Delgocitinib Effective in Treatment of Mild to Moderate Atopic Dermatitis

Delgocitinib is the first and only topical JAK/STAT pathway inhibitor in Japan, and recent data suggests it is effective in the management of atopic dermatitis.

A recent investigation from Japan involving a 4-week treatment period with delgocitinib found that adult patients with mild to moderate atopic dermatitis who were treated with the small-molecule JAK inhibitor experienced improvements of both eczema and stratum corneum hydration.

The investigation was led by Masatoshi Abe, MD, PhD, of the Koninkai Sappaporo Skin Clinic, Japan.

Abe cited that roughly 2%-10% of all adult patients in industrialized countries are affected by the disease, which has been characterized by a strong T helper 2 (Th2) immune response.

Despite complications that are associated with the various manifestations of atopic dermatitis such as inflamed red skin, dryness, and pruritis, new methods for the management of the disease are explored with each passing day.

Recently, delgocitinib had been approved in Japan as the world’s first topical JAK/STAT pathway inhibitor for the treatment of atopic dermatitis, with anti-inflammatory and anti-pruritic effects having been recorded in earlier studies.

In their study, Abe and investigators examined the clinical effects of delgocitinib 0.5% ointment in adult patients with mild-to-moderate atopic dermatitis, with efficacy variables that included skin rash severity and trans-epidermal water loss (TEWL).

The Methods

For their study, Abe and colleagues enrolled Japanese patients 20 years and older who were available for outpatient treatment and who complied with the necessary criteria, which included a diagnosis of atopic dermatitis according to the definition and criteria established by the Japanese Dermatological Association.

A total of 23 patients with atopic dermatitis who visitied the Hosui General Medical Clinic from November 2020 to February 2021 were chosen for the study, with an additional 10 healthy subjects examined in parallel.

Patients with atopic dermatitis were administered delgocitinib 0.5% ointment twice daily in an appropriate amount up to 5 g per application.

The group was examined at the Hosui General Medical Clinic at 3 different time-points, namely baseline, week 2, and week 4.

Assessments were made regarding pEASI, which was scored on a scale of 0–12 points, divided into 4 skin symptom categories: erythema, infiltrates/papules, scratch marks, and lichenification. Each category was scored on a 6-point.

Stratum corneum hydration (SCH) was also measured for the site of observation with a Corneometer CM825 (Courage & Khazaka, Cologne, Germany), and TEWL was measured in a thermo-hydrostatic chamber using a Tewameter TM300 (Courage & Khazaka, Cologne, Germany).

The Findings

Abe and colleagues reported a statistically significant difference in the pEASI score of −31.8%, ±32.2 (mean%, SD) compared to baseline after treatment with delgocitinib 0.5% ointment at 2 weeks.

Additionally, inflammation was no longer visible in patients with atopic dermatitis after 4 weeks of treatment.

A statistically significant increase (p < .05) in the level of stratum corneum hydration from an SCH value of 24.9 AU, ±8.8 (mean, SD) at baseline to an SCH value of 30.5, ±12.0 (mean, SD) after two weeks treatment with delgocitinib 0.5% ointment was observed in patients with atopic dermatitis, with the level of hydration measured in this patient group also increasing further to an SCH value of 37.6 AU, ±11.5 at week 4.

A gradual numerical decrease in the mean TEWL from 9.1 g/h/m2 at baseline to 7.1 g/h/m2 at 2 weeks (p = .206) and 6.9 g/h/m2 at 4 weeks (p = .179, baseline vs four weeks) after delgocitinib 0.5% ointment treatment was also recorded.

The drug was considered well-tolerated among patient with atopic dermatitis based on the lack of adverse events as well as the responses recorded in the study questionnaire.

Overall, the investigators were pleased with the findings of the study, believing delgocitinib to be an effective treatment strategy.

“In addition to providing relief from the debilitating symptoms of AD already from 2 to 4 weeks, the general satisfaction with delgocitinib treatment seen in this study is likely to improve patient adherence during long-term treatment,” the team wrote.

The study, “Clinical effect of delgocitinib 0.5% ointment on atopic dermatitis eczema intensity and skin barrier function,” was published online in the Journal of Cutaneous Immunology and Allergy.