CIBINQO (abrocitinib)

Key points

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

Unfavourable opinion for reimbursement in the treatment of moderate to severe atopic dermatitis in adults in whom topical therapies have failed and who are ciclosporin-naïve, in the absence of comparative data.

What therapeutic improvement?

Therapeutic improvement compared to DUPIXENT (dupilumab) in the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy, in the event of failure, intolerance or contraindication to ciclosporin.

Role in the care pathway?

The overall objective of atopic dermatitis (AD) 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 (tacrolimus). The wet wrapping technique may be used in the event of an inadequate response.

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. 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 immunosuppressive therapies used off-label (methotrexate, mycophenolate mofetil and azathioprine). Their use should be time-limited due to the unfavourable long-term safety profile.

Other treatment options have also become available recently: two biologic interleukin inhibitors administered subcutaneously, dupilumab (anti-IL4 and anti-IL13, in 2017) and tralokinumab (anti-IL-13, in 2021), and two janus kinase inhibitors administered orally, baricitinib (anti-JAK 1 and 2, in 2020) and upadacitinib (anti JAK1 and JAK1/3, in 2021). These treatments are recommended by the Transparency Committee in the event of failure, intolerance or contraindication to ciclosporin.

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 CIBINQO (abrocitinib) in the care pathway:

As knowledge currently stands, in the absence of a direct comparison of abrocitinib (JAK1 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, CIBINQO 50 mg, 100 mg and 200 mg (abrocitinib) is a second-line systemic treatment to be reserved for adults with moderate to severe atopic dermatitis, who are candidates for systemic therapy, in the event of failure, intolerance or contraindication to ciclosporin.

The Transparency Committee specifies that the choice of second-line systemic therapy should be made on a case-by-case basis depending on the severity of the disease, patients’ characteristics, their treatment history, the risks of intolerance and contraindications to the various treatments available.

As regards abrocitinib, it is necessary to take into account its less favourable safety profile than that of dupilumab (see the respective SPCs of these medicinal products), the need to monitor various laboratory parameters (haematological and lipid), its contraindication in the event of pregnancy, as with other JAK inhibitors, as well as uncertainties in terms of safety, in particular relative to the risks of major cardiovascular and thromboembolic events and the carcinogenic risk indicated in the RMP for abrocitinib and shared by other JAK inhibitors.

The superiority of abrocitinib compared to dupilumab has been demonstrated only at the dose of 200 mg, which corresponds to the maximum daily dose according to the SPC.

Special recommendations

The Committee wishes to highlight the fact that abrocitinib is contraindicated during pregnancy, due to the teratogenic effects demonstrated in animals, and that for women of childbearing potential effective contraception should be used during treatment and for 1 month following the final dose of abrocitinib (see the SPC for more details).