Favourable opinion for reimbursement in the treatment of generalised pustular psoriasis (GPP) flares in adolescents from 12 years of age as monotherapy.
Clinical Benefit
Substantial
The clinical benefit provided by SPEVIGO 450 mg (spesolimab) concentrate for solution for infusion is substantial in the indication for the treatment of generalised pustular psoriasis (GPP) flares in adolescents from 12 years of age as monotherapy.
Clinical Added Value
minor
Considering:
an unmet medical need in the treatment of GPP flares in adolescents,
the absence of specific data in adolescents from 12 years of age assessing spesolimab 450 mg (intravenous route) in the treatment of generalised pustular psoriasis (GPP) flares;
but the extrapolation to adolescents that can be made based on:
efficacy data in adults having demonstrated the superiority of spesolimab 450 mg (intravenous route) compared to placebo in the treatment of generalised pustular psoriasis (GPP) flares for the complete disappearance of pustules 1 week after only one infusion (randomised, double-blind, multicentre phase 2 EFFISAYIL 1 study in 53 patients);
efficacy data in adults and adolescents having demonstrated the superiority of spesolimab 150 mg every 4 weeks (Q4W, subcutaneous route) compared to placebo in the preventive treatment of generalised pustular psoriasis (GPP) flares for the time to onset of a first GPP flare and for the proportion of patients having had at least one GPP flare during the 48 weeks of the study (randomised, double-blind, multicentre phase 2 EFFISAYIL 2 study in 125 patients, including 23 in the spesolimab 300 mg Q4W group);
data from the EFFISAYIL ON study (extension study of the EFFISAYIL 1 and 2 studies) demonstrating a low percentage of patients with a GPP flare during the 156-week follow-up period;
pharmacokinetic data demonstrating the coherence of pharmacokinetic profiles between adults and adolescents;
long-term safety data (EFFISAYIL ON) comparable to those obtained initially in the treatment of flares in adults, with no evidence of specific adverse events in adolescents treated with spesolimab, marked primarily by infections, with, however, uncertainties remaining with respect to the risk of the occurrence of serious or opportunistic infections, malignancies and peripheral neuropathy,
the Committee deems that SPEVIGO 450 mg (spesolimab) concentrate for solution for infusion provides a minor clinical added value (CAV IV) in the current management of generalised pustular psoriasis flares in adolescents from 12 years of age.
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