ADTRALZA 150 mg (tralokinumab)

Key points

Favourable opinion for reimbursement in the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy in the event of failure, intolerance, or contraindication to ciclosporin.

Unfavourable opinion for reimbursement following the failure of topical treatments in ciclosporin-naive patients, in the absence of comparative data.

What therapeutic improvement?

No clinical added value in the treatment of adults suffering from moderate to severe atopic dermatitis, requiring systemic treatment, in the event of failure of, intolerance to, or contraindication for ciclosporin.

Role in the care pathway?

The objective of atopic dermatitis treatment is to improve patients’ quality of life by treating their skin lesions and preventing the risk of secondary infections in the event of flare-ups, early relapses and xeroderma. Outside inflammatory flare-ups, all patients should be treated using adjuvant measures (hygiene, emollients) and relapses should be treated at an early stage.

The treatment of acute flare-ups is initially based on the use of topical treatments (topical corticosteroids or, in the event of failure/contraindication, a calcineurin inhibitor), which are very effective in the short-term and well tolerated, although treatment compliance could be better given the corticosteroid phobia of patients.

Phototherapy is mainly recommended in the management of the chronic phase but can be used as second-line treatment in acute flare-ups in the event of failure of topical treatments, although its use is limited by its accessibility.

Systemic treatments are reserved for severe chronic atopic dermatitis resistant to topical corticosteroids or phototherapy, with no sufficient data being available to recommend an optimal treatment regimen. The choice of systemic treatment depends on various factors, in particular comorbidities, age, clinical experience or potential pregnancy plans. Non-biologic systemic treatments are currently available, including ciclosporin used as first-line treatment and, in the event of failure, contraindication or intolerance to ciclosporin, dupilumab (IL4 and IL13 inhibitor) and baricitinib (JAK inhibitor) and medicinal products used off-label (methotrexate, mycophenolate mofetil and azathioprine). The use of the latter is based on an insufficient level of scientific evidence and should be time-limited due to their toxicity.

Alitretinoin, a systemic retinoid, has an MA exclusively for the treatment of severe chronic eczema of the hands, following the failure of potent topical corticosteroids.

Role of the medicinal product in the care pathway

As knowledge currently stands, in the absence of a direct comparison of tralokinumab (IL13 inhibitor) with oral ciclosporin following the failure of topical treatments, its role compared to ciclosporin cannot be determined in first-line systemic therapy (following the failure of topical corticosteroids). Consequently, the Transparency Committee considers that ADTRALZA (tralokinumab) is a second-line systemic treatment to be reserved for adults with moderate to severe atopic dermatitis, in the event of failure, intolerance, or contraindication to ciclosporin.

In the absence of comparative data, its role cannot be determined compared to the currently available alternatives, in particular:

• DUPIXENT (dupilumab), another systemic treatment recommended following the failure of ciclosporin, despite this comparison being feasible,
• The JAK inhibitors RINVOQ (upadacitinib) and OLUMIANT (baricitinib), although comparison with these medicinal products was not expected by the Committee given their concomitant development.

Special recommendations

Given the risk of hypersensitivity reactions with tralokinumab administered subcutaneously (see section 4.4 of the SPC), but also with other biologics, the Transparency Committee recommends that the first subcutaneous injection of this medicinal product be given in an appropriate care structure.