Abrocitinib shows promise in moderate-to-severe atopic dermatitis
Patients with moderate-to-severe atopic dermatitis (AD) see clinical improvements in all body locations when treated with 100- or 200-mg doses of oral abrocitinib as compared with placebo, reports a new posthoc analysis presented at the recently concluded 2020 Virtual Congress of the European Academy of Dermatology and Venereology (EADV 2020).
Drawing from one phase IIb and two phase III trials, the researchers analysed 363, 369, and 210 AD patients who were given 200- or 100-mg abrocitinib or placebo, respectively. Disease severity was assessed using the Eczema Area and Severity Index (EASI). All source trials were randomized, double-blinded, and placebo-controlled in design.
Participants had an average age of 35.0±15.9 years, and more than half (56.2 percent) were male. At baseline, more than a third (37.3 percent) were deemed to have severe AD, as evaluated by the Investigators Global Assessment (IGA) tool. Upon enrolment, patients had had their disease for an average of 23.0±15.5 years, and their mean EASI score was 28.8±12.7. [EADV 2020, abstract P0188]
Over 12 weeks of treatment, patients who were on abrocitinib saw a greater and dose-dependent reduction in least squares mean (LSM) changes in EASI scores relative to baseline. This effect started becoming apparent by week 2.
At 4 weeks, the 100-mg dose led to a –60 change in EASI LSM from baseline in the upper limbs and trunk, while triggering a –40 change in the head and neck and in the lower limbs. The 200-mg dose, in comparison, showed a more pronounced effect, while the placebo treatment almost yielded no change in EASI scores from baseline.
By week 12, both the 100- and 200-mg doses of abrocitinib led to substantial improvements in disease extent and severity, while the placebo arm saw no clear effect.
This was true for all subscores of EASI: erythema, induration or papulation, excoriation, and lichenification. In addition, such improvements were documented across all four body regions assessed, including the head and neck, trunk, and lower and upper limbs.
“Abrocitinib is an oral, once-daily, Janus kinase 1 selective inhibitor under investigation for the treatment of moderate-to-severe AD,” the researchers explained. “Although the overall efficacy of abrocitinib has been described in terms of IGA and composite EASI responses, the signs and extent of AD vary by body location.”
The source trials in the present study’s posthoc analysis all bore encouraging results. The phase IIb trial (NCT02780167) found that monotherapy with abrocitinib was both effective and safe for easing symptoms in patients with moderate-to-severe AD. [JAMA Dermatol 2019;155:1371-1379]
In JADE MONO-1 and JADE MONO-2, the two phase III sources, significantly more of the abrocitinib-treated patients achieved IGA response and showed a ≥75-percent improvement in EASI relative to placebo comparators. [JAMA Dermatol 2020;156:863-873; Lancet 2020;396:255-266]
The present study took all three findings and moved the literature forward by showing that abrocitinib was strongly effective against AD, regardless of the body part, and that dose is an important factor to consider.