Clinical effect of delgocitinib 0.5% ointment on atopic dermatitis eczema intensity and skin barrier function

Abstract

Objectives Delgocitinib is a small‐molecule JAK inhibitor that has recently been approved in Japan as the world's first topical JAK/STAT pathway inhibitor for the treatment of atopic dermatitis (AD). In this study, the effects of delgocitinib 0.5% ointment treatment on skin rash severity and skin‐barrier function were examined. Methods Adult Japanese patients with mild‐moderate AD (n = 23) were recruited into the trial. Healthy subjects (n = 10) were examined in parallel. The effects of four weeks of treatment with delgocitinib 0.5% ointment on the partial eczema area and severity index (pEASI) score, stratum corneum hydration (SCH), and trans‐epidermal water‐loss (TEWL) were examined. Patient reported effects of the treatment were assessed by a questionnaire. Results Four weeks of treatment showed a statistically significant improvement (p < .001) in pEASI score of 61.8%, ±54.0 (mean%, SD) compared to baseline in AD patients. Improvement in SCH at four weeks (37.6AU, ±11.5 (mean, SD), p < .001) was achieved in AD patients compared to baseline (SCH = 24.9AU, ±8.8 (mean, SD)). A trend toward reduction in TEWL over time was seen in the active treatment group (TEWL = 9.1 g/h/m2 at baseline, 7.1 g/h/m2 at two weeks, and 6.9 g/h/m2 at 4 weeks). The pEASI score and SCH and TEWL values improved from two‐to‐four weeks treatment. Patients reported perceived improvements after four weeks of treatment on all parameters associated with skin condition. No safety concerns were identified. Conclusions Treatment with delgocitinib 0.5% ointment was well tolerated and showed improvements of both eczema and SCH in adult AD patients.

Efficacy and safety of topical JAK inhibitors in the treatment of atopic dermatitis in paediatrics and adults: A systematic review

“…Abe et al 19 reported that delgocitinib was an effective topical option in treating AD; only after 2 weeks of treatment with delgocitinib 0.5% ointment, a statistically significant reduction in partial Eczema Area and Severity Index (pEASI) compared to baseline was observed. Such results persisted after 4 weeks of the trial and no evidence of skin inflammation was visible in clinical examination.…”

“…Mild and limited local adverse reactions were observed following the application of topical JAKi; application site erythema, itching, 19,25,32 eczema, 25 erysipelas, impetigo, dermatitis, 20,24,35 folliculitis, herpes simplex, 21 pain, hypoesthesia, 24 urticaria, first degree burn 32 and burning sensation. 22,36 Non-local adverse reactions were reported in few cases including nasopharyngitis, 22,23,25,36 decreased WBC and RBC count, 20,32 glucosuria, 20 increased alanine and aspartate aminotransferase and alteration of liver function tests, 32 transient increased platelet count, 29,31 hand-foot-and-mouth disease, 35 Kaposi varicelliform, 21,22,36 toothache, 25,32,38 backache, headache, 25,32,38 hyperkalaemia, limb abscess, restlessness, nausea, muscle strain, constipation, cough, allergic rhinitis, muscle strain, upper respiratory tract infection and bronchitis 25,32 and postinflammatory hyperpigmentation of the treatment site.…”

Topical application of imatinib mesylate suppresses vitamin D3 analog‐induced dermatitis in Balb/c mice

“…Also suggested was the possibility that topical medication is superior to systemic medication in terms of safety 21 . Tacrolimus hydrate ointment, delgocitinib ointment, and topical corticosteroid formulations are available to treat AD 22 . However, these topical agents are nonselective immunosuppressants associated with susceptibility to viral, bacterial, and fungal infections 22–24 .…”

“…21 Tacrolimus hydrate ointment, delgocitinib ointment, and topical corticosteroid formulations are available to treat AD. 22 However, these topical agents are nonselective immunosuppressants associated with susceptibility to viral, bacterial, and fungal infections. [22][23][24] In addition, skin atrophy and telangiectasia are common side effects of topical corticosteroid use.…”

“…22 However, these topical agents are nonselective immunosuppressants associated with susceptibility to viral, bacterial, and fungal infections. [22][23][24] In addition, skin atrophy and telangiectasia are common side effects of topical corticosteroid use. 24 Owing to these problems, the satisfaction rate with topical treatment for AD is low, 25,26 and other therapeutic agents are required.…”