Monoclonal Antibody Toxicity Profile and Patient Impact



Amy Paller, MD: In pediatrics, the most important thing is safety. And we are always happy to give up a little bit in efficacy to trade for that really strong safety. I'm happy to say that in the dupilumab trial, there were no surprises. We found that the safety was the same as what we've seen in all of the other trials. The only issues that came up at all were injection site reactions, in a minority of children. And then the conjunctivitis, which as in the other trials, we did see an increase, but still in a small minority of the children overall, and it did not tend to lead to discontinuations or any particular problems for these children as a whole.

We found that there were fewer infections, and particularly fewer skin infections, as seen in other studies and as one might expect, because you're improving the atopic dermatitis. Really nothing else came up.

We expect that having dupilumab available for 6-to-11-year-olds will have a tremendous impact on the quality of life, not only of the children, but the entire family. Atopic dermatitis presents such a burden. And what we've seen, and I will say anecdotally in these families, is that when they improve, and they often do improve with the dupilumab greatly, they come back, and their lives are changed. The tremendous time burden that is involved with putting on topicals and emollients over large body surface areas and dealing with the issues of discomfort and lack of sleep, it's so disruptive on life.

When one comes back and is markedly improved, so that although topicals are still used, they're used to a much lesser extent, it’s a huge time saver. And that these children are now able to get out and do more socially with their friends and take part in sports that they were unable to do before, because it made them so itchy between the sweat and the increased reddening of the skin, this is tremendously important for family harmony, for psychosocial development, for the ability of these children to concentrate and learn. It's a game changer.

Transcript Edited for Clarity

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