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Research in Focus_BREEZE-AD7_Video module

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Dear colleagues, my name is Professor Kristian Reich. I work as a dermatologist in Hamburg and Berlin, Germany, but today I sit in Madrid where we have the 28th EADV, and I’m just coming out of the late breaking session where I had the honor to present the 16-week data from the BREEZE-AD7 Phase 3 study. This study tested 2- and 4-mg daily of baricitinib, the JAK1/JAK2 inhibitor, in combination with topical therapy, mostly topical corticosteroids, and compared to placebo plus topical therapy. Why do I think this is so relevant? The way we use dupilumab, the way we will use the JAK inhibitors in our daily practice is in combination with topical therapy. Mean EASI at baseline 30, mean SCORAD higher than 60. A lot of patients had sleeping problems, many patients reported terrible itch, almost all patients reported significant impairment of their everyday life, so a really severely affected patient population to start with. First important finding when we look at the level of patients that achieved clear or almost clear skin, that was the primary endpoint, at Week 16, in the 4-mg group and statistically significant compared to placebo + topical corticosteroids, 3 out of 10, so 30% plus achieved this very high level of response. 2-mg was also significant when we look at nominal p-values until Week 8, did not reach statistical significance at Week 16. EASI75, so at least 75% improvement of this very high baseline EASI that I talked about was achieved in approximately 40% plus patients in the 4-mg arm. Actually, even more important from me, if you think about your patients in your daily practice, what do they really suffer from? They suffer from pruritus, they suffer from skin pain, they suffer from the fact that these skin symptoms lead to sleeping problems. So how did baricitinib impact these major symptoms related to atopic dermatitis? Interestingly and importantly, quite dramatic reductions of itch, quite dramatic reductions of skin pain, already seen after Week 1, after Week 2, and already plateauing from Week 4 on. When we measure sleeping problems, we saw that there was an early improvement again happening in the first 1, 2, 3, 4 weeks of the sleeping problems. To a degree, that in the 4-mg dose group, over the 16-week period patients would say: ‘more than 60% of my nights I could sleep through, I no longer woke up’. I think this is extremely important, from 4% at baseline to 60% after 16 weeks of therapy. The DLQI of 0 or 1 means the patient is no longer impacted by the skin disease in their daily life. So that is an extremely high level. In this BREEZE-AD7 study after 16 weeks of therapy, more than 20% of the patients said: ‘I’m no longer bothered by my disease’, if they had received baricitinib 4-mg daily. So to summarize this efficacy part, a good, a solid and early reduction of the skin signs and for me, in my eyes even more pronounced, even higher improvement of the major skin symptoms. Key question of course, what is the safety profile? On average we saw in 50% of the patients receiving baricitinib any treatment emerging adverse event; we saw the same percentage in the AD1 and AD2 trials these are the large trials looking at baricitinib monotherapy. There was no difference across the groups when we look at serious adverse events. I think this is very important. There were two cases in the 2-mg group that develop more than 600,000 thrombocytes/μL, but I think an otherwise very clean profile when it comes to these laboratory parameters. I should finish by saying that we measured in this study the use of topical corticosteroids. There was a dose-dependent decrease so, again this is exactly what I would hope and expect in my daily practice, that I start by the combination therapy, but that with time, and as much as baricitinib improves the skin condition, my patients need to use less and less topical corticosteroids, and this is exactly what this study showed. So, I’m excited! In combination with topical corticosteroids, these drugs give my patients a very solid improvement of their main clinical signs, and even more pronounced improvement of their main symptoms. Dupilumab is a fantastic drug, but in my daily practice I have a considerable number of patients where I do not reach a satisfying response, so we need clearly, we need more drugs and I think baricitinib will be a very interesting option.

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Duration: 5 minutes and 38 seconds
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Language: English
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Posted by: gabriella61 on Dec 15, 2021

Research in Focus_BREEZE-AD7_Video module

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