Leon Kircik, MD: The other question I have is, do you guys do any baseline depression scale? Because I really think that depression was not related to brodalumab. I think that it’s a disease that causes the depression, not the drug. And I now do this PHQ-9 [Patient Health Questionnaire, depression module]. It’s an easy thing I give them while they’re waiting in the room, to have a baseline for almost all patients with psoriasis. Then I repeat it when they come back in 3 months or 6 months.
Mark Lebwohl, MD: It’s pretty clear that depression, they did institute depression scores in the brodalumab trials; it uniformly improved. It’s a drug that works really well, because as you said, it’s the psoriasis that causes the depression. Their depression scores got much better on average. Whereas, the ones who got placebo, got worse. I think, clearly, if you look at a broad array of patients, the depression was not related to brodalumab. Having said that, I think if we had been in the shoes of the FDA at the time, we probably would have done something similar as this REMS [Risk Evaluation and Mitigation Strategy] program, which is really easy.
I put a patient on brodalumab today. To enroll in the program to be a provider takes 90 seconds, and you’re approved for life. To give it to a patient takes less than a minute. And we have it worked out, and every patient I put on brodalumab knows about the suicides. But here is the story.
There were 4 out of 4000 patients with psoriasis. There were 6 total, but of the patients with psoriasis, here were the 4. One was a guy who was going to jail, and therefore, committed suicide. One was a patient nobody would have called a suicide. It was a drug abuser, alcoholic, who mixed drugs and alcohol, didn’t leave a note, and died. But they called it a suicide because of the emerging cases that were being reported. The third was a guy whose entire income came from disability for psoriasis. He achieved a PASI [Psoriasis Area and Severity Index score of] 100 and they took away his disability, and so he had no source of income.
The fourth one was a guy who you mentioned, James, probably most trials would have excluded him. He was severely depressed. He went on brodalumab. I believe he was on it for almost 3 years. He did great, was thrilled on it. He was actually one of our patients. Then he didn’t come back, and we found out from his family…he had moved where he lived, could not adjust to his new home, and jumped off a roof.
They unfortunately had bad luck with that. There has not been a suicide, I don’t even think there’s been a suicide attempt, since the drug has been on the market. It might be time to revisit that and remove the REMS program. But I think if any of us had been in the shoes of the FDA, the program they put together was actually very reasonable. Unfortunately our colleagues, 1 extra minute of work and they’re not paying attention. It is one of the most effective drugs we’ve ever had.
Erin Boh, MD, PhD, FAAD: I think if patients know this from the get-go. I think the REMS program is great and I agree with you, Mark, brodalumab is very fast, it works really quick. We were in the study, and I’ve used it since. People are happy on that drug. And I have people who have carried diagnoses of depression. I think as long as everybody knows from the get-go, I don’t think you see any higher incidence than you do with any of the other drugs or with any other patients with psoriasis. I do think it limits physicians’ use of it because they get nervous about it. But I think the whole thing is about awareness. If patients know the potential for depression happening, you know it, you can avoid these things and still use the drug. Because I think the drug is one of the fastest ones to work, and I use this when people fail other IL-17s [interleukin-17 inhibitors], especially those who got clear in the beginning with their IL-17, and then they start creeping back with disease. You block the receptor and it’s a home run because all the IL-17 is coming from elsewhere, you’re going to oversaturate your system, and you’ll have too much IL-17. And so, blocking the receptor I think is the way to go. I like to use that drug. I won’t say it’s a salvage drug, but I use it even when they fail other IL-17s, and you’ll get I think a very good response.
Leon Kircik, MD: Well, I think because it also blocks, like elbows, the IL-17C and IL-17F, at the same time because they are receptor blockers.
Erin Boh, MD, PhD, FAAD: It blocks the receptor.
Leon Kircik, MD: It’s the only one that blocks all the other IL-17 cytokines, which is I think helpful, and that’s why we see the great results of the IL-17A and IL-17F combination that’s going to come to the market. I think blocking the IL-17F is a big issue.
But I also like the REMS program because it’s not only easy but also it sort of covers you legally because you told the patient, the patient signed it, you have proof. Versus all others, I don’t take a consent form just because I’m going to start the biologic. So, to have that paperwork it’s almost nice and easy, and it takes 2 minutes.
Transcript Edited for Clarity