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Prophylaxis with anti‐inhibitor coagulant complex improves health‐related quality of life in haemophilia patients with inhibitors: results from FEIBA NF Prophylaxis Study
Author(s) -
Stasyshyn O.,
Antunes S.,
Mamonov V.,
Ye X.,
Epstein J.,
Xiong Y.,
Tangada S.
Publication year - 2014
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/hae.12390
Subject(s) - medicine , visual analogue scale , haemophilia , quality of life (healthcare) , randomized controlled trial , physical therapy , prospective cohort study , dermatology life quality index , surgery , nursing , disease
Summary The Pro‐ FEIBA study reported health‐related quality of life ( HRQ oL) improved following 6‐month of Factor Eight Inhibitor Bypassing Activity ( FEIBA ) prophylaxis. This study investigates whether 12‐month of FEIBA prophylaxis improved HRQ oL in haemophilia patients with inhibitors. Thirty‐six subjects in a 1‐year prospective, randomized, open‐label, parallel‐design study were randomized to prophylaxis (85 ± 15 U kg −1 every other day) or on‐demand treatment. HRQ oL was assessed at screening, 6 and 12‐month termination using the EQ ‐5D, Haem‐A‐QoL, Haemo‐QoL and a general pain visual analog scale ( VAS ). To evaluate changes, paired t ‐tests and criteria for minimally important differences were applied. Repeated measures regression tested the association between annualized bleeding rate ( ABR ) and physical HRQ oL. At 6 and 12 months, prophylaxis subjects reported clinically meaningful improvement in EQ ‐5D index (mean improvement, 0.10 and 0.08, respectively) and both clinically meaningful and statistically significant improvements in EQ ‐ VAS scores (16.9 and 15.7, respectively; P < 0.05) vs. baseline. General pain was significantly reduced during prophylaxis at each follow‐up (mean improvement, 20.3 and 23.2, respectively; both P <0.05). At 12 months, prophylaxis subjects achieved significant improvements in Haem‐A‐QoL Total Score and in four domains: Physical Health, Feeling, View, and Work and School (all P < 0.05). No statistically significant changes, except for Haem‐A‐QoL Physical Health at 6 months, were observed with on‐demand treatment. ABR was decreased by 72.5% with prophylaxis vs. on‐demand treatment ( P = 0.0003) and reduced ABR was associated with better physical HRQ oL ( P < 0.05). FEIBA prophylaxis significantly reduced ABR and improved HRQ oL in inhibitor patients. Subjects with lower ABR reported better physical HRQ oL.