond PEGylation.Journal of controlled release : official journal of the Controlled Release Society · 2016Review
- Analysis of Pre-existing IgG and IgM Antibodies against Polyethylene Glycol (PEG) in the General Population.Analytical chemistry · 2016Article
- Interferons in the Treatment of Multiple Sclerosis: A Clinical Efficacy, Safety, and Tolerability Update.International journal of MS careArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEfficacy of interferon beta in multiple sclerosis (MS) can be dampened in patients who develop neutralizing antidrug antibodies (NAbs). Peginterferon beta1a is an interferon conjugated with a polyethylene glycol (PEG) moiety. Pegylation increases a drug's half life and exposure, and may also reduce immunogenicity.
objectiveThe objective of this study was to characterize the incidence and impact of immunogenicity to peginterferon beta1a over 2 years in patients with MS.
methodsPatients with relapsing-remitting MS (N = 1512) were randomized to subcutaneous peginterferon beta1a 125 μg every 2 or 4 weeks, or placebo, for 1 year; patients in the placebo group were rerandomized to active treatment in year 2. The incidence and titers of binding antibodies (BAbs) and NAbs to interferon and antibodies to PEG (anti-PEG) were assessed in analytically validated assays. The clinical impact of immunogenicity on relapse and magnetic resonance imaging endpoints was evaluated.
resultsOver 2 years, 6%, less than 1%, and 7% of patients developed anti-interferon BAbs, NAbs, and anti-PEG antibodies, respectively. There was no discernible clinically meaningful effect of antibody status on the pharmacodynamic, efficacy, or safety parameters evaluated, although these analyses were limited by the low incidence of treatment-emergent antibodies.
conclusionThe treatment effect of peginterferon beta1a in patients with relapsing-remitting MS is not expected to be attenuated by immunogenicity.
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