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Results of a meta-analysis suggest a pair of recombinant factor VIII (FVIII) products may not increase the risk of FVIII inhibitors in previously untreated patients with severe hemophilia A.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) analyzed data from 3 observational studies and found that patients who received Kogenate or Helixate had a higher incidence of inhibitors than patients who received other recombinant FVIII products.
However, the difference was not significant, and the PRAC concluded that, overall, the evidence does not confirm an increased risk of inhibitors with Kogenate or Helixate.
This conclusion is consistent with the PRAC’s previous conclusions from a review carried out in 2013.
For the current analysis, the PRAC reviewed data from 3 studies, which were conducted by the RODIN study group, the UK Haemophilia Centre Doctors’ Organisation (UKHCDO), and the FranceCoag Network.
The analysis included 1102 previously untreated patients—481 in the RODIN study, 293 in the FranceCoag study, and 328 in the UKHCDO study—who received octocog alfa (Advate, Helixate, or Kogenate), moroctocog alfa (Refacto or Refacto AF), or other recombinant FVIII products.
Results suggested a trend toward an increase of high-titer inhibitor development and all inhibitor development with Kogenate or Helixate compared to Advate.
Overall, 37% of patients treated with Kogenate or Helixate (147/400) developed inhibitory antibodies, 22% of whom (n=88) had high-titer inhibitors. Twenty-six percent of patients who received Advate (100/385) developed inhibitors, 15% of whom (n=57) had high-titer inhibitors.
The PRAC said a similar trend was observed for other recombinant FVIII products, but the results were less pronounced due to sample size constraints.
The committee pointed out that there were several limitations with this meta-analysis, including the possibility of residual confounding. The group also said a number of parameters may have had an impact on the incidence of inhibitors in these previously untreated patients, and adjusting for all of these factors may not be possible.
In addition, the PRAC noted that there has been no signal for a similar trend of increases in inhibitor development with Kogenate in previously treated patients in other studies.
Finally, the committee recommended that companies marketing recombinant FVIII products monitor published studies on inhibitor development with the aim of keeping the product information up to date. 
Results of a meta-analysis suggest a pair of recombinant factor VIII (FVIII) products may not increase the risk of FVIII inhibitors in previously untreated patients with severe hemophilia A.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) analyzed data from 3 observational studies and found that patients who received Kogenate or Helixate had a higher incidence of inhibitors than patients who received other recombinant FVIII products.
However, the difference was not significant, and the PRAC concluded that, overall, the evidence does not confirm an increased risk of inhibitors with Kogenate or Helixate.
This conclusion is consistent with the PRAC’s previous conclusions from a review carried out in 2013.
For the current analysis, the PRAC reviewed data from 3 studies, which were conducted by the RODIN study group, the UK Haemophilia Centre Doctors’ Organisation (UKHCDO), and the FranceCoag Network.
The analysis included 1102 previously untreated patients—481 in the RODIN study, 293 in the FranceCoag study, and 328 in the UKHCDO study—who received octocog alfa (Advate, Helixate, or Kogenate), moroctocog alfa (Refacto or Refacto AF), or other recombinant FVIII products.
Results suggested a trend toward an increase of high-titer inhibitor development and all inhibitor development with Kogenate or Helixate compared to Advate.
Overall, 37% of patients treated with Kogenate or Helixate (147/400) developed inhibitory antibodies, 22% of whom (n=88) had high-titer inhibitors. Twenty-six percent of patients who received Advate (100/385) developed inhibitors, 15% of whom (n=57) had high-titer inhibitors.
The PRAC said a similar trend was observed for other recombinant FVIII products, but the results were less pronounced due to sample size constraints.
The committee pointed out that there were several limitations with this meta-analysis, including the possibility of residual confounding. The group also said a number of parameters may have had an impact on the incidence of inhibitors in these previously untreated patients, and adjusting for all of these factors may not be possible.
In addition, the PRAC noted that there has been no signal for a similar trend of increases in inhibitor development with Kogenate in previously treated patients in other studies.
Finally, the committee recommended that companies marketing recombinant FVIII products monitor published studies on inhibitor development with the aim of keeping the product information up to date.
Results of a meta-analysis suggest a pair of recombinant factor VIII (FVIII) products may not increase the risk of FVIII inhibitors in previously untreated patients with severe hemophilia A.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) analyzed data from 3 observational studies and found that patients who received Kogenate or Helixate had a higher incidence of inhibitors than patients who received other recombinant FVIII products.
However, the difference was not significant, and the PRAC concluded that, overall, the evidence does not confirm an increased risk of inhibitors with Kogenate or Helixate.
This conclusion is consistent with the PRAC’s previous conclusions from a review carried out in 2013.
For the current analysis, the PRAC reviewed data from 3 studies, which were conducted by the RODIN study group, the UK Haemophilia Centre Doctors’ Organisation (UKHCDO), and the FranceCoag Network.
The analysis included 1102 previously untreated patients—481 in the RODIN study, 293 in the FranceCoag study, and 328 in the UKHCDO study—who received octocog alfa (Advate, Helixate, or Kogenate), moroctocog alfa (Refacto or Refacto AF), or other recombinant FVIII products.
Results suggested a trend toward an increase of high-titer inhibitor development and all inhibitor development with Kogenate or Helixate compared to Advate.
Overall, 37% of patients treated with Kogenate or Helixate (147/400) developed inhibitory antibodies, 22% of whom (n=88) had high-titer inhibitors. Twenty-six percent of patients who received Advate (100/385) developed inhibitors, 15% of whom (n=57) had high-titer inhibitors.
The PRAC said a similar trend was observed for other recombinant FVIII products, but the results were less pronounced due to sample size constraints.
The committee pointed out that there were several limitations with this meta-analysis, including the possibility of residual confounding. The group also said a number of parameters may have had an impact on the incidence of inhibitors in these previously untreated patients, and adjusting for all of these factors may not be possible.
In addition, the PRAC noted that there has been no signal for a similar trend of increases in inhibitor development with Kogenate in previously treated patients in other studies.
Finally, the committee recommended that companies marketing recombinant FVIII products monitor published studies on inhibitor development with the aim of keeping the product information up to date.