James Q. Del Rosso, DO, reviews the FDA approval expanding the indication for roflumilast cream 0.3% to children as young as age 2 with plaque psoriasis and discusses the clinical implications for pediatric care.

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application expanding the indication for ZORYVE (roflumilast) cream 0.3% to include the topical treatment of plaque psoriasis, including intertriginous areas, in children as young as 2 years of age. With this approval, roflumilast cream 0.3% becomes the first once-daily, steroid-free topical therapy approved for plaque psoriasis in patients beginning at age 2.

The expanded indication addresses an important treatment gap for young children, a population for whom FDA-approved topical options have historically been limited.

Expanding treatment options for young children with plaque psoriasis

Although pediatric plaque psoriasis is less common in very young children than atopic dermatitis, disease onset during early childhood is well recognized. Approximately 70% of pediatric psoriasis cases present as plaque psoriasis.

Beyond its cutaneous manifestations, pediatric psoriasis has also been associated with an increased risk of systemic comorbidities compared with children without psoriasis.

Topical corticosteroids have remained a primary treatment option for many children despite well-recognized concerns regarding prolonged use, particularly in younger patients who may require repeated or ongoing treatment.

Data supporting the expanded indication

The approval is supported by data from a Maximal Usage Systemic Exposure (MUSE) study evaluating roflumilast cream 0.3% in children aged 2 to 5 years with plaque psoriasis.

The study demonstrated safety and efficacy findings that were generally consistent with those observed in pivotal Phase 3 studies in adolescents and adult.

The most common adverse reactions (≥1%) reported with roflumilast cream 0.3% for plaque psoriasis were:

• Diarrhea (3.1%)  

• Headache (2.4%)  

• Insomnia (1.4%)  

• Nausea (1.2%)  

• Application-site pain (1.0%)  

• Upper respiratory tract infection (1.0%)  

• Urinary tract infection (1.0%)  

Why the psoriasis indication uses the 0.3% formulation

The expanded psoriasis indication differs from pediatric atopic dermatitis, where children ages 6 and older receive the lower-strength 0.15% formulation and children ages 2 to 5 receive the 0.05% formulation.

As Dr Del Rosso explains, this distinction reflects differences in disease biology; in atopic dermatitis, younger children often have substantially impaired skin barrier function and more extensive body surface area involvement, both of which can increase systemic exposure. Lowering the concentration for younger pediatric patients was therefore appropriate.

Plaque psoriasis presents a different clinical scenario. Although the skin barrier is altered within psoriatic plaques, it is not characterized by the same degree of diffuse barrier dysfunction seen in atopic dermatitis. In addition, children enrolled in the psoriasis MUSE study had a mean treated body surface area of just under 10%, considerably lower than that typically observed in pediatric atopic dermatitis studies.

Taken together, the pharmacokinetic, efficacy, and safety findings supported use of the existing 0.3% formulation in children with plaque psoriasis down to age 2.

Clinical perspective

In the accompanying video, Dr Del Rosso discusses why this approval represents more than simply lowering the approved age range.

He highlights the longstanding challenge of managing psoriasis in children younger than 6 years, where clinicians have often relied on topical corticosteroids despite concerns surrounding repeated or prolonged use. The availability of a once-daily, steroid-free topical option expands opportunities to reduce corticosteroid exposure while providing an FDA-approved therapy specifically studied in this young patient population.

Key takeaways

• The FDA expanded the indication for roflumilast cream 0.3% to include children as young as 2 years with plaque psoriasis, including intertriginous areas

• Roflumilast cream 0.3% is the first once-daily, steroid-free topical therapy approved for plaque psoriasis in patients beginning at age 2

• Approval was supported by a MUSE study demonstrating safety, efficacy, and pharmacokinetic findings consistent with those observed in adolescents and adults

• Unlike pediatric atopic dermatitis, pediatric plaque psoriasis continues to use the 0.3% formulation because systemic exposure and barrier characteristics differ between the diseases

• The expanded indication provides clinicians with a nonsteroidal option for young children, potentially reducing reliance on prolonged topical corticosteroid use