SKYRIZI 75 mg (risankizumab)

Key points

Favourable opinion for reimbursement in the treatment of plaque psoriasis in adults, in severe chronic forms only, defined by:

• failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy
• and an extensive form and/or significant psychosocial impact.

Unfavourable opinion for reimbursement in other forms of plaque psoriasis in adults.

The Committee will re-evaluate the reimbursement scope and the role in the care pathway for interleukin inhibitors, including SKYRIZI (risankizumab) in plaque psoriasis in adults and children.

What therapeutic improvement?

Therapeutic improvement compared to COSENTYX (secukinumab).

Role in the care pathway?

Current psoriasis treatments do not result in the definitive cure of the condition, but allow for transient and more or less complete disappearance of the lesions. The therapeutic arsenal includes local and general treatments. Local treatments can be used alone or combined either with each other or with general treatments.

In the most severe forms, systemic treatments can be used: methotrexate (reference treatment), ciclosporin as an alternative to methotrexate, retinoids (acitretin) in certain clinical forms or in combination with light therapy.

If these first-line systemic treatments fail or are not tolerated, systemic biological treatments are recommended: TNFα inhibitors (adalimumab, etanercept, infliximab, certolizumab pegol), IL12 and 23 interleukin inhibitors (ustekinumab), IL17 inhibitors (secukinumab, ixekizumab), IL17 receptor inhibitors (brodalumab) and IL23 inhibitors (risankizumab, guselkumab and tildrakizumab). According to the guidelines of the French society for Dermatology (2019), adalimumab (TNFα inhibitor) and ustekinumab (IL12 and 23 inhibitor) are the first-line systemic biological treatments.  The role of apremilast (phosphodiesterase inhibitor 4) remains poorly defined with results significantly inferior to biological treatments.

The current treatment strategy is "rotational" between the different alternatives, the choice of treatment being guided by patient and disease characteristics (concomitant disease, extent of lesions, previous treatment history) and those of the proprietary medicinal product (adverse effects, cumulative dose).

Until its recent opinions of 2021, the Committee recommended that biological treatments be reserved for severe forms of plaque psoriasis in adults, defined by:

• failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy
• and an extensive form and/or significant psychosocial impact.

However, considering:

• the results of the PSOBIOTEQ observational study, with follow-up for 3 years, demonstrating the establishment in clinical practice of the medicinal products ENBREL (etanercept), REMICADE (infliximab), HUMIRA (adalimumab) or STELARA (ustekinumab):
•  in patients meeting the MA indication for these medicines, i.e.:
  • predominantly having a moderate to severe form of plaque psoriasis based on PGA score and PASI score, along with,
  • extensive lesions and a moderate to high impact on quality of life for a high proportion of patients,
  • in whom conventional systemic treatments (methotrexate, ciclosporin) or phototherapy have failed for the great majority of patients,
  • without challenging the known safety profile for these medicinal products, in particular without demonstrating an increased risk of tumours and serious infections after 3 years of follow-up,

• pharmacovigilance data demonstrating a globally unchanged safety profile,

the Committee now considers that ENBREL (etanercept), REMICADE (infliximab), HUMIRA (adalimumab) and STELARA (ustekinumab), are second-line systemic treatments in moderate to severe forms of plaque psoriasis in adults in the event of failure (insufficient response, contraindication or intolerance) of a first-line non-biological systemic treatment (methotrexate, ciclosporin or acitretin) and possibly phototherapy. The Committee reiterates that methotrexate remains the reference non-biological treatment, in accordance with the guidelines of the French society for Dermatology (2019).

The decision to initiate treatment should take into account the disease history, patients’ characteristics, their treatment history and the severity of their disease, the latter being assessed on the basis of the appearance of the lesions, as well as how extensive they are, the impact of the disease on quality of life and its psychosocial impact.

The Committee has undertaken to reassess the reimbursement scope and the role in the care pathway of all the other biological therapies in plaque psoriasis in adults and children.

Role of the medicinal product in the care pathway

Pending re-evaluation of all the biological medicines not included in the PSOBIOTEQ 1 observational study, including SKYRIZI 75 mg (risankizumab, IL23 inhibitor), this medicinal product remains a treatment reserved for severe chronic forms of plaque psoriasis in adults, defined by:

• failure (insufficient response, contraindication or intolerance) of at least two treatments including non-biological systemic treatments and light therapy
• and an extensive form and/or significant psychosocial impact.

Special recommendations

Given the risk of hypersensitivity reaction to subcutaneous risankizumab (see paragraph 4.4 of the SPC), the Transparency Committee recommends that the first subcutaneous injection of this drug be performed in an appropriate care structure.