Video
Long-Term Data From VOYAGE 1 and VOYAGE 2
Author(s):
Erin Boh, MD, PhD, FAAD, guides the panel in a conversation about the phase 3 and long-term extension data from the VOYAGE 1 and VOYAGE 2 clinical trials of guselkumab in patients with moderate to severe plaque psoriasis.
Brad Glick, DO, MPH: Erin, talk to us a little about the 5-year results from VOYAGE 1 and VOYAGE 2—those are phase 3 trials—and the long-term extension data from guselkumab in patients with moderate to severe plague psoriasis. Give us some of your general thoughts.
Erin Boh, MD, PhD, FAAD: Sure. With guselkumab, they did the VOYAGE 1 and VOYAGE 2 trials. One of the studies was biologic naïve. The other had patients with biologic experience. The comparator drug in this study was adalimumab. Initially, patients were in 3 groups. At the end of week 16, I like to look at these drugs to think about efficacy or time, onset of response, durability, and maintenance of response. Early on, like with the other IL-23s, we saw a very fast response with the guselkumab. In fact, some people were responding as early as week 1 to 2. Efficacy was incredible: 90% of patients achieved a PASI [Psoriasis Area and Severity Index] 75 at week 16, and 73% achieved a PASI 90 at week 16. It was very efficacious, but we want to think about the long term, or maintenance of response. We saw that, over time, patients on IL-23—patients who achieved a PASI 90 maintained that response through 5 years. Following patients out 5 years, patients still maintained their response. That’s very good to know. Even patients who had a PASI 100 in the beginning—at week 16, PASI 100 was close to 50%—patients by 4 years, if you achieved a PASI 100, most people maintained that response.
These were very durable responses throughout the 5-years maintenance of response. Efficacy was maintained, but safety was as well. There were no red flags that occurred throughout the 5 years of following patients. Overall, when you look at the drug, it’s like others in this class. It’s very efficacious and very fast in onset; skin clears quickly. That’s very important for patients who have severe disease or who are depressed because they’ve had psoriasis for a very long time, and they want to know it’s safe. We have 5 years of data that show that these are very safe drugs that are very durable in their response and maintained their response. As I tell everyone, though, this doesn’t mean you won’t have a flare of your psoriasis. You may flare, but you can recapture that response at times. Early on, part of the VOYAGE studies did look at recaptured data, and they saw that when you got off-drug you could recapture that response in nearly 80% of patients if they had a response to start with. That’s very comforting in terms of when you’re looking at a choice between methotrexate or even some of the older biologics. These drugs, as a class, and these data from VOYAGE 1 and 2 show that there’s a very efficacious, durable response; these drugs maintain that response. No safety signals popped up through 5 years of treatment.
Brad Glick, DO, MPH: In my experience, I’ve seen much the same. We just talked about tildrakizumab and guselkumab. They’re very similar—even risankizumab, in terms of durability of response and onset of action, is similar. Maybe it’s not to the same extent or speed that we see with 17 blockers, but this is still very formidable and keeping with the theme that it’s a marathon, not a sprint. It’s nice to see that we’ve rapid onset of action, but you get that long-term durability of response and then no safety signal.
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Transcript edited for clarity.
