Evidence map›Paper›PMID 35207344›Full record

ReviewJournal of clinical medicine2022

IDELVION: A Comprehensive Review of Clinical Trial and Real-World Data.

Miguel Escobar, Maria Elisa Mancuso, Cedric Hermans, Cindy Leissinger, Wilfried Seifert, Yanyan Li, William McKeand, Johannes Oldenburg

Open access · goldAbstract readReview
In one paragraph

Review in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Cathepsin B Processing Is Required for theBioconjugate chemistry · 2024
    Article
  4. The therapeutic age of the neonatal Fc receptor.Nature reviews. Immunology · 2023
    Review
  5. Article
  6. Observational
  7. Article
  8. HAEMFIX: Impact of Switching From SHL-FIX to EHL-FIX in Patients With Haemophilia B.Haemophilia : the official journal of the World Federation of Hemophilia
    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 6 institutions in 4 countries.

Miguel EscobarUniversity of Texas Health Science Center, Houston, TX 77030, USA.ORCID 0000-0002-2944-0240
Maria Elisa MancusoCenter for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.ORCID 0000-0002-7113-4028
Cedric HermansHaemostasis and Thrombosis Unit, Division of Haematology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (UCLouvain), 1200 Brussels, Belgium.
Cindy LeissingerTulane University School of Medicine, New Orleans, LA 70112, USA.
Wilfried SeifertCSL Behring, 35041 Marburg, Germany.
Yanyan LiCSL Behring, King of Prussia, PA 19406, USA.
William McKeandCSL Behring, King of Prussia, PA 19406, USA.
Johannes OldenburgInstitute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, 53127 Bonn, Germany.ORCID 0000-0002-1585-4100
CSL (United States) · USBehringwerke (Germany) · DECliniques Universitaires Saint-Luc · BEIRCCS Humanitas Research Hospital · ITThe University of Texas Health Science Center at Houston · USTulane University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hemophilia B is a bleeding disorder caused by a deficiency of coagulation factor IX (FIX). Treatment with FIX replacement products can increase FIX activity levels to minimize or prevent bleeding events. However, frequent dosing with standard-acting FIX products can create a high treatment burden. Long-acting products have been developed to maintain bleed protection with extended dosing intervals. Recombinant factor IX-albumin fusion protein (rIX-FP) is a long-acting product indicated for the treatment and prophylaxis of bleeding events and perioperative management in adult and pediatric patients. This review outlines data from all previously treated patients in the Prophylaxis and On-Demand Treatment using Longer Half-Life rIX-FP (PROLONG-9FP) clinical trial program and summarizes real-world data evaluating the use of rIX-FP in routine clinical practice. In the PROLONG-9FP program, rIX-FP demonstrated effective hemostasis in all patients at dose regimens of up to 21 days in patients aged ≥ 18 years and up to 14 days in patients aged < 12 years. rIX-FP has a favorable pharmacokinetic profile and an excellent safety and tolerability profile. Extended dosing intervals with rIX-FP led to high levels of adherence and reduced consumption compared with other FIX therapies. Data from real-world practice are encouraging and reflect the results of the clinical trials.

Indexed as

albumin fusion proteinannualized bleeding ratesextended half-lifefactor IXhemophilia B

Identifiers

PMID35207344
PMCPMC8875492
OpenAlexW4214570354

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.