Evidence map›Paper›PMID 29035131›Full record

ReviewExpert review of clinical immunology2017

RI-002, an intravenous immunoglobulin containing high titer neutralizing antibody to RSV and other respiratory viruses for use in primary immunodeficiency disease and other immune compromised populations.

Richard L Wasserman, Benjamin N Greener, James Mond

Open access · bronzeAbstract readReview
In one paragraph

Review in Expert review of clinical immunology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 27 citations in OpenAlex.

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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

3 authors at 3 institutions in 1 country.

Richard L Wassermana Allergy Partners of North Texas Research , Dallas , TX , USA.
Benjamin N Greenerb Clinical Scientist - PPD Inc. , 2400 Research Blvd ., Rockville , MD , USA.
James Mondc Chief Medical and Scientific Officer- ADMA Biologics Inc ., Ramsey , NJ , USA.
ADMA Biologics (United States) · USENT and Allergy · USPharmaceutical Product Development (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNovel immune globulin (IG) products (RI-002, RI-001) have been designed to provide protection against respiratory syncytial virus (RSV) mediated respiratory illness while at the same time meeting the manufacturing requirements established by FDA for antibody supplementation in immunocompromised subjects. Areas covered: This review covers the manufacture and development of both RI-001 and RI-002, including the selection of plasma donors for IG preparation with high-titers of anti-RSV antibody, in vitro, and preclinical data in the cotton rat model S. hispidus, and clinical trials including Phase II and compassionate use studies of RI-001 and a multi-center, pivotal Phase III study of RI-002 in PIDD patients. Expert commentary: The data demonstrate that RI-002 is efficacious in the prevention and treatment of RSV in preclinical normal and immune suppressed animal models and is safe and efficacious in the treatment of patients with various forms of primary immunodeficiency disease (PIDD). This product offers potential advantages over other available IG's for prophylaxis in immunocompromised patients requiring polyclonal immunoglobulin supplementation because of its unique antibody composition. In addition to its enhanced neutralizing anti-RSV activity and its polyclonal IG composition, there is preclinical data to support the use of RI-002 for humoral protection against other respiratory pathogens.

Indexed as

AnimalsAntibodies, NeutralizingAntibodies, ViralClinical Trials as TopicDisease Models, AnimalExpert TestimonyHumansImmunocompromised HostImmunoglobulins, IntravenousImmunologic Deficiency SyndromesImmunotherapyRatsRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsSigmodontinaeAntibodies, NeutralizingAntibodies, ViralImmunoglobulins, IntravenousAnti-RSVinfluenzaIVIGprimary immunodeficiency diseaserespiratory syncytial virusRI-002ribavirinRSV-IVIG

Identifiers

PMID29035131
PMCPMC7103707
OpenAlexW2765599596

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.