Delgocitinib

Table of contents

• What is delgocitinib?
• How does delgocitinib work?
• Which conditions is delgocitinib used or studied for?
• How is delgocitinib given?
• What do the clinical trials show?
• Who can take part in these trials?
• What side effects are known?

What is delgocitinib?

Delgocitinib is a chemically synthesised, small-molecule medicine that belongs to a class called JAK inhibitors. It is classified under ATC code D11AH11, a group of other dermatological preparations.^[1] The substance is also known by the product name Anzupgo 20 mg/g cream.^[3] Delgocitinib is already authorised as a medicine in the European Union, with the authorisation held by LEO Pharma A/S.^[1] In the United Kingdom, it is approved under NICE technology appraisal TA1107 for treating moderate to severe chronic hand eczema in adults when topical corticosteroids have not worked or are not suitable.^[5]

How does delgocitinib work?

Delgocitinib works by blocking enzymes called Janus kinases, or JAKs, which sit inside cells and pass on inflammatory signals. By inhibiting these enzymes, the medicine reduces the inflammation that drives several skin diseases. Because it is applied directly to the skin, its action is focused on the affected area. The Devon Formulary groups delgocitinib under drugs affecting the immune response, reflecting this mechanism.^[7]

Which conditions is delgocitinib used or studied for?

• Chronic hand eczema — delgocitinib is authorised as Anzupgo cream for moderate to severe chronic hand eczema in adults when topical corticosteroids have not worked or are not suitable.^[5]
• Palmoplantar pustulosis — a phase 2 trial is testing delgocitinib cream 20 mg/g against a dummy cream in adults with mild to severe palmoplantar pustulosis.^[1]
• Vitiligo — a 12-person proof-of-concept trial is studying delgocitinib cream for non-segmental vitiligo on the face.^[3]
• Lichen sclerosus — a phase 3 trial is evaluating delgocitinib cream 8 mg/g and 20 mg/g in female participants with lichen sclerosus.^[4]
• Cutaneous T-cell lymphoma and mycosis fungoides — an open-label pilot study is assessing topical delgocitinib in these skin lymphomas.^[2]

How is delgocitinib given?

Delgocitinib is given as a cream for cutaneous use, meaning it is applied directly to the skin. The registered trials use two strengths: 8 mg/g and 20 mg/g.^[4] In the palmoplantar pustulosis trial, the product information describes twice-daily applications of delgocitinib cream 20 mg/g.^[1] The Lincolnshire formulary notes that treatment should be discontinued if no improvement is seen after 12 weeks of continuous use.^[5]

What do the clinical trials show?

Four interventional clinical trials of delgocitinib are registered, all in authorised status, meaning they have been approved to proceed but have not yet reported results. One trial is phase 3, and three are phase 2. The conditions studied are palmoplantar pustulosis, vitiligo, lichen sclerosus, and cutaneous T-cell lymphoma with mycosis fungoides.^[1]–[4]

The largest trial is the phase 3 lichen sclerosus study with 552 participants, which compares delgocitinib cream 8 mg/g and 20 mg/g against a cream vehicle.^[4] The smallest is the vitiligo proof-of-concept trial with 12 participants.^[3] The palmoplantar pustulosis trial enrols 135 adults,^[1] and the cutaneous T-cell lymphoma pilot study enrols 15.^[2]

The trials measure different outcomes. The palmoplantar pustulosis trial uses PPPASI-75 at week 16, meaning the proportion of participants whose palmoplantar pustulosis severity score improves by at least 75%.^[1] The vitiligo trial measures change in F-VASI, a score of facial vitiligo area and severity, from baseline to week 24.^[3] The lichen sclerosus trial uses IGA-LS TS at week 12, a measure of treatment success on a global assessment scale.^[4] The cutaneous T-cell lymphoma study measures skin response with the modified Severity-Weighted Assessment Tool (mSWAT) and reports overall response rate.^[2]

Who can take part in these trials?

The trials enrol different populations. The palmoplantar pustulosis trial is for adults with mild to severe palmoplantar pustulosis.^[1] The lichen sclerosus trial is restricted to female participants with lichen sclerosus.^[4] The vitiligo trial is for patients with non-segmental vitiligo in the facial area.^[3] The cutaneous T-cell lymphoma study enrols patients with cutaneous T-cell lymphoma or mycosis fungoides.^[2]

What side effects are known?

The supplementary^[6] formulary sources provided do not list specific side effects for delgocitinib. They note that the medicine is expensive and that treatment should be stopped if there is no improvement after 12 weeks, but no adverse effect profile is described in these records.^[5]