Roflumilast Cream Safe and Effective in Treatment of Atopic Dermatitis: JAMA

According to the recent study published in the Journal of American Medical Association, a new topical treatment for atopic dermatitis (AD) has been shown as a safe, effective, and well-tolerated option for patients with this chronic skin condition. This two phase 3 clinical trials, titled INTEGUMENT-1 and INTEGUMENT-2, evaluated the efficacy and safety of roflumilast cream, 0.15% and compared to a vehicle (placebo) cream, with findings suggesting significant improvement in AD symptoms after just four weeks of use.

Atopic dermatitis is a chronic inflammatory skin disorder that affects millions of people globally, causing itchy, red, and inflamed skin. Despite the prevalence of the condition, long-term treatment options remain limited, and adherence rates are often low due to side effects or lack of effectiveness. Roflumilast is a phosphodiesterase-4 (PDE4) inhibitor and has emerged as a potential alternative with its once-daily topical formulation.

In the INTEGUMENT-1 and INTEGUMENT-2 trials, a total of 1,337 patients, aged 6 and above, from the United States, Canada, and Poland were enrolled. These patients had mild to moderate AD, as determined by the Validated Global Assessment for Atopic Dermatitis to measure disease severity. These participants were randomized in a 2:1 ratio to either receive roflumilast cream, 0.15%, or vehicle cream for four weeks.

The primary outcome measured was the success rate on the Validated Investigator Global Assessment (VIGA) for Atopic Dermatitis. This required a score of 0 (clear) or 1 (almost clear) plus an improvement of at least two grades from the baseline assessment by week 4. The results found 32% of patients in the INTEGUMENT-1 trial and 28.9% in the INTEGUMENT-2 trial who used roflumilast to achieve the primary endpoint when compared to 15.2% and 12.0% of the ones using the vehicle cream, respectively. These differences were statistically significant (P < .001).

Secondary outcomes, such as reductions in the Eczema Area and Severity Index (EASI) and improvements in the Worst Itch Numeric Rating Scale, also favored roflumilast. Over 43% of patients in the INTEGUMENT-1 trial and 42% in INTEGUMENT-2 experienced at least a 75% reduction in EASI scores, a marked improvement when compared to 22% and 19.7% in the vehicle groups.

Also, roflumilast cream was well tolerated by patients. More than 95% of participants reported no irritation at the application site, and 90% noted no or only mild sensations upon use. Adverse events were rare, further strengthening its safety profile. Overall, these trials highlight roflumilast cream as a promising option for patients with mild to moderate atopic dermatitis.

Source:

Simpson, E. L., Eichenfield, L. F., Alonso-Llamazares, J., Draelos, Z. D., Ferris, L. K., Forman, S. B., Gooderham, M., Gonzalez, M. E., Hebert, A. A., Kircik, L. H., Lomaga, M., Moore, A., Papp, K. A., Prajapati, V. H., Hanna, D., Snyder, S., Krupa, D., Burnett, P., Almaraz, E., … Berk, D. R. (2024). Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children. In JAMA Dermatology. American Medical Association (AMA). https://doi.org/10.1001/jamadermatol.2024.3121