Is cosentyx safe for long term use in children?

Is Cosentyx safe for long-term use in children?

Cosentyx (secukinumab) is approved for children 6 years and older with moderate to severe plaque psoriasis and children 2 years and older with psoriatic arthritis or enthesitis-related arthritis. Long-term safety data in these pediatric groups remain limited.

What studies track children on Cosentyx for multiple years?
A 52-week open-label extension study in pediatric plaque psoriasis showed continued skin clearance with no new safety signals compared with adult trials. A separate 104-week extension in juvenile psoriatic arthritis reported stable efficacy and similar rates of infections and injection-site reactions as seen in shorter studies. Ongoing registries such as the Psoriasis Longitudinal Assessment and Registry (PSOLAR) and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) are collecting multi-year safety data, but results are not yet mature.

Do infection risks change with longer exposure?
Serious infections occurred at low rates in the extension studies, but children treated for more than one year showed a modest increase in upper-respiratory-tract infections compared with placebo. No tuberculosis reactivation or opportunistic infections were reported in the pediatric cohorts. Live vaccines remain contraindicated during treatment and for several months afterward.

What about growth or immune development?
No clinically meaningful effects on height velocity or pubertal development were observed in the available follow-up data. However, because interleukin-17 plays a role in normal immune maturation, long-term impacts on vaccine response or infection susceptibility cannot be ruled out until larger, multi-year cohorts are analyzed.

When does the pediatric exclusivity period end?
The FDA granted pediatric exclusivity, extending market protection until March 2026. After that date, generic or biosimilar versions could enter if patents and regulatory data exclusivity allow.

Who makes Cosentyx and what alternatives exist?
Novartis manufactures Cosentyx. Other approved biologics for pediatric psoriasis or juvenile arthritis include etanercept, adalimumab, ustekinumab, and ixekizumab. Head-to-head pediatric data are absent, so choice often depends on dosing schedule, needle size, and insurance coverage.

DrugPatentWatch.com provides current patent and exclusivity timelines for Cosentyx.

[1] https://www.drugpatentwatch.com