Viaskin Milk

QuoteA pilot clinical trial of Viaskin® Milk with the AP-HP

We conducted a double-blind, placebo-controlled pilot clinical trial of Viaskin® Milk with the AP-HP in 2005 in subjects with CMPA.
In this clinical trial, children (age 3 months to 15 years) with high levels of specific IgE were unable to consume more than 10 mL of cow's milk.

In 2010, the final results of this trial were published in The Journal of Allergy and Clinical Immunology. In the trial, at the end of a three-month treatment, the mean cumulative tolerated dose increment was 12-fold in the active group versus 8% in the placebo group.

At the start of the clinical trial, out of the 19 patients included, some patients could not tolerate the equivalent of one drop of milk without having severe reactions. However, after three or six months of treatment, almost half of the Viaskin® Milk treatment group was able to ingest milk in large quantities. In contrast, no patients treated during the first three months with a placebo (patch without active substance) showed meaningful improvement. These same non-responder patients were then treated with Viaskin® Milk and after three or six months of treatment, 80% of them experienced an improvement in their tolerance of milk. There were no serious or unexpected adverse events in the trial nor premature withdrawal from the clinical trial. Although larger studies are needed to confirm the statistical efficacy, the results of the pilot clinical trial provide proof-of-concept for specific immunotherapy via the epicutaneous route for this indication.

AAAAI: Travel Difficult for People with Food Aller

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jw Posted: 03/22/09 at 03:10 pm     

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AAAAI: Travel Difficult for People with Food Allergies
http://www.medpagetoday.com/MeetingCoverage/AAAAI/13276

Patch Helps Allergic Kids Tolerate Milk

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lostone Posted: 03/18/09 at 06:20 am     

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An interesting article - link and text

http://www.medpagetoday.com/MeetingCoverage/AAAAI/13296

AAAAI: Patch Helps Allergic Kids Tolerate Milk

WASHINGTON, March 17 -- Children with dairy allergies were able to tolerate significant quantities of cow's milk after treatment with an investigational dermal patch-based immunotherapy (Viaskin), a researcher said here.

In eight of 13 evaluable children receiving the treatment for three months in a placebo-controlled pilot trial, the maximum amount of milk they were able to tolerate increased at least threefold, reported Christophe Dupont, M.D., Ph.D., of Hopital Saint Vincent de Paul in Paris.

However, Dr. Dupont said, the improvements seen in most participants were enough to prevent them from reacting to foods with trace quantities of milk proteins.

The patch contained 1 mg of milk protein or placebo and was applied every other day to children in the study. Participants were from three months to 15 years of age and underwent oral milk challenges at baseline and after two and three months in the trial.

The mean maximum tolerated milk dose at baseline was 2.1 mL (SD 2.6) and 4.4 mL (SD 5.9) in the active-treatment and placebo groups, respectively.

After three months, the mean tolerated dose tended to increase to 21 mL (SD 24.3) in the active-treatment group compared with 5.4 (SD 5.9) in the placebo group (P=0.37).

But when the summary results were expressed as the median change from baseline, the improvements seen with the active patch were significantly greater than with placebo (5.6 mL versus 0.17 mL, P=0.02).

Skin prick testing also showed substantial reduction in wheal diameters in most of the treated children. Little change was seen in the placebo group.

About half of the children in both groups reported occasional dermatitis or itching at the patch site. Other adverse effects were less common and did not differ between groups.

Patch-based immunotherapy is an attractive approach to treating milk allergy because it is a proven technology, said Dr. Dupont, who is also co-founder of the company developing the product, DBV Technologies.

Subcutaneous immunotherapy is already available for milk allergy. "We thought we could get the same effect just by applying the patch on the skin," he said.

The main advantage is safety, he added. "If you see a reaction, you can remove the patch," he said, whereas subcutaneous injections can't be reversed.

A. Wesley Burks, M.D., a pediatric allergist at Duke University in Durham, N.C., who was not involved with the study, said the milk-allergy patch was a promising approach.

"It's an easy way to stimulate the immune system," he said, although more safety data are needed.

"Topically [delivered. immunotherapy] can be quite sensitizing," Dr. Burks said, and dangerous reactions may not appear immediately.

Consequently, children treated with patches would need close monitoring, he said.

The manufacturer of the patch, DBV Technologies, is also developing a similar patch-based immunotherapy for dust mite allergies.

None of the seven children in the placebo group showed that high an increase in tolerance, he said here at the American Academy of Allergy, Asthma, and Immunology meeting.

He said the improvements seen with the treatment were clinically significant.

"In some of [the. children], you can normalize the diet," he said. One participant in the study was able to tolerate 670 mL (nearly 3 cups) after three months. But that was exceptional, as the median tolerance after three months was less than 6 mL. 

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JanaR Posted: 03/18/09 at 07:43 am       

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I hope there is hope for adults with life-threatening milk allergies, too!
I'm still not sure if the Duke study and this study will benefit those past puberty or not - is there something about children still growing that makes these desensitizations work? My mom pointed out that my dad didn't have his allergy pollen shots until he was an adult so hopefully we don't give up on our adults with food allergies. 

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CMdeux Posted: 03/18/09 at 09:05 am       

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I saw this, too. It is interesting to me that this one works for anyone at all-- for the reason that Burks mentioned.

It has been demonstrated that topical exposure isn't the same as oral exposure from an immunological standpoint...

So I have to wonder if it just plain won't work at all for some people... or if it could potentially even make things WORSE for some... (yikes)

But it sure is interesting.