Active ingredient: delgocitinib

Brand name (sponsor): Anzupgo (Leo Pharma)

Presentation: cream containing delgocitinib 20 mg/g in 15 g and 60 g tubes

Route of administration: topical

Approved indication: treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate


Background:
Hand eczema is a common inflammatory skin disease affecting the hands and wrists. It occurs in approximately 1 in 10 adults.1 More than half of affected individuals develop chronic disease, defined as hand eczema persisting for more than 3 months or recurring twice or more within a year.2 People with chronic hand eczema experience itchy, painful, blistered or fissured skin, which often interferes with daily activities and impairs quality of life.

Management involves trigger avoidance, regular emollient use, and anti-inflammatory therapy. Topical corticosteroids are the first-line anti-inflammatory therapy, but prolonged and repeated use is associated with adverse effects such as skin atrophy and impaired skin barrier repair. Topical calcineurin inhibitors (e.g. tacrolimus, pimecrolimus) are used (off-label) as second-line, steroid-sparing therapies. In severe cases, phototherapy or systemic treatment (oral corticosteroids, retinoids or immunosuppressants) may be required.2

Delgocitinib is the first nonsteroidal topical treatment approved for chronic hand eczema in Australia.

Mechanism of action:
Delgocitinib is a pan–Janus kinase (JAK) inhibitor, inhibiting all four JAK enzymes (i.e. JAK1, JAK2, JAK3 and tyrosine kinase 2 [TYK2]), thereby suppressing multiple inflammatory cytokine-mediated pathways. This results in downregulation of immune and inflammatory markers and increased expression of genes involved in skin barrier function.3,4

Clinical trials:
The efficacy and safety of delgocitinib were evaluated in the phase 3 DELTA 1 and DELTA 2 trials, which were conducted in different countries.3 Adults with moderate to severe chronic hand eczema and an inadequate response to topical corticosteroids, or who were unsuitable for topical corticosteroid treatment, were randomised to treatment with delgocitinib 20 mg/g cream or vehicle cream, applied twice daily for 16 weeks. People who were previously treated with topical or systemic JAK inhibitors or who had other skin diseases affecting the hands were excluded. Patients receiving immunosuppressants or other immunomodulators before the trials underwent a drug washout period. The primary endpoint was treatment success at week 16, defined as an Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0 (clear skin; no signs of erythema, scaling, hyperkeratosis, lichenification, oedema or fissures) or 1 (almost clear skin; barely perceptible erythema with no other signs), with at least a 2-step improvement from baseline. Key secondary endpoints included the severity of hand eczema symptoms (itch and pain).3

A greater proportion of delgocitinib-treated patients achieved treatment success at week 16 compared with vehicle-treated patients in the 2 trials; however, around 70 to 80% of delgocitinib-treated patients did not achieve an IGA-CHE score of 0 or 1 (Table 1).3

Table 1 Delgocitinib efficacy results from the DELTA 1 and DELTA 2 trials in adults with chronic hand eczema3

Endpoints DELTA 1 trial (n=487) DELTA 2 trial (n=472)
Delgocitinib 20 mg/g Vehicle Delgocitinib 20 mg/g Vehicle
Primary endpoint

Treatment success at week 16 [NB1]

19.7% (64/325)

9.9% (16/162)

29.1% (91/313)

6.9% (11/159)

Secondary endpoints

Itch reduction at week 16 [NB2]

47.1% (152/323)

23.0% (37/161)

47.2% (146/309)

19.9% (31/156)

Pain reduction at week 16 [NB2]

49.1% (143/291)

27.5% (41/149)

48.6% (143/294)

22.7% (32/141)

NB1: Defined as an Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0 (clear skin) or 1 (almost clear skin), with at least a 2-step improvement from baseline to week 16 NB2: Defined as a reduction in patient-reported Hand Eczema Symptom Diary (HESD) scores (weekly average) of at least 4 points (on a scale of 0 to 10) from baseline to week 16, calculated among patients with a baseline HESD score of at least 4 points

Extension study (DELTA 3) data, representing a total of 52 weeks of delgocitinib treatment, indicate maintained tolerability and efficacy with ongoing as-needed treatment.5 Most patients who responded to delgocitinib and stopped treatment after the 16-week DELTA 1 or DELTA 2 clinical trial experienced symptom recurrence after 4 to 8 weeks. Clinical response was regained within a median of 8 weeks in 81% of patients after treatment was restarted.5

Adverse effects:
Delgocitinib was well tolerated in the clinical trials. Most adverse effects were mild to moderate in severity, not considered treatment related and occurred at similar rates in the delgocitinib and vehicle groups.3

Dosage and administration:
A thin layer of delgocitinib cream should be applied twice daily (approximately 12-hourly) to clean, dry skin on the affected areas of the hands and wrists until the skin is clear or almost clear. Treatment should be stopped if no improvement is seen after 12 weeks of continuous treatment.4

If symptoms recur (flare) after stopping delgocitinib, twice-daily application may be restarted.4

Contact with eyes, mouth or other mucous membranes should be avoided. If another person assists with delgocitinib application, they should wash their hands afterward.

Practice points:
Patients should continue standard eczema self-care, including trigger avoidance and regular emollient use. Application of emollients and other topical products should be avoided within 2 hours of delgocitinib application.

Regular skin examinations are recommended, especially for those with risk factors for skin cancer, due to reports of nonmelanoma skin cancer in patients treated with topical JAK inhibitors.4

Use in pregnancy and breastfeeding:
Data on the use of delgocitinib in human pregnancy are limited. As a precaution, its use may be avoided during pregnancy. Delgocitinib may be used during breastfeeding; however, direct contact between the treated skin and the nipple or surrounding area, as well as contact with the infant, should be avoided after delgocitinib application.4

Place in therapy:
Delgocitinib provides a topical treatment option for adults with chronic hand eczema who are unable to use, or have an inadequate response to, topical corticosteroids. Relapse may occur after treatment cessation; if this occurs, twice-daily application may be restarted, and clinical response may be re-established, typically within 8 weeks.5 Ongoing or intermittent application may be required to maintain disease control.

Combination treatment strategies, such as using topical corticosteroids for acute flares followed by delgocitinib for maintenance, have been suggested but not yet studied. Head-to-head trials comparing delgocitinib with topical corticosteroids and topical calcineurin inhibitors are required to better define its place in therapy.6

This new drug comment was finalised on 28 August 2026. It was prepared by Sherilyn Wong, Clinical Editor, Australian Prescriber, and reviewed by Mitchel Hurlbert, Clinical Pharmacology Advanced Trainee, St Vincent’s Hospital Sydney.

At the time this new drug comment was prepared, the Australian Public Assessment Report was available from the Therapeutic Goods Administration. The sponsor did not provide the Clinical Evaluation Report.

This article is peer reviewed.

 

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