SPEVIGO 150 mg (spesolimab) - Psoriasis (GPP) flares in adults and adolescents

The clinical benefit of SPEVIGO 150 mg (spesolimab) solution for injection in pre-filled syringe is substantial in the MA indication.

Considering:

• the superiority of spesolimab (300 mg SC every 4 weeks after a loading dose of 600 mg), as monotherapy, demonstrated versus placebo in a randomised, double-blind, multicentre phase IIb study (EFFISAYIL 2), conducted in 123 adults and adolescents from 12 years of age with moderate to severe generalised pustular psoriasis (GPP), on the percentage of patients with at least one GPP flare up to week 48,
• the lack of evidence of a superiority of spesolimab compared to placebo for the ranked subjective secondary endpoints for the disease (PSS[1] and DLQI[2] scores), due to interruption of the analysis at the second endpoint of the ranked sequence (PSS endpoint),
• exploratory data at week 156 suggesting maintenance of efficacy in the longer term (occurrence of a first flare in 3/23 patients, i.e. 13%),
• the safety as maintenance therapy consistent with the previously established profile in the treatment of flares, primarily marked by infections and injection site reactions,
• persistent uncertainties with respect to the risks of serious or opportunistic infections, systemic hypersensitivity reactions, malignancies and peripheral neuropathy,
• the unmet medical need given the fact that current management of GPP recurrences consists only of treatments with a low level of evidence (grade C) and used off-label, with the exception of methotrexate, which has an MA in GPP in adults, without any study having assessed the benefit of methotrexate in the treatment of GPP,

the Committee deems that SPEVIGO 150 mg (spesolimab) solution for injection in pre-filled syringe provides a minor clinical added value (CAV IV) in the care pathway for the prevention of generalised pustular psoriasis flares in adults and adolescents from 12 years of age.