Fumaric acid esters in children with psoriasis ongoing study

[Fred]

This is an ongoing study from Germany looking at Fumaric acid esters in children with psoriasis.

Quote:

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Background:
Given that there is no standard systemic treatment for children and adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective study collected data on the efficacy and safety of long-term treatment with fumaric acid esters (FAEs) in this particular patient group.

Patients and methods:
In patients younger than 18 years of age at the start of FAE treatment, data on efficacy and safety was retrospectively collected for at least 36 months.

Results:
Data from 127 patients (aged 6–17 years) was collected for treatment durations of up to 60 months. Physician's Global Assessment, Psoriasis Area and Severity Index, and Body Surface Area showed marked improvement in the first six months. After 36 months, these parameters had, on average, improved by up to two-thirds of baseline values. Thirty-seven patients experienced at least one adverse event (AE), which was FAE-related in 36 individuals. Three AEs (proteinuria (one case), flushing (two cases)) persisted during the observation period while on treatment. Fifteen AEs led to the discontinuation of therapy; nearly all of these cases were related to gastrointestinal disorders.

Conclusions:
The KIDS FUTURE study – for the first time – included a larger population of children and adolescents with psoriasis who were treated with FAEs. The data obtained suggests that long-term FAE therapy in this patient group may be effective and safe. The results are currently being verified in an ongoing clinical study.

Source: onlinelibrary.wiley.com

Author Information:
Dermatologikum Hamburg, Germany
Dermatology/Allergology Practice, Eltville, Germany
Department of Dermatology, Venereology, and Allergology of the Ruhr University, Bochum, Germany
SCIderm GmbH Hamburg, Germany

[jiml]

This is an ongoing study from Germany looking at Fumaric acid esters in children with psoriasis.

Quote:

---

Background:
Given that there is no standard systemic treatment for children and adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective study collected data on the efficacy and safety of long-term treatment with fumaric acid esters (FAEs) in this particular patient group.

Patients and methods:
In patients younger than 18 years of age at the start of FAE treatment, data on efficacy and safety was retrospectively collected for at least 36 months.

Results:
Data from 127 patients (aged 6–17 years) was collected for treatment durations of up to 60 months. Physician's Global Assessment, Psoriasis Area and Severity Index, and Body Surface Area showed marked improvement in the first six months. After 36 months, these parameters had, on average, improved by up to two-thirds of baseline values. Thirty-seven patients experienced at least one adverse event (AE), which was FAE-related in 36 individuals. Three AEs (proteinuria (one case), flushing (two cases)) persisted during the observation period while on treatment. Fifteen AEs led to the discontinuation of therapy; nearly all of these cases were related to gastrointestinal disorders.

Conclusions:
The KIDS FUTURE study – for the first time – included a larger population of children and adolescents with psoriasis who were treated with FAEs. The data obtained suggests that long-term FAE therapy in this patient group may be effective and safe. The results are currently being verified in an ongoing clinical study.

Source: onlinelibrary.wiley.com

Author Information:
Dermatologikum Hamburg, Germany
Dermatology/Allergology Practice, Eltville, Germany
Department of Dermatology, Venereology, and Allergology of the Ruhr University, Bochum, Germany
SCIderm GmbH Hamburg, Germany

That's a great study with a great outcome for kids, that desperately need something to control the psoriasis safely and I'm of the opinion there is nothing safer ( with monitoring of course)
I hope this gets picked up by dermatologists and start giving kids a safe bright future

[Caroline]

Certainly this looks very good for the Kids.
What I hope is that Big Pharma is not running away with it and that it will stay as cheap as possible.

By the way, flushing can hardly be mentioned as an Adverse Event as it is quite common.

[Fred]

By the way, flushing can hardly be mentioned as an Adverse Event as it is quite common.

Quote:

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An adverse event is any undesirable experience associated with the use of a medical product in a patient.

FDA

I would class flushing as an adverse event.

[Caroline]

By the way, flushing can hardly be mentioned as an Adverse Event as it is quite common.

Quote:

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An adverse event is any undesirable experience associated with the use of a medical product in a patient.

FDA

I would class flushing as an adverse event.

In that case it is very odd that there were only two AE's in flushing.
It is very common that nearly everyone using Fumaric acid esters gets flushing.
And I don't think that the total population of the research is about three children.  


Additional: if you consider that the best way to tell if the FAE is working is getting a flush, than you might consider it a wished Event and not an AE.

[Fred]

By the way, flushing can hardly be mentioned as an Adverse Event as it is quite common.

Quote:

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An adverse event is any undesirable experience associated with the use of a medical product in a patient.

FDA

I would class flushing as an adverse event.

In that case it is very odd that there were only two AE's in flushing.
It is very common that nearly everyone using Fumaric acid esters gets flushing.
And I don't think that the total population of the research is about three children.  


Additional: if you consider that the best way to tell if the FAE is working is getting a flush, than you might consider it a wished Event and not an AE.

I don't have a clue what you are on about. I'm only giving the information you make of it what you will.  

[Caroline]

By the way, flushing can hardly be mentioned as an Adverse Event as it is quite common.

Quote:

---

An adverse event is any undesirable experience associated with the use of a medical product in a patient.

FDA

I would class flushing as an adverse event.

In that case it is very odd that there were only two AE's in flushing.
It is very common that nearly everyone using Fumaric acid esters gets flushing.
And I don't think that the total population of the research is about three children.  


Additional: if you consider that the best way to tell if the FAE is working is getting a flush, than you might consider it a wished Event and not an AE.

I don't have a clue what you are on about. I'm only giving the information you make of it what you will.  

You don't give the information for nothing.
So I read it. Think about it and if I have a comment I state that.
It's your decision to react again on my comment

[Fred]

It's your decision to react again on my comment

I'm not going to then.

Spoiler

Oh I just did though didn't I.  

[jiml]

It's your decision to react again on my comment

I'm not going to then.

Spoiler

Oh I just did though didn't I.  

[jiml]

I wouldn't regard flushing as an AE however it might be difficult for a young child to cope with .
As Caroline rightly points out flushing is an indication the drug is working