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OLUMIANT - Dermatite atopique modérée à sévère de l’adulte (baricitinib)

Opinions on drugs - Posted on Feb 11 2021

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy only 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 therapeutic strategy.

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 medicinal products used off-label (methotrexate and azathioprine). The use of methotrexate and azathioprine 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

On the basis of currently available data, in the absence of direct comparison of baricitinib (JAK inhibitor) with oral ciclosporin following the failure of topical treatments, whereas this comparison could have been performed, its role compared to ciclosporin cannot be determined.

Consequently, OLUMIANT (baricitinib) is a second-line systemic treatment to be reserved for adults with moderate to severe AD, in the event of failure, intolerance, or contraindication to ciclosporin.

There is no available comparative data versus DUPIXENT (dupilumab).


Clinical Benefit

Low

The Committee deems that the clinical benefit of OLUMIANT 2 mg and 4 mg (baricitinib) film-coated tablets is low in the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy only in the event of failure, intolerance, or contraindication to ciclosporin.

Insufficient

The Committee deems that the clinical benefit of OLUMIANT 2 mg and 4 mg (baricitinib) film-coated tablets is insufficient to justify public funding cover in view of the available alternatives in ciclosporin-naive patients who have not responded adequately to topical treatments, in the absence of comparative data.


Clinical Added Value

no clinical added value

Considering:

  • the very modest effects observed with baricitinib versus placebo, in all the studies (as monotherapy or in combination with topical corticosteroids, particularly in patients who have not responded adequately to ciclosporin treatment) and for all the endpoints,
  • the absence of a demonstrated impact in terms of quality of life,
  • the absence of a comparison with dupilumab following the failure of ciclosporin, whereas this could have been performed,

the proprietary medicinal products OLUMIANT 2 mg and 4 mg (baricitinib) film-coated tablets provide no clinical added value (CAV V) in the care pathway for moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy in the event of failure, intolerance, or contraindication to ciclosporin. At this stage of the strategy, DUPIXENT (dupilumab) and two systemic immunosuppressants used off-label (methotrexate, azathioprine) are available.

Not applicable

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