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hemophilia-b

Hemophilia B

Due to the distinct behavior of factor IX, multiple PK parameters should be considered when assessing bleed prevention. Learn how a broader view of PK may influence evaluation of treatment and management for patients with hemophilia B.1,2

HEMOPHILIA-B

RARE-BLOOD-DISORDERS

Learn More About a Treatment Option

<h2>Hemophilia A and hemophilia B are different bleeding disorders&nbsp;with unique pathologies and clinical features3</h2>

<ul>
 <li>Since bleeding phenotype may differ between severe hemophilia A and B,&nbsp;management strategies should be individualized1</li>
</ul>

<h2>Factor VIII and factor IX have unique pharmacokinetic profiles and behave differently in the body1,2,5-7</h2>

<h3>The 4 key PK differences between factor VIII and factor IX are</h3>
<ul>
 <li>half-life:&nbsp;The time it takes for the concentration of the drug in the plasma to be half of the initial concentration,&nbsp;</li>
 <li>clearance:&nbsp;The ratio of administered dose and area under the curve, showing the amount of plasma free of drug in a given period of time,&nbsp;</li>
 <li>recovery:&nbsp;The increase of coagulation factor activity in the plasma after dose administration</li>
 <li>and volume of distribution:&nbsp;The relationship between the amount of drug in the body and the plasma drug concentration. Drugs with a high volume of distribution will tend to have lower trough levels.</li>
</ul>

<ul>
 <li>Factor VIII and factor IX are unique blood-clotting proteins with distinct functions in the coagulation cascade5-7</li>
</ul>
<h3>See a broader view of PK</h3>

It's time to&nbsp;look at the bigger picture&nbsp;in hemophilia B

Hemophilia B is different. Let’s manage it that way

<h2>The unique pharmacokinetic profile of factor IX is explained by its widespread distribution in the extravascular space5,8-10</h2>

<h2>Compartment models are commonly used to describe the PK of therapies such as factor VIII and factor IX5,14</h2>
<h3>The PK of infused factor VIII may be described by a 2-compartment model5</h3>

<ul>
 <li>After infusion of factor VIII, there is a rapid distribution phase (binding to vWF), followed by elimination. Therefore, its PK may be described by the 2-compartment model5</li>
 <li>However, this early, rapid phase of distribution to vWF rarely contributes to a noticeable difference in the area under the curve (AUC), allowing for an easier PK analysis16</li>
</ul>

<h3>The PK of factor IX can be described by the 3-compartment model, so accurate measurement of its activity is more complex than that of factor VIII5</h3>
Due to the distribution of factor IX outside of the plasma and into the extravascular space, the PK behavior is more complex than that of factor VIII5,13

Adapted from Iorio, et al.&nbsp;Thromb Haemost.&nbsp;2017.

<ul>
 <li>After factor IX enters the plasma, it rapidly distributes into peripheral compartments and eventually redistributes into the central compartment for elimination5</li>
</ul>

<h3>Because factor IX may reside in 3 different compartments, and trough only accounts for one compartment (plasma), trough may not account for all the factor IX activity in the body.5,13</h3>

Clinical studies have shown that factor IX spends more than half of its total time in the body outside the plasma3,5

<h2>Factor IX binds to type IV collagen, which may play a key role in coagulation15,18</h2>

Learn more about this study

<h3>Additional research in humans is needed to confirm these findings.8</h3>
Purple dots represent the length of bleeding time from time of tail clip to bleeding cessation for each mouse. After 10 minutes, bleeding was terminated by firm pressure. Solid purple bars indicate mean bleeding times for the groups.

<h2>Due to the complexity of factor IX, evaluation of factor IX replacement therapies should look at multiple PK indicators5</h2>
<h3>Parameters</h3>

The ISTH recommends that PK assessments include at least 6 parameters13

<h2>Trough levels, which measure factor in the plasma, may not always correlate with bleed rates1,2</h2>

Although clinical trials have not directly compared extended half-life factor IX replacement drugs, individual trials have shown21,22:

A broad range of trough levels 
1% to 27%

A narrow range of bleed rates 
1.04 to 1.40

Despite a wide range of trough levels, bleed rates have shown a narrow range1,2,23

<h2>Multiple considerations may be needed to help evaluate the treatment and management of hemophilia B5,13</h2>
<ul>
 <li>Due to the distinct behavior and&nbsp;extravascular distribution of factor IX, there is a need to consider hemophilia B as a unique bleeding disorder5,13</li>
 <li>Trough alone may not provide a full picture of factor IX activity and should be&nbsp;one of multiple ways&nbsp;we measure bleed prevention in hemophilia B1,2,19,24,25</li>
 <li>A more&nbsp;complete PK assessment&nbsp;(including half-life, trough, peak, AUC, clearance, and volume of distribution) may provide a different way of thinking about bleed prevention in hemophilia B1,2,5,13,26</li>
 <li>A&nbsp;patient-centered approach&nbsp;that includes evaluation of bleed rates, joint bleed prevention, adherence, and quality of life should be considered when assessing your patients with hemophilia B25,27</li>
</ul>
<h2><a tabindex="0">INFOGRAPHIC:&nbsp;View factor IX differences</a></h2>

It's time to look at the bigger picture in hemophilia B

Hemophilia B

Latest Articles

Hemophilia B is different. Let’s manage it that way

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Take a closer look at Factor IX