FAQ – Zoryve (roflumilast foam 0.3% or cream 0.15%)

What is Zoryve?

Zoryve (roflumilast) is a topical treatment approved by the FDA for seborrheic dermatitis and atopic dermatitis. It is available as a foam (roflumilast 0.3%) for treatment of seborrheic dermatitis and as a cream (roflumilast 0.15%) for atopic dermatitis.

Zoryve foam is FDA-approved for the treatment of seborrheic dermatitis in adults and children ages 9 and older. Zoryve cream is FDA-approved for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 and older.

Together, you and your healthcare provider can determine if Zoryve is an appropriate treatment option.

How does Zoryve work?

Zoryve is not a topical steroid. Zoryve inhibits the enzyme phosphodiesterase-4 (PDE4), which is involved in the production of pro-inflammatory mediators. This action reduces inflammation in dermatological conditions.

How do you use Zoryve?

Zoryve is applied as a thin film once daily to the affected areas of skin. For Zoryve foam this should be done when skin is not wet.

How effective is Zoryve foam for seborrheic dermatitis?

In the Phase 2 (Trial 203) and STRATUM Phase 3 clinical trials for Zoryve foam, after 8 weeks of continuous use¹:

79.5% (STRATUM) and 73.1% (Trial 203) of individuals treated with Zoryve foam achieved the primary endpoint Investigator Global Assessment (IGA) of 0-1 (clear or almost clear) with at least a 2-grade improvement from the start of the trial compared to 58% (Trial 203) and 40.8% (STRATUM) of those not treated with Zoryve foam.
In the STRATUM trial, 50.6% of individuals treated with Zoryve reached complete clearance (IGA=0) at Week 8.
Investigator Global Assessment (IGA) is a 5-point scale that provides a global clinical assessment of atopic dermatitis by the investigator, based on signs and symptoms.

Secondary endpoints in these trials after 8 weeks of continuous use of Zoryve foam included itch, scaling, and erythema (redness)¹:

More than 60% of individuals achieved a ≥4-point reduction in itch at Week 8 (62.8% with Zoryve vs 40.6% vehicle).
More than 50% of individuals treated with Zoryve achieved an erythema score of 0 at week 8.
More than 50% of individuals treated with Zoryve achieved a scaling score of 0 at week 8.

How effective is Zoryve cream for atopic dermatitis?

For adults and children age 6 and older with mild to moderate atopic dermatitis, results from two Phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2) indicate that after 4 weeks of once-daily use²:

32.0% and 28.9% treated with Zoryve cream achieved the primary endpoint of IGA Success (defined as a vIGA (validated Investigator Global Assessment) score of 0 (clear) or 1 (almost clear) plus a 2-grade improvement from baseline at Week 4 compared to 15.2% and 12% of those treated with the vehicle.
- In both studies approximately 40% of children and adults treated with Zoryve cream achieved a vIGA-AD score of 0-1 (Clear or Almost Clear) at Week 4 with significant improvement as early as Week 1.
33.6% and 30.2% treated with Zoryve cream achieved at least a 4-point itch reduction on the WI-NRS 0-10 scale (worst itch numeric rating scale) compared to 20.7% and 12.4% of those treated with the vehicle.
- Statistically significant Improvement in itch was observed within 24 hours of the first application.

Pooled analysis from these two Phase 3 trials also indicates that after 4 weeks of once-daily use^3-4

69.2% treated with Zoryve cream achieved a 50% reduction in EASI (eczema area and severity index) score (EASI-50) compared to 44.4% of those treated with the vehicle.
- 44.5% achieved EASI-75 (21.2% vehicle)
- 22.4% achieved EASI-90 (8.6% vehicle)
- 9.8 % achieved EASI-100 (4.8% vehicle)
For clinical trial participants who achieved an Investigator Global Assessment (IGA) of 0 (clear), switching to twice-weekly application resulted in maintenance of disease control (IGA 0-1; clear/almost clear) for a median of 281 days.

What are the side effects of Zoryve?

In Phase 2 and 3 clinical trials for Zoryve foam, the most common side effects (over 1%) were nasopharyngitis (1.5%), nausea (1.3%) and headache (1.1%).¹

In Phase 3 clinical trials for Zoryve cream, the most common side effects were headache (2.9%), application site pain (1.5%), diarrhea (1.5%) and vomiting (1.5%).

The full prescribing information for Zoryve foam can be found here and Zoryve cream here.

How is Zoryve different from topical corticosteroids (TCS)?

Topical corticosteroids work to reduce inflammation in the skin by preventing cells from producing inflammation-causing chemicals that are released in response to a variety of different triggers. Zoryve reduces inflammation by more specifically inhibiting a specific enzyme called PDE4 that contributes to skin inflammation. And because Zoryve is not a TCS, it is able to be used over a longer period of time and anywhere on the body, including areas where TCS use is not preferred.

How long do I have to use Zoryve?

In clinical trials, the duration of use for Zoryve was 8 weeks (seborrheic dermatitis) or 4 weeks (atopic dermatitis) with further study out to 56 weeks in an open-label extension trial.^1-3

Together, you and your healthcare provider can determine what is the most appropriate treatment approach with Zoryve, including overall duration of use.

Can children use Zoryve?

Yes. Zoryve foam is FDA-approved for children ages 9 years and older, and Zoryve cream is FDA-approved for children ages 6 and older. Zoryve cream is additionally being studied in clinical trials for children ages 2-5.⁵

How much does Zoryve cost?

Cost depends on your health insurance coverage for prescriptions. Arcutis, the company that makes Zoryve, has programs to help with your copay costs if needed. You can find more information at Arcutis Cares or call 855.600.3755, Monday through Friday, from 8 a.m. to 8 p.m. ET.

How do I know if Zoryve is right for me?

It’s important to talk to your doctor about how seborrheic dermatitis and/or atopic dermatitis affects your skin and other aspects of your life. Together, you and your healthcare provider can determine if Zoryve is an appropriate treatment option.

How can I get Zoryve?

Zoryve is available by prescription only. Talk to your health care provider and visit Zoryve.com to learn more.

Can I use Zoryve with other prescription therapies for seborrheic dermatitis or atopic dermatitis?

Talk to your health care provider about using Zoryve with other prescriptions and over the counter therapies for seborrheic dermatitis or atopic dermatitis. Be sure your doctor knows all medications you are using for these forms of eczema as well as other medical conditions.

References