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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

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
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
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.
0957-5235
224-229
Lentz, Steven R.
0b1927e0-9b01-4bf7-b393-d690d2929081
Rangarajan, Savita
9a5e4c7e-55ba-4a3a-b5f6-f1e269d927c3
Karim, Faraizah A.
54b95779-9c7c-4f9b-8f7e-9e77cfb95174
Andersen, Philip D.
a45f30bc-240f-4a2d-8beb-f2415249b03c
Arkhammar, Per
3b64b94f-0fac-4830-a8e3-0273dcb65e29
Rosu, Gabriela
c32e5009-45af-418c-b3b4-bb434932bf0d
Mahlangu, Johnny
d9dbd61a-b94a-4fbc-812d-55c6434fbc09
Lentz, Steven R.
0b1927e0-9b01-4bf7-b393-d690d2929081
Rangarajan, Savita
9a5e4c7e-55ba-4a3a-b5f6-f1e269d927c3
Karim, Faraizah A.
54b95779-9c7c-4f9b-8f7e-9e77cfb95174
Andersen, Philip D.
a45f30bc-240f-4a2d-8beb-f2415249b03c
Arkhammar, Per
3b64b94f-0fac-4830-a8e3-0273dcb65e29
Rosu, Gabriela
c32e5009-45af-418c-b3b4-bb434932bf0d
Mahlangu, Johnny
d9dbd61a-b94a-4fbc-812d-55c6434fbc09

Lentz, Steven R., Rangarajan, Savita, Karim, Faraizah A., Andersen, Philip D., Arkhammar, Per, Rosu, Gabriela and Mahlangu, Johnny (2017) 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. Blood Coagulation & Fibrinolysis, 28 (3), 224-229. (doi:10.1097/MBC.0000000000000584).

Record type: Article

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.

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More information

Accepted/In Press date: 21 May 2016
Published date: 1 April 2017

Identifiers

Local EPrints ID: 442859
URI: http://eprints.soton.ac.uk/id/eprint/442859
ISSN: 0957-5235
PURE UUID: cc9c88f9-591d-49df-97cb-5a67fc144e6f
ORCID for Savita Rangarajan: ORCID iD orcid.org/0000-0001-7367-133X

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Date deposited: 29 Jul 2020 16:34
Last modified: 17 Mar 2024 04:02

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Contributors

Author: Steven R. Lentz
Author: Faraizah A. Karim
Author: Philip D. Andersen
Author: Per Arkhammar
Author: Gabriela Rosu
Author: Johnny Mahlangu

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