Margaret Bobonich, DNP, FNP-C, DCNP, FAANP, and Douglas Di Ruggiero, DMSc, PA-C, provide an overview of current and emerging systemic therapies for atopic dermatitis.
Margaret Bobonich, DNP, FNP-C, DCNP, FAANP: Now let’s talk about some of the systemics that we have available for our patients with moderate to severe atopic dermatitis who don’t respond to those topical therapies.
Douglas DiRuggiero, DMSc, PA-C: Yeah, you know we have medicines that have been used for more than 20 years and we have ones that have come out more recently. I would say that the only medication that is FDA-approved ages six and up for moderate to severe atopic dermatitis is dupilumab. From that standpoint, having it in our hands for the last four years, it has really been a life-changer for a lot of patients. Improvement in skin barrier function, decrease in infection rate, and pretty good improvement overall in clearance and pushing skin towards clear and almost clear. Now there are some side effects that we’ve talked about, and we know how to manage. But I would say that that’s probably considered a first-line treatment for moderate to severe in the systemic world. But prior to dupilumab coming out, we still had cyclosporine, methotrexate, phototherapy, mycophenolate, all these things that have been used but are not FDA-approved for atopic dermatitis. Cyclosporine can be extraordinarily helpful because of how fast it works. The problem with cyclosporine is that you can’t use it greater than 12 months. Some people would even say six. You’ve got to watch renal function, you got to watch blood pressure. And it’s got some side effects. You got to monitor blood work on it every month. Methotrexate can also be beneficial. Again, it can be used longer term than cyclosporine, but it’s got liver potential problems, some other side effects, also requires blood monitoring.
These medications while they may be forced to be used in some regions of the country or insurance agencies that want you to use these traditional DMARDs before you can get onto dupilumab and they also have an advantage of not being a shot but being oral. Despite those things, dupilumab is still considered really the first-line treatment that we have in our hands right now. What I think we can do is probably even move beyond dupilumab and say what’s going to be its competitor. And we’ve got really kind of four really emerging therapies that are going to be available to us probably in 2021 in the next six to 12 months. We have many more beyond four that are on the horizon that are going to be new monoclonal antibodies for treatment of atopic dermatitis and new JAK inhibitors or small molecule non-immunosuppressive, a non-biologic. I’m sorry. They are immunosuppressive molecules that are kind of on the horizon.
Margaret Bobonich, DNP, FNP-C, DCNP, FAANP: And this is really so exciting. Like I mentioned earlier, this decade has been revolutionary. And now that we have dupilumab and knowing how we’re – how great it’s been for my patients, and I say that because of the quality of life. And I can’t even appreciate it but to say when my patient comes into the room for a follow-up visit and they say, you know this has changed my life. And I didn’t even understand how much it impacted my outlook on life. It’s so exciting that with dupilumab and the changes that I’ve seen, the excitement about these new agents coming down the line too because there are patients who may not respond or who may lose efficacy. Looking to these new agents is important Doug.
Douglas DiRuggiero, DMSc, PA-C: It is and I echo that that dupilumab has been kind of a rock star in our world in terms of changing life. But its efficacy is not 100 percent so – and we also know that this is a very complex multi-factorial disease with multiple cytokines or inflammatory molecules involved. So having these options for those patients who do not respond to dupilumab and we don’t want to put on the traditional DMARDs, it’s exciting. You know we do have a new monoclonal antibody coming out. It’s called tralokinumab. And anytime we see that word mab at the end of a molecule it means monoclonal antibody. And you know dupilumab really is able to receptor block the IL-4 and IL-13. And so this tralokinumab focuses only on IL-13. And we’ll have to see. The studies are showing that it’s got IGA or investigative global assessment clearance of clear or almost clear that’s about the same as dupilumab. It’s not coming out and just saying that its head and shoulders above dupilumab in any way, but it’s got maybe a couple of nuances that would make it attractive for folks. It’s still an injection, so same there. It’s dosed 32 weeks just like dupilumab is. But they do have some data that show that you could switch after someone has gone through the first 16 weeks of treatment you could switch them over to a Q4 dosing, Q4 week dosing. And a good handful of those patients, more than 50 percent maintained their clearance on the Q4. It’s got a little bit of a stretching out of its maintenance schedule that may be slightly advantageous. Also still there, a signal for conjunctivitis with this medication but maybe slightly less than dupilumab itself. We see that tralokinumab, which focuses on IL-13 doesn’t hit both 4 and 13 like dupilumab does may have some utility with a similar side effect profile, maybe less conjunctivitis, and maybe some dose maintenance stretching of that shot.
The other one that’s kind of on the horizon too is nemolizumab and that targets IL-31. That is what we consider the itch cytokine. This medicine is going to be really fantastic for pruritus. It’s got extraordinarily good data showing pruritus; not great data on overall improving the EASI score for atopic dermatitis. Its atopic dermatitis or EASI improvement is less than ten percent, around six to eight percent so it kind of pales in comparison to the IL-4s and IL-13s in terms of overall improvement of atopic dermatitis in its appearance and its morphology, but extraordinarily good at reducing itch while the others reduce itch as well. And the only other monoclonal antibody that we’re looking – that we can see on the mountain top there is lebrikizumab, which is in Phase III trials and it’s not yet – the data I have not seen and can’t comment on it. So really the one on the monoclonal antibody side that’s closest to getting in our hands is the IL-13 that is the tralokinumab, not the IL-13 lebrikizumab and the IL-31 nemolizumab, which will be a little further down the road. So outside of that we would move into the new JAKs that are going to come out.
Margaret Bobonich, DNP, FNP-C, DCNP, FAANP: Right. We’ll have to see what happens with those new things coming out. The great thing about dupilumab is that there’s no monitoring the way we do a lot of the biologics for psoriasis.
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Transcript Edited for Clarity