Evaluating Clinical Trial Data for Deucravacitinib in Plaque Psoriasis

Linda Stein Gold, MD: We’ve gotten all the background on why it would make sense to have a targeted TYK2 inhibitor for psoriasis, especially for plaque psoriasis. And we did have 2 large phase 3 clinical trials that looked at the efficacy of patients with moderate to severe plaque psoriasis with deucravacitinib. It was a unique study in that it wasn’t just the active drug versus the placebo, but they had the active control of apremilast. So, when patients then ask us, how does this compare with something we know, we now have those data. Can you explain to us a bit about what did we see with the phase 3 trials?

Bruce Strober, MD, PhD: Right, so as you say the true comparison was not only against the placebo group, but also against apremilast, with the primary end point of PASI 75 [75% improvement in the Psoriasis Area and Severity Index] , IGA 0/1 [Investigator’s Global Assessment 0/1 responder rates] at week 16, comparing deucravacitinib to a placebo group. Deucravacitinib was able to achieve PASI 75, depending on one of those studies, around 55% to 60% of patients, depending on which study you look at. Whereas the placebo group was extraordinarily low in its response, less than 10%. That was the first finding. The second was that deucravacitinib was superior to apremilast. Again, with deucravacitinib hitting a PASI 75, 55% to 60% at week 16. Apremilast was roughly 35% to 40%. So, a significant difference between the 2 drugs and a PASI 75 achievement rate. And more importantly, if you carry out that comparison to 24 weeks, apremilast versus deucravacitinib, the gap widens a bit. With deucravacitinib now it’s upward of 65% to 70% of patients perhaps, that’s the way I roughly estimate it, have PASI 75, and apremilast sticks to the 40% range. There’s no doubt that over 6 months approximately, you’re going to get many more patients to a PASI 75 on deucravacitinib.

Linda Stein Gold, MD: Talk to me for a minute about, with apremilast, we have to do that dose adjusting initially for 2 weeks. With deucravacitinib, how is that dosed in the trials? Did they have to do a dose modification initially, or how did that work?

Bruce Strober, MD, PhD: It’s really simple. There is only 1 dose for deucravacitinib, it’s 6 mg, in 1 pill. When you start the patient, it’s 1 pill a day, and that’s where they’re going to be forever. There’s no dose adjustment based on weight, prior treatment history, gender, age, etc. You give 1 dose for everyone.

Linda Stein Gold, MD: We know a lot of our patients with psoriasis have a number of comorbidities, many of them are on other medications. It can be kind of a challenge trying to figure out what everybody is on. Can you talk to us a bit about the drug-drug interactions we would see with deucravacitinib?

Bruce Strober, MD, PhD: With deucravacitinib, you don’t think about it because there are none. There are no drug-drug interactions. When I’m in a room with a patient and I add another drug, I always have my little app that tells me if I can do this safely by adding all the other drugs the patient is on. I don’t have to do that with deucravacitinib, it’s that simple. Additionally, you don’t have to tell them to take it on an empty stomach or take it with a meal, either is fine.

Linda Stein Gold, MD: That’s nice. It helps to set patients up for success, the limited amount of restrictions we put on them. You talked to us about the plaque psoriasis data, they were statistically better than the vehicle, and statistically better than the apremilast. They did also look at some areas that are more difficult to treat, like the scalp. The scalp is always funny to me because we know if we do a scalp biopsy, for me, I generally hit a vessel. We know it’s very vascular. Penetration into the scalp is great, yet our patients don’t tend to do well on topical therapy. It’s an area, as you mentioned, of special interest, special need. They did look specifically at the scalp in some of these trials.

Bruce Strober, MD, PhD: Right, so not surprisingly, deucravacitinib is a very effective scalp psoriasis therapy, and I’ve used it in many different patients just for that purpose. They just have scalp psoriasis, and they didn’t do well on topicals, or it’s just too extensive. Deucravacitinib is able to reduce what we would call a scalp PASI score by a large percentage, 75% or 80% over the course of 16 weeks, in patients who had significant scalp psoriasis. I would say it’s an excellent first-line drug, systemic, for scalp psoriasis, and that’s how I’m using it.

Linda Stein Gold, MD: Great.

Transcript edited for clarity