Novartis AG — Cosentyx EMA EPAR variation assessment report (EMEA/H/C/003729, 2015)
Novartis AG · 2015 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a 52-week, real-world, prospective, multicenter study (CAIN457A2406) evaluating secukinumab (Cosentyx) in Chinese pediatric patients (6 to <18 years) with moderate to severe chronic plaque psoriasis. The study aimed to assess the safety and effectiveness of secukinumab in a real-world setting. The findings demonstrate the benefits of secukinumab in this population, with a safety profile consistent with the existing Summary of Product Characteristics (SmPC).
Key findings — cited to the page
| Study type | real-world, prospective, multicenter, non-interventional | CAIN457A2406 · China · p.4 |
| Age range of participants | 6 to less than 18 years | CAIN457A2406 · China · p.4 |
| Study duration | up to 52 weeks | CAIN457A2406 · p.4 |
| First patient first visit date | 08-Sep-2022 | CAIN457A2406 · p.4 |
| Last patient last visit date | 27-Feb-2025 | CAIN457A2406 · p.4 |
| Number of enrolled patients | 42 | CAIN457A2406 · p.6 |
| Mean age of patients | 11.9 years | CAIN457A2406 · p.7 |
| Percentage of patients aged >=12 years | 61.9 % | CAIN457A2406 · p.7 |
| Percentage of male patients | 54.8 % | CAIN457A2406 · p.7 |
| Mean baseline PASI score | 14.7 | CAIN457A2406 · p.7 |
| Mean baseline IGA mod 2011 score | 3.1 | CAIN457A2406 · p.7 |
| Procedure number | EMA/PAM/0000301644 | Cosentyx · p.1 |
Source: Novartis AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →