Abrocitinib Dosing Effective in Atopic Dermatitis Management

Data from the JADE COMPARE controlled trial found that significant improvements in patient-reported outcomes (PROs) were recorded in patients with moderate-to-severe atopic dermatitis (AD) who were given abrocitinib (PF-04965842; Pfizer)compared to both the placebo and dupilumab (Dupixent; Sanofi and Regeneron) groups.

Investigators led by Marco DiBonaventura, PhD, Pfizer Incorporated, New York, NY, noted that early findings from the trial showed that abrocitinib improved the severity of the disease and demonstrated rapid itch relief.

For their study, DiBonaventura and colleagues evaluated the PROs of adults with moderate-to-severe AD who were enrolled in the JADE COMPARE trial.

The Methods

The JADE COMPARE study was a multi-center, phase 3 randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of abrocitinib 200 mg and 100 mg once daily versus placebo and dupilumab.

From October 29, 2018, to August 5, 2019, the study enrolled patients from across the world including North and South America, Australia, Europe, and Asia.

All eligible patients were required to be 18 years or older with moderate-to-severe AD at baseline and a history of inadequate response to 4 or more weeks of medicated topical therapy or required systemic therapy.

A total of 837 adult patients were included in the study.

Patients were randomized 2:2:2:1 to receive either oral abrocitinib 200 mg or 100 mg once-daily, subcutaneous dupilumab 300 mg every other week, or placebo.

Background topical therapy with low- or medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors were applied to areas with active lesions and for 7 days after lesions were under control.

Patient-reported outcomes included Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), Night time Itch Scale (NTIS), Pruritis and Symptoms Assessment for Atopic Dermatitis, Patient Global Assessment, SCORing Atopic Dermatitis (SCORAD), and Hospital Anxiety and Depression Scale.

The Findings

Investigators reported a significant decrease in POEM scores were observed in both abrocitinib groups at week 12 and 16 compared to the placebo group.

Additionally, a higher proportion of patients in the abrocitinib groups met the criteria for a clinical meaningful improvement in POEM at weeks 12 and 16 in a post hoc analysis.

For the abrocitinib groups, a significant decrease in AD symptom severity as measured by the PSAAD scale was observed, an improvement that was maintained through week 16.

At week 16, LSM change from baseline in PSAAD was −3.6 points for abrocitinib 200 mg, −2.8 for abrocitinib 100 mg, −3.4 for dupilumab, and −1.7 for placebo (vs both abrocitinib groups, P < 0.0001).

A post hoc analysis of the proportion of patients in each PTGA category indicated greater improvements with both abrocitinib doses compared with placebo, with investigators noting changes seen as early as week 2.

The proportion of patients having achieved ≥4-point improvement from baseline in NTIS severity was 64.3% and 52.4% for 200 mg and 100 mg abrocitinib, 54.0% for dupilumab, and 34.4% for placebo (vs abrocitinib, P < 0.0001 and P = 0.007).

Finally, the proportions of patietns who achieved ≥4-point improvement from baseline in DLQI was 85.0% and 74.4% for 200 mg and 100 mg abrocitinib, 83.4% for dupilumab, and 59.7% for placebo (vs abrocitinib, P <0.0001 and P = 0.005).

The investigators noted that the study was not designed to evaluate the superiority of abrocitinib over dupilumab.

“However, results of these PROs consistently suggested that better efficacy was achieved with abrocitinib 200 mg than with abrocitinib 100 mg or dupilumab 300 mg every other week,” the team wrote. “The efficacy of abrocitinib 100 mg and dupilumab appeared to be similar.”

The study, “Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis,” was published online in the Journal of The European Academy of Dermatology and Venereology.

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