Abrocitinib tx DA

Abrocitinib Consistent, Superior for Treatment of AD in Phase 3 and 2b Trials

June 22, 2020

Treatment with a once-daily oral JAK1 selective inhibitor — abrocitinib — was associated with a significant percentage of patients with moderate to severeatopic dermatitis (AD) achieving an Investigator's Global Assessment (IGA) response of "clear" or "almost clear" and an Eczema Area and Severity Index (EASI) of 75 at 12 weeks compared with placebo, according to study results presented at the American Academy of Dermatology's Virtual Meeting Experience (AAD VMX) 2020, held online from June 12 to 14, 2020.

These findings were according to phase 3 and phase 2b trials of patients with moderate to severe AD. The phase 3 trial included patients aged ≥12 years, whereas the phase 2b trial included patients aged 18 to 75 years. In the phase 3 study, patients were randomly assigned into the following groups for a total of 12 weeks: placebo (n=77), once-daily use of 100 mg abrocitinib (n=156), or once-daily use of 200 mg abrocitinib (n=154). In the phase 2b trial, patients were also randomly assigned to placebo (n=56), 100 mg abrocitinib (n=56), or 200 mg abrocitinib (n=55) for 12 weeks.

The primary endpoint for both studies was the percentage of patients who achieved an IGA response of clear (0) or almost clear (1) with a ≥2-grade improvement at 12 weeks. A coprimary endpoint and secondary endpoint for the phase 3 and phase 2b studies, respectively, was the percentage of patients who achieved the EASI-75 (≥75 improvement) at 12 weeks.

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In the phase 3 trial, a significantly greater percentage of patients in the 100 mg and 200 mg abrocitinib groups achieved the primary endpoint compared with those receiving placebo (43.8% and 23.7% vs 7.9%, respectively; P ≤.01 for both). The phase 2b trial also reported a significantly greater percentage of patients in the 200 mg and 100 mg abrocitinib groups achieving an IGA of clear or almost clear compared with those in the placebo group (43.8% and 29.6% vs 5.8%, respectively; P ≤.01 for both).

The percentages of patients who achieved EASI-75 responses were significantly greater for the 200 mg and 100 mg abrocitinib arms compared with the placebo arm in the phase 3 trial (62.7% and 39.7% vs 11.8%, respectively; P <.0001 for both) and the phase 2b trial (64.6% and 40.7% vs 15.4%; P <.01 for both).

In the phase 3 trial, incidence of any treatment-emergent adverse event (TEAE) was reported in 57.1% of patients randomly assigned to placebo vs 69.2% of patients assigned to 100 mg and 77.9% of patients assigned to 200 mg abrocitinib. In the phase 2b trial, incidence of any TEAE was reported in 57.1% of patients randomly assigned to placebo vs 76.8% of patients treated with 100 mg and 74.5% of patients treated with 200 mg abrocitinib. Most adverse events were mild, however, and considered unrelated to therapy.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors' disclosures.

Reference

DiGiulio D, Gooderham MJ, King BA, et al. Abrocitinib treatment in patients with moderate-to-severe atopic dermatitis (AD): Consistency of efficacy responses from randomized, controlled phase 3 and phase 2b clinical trials. Presented at: AAD VMX 2020; June 12-14, 2020. Abstract/Poster 16405.

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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