OTEZLA (apremilast) - Moderate to severe plaque psoriasis in children and adolescents from the age of 6 years

The Committee deems that the clinical benefit of the proprietary medicinal products OTEZLA 10 mg, 20 mg and 30 mg film-coated tablets is moderate in the MA indication.

Considering:

• evidence in a multicentre, randomised, double blind, placebo-controlled phase 3 trial (SPROUT) having included paediatric subjects 6 to 17 years of age with moderate to severe plaque psoriasis who were candidates for systemic therapy or phototherapy;
• the superiority of apremilast compared to placebo, with a modest effect size, on sPGA 0/1 responses (primary endpoint; 33.1% vs 11.5%, p < 0.0001) and PASI 75 (ranked secondary endpoint; 45.4% vs 16.1%, p < 0.0001);
• longer-term interim and exploratory results from the SPROUT-LTE extension trial, at week 52 (i.e. 2 years following inclusion of subjects in the SPROUT trial), suggesting maintenance of the clinical responses observed in the initial study with apremilast;
• the safety profile of apremilast similar to that established in the indication in adults, primarily marked by diarrhoea, abdominal pain, nausea and vomiting;

but taking into account:

• the lack of evidence of a clinically relevant benefit in terms of quality of life, which is nonetheless particularly impaired in moderate to severe forms of this disease;
• the low clinical relevance of the PASI 75 endpoint, which has now been replaced with more restrictive endpoints, such as PASI 90 and PASI 100 responses;
• the absence of direct comparison in a phase 3 study with adalimumab (HUMIRA), another treatment with an MA in the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies;
• the absence of direct comparison with secukinumab (COSENTYX) in a phase 3 study given their concomitant development;
• the important identified risks of serious depression, suicidal ideation and behaviour,

the Committee deems that OTEZLA (apremilast) film-coated tablets medicinal products do not provide any clinical added value (CAV V) in the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy.