Mark Lebwohl, MD: Let me ask a couple more questions in terms of unmet needs. Women of child-bearing age and pediatric considerations, Leon, tell me about that.
Leon Kircik, MD: I think those are not unmet needs anymore, because we have certolizumab definitely indicated for pregnancy, it doesn’t cross the placenta. And also it can be used by breast-feeding women because they had studies that showed a minimal or negligent amount in the breast milk, so it’s safe to have that.
Then on the pediatric considerations, for a very long time, for one reason or another, the FDA did not approve a psoriasis indication for any of the biologics, even though they had approved for JIA, juvenile idiopathic arthritis. For example, Enbrel [etanercept] was approved all the way down to 2 years of age for JIA, but they did not approve the same drug for patients with psoriasis for one reason or another. Probably they didn’t view psoriasis as such an important thing.
Now it’s approved down to 4 years of age, as far as I remember. I believe Taltz, ixekizumab, recently got approved down to 6 years of age. I believe ustekinumab is approved down to what, 12 years of age?
James Song, MD, FAAD: It recently got approved for 6 years of age.
Leon Kircik, MD: OK. Adalimumab, even though they had the studies, and I’m pretty sure it’s approved in the EU [European Union], in Europe, they didn’t get the approval, or they didn’t seek the approval in the US. To summarize, at least we have 3 approved drugs for pediatric psoriasis, which is excellent, compared to a couple of years ago when we had absolutely none.
Mark Lebwohl, MD: OK. A very good and thorough answer. Secukinumab now has data too in pediatrics, I think.
Leon Kircik, MD: They are doing the studies. It hasn’t been approved yet, but they are doing studies, yes.
Mark Lebwohl, MD: Let me ask one more question, which all of you can think about. But Erin, let me ask you this question. The treatment landscape, we have a very crowded landscape in psoriasis. There are a lot of biologics. How do you see that evolving? Are there any new, exciting developments coming out in the field?
Erin Boh, MD, PhD, FAAD: There are a number of new drugs, and not only just biologics that are injectables, there are a lot of oral agents, small molecular weight agents, that are going to give us a lot more flexibility in the responses. There’s also, of course we mentioned earlier, bimekizumab. There are a lot of new drugs on the landscape.
What I would like to see as a development in the field would be to find a tool that would help the physicians make the best decision as to which drug is good for which patient. Now, whether that’s going to be a blood test, whether it’s going to be looking at gene sequencing to see what is the patient’s particular genetic defect, or mutation. Say, some patients will oversecrete TNF [tumor necrosis factor], but other patients have defects in IL-17 [interleukin-17]. I think it would be useful to know that. You would save a lot of money by not having to do 4 or 5 steps to get to the right drug.
So I would like to have research, and I’ve been trying to submit grants for this all the time, to look at the individual and see what particular genetic defect or permutation is on with that person so that you could tailor the drug to the defect of the individual and not to just comorbidity. And then I think it would make all of these drugs super cost-effective even though individually they’re quite expensive.
Right now, you might go through 3 or 4 drugs to get to the home run, when if we knew the defect or that, we could go straight away to the drug. The second impediment is insurance limitations on what we think is the best drug for the individual. Because I don’t think it’s always the drug with the highest PASI [Psoriasis Area and Severity Index score], I think it’s the individual’s baggage that makes the drug most acceptable. I would like to find that, and that’s a big unmet need, to find out how we can get the defect to correlate with the choice of therapy later.
Mark Lebwohl, MD: Yes, so personalized medicine….
Erin Boh, MD, PhD, FAAD: Very personalized.
Mark Lebwohl, MD: …for psoriasis and psoriatic arthritis would be a blessing. You mentioned bimekizumab, which certainly has very exciting results. There’s another from Serono Merck, I think, which is a bispecific IL-17A/F linked to serum albumin. Their phase 1 data were extraordinary.
Erin Boh, MD, PhD, FAAD: Bimekizumab, what’s so cool about it, it has 1 shot and people are clear for like 7, 8 months before it even starts to come back. That would be, again, cost-effective, if it were priced correctly, that you could even consider dosing not as frequently.
Mark Lebwohl, MD: Right, risankizumab similarly has the long remission. So does tildrakizumab actually. And guselkumab is not bad there either. We have a lot of drugs that give us nice remissions.
In oral therapy, you all know I’m sure about the TYK2 [tyrosine kinase 2] inhibitor coming soon. That should be a real breakthrough because we have a highly effective oral drug that at least so far does not seem to have a lot of the JAK [Janus] kinase inhibitor adverse effects that we’ve learned to be afraid of.
With that I’m going to thank all of you for this wonderful, rich, informative discussion. Before we conclude, I’d like to get final thoughts from each of you. Why don’t we start with you, Leon.
Leon Kircik, MD: Sure. I agree 1000% with what Erin said, that the future of medicine and the future of dermatology is going to be personalized medicine, to find a genetic marker that’s going be incredibly cost-effective for us, for patients, for the insurance companies, for everybody.
Mark Lebwohl, MD: OK, James?
James Song, MD, FAAD: Agreed. I think personalized medicine is the future. We do have some preliminary studies showing that you can predict which patients will response to which biologics. I think that’s really exciting. The topical landscape, I think that we have a couple topical agents, new mechanisms finally, that are going to get approved soon, and I’m looking forward to that as well.
Mark Lebwohl, MD: OK. And Erin, final comments?
Erin Boh, MD, PhD, FAAD: I would like to see many more dermatologists jump on board in prescribing these drugs. I can get it, with the older drugs, there’s a little bit more you have to pay attention to. But with these newer agents, it’s so easy, I think that the days of sending them all patients to the university should be behind us. And dermatologists should embrace these new drugs and realize how easy but effective they are and start using them so that patients will benefit from the drugs as much as the patients who we usually end up treating. But I think all of us as dermatologists could certainly use these drugs very easily and readily. It’s just going to take a couple of extra minutes per patient. And Mark, you mentioned that. You can do this in your office, you just have to have the will to do it. And it’s not a lot of time, it’s about organization and efficiency of that time.
Mark Lebwohl, MD: Yes. I have to say, if you asked this group 10 years ago, we were probably not even treating 20% of the patients with moderate to severe psoriasis with appropriate therapies. That number today is closer to 50%, but it’s still barely 50%. And that means half of the patients out there are not being treated.
Part of that problem is from legislation and the insurance industry. Part of that problem is definitely cost of the drugs. But part of the problem is our colleagues don’t want to put that work into getting the drugs approved for their patients. And we’ve got to encourage our colleagues that they should be doing that.
With that, thank you all for these wonderful presentations; I’m going to thank you again. And to our viewing audience, we hope you found this HCPLive® Peer Exchange discussion to be useful and informative. Thanks a lot.
Transcript Edited for Clarity