Changing treatments

Changing treatments?

Are you thinking about going on a trip, starting a new job or joining the match on Saturday? Wondering which haemophilia treatment is the right one for you? Considering which best suits your ambitions and gives you the freedom to lead the life you want? Choosing a treatment is a big decision and figuring out the best option for your needs might require some research. Whichever way you go about it, it’s important that you and your doctor (or treatment centre) work together to make sure you’re well informed to make a decision you feel comfortable and happy with. 

CHANGING IT UP

 

You’re not tied to the first treatment you choose forever. If it’s not right for you, you will in most cases have the option to change to one that better suits your needs. And you won’t be the only one: most people with haemophilia have changed treatments at some point in their lives1. There’s little current evidence indicating particular safety issues related to changing from one factor concentrate to another; it’s just recommended that you be assessed and monitored for inhibitor development after the switch1,2,4. 

Personalised treatment plan

What about inhibitors?

 

So what are inhibitors, and why do you need to be monitored for them if you switch treatments? They’re mentioned here because there is a perception that switching treatments may increase the risk of developing inhibitors. 

In reality, the risk of developing inhibitors is dependent on multiple things – and some of these are totally unrelated to your treatment1. As mentioned, many people with haemophilia have switched to different factor concentrates over the course of their treatment1. For the vast majority of patients, switching products does not lead to inhibitor development.4

The World Federation of Hemophilia (WFH) recommends that people living with haemophilia who change to new clotting factors should be monitored for inhibitor development.4 Speak to your doctor if you have concerns or questions about developing inhibitors when switching treatments – they’ll know all about it. 

In order to embrace the opportunities your life has to offer, you need to feel safe and comfortable with your treatment plan. If you’re thinking about changing treatments, it’s a good idea to reach out to your treatment centre as soon as you can. They will assess your personal and clinical information to see if a switch is a good idea.3 And, they can make sure the process of switching treatments is as safe and smooth as possible.3

Ease your mind

If you’re feeling even the slightest bit anxious about treatment safety, the best thing you can do is to learn more about the drug approval process your approved treatment has already been through. This will also make you better prepared for conversations with your doctor or nurse, and help you feel more comfortable with (and confident in) the therapy you’ve chosen, or the therapies you’re considering. 
All established treatment methods (such as EHL) have been through this very strict approval process. Before a new clotting factor is even considered for approval, it first needs to go through many rounds of clinical and lab studies. These can take up to 10 years, and generally involve at least 100 patients for haemophilia A, and 40 patients for haemophilia B. Only after these are completed will an independent regulating agency consider approving the therapy. Then, even after a new therapy is approved, its effectiveness (called efficacy) and safety for patients will be continuously investigated. It will go through more rounds of larger studies that involve even more patients (at least 200).4, 7 So you can rest assured that your treatment has a proven safety record to help people just like yourself. 

Make the most of your doctor's visit

 

REFERENCES:

1. IorioI, PuccettoP, Makris M. Clotting factor concentrate switching and inhibitor development in hemophiliaA. Blood. 2012 Jul 26;120(4):720–727.

2. Coppola A, MarroneE, Conca P, Cimino E, Mormile R, Baldacci E, et al. Safety of switching factor VIII products in the era of evolving concentrates: myths and facts. SeminThrombHemost. 2016 Jul;42(5):563–576.

3. Harrington C, Hay C, Vidler V, DattaniR,HeygateK. Switching factor products: selecting patients and managing the process. Journal of Haemophilia Practice 2014 May;1:24–29.

4. World Federation of Hemophilia. Guidelines for the management of haemophilia 2nd edition. 2012. Available at: https:// www1.wfh.org/publication/files/pdf-1472.pdf (accessed June 2019).

5. Hay CR, Palmer BP, Chalmers EA, Hart DP, LiesnerR, Rangarajan S, et al. The incidence of factor VIII inhibitors in severe haemophilia A following a major switch from full-length to B-domain-deleted factor VIII: a prospective cohort comparison. Haemophilia. 2015 Mar;21(2):219-226.

6. European Medicines Agency. Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products EMA/CHMP/BPWP/144533/2009. 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109692.pdf (accessed June 2019).

7. European Medicines Agency. Guideline on clinical investigation of recombinant and human plasma-derived factor IX products EMA/CHMP/BPWP/144552/2009 Rev. 1, Corr. 1 *. 2015. 

