Evidence map›Paper›PMID 32012928›Full record

ArticleMolecules (Basel, Switzerland)2020

PEGylated Liposomal Methyl Prednisolone Succinate does not Induce Infusion Reactions in Patients: A Correlation Between in Vitro Immunological and in Vivo Clinical Studies.

Yaelle Bavli, Bing-Mae Chen, Steve R Roffler, Marina A Dobrovolskaia, Eldad Elnekave, Shifra Ash, Yechezkel Barenholz, Keren Turjeman

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Molecules (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

8 authors at 4 institutions in 3 countries.

Yaelle BavliLaboratory of Membrane and Liposome Research, Department of Biochemistry, Institute for Medical Research Israel-Canada, Hebrew University-Hadassah Medical School, Jerusalem 9112102, Israel.
Bing-Mae ChenInstitute of Biomedical Sciences, Academia Sinica, Taipei 11529, Taiwan.
Steve R RofflerInstitute of Biomedical Sciences, Academia Sinica, Taipei 11529, Taiwan.
Marina A DobrovolskaiaNanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Frederick, MD 21702, USA.
Eldad ElnekaveDavidoff Cancer Institute, Rabin Medical Center, Petach Tikva 4941492, Israel.
Shifra AshRina Zaizov Pediatric Hematology Oncology Division, Schneider Children's Medical Center of Israel, Petach Tiqva, Tel Aviv University, Tel Aviv 4920235, Israel.
Yechezkel BarenholzLaboratory of Membrane and Liposome Research, Department of Biochemistry, Institute for Medical Research Israel-Canada, Hebrew University-Hadassah Medical School, Jerusalem 9112102, Israel.
Keren TurjemanLaboratory of Membrane and Liposome Research, Department of Biochemistry, Institute for Medical Research Israel-Canada, Hebrew University-Hadassah Medical School, Jerusalem 9112102, Israel.
Institute of Biomedical Sciences, Academia Sinica · TWFrederick National Laboratory for Cancer Research · USRabin Medical Center · ILTel Aviv University · IL

Funding

Hebrew University Barenholz fundInnovative Materials and Analytical Technology Exploration (i-MATE) Program of Academia Sinica, Taiwan AS-iMATE-107-97NCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

PEGylated nanomedicines are known to induce infusion reactions (IRs) that in some cases can be life-threatening. Herein, we report a case study in which a patient with rare mediastinal and intracardiac IgG4-related sclerosing disease received 8 treatments of intravenously administered PEGylated liposomal methylprednisolone-succinate (NSSL-MPS). Due to the ethical requirements to reduce IRs, the patient received a cocktail of premedication including low dose of steroids, acetaminophen and H2 blockers before each infusion. The treatment was well-tolerated in that IRs, complement activation, anti-PEG antibodies and accelerated blood clearance of the PEGylated drug were not detected. Prior to the clinical study, an in vitro panel of assays utilizing blood of healthy donors was used to determine the potential of a PEGylated drug to activate complement system, elicit pro-inflammatory cytokines, damage erythrocytes and affect various components of the blood coagulation system. The overall findings of the in vitro panel were negative and correlated with the results observed in the clinical phase.

Indexed as

LiposomesBiomarkersComplement ActivationComplement System ProteinsDisease SusceptibilityFemaleHumansImmunologic FactorsInflammationMaleMethylprednisolone HemisuccinatePolyethylene GlycolsBiomarkersComplement System ProteinsImmunologic FactorsLiposomesMethylprednisolone HemisuccinatePolyethylene Glycolsanti-PEG antibodiescomplement activationhypersensitive reactionsIgG4 related diseaseliposomal steroidsPEGylated nanodrugs

Identifiers

PMID32012928
PMCPMC7037198
OpenAlexW3003272008

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.