The potential correlation between patient-reported symptoms and the use of additional haemostatic medication for joint bleeding in haemophilia patients with inhibitors: a post hoc exploratory analysis of recombinant activated factor VII data from the ADEPT2 trial

Steven R Lentz; Savita Rangarajan; Faraizah A Karim; Philip D Andersen; Per Arkhammar; Gabriela Rosu; Johnny Mahlangu

doi:10.1097/MBC.0000000000000584

Back

The potential correlation between patient-reported symptoms and the use of additional haemostatic medication for joint bleeding in haemophilia patients with inhibitors: a post hoc exploratory analysis of recombinant activated factor VII data from the ADEPT2 trial

Journal article

Open access

Peer reviewed

The potential correlation between patient-reported symptoms and the use of additional haemostatic medication for joint bleeding in haemophilia patients with inhibitors: a post hoc exploratory analysis of recombinant activated factor VII data from the ADEPT2 trial

Steven R Lentz, Savita Rangarajan, Faraizah A Karim, Philip D Andersen, Per Arkhammar, Gabriela Rosu and Johnny Mahlangu

Blood coagulation & fibrinolysis, Vol.28(3), pp.224-229

04/2017

DOI: 10.1097/MBC.0000000000000584

PMCID: PMC5407628

PMID: 27427786

Files and links (1)

url

https://doi.org/10.1097/MBC.0000000000000584View

Published (Version of record) Open Access

Abstract

Haemophilia treatment guidelines advocate early home-based treatment of acute bleeds. In the ADEPT2 trial, data were collected on the home treatment of bleeds with recombinant activated factor VII (rFVIIa) in haemophilia patients with inhibitors and self-reported bleeding-related symptoms. A total of 93% of all bleeds, and 91.5% of joint bleeds, were treated successfully with one to three doses of 90 μg/kg rFVIIa. However, some patients self-administered additional haemostatic medication (AHM) up to 48 h after the first rFVIIa treatment. The aim of this trial was to investigate the relationship between patient-reported symptoms, time to treatment initiation, and the use of AHM. A post hoc analysis was conducted on 177 joint bleeds and the patient-reported categorical symptoms of pain, swelling, mobility, tingling, and warmth, and the pain visual analogue scale (VAS) score. Analyses were descriptive and used logistic regression modelling. Complete symptom data were available for 141, 136, and 129 joint bleeds at 0 or 1, 3, and 6 h, respectively. Pain and pain VAS assessments were the best predictors of AHM use. Patients who self-administered AHM had higher mean pain VAS scores at each time point; both pain and pain VAS scores declined over time. Time to treatment initiation was an independent predictor for AHM use. Higher initial pain scores and longer time to treatment were the best predictors for administration of AHM. The observation that some patients chose to self-infuse in the face of declining levels of pain warrants further study to better understand the reasons behind patient decision-making.

bleeding

inhibitor

Original

factor VII

recombinant activated factor VII

Details

Title: Subtitle: The potential correlation between patient-reported symptoms and the use of additional haemostatic medication for joint bleeding in haemophilia patients with inhibitors: a post hoc exploratory analysis of recombinant activated factor VII data from the ADEPT2 trial
Creators: Steven R Lentz - Department of Internal Medicine, University of Iowa, Iowa City, Iowa, USA
Savita Rangarajan - North Hampshire Haemophilia Centre, Basingstoke, UK
Faraizah A Karim - National Blood Centre, Kuala Lumpur, Malaysia
Philip D Andersen - Novo Nordisk A/S, Søborg, Denmark
Per Arkhammar - Novo Nordisk A/S, Søborg, Denmark
Gabriela Rosu - Novo Nordisk A/S, Søborg, Denmark
Johnny Mahlangu - Faculty of Health Science, University of the Witwatersrand, and NHLS, Johannesburg, South Africa
Resource Type: Journal article
Publication Details: Blood coagulation & fibrinolysis, Vol.28(3), pp.224-229
DOI: 10.1097/MBC.0000000000000584
PMID: 27427786
PMCID: PMC5407628
NLM abbreviation: Blood Coagul Fibrinolysis
ISSN: 0957-5235
eISSN: 1473-5733
Publisher: Lippincott Williams And Wilkins
Language: English
Date published: 04/2017
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984094216602771

Metrics

23 Record Views

3 Times Cited - Web of Science