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HUMIRA - Maladie de Verneuil (adalimumab)

Opinions on drugs - Posted on Mar 22 2021

Reason for request

Reevaluation

Key points

Favourable opinion for reimbursement in the treatment of active moderate to severe hidradenitis suppurativa (HS, acne inversa) in adults with an inadequate response to conventional systemic HS therapy.

The clinical benefit is now low (it was previously insufficient) in this indication.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

A global management strategy is required for HS, based firstly on dietary and lifestyle measures (weight loss, stopping smoking), as well as management of pain and the psychological impact. It should be adjusted on the basis of the HS phenotype, its severity, the frequency of flares, of recurrence at the same site and the existence or otherwise of aggravating factors or concomitant inflammatory diseases.

Washing with soap and water should be the first-line treatment in the event of a flare. Initial medicinal treatment in the event of infectious episodes is based on short-term systemic probabilistic antibiotic therapy with an amoxicillin-clavulanic acid combination or with pristinamycin, except in the event of fever, in which case it is necessary to take a microbiological sample to identify the microorganisms responsible.

Antibiotic therapy may also be considered as secondary prophylaxis (reassessment after 24 weeks or 12 weeks in the event of exacerbation or stagnation of the disease) and preoperatively.

In moderate forms (Hurley stage II), the initial treatment in the event of a flare includes analgesic incision and drainage in addition to antibiotic therapy. Prophylactic cyclin or cotrimoxazole treatment may then be initiated (reassessment after 6 months). In the event of a recurrence at the same site, limited excision surgery will be performed.

In the event of treatment failure observed at the reassessment after 3 to 6 months, the treatment will include broad excision of the cords and sinuous tracts or marsupialisation, and the patient should receive a Hurley stage III treatment (severe forms).

This involves a specialised multidisciplinary team. After the initial treatment, several options can be considered:

  • surgery with broad excision;
  • and/or prophylactic antibiotic therapy (cyclin or cotrimoxazole) with reassessment after 6 months;
  • and/or adalimumab, a TNFα inhibitor with reassessment after 6 months.

Role of the medicinal product in the care pathway:

HUMIRA (adalimumab) is a second-line treatment following an inadequate response to antibiotic therapy in active moderate to severe HS in adults.

HUMIRA (adalimumab) may be used after antibiotic therapy or in combination with it.

 


Clinical Benefit
Low

The Committee deems that the clinical benefit of HUMIRA (adalimumab) 40 mg/0.4 ml and 80 mg/0.8 ml solution for injection in pre-filled syringe and pen is low in the MA indication.

Clinical Added Value
no clinical added value

Considering:

  • demonstration of the superiority of adalimumab versus placebo in a new phase 4 study, on an endpoint already deemed to be of little relevance, i.e. reduction of the number of inflammatory lesions assessed by the Hi-SCR score after 12 weeks of treatment, in adults with active moderate to severe hidradenitis suppurativa who are candidates for surgery, and with a modest effect size;
  • the absence of demonstration of an impact on recourse to elective surgery (cancellation or reduction of its extent), a more clinically relevant endpoint,
  • a medium-term safety profile marked by the onset of serious and opportunistic infections and malignant tumours in this disease with a not insignificant infectious and oncogenic risk;
  • the absence of a demonstrated benefit in terms of quality of life, which is nonetheless particularly impaired in severe forms of this disease,
  • and despite the identified medical need in the event of an inadequate response to prophylactic antibiotic therapy,

the Transparency Committee considers that HUMIRA (adalimumab) provides no clinical added value (CAV V) in the care pathway for hidradenitis suppurativa.

 

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