Secukinumab (5) – Cosentyx®

• Clinical trials
  • The CAIN457A2310 study was a randomised, parallel-group trial in which secukinumab, at two different doses, was compared with etanercept and placebo in children and adolescents aged 6 to under 18 years with severe plaque psoriasis.

Children and adolescents aged 6 years and over with moderate to severe plaque psoriasis who are eligible for systemic therapy

• For the treatment of children and adolescents with moderate to severe plaque psoriasis who are eligible for systemic therapy, there is a hint of a minor additional benefit of secukinumab compared with the appropriate comparator therapy, etanercept.
• Overall, the positive effects of secukinumab on the morbidity endpoints investigated, compared with the appropriate comparator therapy, are assessed as an improvement in treatment-related benefit, and the extent of the additional benefit is classified as minor.
• The certainty of the evidence is classified as a ‘hint’.
• mortality
  • No deaths occurred in the CAIN457A2310 study.
• Morbidity – Psoriasis Area and Severity Index (PASI)
  • For the endpoint of remission, as determined by PASI 100, a statistically significant advantage in favour of secukinumab over etanercept was observed at week 24 in both analyses (sensitivity analysis C and main analysis).
  • Furthermore, based on the proportion of patients showing an improvement in their PASI score from baseline to week 24 of 75 per cent (PASI 75) or 90 per cent (PASI 90) from baseline to week 24, both analyses showed a statistically significant advantage for secukinumab over etanercept.
  • The proportion of patients in the relevant population (Sensitivity Analysis C) with an improvement in PASI score by week 52 of 100%, 75 per cent (PASI 75) and 90 per cent (PASI 90) respectively, showed no statistically significant differences between secukinumab and etanercept.
• Quality of life – Children’s Dermatology Life Quality Index (CDLQI) response
  • No statistically significant difference was observed between the treatment groups for the CDLQI (CDLQI 0 or 1).
• Side effects
  • For the endpoints of SUEs, discontinuation due to AEs and infections, there was no statistically significant difference between the treatment groups in any case.
• Overall assessment / Conclusion
  • For children and adolescents with severe plaque psoriasis, both the sensitivity analysis and the main analysis showed a statistically significant benefit in favour of secukinumab over the standard comparator therapy etanercept in the morbidity endpoint category, both in terms of remission as measured by PASI 100 and in terms of an improvement in the PASI score of 75 per cent or 90 per cent by week 24, a statistically significant advantage in favour of secukinumab over the appropriate comparator therapy, etanercept.
  • With regard to the endpoint categories of quality of life and side effects, secukinumab showed neither an advantage nor a disadvantage compared with etanercept.
  • Overall, the positive effects of secukinumab on the morbidity endpoints investigated, compared with the appropriate comparator therapy, are assessed as an improvement in treatment-related benefit, and the extent of the additional benefit is classified as minor.

Courtesy translation only, please refer to the German original.