REMSIMA (infliximab) - Psoriasis en plaques de l'adulte

Key points

Reassessment for the indication of adult plaque psoriasis:

Retention of approval for reimbursement for the entire marketing authorisation indication.

Role in therapeutic strategy?

Current psoriasis treatments do not definitively cure the condition, but help lesions temporarily resolve, more or less completely. The therapeutic arsenal includes topical and systemic treatments. Topical treatments may be used alone or in association with each other or with systemic treatments.

In the most severe forms, systemic treatments will be used: methotrexate (conventional treatment), ciclosporin as an alternative to methotrexate, retinoids (acitretin) in some clinical forms or in association with phototherapy.

According to the 2019 French Dermatology Society (SFD) guidelines, methotrexate remains the conventional systemic treatment for extensive or severe forms of psoriasis. The alternative is ciclosporin, for which the duration of treatment is often limited by renal toxicity and the risk of arterial hypertension. Retinoids (acitretin) have a benefit in some clinical forms, particularly diffuse forms, or in association with phototherapy.

Biological systemic treatments are proposed after conventional treatments have failed. Anti-TNF drugs (etanercept, adalimumab, infliximab, certolizumab pegol), an anti-IL-12/23 drug (ustekinumab), anti-IL17 drugs (secukinumab and ixekizumab), an anti-IL17 receptor (brodalumab), an anti-IL17A/17F drug (bimekizumab) and anti-IL23 drugs (guselkumab, risankizumab and tildrakizumab) are available. Apremilast, a phosphodiesterase 4 inhibitor is also available. Its role in the therapeutic strategy is poorly defined in the absence of comparison to biological systemic treatments. The SFD guidelines, particularly with respect to the ranking of use of these treatments, are currently being updated.

In its opinions of 5 May 2021, pertaining to the reassessment of 4 biological systemic medicinal products, considering:

• the reassuring data from the PSOBIOTEQ 1 observational study, on patients commencing ENBREL (etanercept), REMICADE (infliximab), HUMIRA (adalimumab) or STELARA (ustekinumab) treatment on compliance with conditions for placing patients under treatment in terms of symptom severity, extent of lesions, impact on quality of life, and previous treatment history, and
• the updated pharmacovigilance data demonstrating an overall unchanged safety profile,

the Committee deemed that these proprietary medicinal products were second-line systemic treatments for moderate to severe forms of adult plaque psoriasis in the event of failure (lack of efficacy, contraindication or intolerance) of a first-line non-biological systemic treatment (methotrexate, ciclosporin or acitretin), and of phototherapy if applicable. The Committee pointed out that methotrexate remained the conventional basic non-biological treatment, in accordance with French Dermatology Society guidelines (2019).

The decision whether to place under treatment must account for the disease history, the patient’s characteristics, previous history of treatment and severity of the disease, assessed with regard to the appearance and extent of lesions, the impact of the disease on quality of life, and the significance of its psychosocial impact.

Role of the medicinal product:

Considering:

• the long-term efficacy data demonstrating the continued efficacy of these medicinal products;
• the reassuring data from the PSOBIOTEQ 2 observational study on compliance with the conditions for placing patients under treatment in terms of symptom severity, extent of lesions, impact on quality of life, and previous treatment history, among patients having commenced COSENTYX (secukinumab), TALTZ (ixekizumab), KYNTHEUM (brodalumab) treatment;
• the pharmakokinetic data demonstrating the equivalence between infliximab by the subcutaneous (SC) route, and infliximab by the intravenous (IV) route (REMSIMA 100 mg (IV), a biosimilar of REMICADE, previously reassessed) among patients with rheumatoid arthritis and the non-inferiority of infliximab SC with respect to infliximab IV among patients with Crohn’s disease or ulcerative colitis, supplemented by clinical data demonstrating the equivalence between the SC and IV forms of infliximab in patients with rheumatoid arthritis;
• the updated pharmacovigilance data demonstrating an overall unchanged safety profile for these medicinal products,

the Committee deems that the proprietary medicinal products REMSIMA 120 mg (SC) (infliximab), CIMZIA (certolizumab pegol), COSENTYX (secukinumab), TALTZ (ixekizumab), KYNTHEUM (brodalumab), TREMFYA (guselkumab), SKYRIZI (risankizumab) and ILUMETRI (tildrakizumab) are second-line systemic treatments for moderate to severe forms of adult plaque psoriasis in the event of failure (lack of efficacy, contraindication or intolerance) after a first-line non-biological treatment (methotrexate, ciclosporin or acitretin), and of phototherapy if applicable. The Committee points out that methotrexate remains the conventional basic non-biological treatment, in accordance with SFD guidelines (2019).

The decision whether to place under treatment must account for the disease history, the patient’s characteristics, previous history of treatment and severity of the disease, assessed with regard to the appearance and extent of lesions, the impact of the disease on quality of life, and the significance of its psychosocial impact.