Clinical factors affecting quality of the response to Stelara for psoriasis

[Fred]

This is an early view before publication and it looks at the Clinical factors affecting quality of the response to Stelara (ustekinumab) for psoriasis.

Quote:

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Ustekinumab has demonstrated efficacy for psoriasis. However, it is known that approximately 30% of patients have shown insufficient response.

The aim of the current study is to clarify the specific clinical factors that could be associated with response to ustekinumab treatment. We reviewed the medical records of all patients who were treated with ustekinumab. The Psoriasis Area and Severity Index (PASI) score was calculated, and the efficacy was evaluated at week 0 and week 16. The relationship between clinical efficacy and the patients’ background was investigated. The patients, who showed a <74% reduction in the PASI score, were classified as insufficient-responders. A total of 74 patients (average 60.3 years old, male to female ratio 54:20) were examined retrospectively. Eighteen patients were identified as insufficient-responders.

Each of the factors, body weight (BW) over 80 kg, body mass index (BMI) over 25, or smoking habit over 20 cigarettes/day showed a higher proportion of insufficient-responders compared with responders, although the difference was not statistically significant. Patients with previous exposure to biologics showed a significantly lower response to the treatment. Furthermore, a statistical difference was identified between patients with none of these factors and patients with some of these factors.

Our data suggest that some factors, such as high BW, high BMI, a smoking habit over 20 cigarettes/day, or exposure previous treatment with biologics are likely to affect the quality of the response to ustekinumab. Therefore, these factors need to be taken into account when ustekinumab is administrated.

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[jiml]

So if I read this right people with with a body weight over 80kg and BMI over 25 are likely in the future to be turned down for the drug if the findings of this study are acted upon by dermatologists
Although it was a small scale study ( just 74patients) it would be interesting to see it expanded upon.
Who funded the study was it the makers who would like to see a better % efficacy, and one way to get it is to restrict the use to perfect specimens.

[Fred]

So if I read this right people with with a body weight over 80kg and BMI over 25 are likely in the future to be turned down for the drug if the findings of this study are acted upon by dermatologists
Although it was a small scale study ( just 74patients) it would be interesting to see it expanded upon.
Who funded the study was it the makers who would like to see a better % efficacy, and one way to get it is to restrict the use to perfect specimens.

It was by Yoshinori Umezawa, Hidehisa Saeki, Hidemi Nakagawa, and will be published in The Journal of Dermatology. Sorry I know no more at the moment.

I'm 100kg and have not been refused it, I have also been offered a double dose as recommended by Stelara for anyone over 100kg but the double dose was to much for me, so I now have one does every 8 weeks instead of the recommended 12 weeks.

I think they are suggesting it may be something to look into before prescribing Stelara.

[jiml]

So if I read this right people with with a body weight over 80kg and BMI over 25 are likely in the future to be turned down for the drug if the findings of this study are acted upon by dermatologists
Although it was a small scale study ( just 74patients) it would be interesting to see it expanded upon.
Who funded the study was it the makers who would like to see a better % efficacy, and one way to get it is to restrict the use to perfect specimens.

It was by Yoshinori Umezawa, Hidehisa Saeki, Hidemi Nakagawa, and will be published in The Journal of Dermatology. Sorry I know no more at the moment.

I'm 100kg and have not been refused it, I have also been offered a double dose as recommended by Stelara for anyone over 100kg but the double dose was to much for me, so I now have one does every 8 weeks instead of the recommended 12 weeks.

I think they are suggesting it may be something to look into before prescribing Stelara.

That's fine as long as they use it to regulate the dose, and not to deny the use by a smoker who's a bit overweight

[Fred]

That's fine as long as they use it to regulate the dose, and not to deny the use by a smoker who's a bit overweight

That's a good point Jim as a lot of people with Psoriasis are overweight, smokers, drinkers, etc. (No Caroline not all ) and it doesn't mean that's why they have psoriasis, it probably means we need a little comfort from having it.

[Bill]

I think it is more about clinicians being able to give better advice to their patients. With good advice you can maximise the effect of any lifestyle changes you choose to make as a patient. A blanket ban on smoking, alcohol, cooked food, meat, fat, sugar, gluten and dairy might appeal to the desperate, but will have lousy compliance and carries nutritional risks.

For the record I supplement with magnesium before exercise (less cramping and more energy), vitamin B daily (stops my fingers going to sleep at night), and zinc a few times a week (a left over from when I was making loads of skin, but good when exercising).

Cheers,

Bill

[mataribot]

"The patients, who showed a <74% reduction in the PASI score, were classified as insufficient-responders." That's just an insanely high tolerance. Fred, I bet you would be considered a insufficient responder. Sounds like someone doesn't want to pay for treatment.

[Caroline]

Quote:

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Each of the factors, body weight (BW) over 80 kg, body mass index (BMI) over 25, or smoking habit over 20 cigarettes/day showed a higher proportion of insufficient-responders compared with responders, although the difference was not statistically significant. Patients with previous exposure to biologics showed a significantly lower response to the treatment. Furthermore, a statistical difference was identified between patients with none of these factors and patients with some of these factors.

If I read it carefully that in above sentence there is a major discrepancy.
It says in the first part that each of the factors showed a difference. But that difference was not statistically significant.
As statistics is already a very wonky type of mathematics, the conclusion of it being not significant is sufficient to admit that there is NO connection.

Then in the same sentence they say. A statistical difference was identified between the ones with none of the factors and with some of the factors.
That is contradictory.
First there is no connection then suddenly it appears to have a connection. So 0 + 0 = 1
And that all around a score of 74%, not 73%, not 75%, no.... 74.

Still I can imagine there is a difference between people who have overweight, drink, smoke and feed the cat, compared to those who don't. But I bet there is the same statistical difference between people who do not have psoriasis.

One investigation down the drain....

[mataribot]

The whole point - they don't want to pay for continuous treatment. The whole new idea is to treat with biologic until clinical remission, pull the treatment and add low dose DMARD to prevent flares. Saves money for some third party. Seriously, it's going to fail before it even starts. Can't force people to take medication, and there isn't any incentive if you're clear.

[Bill]

Nothing illogical. Patients with several risk factors are less likely to respond well to treatment than those with none or one. And with such a small number you need to set the bar high else there is no one to study.

I dont think the health funds will be using this study as ammo, albeit from my <$20 per year unsubsidised drug cost perspective.

Cheers,

Bill