Availability of Apremilast in US for Pediatric Patients Opens Avenues for Expanded Treatment Options and Oral Therapy

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Amgen Inc recently announced that apremilast (Otezla) is now available in the US for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis.¹ Children and adolescents are considered candidates for apremilast at a weight of at least 20 kg (44 pounds) and must also be candidates for phototherapy or systemic therapy.

The market availability comes 4 months after the drug was approved by the US Food and Drug Administration for this indication in April.² Apremilast is now the first and only oral agent for psoriasis approved in the US for young patients.

Dermatology Times recently spoke with Leah Howard, JD, president and CEO of the National Psoriasis Foundation (NPF); and Trisha, the mother of a 10-year-old girl with plaque psoriasis; to discuss the implications of the approval and subsequent availability for young patients affected by psoriatic disease.

The Significance of New Treatment Approaches

"At the National Psoriasis Foundation, we celebrate every time a new treatment option becomes available for the psoriatic disease community," Howard said. "We are grateful every time a company invests in the research needed to bring forward those new options."

Howard highlighted the importance of pediatric-specific research, explaining, “We know that children are not little adults... the physiology that they have requires that treatments that may exist for adults be thoroughly tested to assure that those medications perform to the level they need to be approved for children.”

This distinction is crucial as it ensures that treatments are not only safe but also effective for younger patients.

"We’re really just celebrating this option for children and their families... It’s an exciting time in pediatric psoriasis, and this new approval is a part of that," she said.

The Personal Impacts of PsO

For Trisha and her daughter Joee, who has been living with psoriasis, the availability of new treatments is particularly significant.

Reflecting on the challenges they faced, Trisha shared, "When Joee was first diagnosed, it was extremely hard to get answers, number 1; and then number 2, trying to find the right therapy."

The difficulties extended beyond finding an effective treatment; they included managing the emotional and social impact of the disease.

"Just dealing with the day-to-day stress of the actual itchiness, and trying to help her through all of that, from trying to figure out cold rags or what what helped best, down to friends at school and what they were saying... that was the most stressful part," she said.

The Role of Advocacy and Policy

The role of patient advocacy organizations like the NPF is crucial in bridging the gap between research and patient care.

"We have the unique ability to really put a spotlight on the challenges of the psoriatic disease community overall, and then individual subpopulations of that community," Howard noted. This involves not only advocating for research but also ensuring that new treatments are accessible and effective for all patients.

Howard highlighted ongoing efforts to improve access to care through legislative and policy initiatives.

"A big part of our work has been really trying to raise awareness about the fact that approvals don’t always translate into great access," she said.

The NPF’s new 5-year strategic plan emphasizes the need for improved access, especially for underserved populations like children.

Accommodating Treatment Preferences

From Trisha’s perspective, the advent of oral medications like apremilast represents a significant improvement over previous treatments.

"When you're having to take a shot every week or every 2 weeks or every month, I think an oral would be a lot way easier than having to try to say, 'Here, let’s stick you every single week or every month,'" she said.

This preference for oral medication underscores the broader impact of new treatments on quality of life. Trisha emphasized the practical benefits: "That is a huge benefit," highlighting the reduced burden of frequent injections.

Advice for Families and Clinicians

Howard advised clinicians to remain engaged with patient advocacy organizations and utilize available resources.

"As I talk to clinicians, I think one of the things that I just really hear often is still how little that is understood... the complexity of living with psoriasis and psoriatic arthritis alongside other conditions," she said.

She encouraged clinicians to leverage resources provided by organizations like the NPF, which offer guidelines and tools for managing comorbidities.

Trisha offered practical advice for other parents whose children are navigating psoriasis.

"There’s so many different methods that you can go to. You have to find the right one that's best for you and your family and the child," Trisha said.

She stressed the importance of working closely with dermatologists and considering the child’s perspective while making treatment decisions: "Work with your dermatologist... and get your child's opinion, but also, you have to do what's right by the child."

Finding Hope and Support

Both Howard and Trisha emphasized the importance of hope and support in managing psoriasis. Howard’s enthusiasm for new treatments reflects the optimism within the psoriatic disease community. "It’s an exciting time in pediatric psoriasis," she said.

Trisha and Joee's stories are a testament to the resilience of families dealing with chronic skin conditions. Despite the challenges, “There is hope out there... once you start researching things and you get the right diagnosis, it just makes all the difference in the world," Trisha said.

References

1. Otezla (apremilast) now available in the US for moderate to severe pediatric plaque psoriasis. Amgen. August 20, 2024. Accessed September 6, 2024. https://investors.amgen.com/news-releases/news-release-details/otezlar-apremilast-now-available-us-moderate-severe-pediatric
2. FDA approves Otezla (apremilast) for the treatment of pediatric patients 6 years of age and older with moderate to severe plaque psoriasis. News release. Drugs.com. April 25, 2024. Accessed September 6, 2024. https://www.drugs.com/newdrugs/fda-approves-otezla-apremilast-pediatric-patients-6-years-age-older-moderate-severe-plaque-psoriasis-6289.html#:~:text=Optum%20RX%3A%20April%2025%2C%202024,for%20phototherapy%20or%20systemic%20therapy