 

 

NP-7934

Changing treatments?

Are you thinking about going on a trip, starting a new job or joining the match on Saturday? Wondering which haemophilia treatment is the right one for you? Considering which best suits your ambitions and gives you the freedom to lead the life you want? Choosing a treatment is a big decision and figuring out the best option for your needs might require some research. Whichever way you go about it, it’s important that you and your doctor (or treatment centre) work together to make sure you’re well informed to make a decision you feel comfortable and happy with. 

CHANGING IT UP

 

You’re not tied to the first treatment you choose forever. If it’s not right for you, you will in most cases have the option to change to one that better suits your needs. And you won’t be the only one: most people with haemophilia have changed treatments at some point in their lives1. There’s little current evidence indicating particular safety issues related to changing from one factor concentrate to another; it’s just recommended that you be assessed and monitored for inhibitor development after the switch1,2,4. 

Personalised treatment plan

What about inhibitors?

 

So what are inhibitors, and why do you need to be monitored for them if you switch treatments? They’re mentioned here because there is a perception that switching treatments may increase the risk of developing inhibitors. 

In reality, the risk of developing inhibitors is dependent on multiple things – and some of these are totally unrelated to your treatment1. As mentioned, many people with haemophilia have switched to different factor concentrates over the course of their treatment1. For the vast majority of patients, switching products does not lead to inhibitor development.4

The World Federation of Hemophilia (WFH) recommends that people living with haemophilia who change to new clotting factors should be monitored for inhibitor development.4 Speak to your doctor if you have concerns or questions about developing inhibitors when switching treatments – they’ll know all about it. 

In order to embrace the opportunities your life has to offer, you need to feel safe and comfortable with your treatment plan. If you’re thinking about changing treatments, it’s a good idea to reach out to your treatment centre as soon as you can. They will assess your personal and clinical information to see if a switch is a good idea.3 And, they can make sure the process of switching treatments is as safe and smooth as possible.3

Ease your mind

If you’re feeling even the slightest bit anxious about treatment safety, the best thing you can do is to learn more about the drug approval process your approved treatment has already been through. This will also make you better prepared for conversations with your doctor or nurse, and help you feel more comfortable with (and confident in) the therapy you’ve chosen, or the therapies you’re considering. 
All established treatment methods (such as EHL) have been through this very strict approval process. Before a new clotting factor is even considered for approval, it first needs to go through many rounds of clinical and lab studies. These can take up to 10 years, and generally involve at least 100 patients for haemophilia A, and 40 patients for haemophilia B. Only after these are completed will an independent regulating agency consider approving the therapy. Then, even after a new therapy is approved, its effectiveness (called efficacy) and safety for patients will be continuously investigated. It will go through more rounds of larger studies that involve even more patients (at least 200).4, 7 So you can rest assured that your treatment has a proven safety record to help people just like yourself. 

Make the most of your doctor's visit

 

REFERENCES:

1. IorioI, PuccettoP, Makris M. Clotting factor concentrate switching and inhibitor development in hemophiliaA. Blood. 2012 Jul 26;120(4):720–727.

2. Coppola A, MarroneE, Conca P, Cimino E, Mormile R, Baldacci E, et al. Safety of switching factor VIII products in the era of evolving concentrates: myths and facts. SeminThrombHemost. 2016 Jul;42(5):563–576.

3. Harrington C, Hay C, Vidler V, DattaniR,HeygateK. Switching factor products: selecting patients and managing the process. Journal of Haemophilia Practice 2014 May;1:24–29.

4. World Federation of Hemophilia. Guidelines for the management of haemophilia 2nd edition. 2012. Available at: https:// www1.wfh.org/publication/files/pdf-1472.pdf (accessed June 2019).

5. Hay CR, Palmer BP, Chalmers EA, Hart DP, LiesnerR, Rangarajan S, et al. The incidence of factor VIII inhibitors in severe haemophilia A following a major switch from full-length to B-domain-deleted factor VIII: a prospective cohort comparison. Haemophilia. 2015 Mar;21(2):219-226.

6. European Medicines Agency. Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products EMA/CHMP/BPWP/144533/2009. 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109692.pdf (accessed June 2019).

7. European Medicines Agency. Guideline on clinical investigation of recombinant and human plasma-derived factor IX products EMA/CHMP/BPWP/144552/2009 Rev. 1, Corr. 1 *. 2015. 

 

 

NP-7934