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Topical roflumilast beneficial in atopic dermatitis

Presented By
Prof. Lawrence Eichenfield, University of California San Diego, CA, USA
AAD 2023

Early itch reduction in patients with atopic dermatitis (AD) was observed as soon as 1 day after the application of roflumilast cream. The primary endpoint of a validated Investigator’s Global Assessment (vIGA) of 0/1 was achieved by around 30%.

In 2022, the FDA approved the phosphodiesterase 4 inhibitor roflumilast as a 0.3% water-based cream for the treatment of plaque psoriasis. The drug is also studied in other indications, such as seborrheic and atopic dermatitis, the latter most recently in the 2 presented phase 3 trials INTEGUMENT-I (NCT04773587) and INTEGUMENT-II (NCT04773600) [1–3].

A total of 1,337 patients were randomised to a vehicle or once-daily roflumilast 0.15% cream use over 4 weeks [1]. Participants had to be at least 6 years old and present with mild or moderate AD. Prof. Lawrence Eichenfield (University of California San Diego, CA, USA) underlined that almost 50% of the participants were paediatric patients between 5‒17 years of age. Around one-third of the participants in both trials presented a vIGA of 3 at baseline, mean Eczema Area and Severity Index (EASI) scores ranged from 9.8 to 10.3, and mean Worst Itch Numeric Rating Scale (WI-NRS) values ranged from 5.9 to 6.2.

At week 4, the proportions of participants achieving the primary endpoint of vIGA of clear or almost clear skin plus a 2-grade amelioration were significantly higher in the roflumilast arms than in the vehicle arms: 32.0% versus 15.5% (P<0.0001) and 28.9% versus 12.0% (P<0.0001) in INTEGEMUNT-I and INTEGEMUNT-II, respectively. Also, the EASI75 results were in favour of roflumilast cream (43.2% vs 22.0% for INTEGUMENT-I and 42.0% vs 19.7% for INTEGUMENT-II), with a significance level of P<0.0001 for both trials.

Since itch is an important symptom of AD, reaching a ≥4-point WI-NRS reduction was also evaluated as a secondary endpoint: in INTEGEMUNT-I, the ratios were 33.6% versus 20.7% at week 4 (P=0.0089) and in INTEGEMUNT-II were 30.2% versus 12.4% (P=0.0014) for roflumilast and vehicle, respectively. Prof. Eichenfield stressed that an itch improvement could be noted within 24 hours after the first application of roflumilast.

The most common treatment-emergent adverse effects were headache, nausea, application site pain, and nasopharyngitis, but none of these events occurred at a rate above 3.5% in the roflumilast groups. Thus, the investigators adjudicated an overall favourable safety and tolerability profile to the active treatment.

  1. Eichenfield L. Efficacy and safety of roflumilast cream 0.15% in adults and children aged ≥6 with mild to moderate atopic dermatitis in two phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2). S025, AAD Annual Meeting 2023, 17–21 March, New Orleans, USA.
  2. Thurston Jr AW, et al. Am J Clin Dermatol. 2023;24:315–24.
  3. Jackson JM, et al. J Am Acad Dermatol. 2022;S0190-9622:03307–2.

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