Arcutis Biotherapeutics has published data from the phase 3 open-label extension (OLE) study (INTEGUMENT-OLE) evaluating ZORYVE (roflumilast) in children aged two to five years with mild-to-moderate atopic dermatitis. 

Published in Pediatric Dermatology, the results showed ZORYVE cream 0.05% is safe, well tolerated and had an improving efficacy with up to 56 weeks of treatment. 

Affecting approximately 9.6 million children in the US, atopic dermatitis is the most common type of eczema. 

The more recent data builds on results from the four-week phase 3 INTEGUMENT-PED trial, which established the efficacy and safety of ZORYVE once-daily cream 0.05% in this paediatric population. 

INTEGUMENT-OLE involved participants aged between two and five years old with mild-to-moderate atopic dermatitis who have previously received ZORVYE cream 0.05% or vehicle cream in the INTEGUMENT-PED study. 

During the OLE safety trial, which lasted 52 weeks, all participants received ZORVYE cream once daily.  Children who achieved clear skin after Week 4 moved to a twice-weekly (BIW) regimen, with the published results containing data from both treatment regimens. 

In the OLE study, 49.8% of participants experienced treatment-emergent adverse events (TEAEs), 24.7% of which were mild and 22.2% were moderate. 

Upper respiratory tract infection, nasopharyngitis and pyrexia were the most common TEAEs. A further 4.4% of participants experienced gastrointestinal adverse events, most commonly vomiting and diarrhoea.

Overall, 14 of 562 participants (2.5%) experienced treatment-related AEs, and four participants (0.7%) experienced application site pain. 

Of participants who completed 56 weeks of treatment, 63.1% achieved a vIGA-AD score of Clear or Almost Clear (0 or 1) at Week 56. At Week 56, 71.9% of children who continued treatment with ZORYVE cream 0.05% and 76.0% of children who switched from vehicle to ZORYVE cream 0.05% achieved at least a 75% reduction in the Eczema Area and Severity Index (EASI-75).