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ADVATE prophylaxis: post hoc analysis of joint bleeding episodes
Author(s) -
Valentino L. A.,
Reyes C. M.,
Ewenstein B.,
GuzmánBecerra N.,
Wong W. Y.,
SchoenigDiesing C.,
Romanov V.
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.12382
Subject(s) - medicine , interquartile range , post hoc analysis , on demand , gastroenterology , surgery , computer science , multimedia
Summary Introduction The ADVATE ( rAHF ‐PFM) Prophylaxis Study compared the efficacy of (i) standard factor (F) VIIII prophylaxis (SP) (20–40 IU kg −1 every other day) vs. pharmacokinetic‐tailored prophylaxis (PKP) (20–80 IU kg −1 every third day) and (ii) both prophylactic regimens with on‐demand therapy (OD) in 66 previously on‐demand‐treated patients (median age: 26 years; range: 7–59) with FVIII ≤2% and ≥8 joint haemorrhages in the year before enrolment. Aim The aim of this study was to evaluate joint bleeding episodes during the on‐demand and prophylactic study periods. Methods A post hoc analysis of joint bleeding episodes in the per protocol analysis set ( n = 53) was conducted. Results The annualized joint bleeding rate ( AJBR ) was significantly lower for subjects treated with 12 months of SP ( n = 30) or PKP ( n = 23) as compared with 6 months of OD ( n = 53): 55 {median AJBR 0.48 [interquartile range ( IQR ) 1.96]}, 72 [1.00 (4.07)] and 1164 [38.65 (24.81)] respectively ( P < 0.0001). Median AJBR was comparable during both prophylaxis arms (0.5 and 1.0 respectively). In contrast, median AJBR during on‐demand therapy was 38.7 ( P < 0.0001). Conclusion Both SP and PKP significantly increased the median number of days between joint bleeding episodes compared with OD : 268.9, 182.9 and 7.4 respectively ( P < 0.0001). Study subjects experienced these joint‐protective benefits of prophylaxis regardless of the number of baseline target joints.