Abrocitinib Monotherapy Efficacious in Moderate to Severe AD Regardless of Race, Ethnicity

In an iPoster at the 2022 Skin of Color Society Scientific Symposium, held March 24 in Boston, Massachusetts, Andrew Alexis, MD, MPH, vice chair for diversity and inclusion, Department of Dermatology, Weill Cornell Medicine, New York, New York, and Dermatology Times® board member, along with colleagues, examined the efficacy of abrocitinib (Cibinqo; Pfizer) monotherapy for the treatment of moderate to severe atopic dermatitis (AD) in different racial and ethnic subgroups. The stated objective was to assess the efficacy of abrocitinib among patients with AD based on racial and ethnic self-identification.

To do this, data was pooled from 3 different abrocitinib monotherapy trials – B7451006, NCT02780167; JADE MONO-1, NCT03349060; and JADE MONO-2, NCT03575871. Study participants self-reported their race or ethnic origin. Participants (≥18, phase 2b study; ≥12, phase 3 studies) with moderate to severe AD were randomized to receive either abrocitinib 100 mg, abrocitinib 200, or placebo once daily for 12 weeks.

Endpoints were examined for the proportion of patients who achieved Investigators Global Assessment (IGA) 0/1, Eczema Area and Severity Index (EASI)-75, and a 4-point improvement in Peak Puritus Numeric Rating Scale (phase 2b)/PP NRS (PP-NRS4; phase 3) at week 12. Additionally, P values between abrocitinib groups and placebo were calculated using the Cochran-Mantel-Haenszel test.

The AD medication was administered to Caucasian (232, 254, and 142, respectively), Black (30, 31, and 22), Asian (85, 80, and 39), Hispanic/LatinX (12, 14, and 11), and non-Hispanic/LatinX (349, 352, and 196) participants.

A significantly greater proportion of participants who received either the 100 or 200 mg doses achieved an IGA of 0/1 response at week 12 vs placebo in Caucasian (43.1% and 24.4% vs 8.8%; both P < .001), Black (27.6% and 35.5% vs 0%; both P < .01), Asian (37.6% and 30.4% vs 10.3%; both P < .05), and non-Hispanic/LatinX (41.9% and 27.3% vs 8.3%; both P < .0001) groups. IGA 0/1 response, according to the poster, was numerically greater but not significantly different in Hispanic/LatinX participants (20% and 14.3% vs 0%).

The EASI-75 response was reported as significantly greater for the 100 mg or 200 mg dose vs placebo at 12 weeks—Caucasian (64.3% and 39.2% vs 12.5%; both P < .001), Asian (61.2% and 48.1% vs 12.8%; both P < .001), Hispanic/LatinX (50% and 42.9% vs 0%; both P < .05), and non-Hispanic/LatinX (62.7% and 42.2% vs 12.5%; both P < .0001). Black patients had an EASI-75 response that was significantly greater with acrocitinib 100 mg vs placebo (48.4% vs 13.6%; P = .02).

A greater proportion of participants achieved PP-NRS4 with abrocitinib 200 mg or 100 mg vs placebo at week 12— Caucasian (61.2% and 38.2% vs 16.8%; both P < .0001), Asian (49.3% and 47.8% vs 8.6%; both P < .001), and non-Hispanic/LatinX (57.2% and 42.6% vs 18.1%; both P < .0001) groups. The PP-NRS4 response in Black participants was numerically greater but not significantly different. However, in Hispanic/LatinX participants, the response was significantly greater with abrocitinib 200 mg vs placebo (50% vs 0%; P < .002), but not 100 mg (38.5%).

Alexis et al wrote that both abrocitinib 100 mg and 200 mg monotherapy was more effective than placebo in moderate the severe AD improvement, with no different seen in racial or ethnic subgroups. They noted that the lower efficacy of response in Black and Hispanic/LatinX participants are confounded by the small study population. Additionally, the researchers concluded that greater representation of Black and Hispanic/LatinX participants is needed in future studies.

Reference:

Alexis A, et al. Efficacy of abrocitinib for the treatment of moderate to severe atopic dermatitis across different racial and ethnic subgroups. iPoster at: 18th Skin of Color Society Scientific Symposium; March 24, 2022; Boston, MA.