SPROUT Trial Highlights Benefits of Apremilast for Pediatric Psoriasis

Shauna Jardon, PharmD, Amgen’s US medical lead for Otezla, spoke with Dermatology Times on the efficacy, safety, and future of apremilast.

TRANSCRIPT

Shauna Jardon: My name is Shauna Jardon, and I am the US medical lead for Otezla.

Dermatology Times: What are the key takeaways from the SPROUT trial?

Jardon: The key takeaways that were most important to us is finding out that we have an oral option for these burdened pediatric patients and finding out that Otezla is a safe and effective systemic therapy for pediatric patients ages 6 to 17 years old. We saw statistically significant, and perhaps more importantly, clinically relevant improvements in the pediatric patients, inclusive of their plaques, of their itch, of their high impact areas, which are just as burdensome for pediatric patients as we know they are for adults. When we think about the cumulative life course impairment that goes on with psoriasis, when we think about kids growing up and dealing with a skin forward disease such as psoriasis, having an oral option is incredibly important, and we're proud. Amgen is proud to bring that forward for these patients.In the current treatment milieu out there for pediatric psoriasis, what we know through much research that's been done with this patient population is that it's not just burdensome for the pediatric patients, but as well, for caregivers. If you think about the application of topical therapies and the time that that takes, and then if we think about injectable therapies and the needle phobia that can come along with that, as well as laboratory monitoring.With Otezla being oral, with no need for laboratory monitoring, and having you know the safety and efficacy that goes along with it, I think that we're just happy to be able to bring that to the pediatric population.

DT: Were there any differences in the safety profile of apremilast when comparing adult and pediatric populations?

Jardon: Speaking from an Otezla point of view, what we found is that it is remarkably similar. In terms of there being any new safety signals, that was not seen.Children are resilient, and so something that is a little different than what we have seen in our adult population with apremilast is some of the GI adverse effects that can be experienced in the beginning of use, perhaps over the first 1 to 2 weeks. What we saw was diarrhea and abdominal pain for over 70% of the pediatric population attenuated over the first 72 hours. I think it's just a real call out to the resilience that we see in children. And, we had 21 pediatric patients in this trial that received immunizations. When you think about systemic therapy and immunizations, what we saw was no safety signals there as well. There were no, just like our adult population, restraints around patients receiving immunizations. These pediatric patients went ahead with immunizations, and in fact, COVID-19 vaccines, and we saw no safety issues with that as well. It's nice to have that background knowledge when we think about children being in any sort of stage for receiving immunizations.

DT: Can you speak to the long-term efficacy of apremilast?

Jardon: If we think about from that first 16-week data out to the 52-week, we continue to see an increase in efficacy and the maintenance of effect that was important to see, and the safety profile held.That's the important piece. We presented that 1-year data at AAD (American Academy of Dermatology meeting), and we are working on presenting unpublished 2-year data that's going to be coming up.

DT: What are the next steps in your team’s research?

Jardon: We look forward to bringing that data forward, because we're always concerned as children are growing. Safety is king when we think about the pediatric population.As we follow along the lines of research that we have done in the adult population with psoriasis and psoriatic disease, we will also be looking at any sort of important metabolic improvements that might be possible in the pediatric population. We've done a body of research in that for adult patients of improving cardiometabolic parameters, and we look forward to also looking at that as well in the pediatric population. We know that the psoriatic population is burdened with these metabolic changes. So, that will be another area of interest that we have certainly asked about. It's a known positive quality to Otezla in the adult population and we look forward to interrogating that in the pediatric population as well.

DT: How do you envision apremilast impacting the overall treatment of psoriasis?

Jardon: I think what was nice and comforting was the parallels that we could draw between the adult population and the pediatric population. Two things, first, seeing that continuous safety in the patient population is a boon for adults that are hesitant to begin systemic therapy. There could be a positive vote of confidence for adults that may have been on the fence when they think about starting systemic therapy, that could help their disease trajectory as well. And second, when you think about cumulative life course impairment for psoriatic patients and the earlier that an intervention can be made, we feel very encouraged that we would be able to help this population earlier and ameliorate all of the problems that can go along with having a chronic, systemic inflammatory disease. We look forward to the earlier intervention, really bringing about a change in disease trajectory and quality of life impairment.We also have trials underway in pediatric psoriatic arthritis. We have that indication for adults. We now have it in psoriasis. And we are hopeful that we will expand into an indication there as well.We really want to make sure that we're helping as many pediatric patients with this new body of research as possible. For all the reasons that we've mentioned before.

[Transcript has been edited for clarity.]