Biologic, Topical Therapies Both Effective in Treating AD in Skin of Color

This content was produced independently by The American Journal of Managed Care^® and is not endorsed by the American Academy of Dermatology.

Posters presented during the 2024 American Academy of Dermatology Annual Meeting showed that atopic dermatitis (AD) in skin of color can be treated using either topical or biologic therapy. Moderate to severe AD was the primary target of the phase 3 trials covered in the posters.

The first poster¹ described a systematic review of results on using biologic treatments in moderate to severe atopic dermatitis and psoriasis in skin of color with a primary focus on phase 3 trials. According to the poster, investigations into differential response to treatment are limited when it comes to conditions of commonality and diagnosis in skin of color, which was the primary reasoning for conducting the review.

Atopic dermatitis | Image credit: sinhyu - stock.adobe.com

The researchers used MEDLINE, Cochrane, and Embase to conduct the search. All phase 3 trials that included non-White adult participants who had moderate to severe AD or psoriasis and had results and outcomes of biologic treatments were included in the study. Quality of evidence was evaluated using the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence.

There were 11 studies that included 1781 patients who had moderate to severe AD and psoriasis on skin of color. The mean (SD) age of the participants was 40.99 (6.3) years, 64.3% were Chinese, 24.2% were Japanese, 4.5% were Taiwanese, 3.4% were Korean, and 3.5% of participants did not have a reported ethnicity. The researchers found that all ethnicities had differences in baseline characteristics and comorbidities, which indicated that ethnic background and race should be considered when treatment is prescribed. There were no significant outcomes by the population of those with skin of color found in the treatment groups.

There were a few reported limitations, including the small sample size, the review including primarily participants of East Asian descent, individual genetic or baseline variability did not have individual response to treatment included, and treatment outcomes were not the same in all studies, which limited the comparability.

The researchers concluded that outcomes in participants with skin of color were consistent in all studies, which indicated that the biologics were safe and efficient when treating moderate to severe psoriasis or AD in patients with skin of color. The researchers stated that diversity can be considered to get more information on the effects on diagnosis and treatment response in this population.

The second poster² featured a study on the efficacy of tapinarof cream 1% when treating moderate to severe AD in skin of color. The researchers reported that little data on this group have been reported, which can be a problem due to the unknown effects of pigment change on this population. ADORING 1 and 2, which are phase 3 trials, found that tapinarof cream 1% once daily was efficient in treating AD in adults and children aged 2 years and older. This study aimed to report the efficacy specifically in skin of color based on the Fitzpatrick skin type.

In the ADORING 1 and 2 trials, which were randomized and double-blind, all patients were assigned 2:1 to either tapinarof 1% or a placebo for 8 weeks. ADORING 1 featured 407 patients whereas ADORING 2 included 406 patients; the tapinarof groups contained 270 and 271 patients, respectively. A score of 0 or 1 on the Validated Investigator Global Assessment scale for Atopic Dermatitis and a 2-grade improvement or higher was considered the primary end point. A secondary end point was an Eczema Area and Severity Index (EASI) 75 response, with 75% or more improvement in the EASI score.

The mean age of the participants was 15.6 and 16.5 years in ADORING 1 and 2, respectively, and 43.1% and 48.2% were male. Participants with skin of color made up approximately 50% of the participants, with 26.5% and 35.0% being Black, 8.8% and 15.3% being Asian, and 44.8% and 56.8% being White. Skin type IV was seen in 23.8% and 25.1% of the participants, skin type V was seen in 20.6% and 22.2% of the participants, and skin type VI was seen in 7.6% and 8.9% of the participants.

Overall, the primary end point was met by 45.4% vs 13.9% in ADORING 1 and 46.4% vs 18.0% in ADORING 2 when comparing the tapinarof cream vs the vehicle. Efficacy was found in all races, with all of Asian, Black, and White participants having between 39.5% and 52.1% efficacy in the tapinarof arms of ADORING 1 and 2, respectively, compared with a range of 3.7% to 24.1% in the placebo arms. Participants who were classified as “other” race had an efficacy of 44.8% and 26.0% in the tapinarof arms of ADORING 1 and 2, respectively, compared with 40.2% and 0% for placebo.

ADORING 1 found that 44.8% of the participants with skin types I, II, and III met the primary end point when using tapinarof compared with 13.5% using the vehicle; the same trial found that skin types IV, V, and VI saw 49.6% of participants with tapinarof meet the primary end point compared with 15.3% who used the vehicle. ADORING 2 had similar results, with the primary end point being met by 49.9% of those with skin types I, II, and III and 46.8% of those with skin types IV, V, and VI who used tapinarof compared with 17.7% and 19.5% who used vehicles in those groups. Overall, EASI75 response was met in ADORING 1 with 55.8% meeting the end point with tapinarof vs 22.9% in the control arm; ADORING 2 had similar results with 59.1% of patients using tapinarof meeting the end point compared with 21.2% of those using the vehicle.

The researchers concluded that tapinarof was efficient when treating skin of color for moderate to severe AD in patients aged 2 years and older. All types of skin were benefited through tapinarof in this study.

Both the review and study found that skin of color could be treated with either biologic or topical treatment without any significant adverse events or outcomes.

References

1. Rijal H, Bouadi N, Aduelmula A, et al. Response to therapy in skin of colour participants with moderate-to-severe psoriasis and atopic dermatitis: a systematic review. Abstract presented at: American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 50793.
2. Alexis AF, Kircik L, Chovatiya R, et al. Tapinarof cream 1% once daily is efficacious for the treatment of moderate to severe atopic dermatitis in patients with skin of color down to 2 years of age in two pivotal phase 3 trials. Abstract presented at American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 52871.