Mark G. Lebwohl, MD, and Alice B. Gottlieb, MD, PhD, discuss gaps in care for the treatment of plaque psoriasis.
Mark G. Lebwohl, MD: As the treatment landscape continues to evolve, what are some of the gaps that remain regarding the care of patients with moderate to severe psoriasis? How do you think these will be and should be addressed in the future?
Alice B. Gottlieb, MD, PhD: There are subgroups of patients for which we have inadequate data. One of them is older adults. We don’t have a lot of data because they’re excluded from clinical trials for a variety of reasons. We don’t have a lot of people of color. We don’t have a lot of data on HIV-positive patients. In my clinic, I see HIV patients quite a bit. There are no data on that. We need more data in pediatrics than we have in real-world data. I’ve already had patients come and say they’re pregnant. The numbers of patients are small who have been pregnant on IL-17 blockers. I’m sure I don’t have all the subgroups, but I’m looking forward to getting patients with preexisting cancers—not just skin cancers but also solid organ. I have a feeling we’re never going to see patients with lymphomas and leukemias because I don’t think anybody is going to do that; they’re too scared.
In all these special populations, the gap remains. This has nothing to do with medicine. It has to do with accessibility. Especially with the Medicare population, which is an underserved population that needs an advocate. Those patients have few biologic choices because they can’t afford it. Accessibility is still a huge issue. We need better drugs in psoriatic arthritis. For all the wonderful progress we’ve made, we’ve never been able to get past the 60% ACR20 [American College of Rheumatology score], which is not the world’s highest hurdle. There seems to be a ceiling, even if it’s part of the outcome measure, but I don’t think it is. Part of the reason is that we already have damage that’s not going to reverse. We still have to make big improvements.
Mark G. Lebwohl, MD: Your answer hit a lot of triggers for me. I’m going to go through what I have listed here. I jotted down 6 items as you were speaking. The first is Medicare. The cost of these drugs is exorbitant. The companies that make them have been incredibly generous about waving co-pays and helping patients with their assistance programs, but you aren’t allowed to use those for Medicare patients.
Alice B. Gottlieb, MD, PhD: Or Medicaid.
Mark G. Lebwohl, MD: Or Medicaid. Although with Medicaid, what happens is Medicaid usually covers the drugs.
Alice B. Gottlieb, MD, PhD: They’ll cover.
Mark G. Lebwohl, MD: With Medicare, you’re in a bind. If you were poorer and on Medicaid, it would be covered. If you were on any insurance other than Medicare, the company would help you do it. They’re not allowed to help you get it if you’re on Medicare, so we need a solution for that almost as badly as we need almost any other solution. The second item you mentioned is people of color. We’re great at getting rid of psoriasis, but that postinflammatory hyperpigmentation that occasionally can last more than a year is still a problem for us. If anyone comes up with a solution for that, it will be very welcome. The third item you mentioned is pediatrics. Etanercept and adalimumab are prudent pediatrics, and so are secukinumab, infliximab…and ustekinumab. Ustekinumab is the only 1 that’s given as infrequently as every 3 months. Among the more effective treatments are the IL-23 blockers, which are given every 2 or 3 months. Coming will hopefully be bimekizumab, which we didn’t talk about. It’s dosed every 4 weeks for the first 16 weeks, but then it’s up to every 4 to 8 weeks. The 8 weeks seems to be as good as 4 weeks. We have a treatment that would be ideal for pediatrics. None of those treatments is approved for pediatrics because kids don’t like needles. We’ve got to get that.
You also mentioned malignancy. We have some data from registries. We have some data recently published on secukinumab looking across all their trials in patients followed for years. The frequency of malignancy was 1% lower than in their control group. It appears that malignancies aren’t an issue for IL-17 blockers. When you see those television ads for the IL-17 and IL-23 blockers, if you listen to the TNF [tumor necrosis factor] blockers, they warn about malignancy. But not for the IL-17 or IL-23 blockers. The word malignant doesn’t appear in the ads. It doesn’t appear in their package inserts. Those appear to be safer vis-à-vis malignancy.
The other items that come to my mind are the good data from registries showing that TNF blockers reduce heart disease in patients with psoriasis. We know psoriasis predisposes to heart disease. Data are beginning to emerge on the IL-17 blockers—secukinumab in particular has done a lot of that work— showing there’s a reduction in atherosclerotic plaque and some other markers for cardiovascular disease. Hopefully, we will see the same reduction in heart disease with IL-17 blockers as has come through in registries for TNF blockers.
Lastly, there are many other comorbidities, including patients with positive tests for TB [tuberculosis]. You might not want to put on a TNF blocker, which we know triggers reactivation of latent TB. Patients with hepatitis B don’t do well with TNF blockade, so if they have hepatitis B surface antigen positivity or even core antibody positivity, a TNF blocker might not be your first choice and an IL-17 or IL-23 blocker might be better. I’ll qualify that by saying that limited studies have shown that if those patients are concomitantly treated with antiviral medications, they do better. They have little reactivation of hepatitis B in those patients.
Alice B. Gottlieb, MD, PhD: I realize that we’re focusing a lot on IL-17 blockers, but for the pregnant patient, certolizumab pegol might be a wonderful choice. It’s a TNF blocker, but because it lacks an FC part—this is shown in an investigator-initiated study, and it’s in the package insert—it doesn’t cross the placenta, so you don’t find it on the baby side of the placenta, so to speak. Also, it’s not found in mother’s milk either. If somebody wants a biologic, what’s the safest drug with respect to the baby? At this point, I’d say it’s certolizumab pegol. Even though the registry data are great for all the other drugs, if the drug doesn’t get there, it’s even safer. That’s one not to be forgotten about.
Transcript edited for clarity