Table 2

Patient characteristics according to the first recombinant VIII product received

CharacteristicsFirst recombinant FVIII product received
Product E (n = 97)Product D (n = 111)Product A (n = 48)Product C (n = 27)All rFVIII products* (n = 303)
No.%MIQRNo.%MIQRNo.%MIQRNo.%MIQRNo.%MIQR
Fixed risk factors
F8 gene defect
  Low risk3030.91917.11122.9622.26822.4
  High risk 6263.98576.63572.92177.821470.6
  Undetermined (eg, untested, unidentified)55.276.324.200.0216.9
 Family history
  Hemophilia without inhibitor4546.43733.31327.1933.311036.3
  Hemophilia with inhibitor99.31513.5612.5311.13611.9
  No family history of hemophilia4344.35953.22960.41555.615751.8
 Ethnic origin
  White only (both parents)7476.38576.63777.12074.123376.9
  Others not African or African-American1717.52320.7714.6622.25518.2
  African or African-American (at least one grandparent)66.232.748.313.7155.0
 Calendar period of first exposure to rFVIII
  Before 200000.01917.13572.91970.48327.4
  2000-20032424.73127.91225.0725.97424.4
  2004-20073536.13127.912.113.76922.8
  2008 and after3839.23027.000.000.07725.4
 Age at first exposure to rFVIII, months9.53.6-13.311.67.4-14.510.15.3-16.810.64.7-16.710.45.6-14.3
  <63030.92320.71429.2725.97825.7
  6-113536.13531.51531.3829.610233.7
  ≥123233.05347.71939.61244.412340.6
Time-varying risk factors
 Initiation of regular prophylaxis within first 50 EDs§5657.74944.11939.6933.314547.9
 Cumulative EDs at start of prophylaxis157-262010-332216-473020-542011-33
 Peak treatment episode at first exposure, consecutive EDs
  ≥33132.03531.51225.0518.59130.0
  ≥51414.42118.9816.7311.15016.5
  ≥1088.2119.924.213.7237.6
 History of peak treatment episodes (≥1 during follow-up), consecutive EDs
  ≥36364.97567.63777.12177.821069.3
  ≥53536.14439.62245.81244.412139.9
  ≥101414.41715.3510.4414.84113.5
 First exposure linked to surgical procedure (with ≥3 EDs)22.110.900.000.051.7
 History of surgical procedures (with ≥3 EDs) during follow-up1010.387.21020.8518.53812.5
 First exposure linked to severe bleeding episode1010.3109.024.200.0227.3
 History of severe bleeding episodes during follow-up1313.41715.336.327.43511.6
Outcomes
 All inhibitors3334.05549.51327.1725.911437.6
 High-titer inhibitors2020.62825.2714.6518.56320.8
 Inhibitors occurring during the first 75 EDs and treated at any time during FranceCoag follow-up
   Cases treated with bypassing agents2424.73834.2612.5622.27725.4
   Cases treated with ITI2323.74036.0714.6518.57926.1
   Cases treated with bypassing agents and/or ITI2929.94742.3816.7725.99531.4
  • M, median.

  • * Product B (n = 10) and Product F (n = 10) are included in all rFVIII products.

  • High-risk gene defects include large deletions (≥1 exon), intron 1 and 22 inversions, small deletions/insertions with stop codon (out of A-run), and nonsense mutations.

  • Up to four ethnic origins per patient could be recorded (one for each grandparent).

  • § The initiation of regular prophylaxis was defined as the moment at which at least 3 consecutive prophylactic infusions of rFVIII were given within a period of at least 15 days (RODIN definition).14