Apremilast (3) – Otezla®

• Clinical trials
  • The pharmaceutical manufacturer has submitted the SPROUT trial, on which the marketing authorisation is based, in which apremilast was compared with placebo in children and adolescents over a period of 16 weeks.

Children and adolescents aged 6 to < 18 years and weighing at least 20 kg with moderate to severe plaque psoriasis for whom systemic therapy is an option

• For children and adolescents aged 6 to < 18 years and weighing at least 20 kg with moderate to severe plaque psoriasis for whom systemic therapy is an option, the additional benefit compared with the appropriate comparator therapy is not proven.
• The pharmaceutical manufacturer has not identified any comparative studies against the appropriate comparator therapy for the assessment of the additional benefit of apremilast.
• Due to the lack of comparison with the appropriate comparator therapy, the study is not suitable for assessing additional benefit.
• On balance, the G-BA therefore concludes that for children and adolescents aged 6 to < 18 years and weighing at least 20 kg with moderate to severe plaque psoriasis for whom systemic therapy is an option, The additional benefit of apremilast compared with the appropriate comparator therapy is not proven.
• Overall assessment
  • On balance, the G-BA therefore concludes that for children and adolescents aged 6 to < 18 years and weighing at least 20 kg with moderate to severe plaque psoriasis, for whom systemic therapy is an option, The additional benefit of apremilast compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.