Clinical update on the treatment of atopic dermatitis: SOLO 1 and SOLO 2 dupilumab Phase 3 data

Clinical update on the treatment of atopic dermatitis: SOLO 1 and SOLO 2 dupilumab Phase 3 data


Hi my name is Ken Gordon, I’m a dermatologist
at Northwestern University. I’d like to talk to you today about a new
medication for atopic dermatitis called dupilumab. Recently in New England Journal of Medicine
there was an article published of two studies of dupilumab for moderate to severe atopic
dermatitis. Now this article has far-reaching implications,
not only for the medication itself but for the understanding of atopic dermatitis. Dupilumab is a medication that blocks one
subunit of the interleukin-4 receptor. This blocks the ability of both interleukin-4
and interleukin-13, to have this pathophysiological effect on atopic dermatitis. What’s important about this study however
is not just so much the physiology suggesting that this medication works for the disease,
but also the implication for understanding how clinical trials are done and the meaning
of clinical trials in atopic dermatitis. Because this is the first of hopefully a number
of new Phase 3 registry development trials for atopic dermatitis with multiple new medications, we don’t quite know how the data will
stack up over time. In reference with psoriasis, in years gone
by when we had early biologics, we didn’t know what a PASI 75 really meant or what we
were able to reach in the future. In this study, with two studies (the SOLO
1 and SOLO 2 study), it was found that dupilumab worked in getting the primary endpoint of
an Investigator Global Assessment (IGA) about 35 to 40% of the time and then IGA
of 0 or 1 which means clear or almost clear. Likewise the EASI scores (which was the primary
second endpoint) reached statistical significance against placebo, at or right about EASI 75,
of anywhere around 50%. What that means however for new development
for atopic dermatitis is unclear. We really don’t know based on comparisons
to other Phase 3 development programs how far we can push that or is this medication
going to be as good as we can get for atopic dermatitis—a very, very important point. A couple of other specifics of the study I
think need to be brought out. First of all there were two dosing periods:
one was dosing at every other week and one was dosing every week for dupilumab. It turns out the two doses seem to behave
about the same, that there seems to be about equal efficacy between the two doses. What’s more, and very importantly, the safety
record of dupilumab for the 16-week trial seems very, very good. There were no signals that would bring out
any concern to me. What that means for long-term therapy for
atopic dermatitis is still unclear. One other point that I think is really important
is how this study was performed. It was a placebo-controlled trial without
concomitant medications. There is some question as to whether atopic
dermatitis trials should allow patients to have topical corticosteroids for example. In this case it was chosen not to have those
concomitant medications which resulted in, I think, a very clean outcome in the clinical
trial results suggesting, I think, that the way this study was done with a true monotherapy
study is probably for the best. So I think the conclusions of the study are
clear: dupilumab does work for atopic dermatitis and improves when in comparison to placebo
in this monotherapy placebo-controlled trial. We don’t know the implications for the long-term
safety but the short-term safety seems quite good. But what’s even more important is we’re going
to have to get a detailed understanding of what is the levels of care and the level of
clearance that we want in atopic dermatitis studies in the future. And this is just the first of the studies
that will hopefully lead us to a better understanding of how we treat the disease. Thank you very much.

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