Q&A: Amy McMichael, MD, Discusses 48-Week VISIBLE Study Results on Psoriasis in Patients With Skin of Color

The VISIBLE study, focused on patients with skin of color and moderate to severe plaque and scalp psoriasis, has shown strong results with guselkumab (Tremfya) at week 48. Presented at the 2024 Skin of Color Update, the study demonstrated significant skin clearance, with more than 70% of participants achieving clear or minimal disease and over half reaching complete clearance.

VISIBLE exceeded expectations, enrolling participants 7 times faster than planned and maintaining a retention rate of over 90%. The study also plans to release a photographic library to assist providers in better recognizing psoriasis across all skin tones.

Read more from Dermatology Times.

Dermatology Times recently spoke with Amy McMichael, MD, a professor of dermatology and former chair at Wake Forest University, to discuss the study's clinical significance. McMichael is also a member of the VISIBLE Steering Committee.

Amy McMichael, MD | Image Credit: © Wake Forest University School of Medicine

Q&A

Q: The VISIBLE study enrolled participants 7 times faster than expected. What specific recruitment strategies contributed to this success, especially among patients with skin of color, and what measures were taken to enhance participant retention?

A: I think one of the big factors was that Janssen actually listened to the leaders in the field. That's not always happening when clinical trials are designed, and that's not just in dermatology—that's across medicine in general. I think that when we met initially just to talk about this idea and hash out how the trial was going to go, they listened to us and said, "Okay, what do you think is going to work?" We said, "We think that it's going to work better if you get to the providers that actually take care of these patients." It's great if you have great sites that can get a lot of psoriasis patients in quickly, but if they don't have the patients that you want, it's going to take forever to get someone in the trial. I think that was the first step.

Then I think once the people were chosen, they actually committed to training new investigators and pairing them with more seasoned investigators to get them off the ground. It was intentionally designed with patient inclusivity in mind, and a selection of sites and investigators from diverse communities was part of the structure, and that's exactly what I'm talking about. The leaders, the folks who are planning the trial, said, "Okay, where do we go to get these patients?" They asked the the leaders in dermatology: Where? We told them where, and that's where they went, and then they made sure that those people were armed with everything they needed to actually run a reasonable trial. I think that's really what it was. I think there was also just an excitement around the idea of the trial that was for all skin of color patients. There were a lot of factors that played a role.

The study did provide for people to get car service to their site, and also to do dosing at home, and also to have translation of materials into 8 different languages so that caregivers could accompany participants for any translation needs. That was another reason why we could get people in, because we didn't have to worry about whether or not we were using English as the only language for the study.

Q: The week 48 data demonstrates durable skin clearance in patients with moderate to severe plaque and scalp psoriasis. Can you elaborate on the clinical significance of these findings for long-term disease management?

A: I think it was one of those things that was assumed, that people with skin of color would would respond in the same way that people of Caucasian race and non-Hispanic ethnicity would, but that wasn't clear. We thought, "Okay, this seems like a good drug. Is that the truth for everyone?" I think that this trial has allowed us to actually say: This drug works for psoriasis, both scalp and body, in patients with skin of color, and the reason why that's important is because, particularly in people who self-identify as Black or African American, it's known that their psoriasis tends to be more hypertrophic, thicker, causing much more hypertrophy of the skin, which makes it harder to treat and takes longer to go away with most therapies.

What we saw in this trial is that every person in the rainbow, this skin of color trial, actually responded; every person. The trial showed significant improvement in every skin type, so I think that's where we really win with the outcomes. We know that this is not just a one off on people who have fair skin, but that it actually treats this psoriasis in everybody of every color.

Q: Post-inflammatory pigmentation is a key concern in patients with skin of color. How do the results from the VISIBLE study address this issue?

A: I think the main thing that was done, and this was also something that was in discussion with the leaders, was to make sure that the compendium of photographs was expanded so that we had really excellent photography for these skin types, which is not always easy, and to do it over the time frame of the entire study to get to see not just the beginning and the end but what happens all throughout the study. I think that while not everything has been evaluated in terms of post inflammatory hyperpigmentation, we now have this huge library of photos that's going to be used for, I don't even know how many different uses, over the next probably 20 years, to understand how pigmentation is affected by treatment.

Q: How can dermatologists ensure that patients with skin of color are adequately represented in future studies, particularly for chronic skin conditions like psoriasis?

A: I think dermatologists and patients, the stakeholders in this, have to demand that people with skin of color are included in trials, because that's really the only thing that's going to do it. As you probably know, the NIH and other organizations have mandated this for years, and it just doesn't happen. I think that if investigators demand that patients of color are included, and that they're given the things, the tools, that they need to actually recruit these patients before they start the trial, it's going to happen. But we all have to band together to do that.

If you have these sites that just care about, "We'll get paid to do it," and the companies just go to them to do fast recruitment, then we will never get this kind of data. Or if we go to another country, for instance, to do these trials where maybe there aren't as many patients with skin of color, because it's a less expensive venture, we're going to lose out. We're not going to be able to apply this data to our population here in the US, because by 2050, 2060, we know that we're going to be a majority minority country, and a majority of those people are going to have skin of color. I think we have to demand it. We have to recognize it as a reality in our future, and I think dermatologists, both with patients, are going to have to put their foot down and just do it. This is an example of how it can actually work better than a typical trial where you don't have skin of color patients. I think that was really the message.

Q: What else would you like to share with dermatology clinicians?

A: I think for the clinician who's not doing the trial, they're not the person that's thinking about, "How is this patient getting to and from the trial?" There's lots of things, lots of moving parts and trials, that if you just go to work every day and take care of patients, you may not have to think about. For those people, I think what they need to do is start to increase their knowledge base by paying attention to this trial and looking for these types of data in other trials, and they'll take better care of their patients. There are still dermatologists out there that say, "Well, people with skin of color don't really do well on biologics." They still believe that. I think we have to get the message out to every practitioner, whether it's a board-certified dermatologist, or potentially an extender, an APP, these drugs can work. We just have to get them in the trials to show that people with skin of color do actually respond. I think that that message needs to go out, and I think that's what the everyday practitioner needs to know.