Anti-TNF treatments

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Anti-TNFα: Adalimumab

The PIONEER Ⅰ and Ⅱ trials lead to the granting of a European MA in 2015 with the indication: “Humira® is indicated for the treatment of active moderate to severe hidradenitis suppurative (Verneuil disease), in adults with an inadequate response to conventional systemic HS therapy”.

In 2016, the Transparency Committee of the French Haute Autorité de Santé (HAS) (in charge of the drug-reimbursement policy) determined that the therapeutic value of adalimumab was insufficient to justify its reimbursement from public solidarity funds for the above-mentioned treatment, considering:

• adalimumab’s low-level and short-term efficacy, as evaluated from scores showing little clinical relevance;
• that severe forms of HS can have a particularly heavy impact on patient quality of life, but that adalimumab offers no proven benefits in this regard;
• that the long-term tolerance of adalimumab at recommended doses is uncertain;
• where no other therapeutic alternatives exist, and despite its limited efficacy, this treatment may be considered in patients presenting HS with Hurley stage Ⅱ and Ⅲ lesions as a backup to large-spectrum antibiotherapy (as described above).
• this treatment should be reviewed regularly, and should be interrupted if the expected efficacy is not observed in 3 to 6 months.

Adalimumab, considering the data in the literature, does not appear to be a viable candidate for long-term treatment in HS patients (loss of efficacy). A dialogue with the patient should be engaged on therapeutic possibilities when introducing this biomedicine.

For patients presenting an associated disease such as inflammatory rheumatism or a chronic bowel inflammation disease, adalimumab may be considered at an earlier stage of treatment.

Where no other therapeutic alternatives exist, and despite its limited efficacy, this treatment may be considered in patients presenting HS with Hurley stage Ⅱ and Ⅲ lesions as a backup to large-spectrum antibiotherapy (as described above). This treatment should be reviewed regularly, and should be interrupted if the expected efficacy is not observed in 3 to 6 months

Under the current health regulations regarding anti-TNFα medicines in the treatment of HS, the delivery of adalimumab on prescription cannot be reimbursed, although it may be declared reimbursable after amicable negotiation with the local social security establishment.

Anti-TNFα: Infliximab

HS is not indicated in the MA for infliximab. The work group nevertheless recommends its use by analogy with adalimumab, which is not covered by social security reimbursement. This medicine should be restricted for use only by teams specialised in the treatment of patients with severe HS, or forms resistant to first-line treatment. Its indication should be re-evaluated after 3 to 6 months.

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