Clinical Trials Including Elderly Patients
Cosentyx (secukinumab) trials for psoriasis, psoriatic arthritis, and ankylosing spondylitis included patients over 65. In the Phase 3 FUTURE 5 trial for psoriatic arthritis (n=996), 12% were aged 65+, showing similar efficacy and safety to younger groups, with no new signals in pharmacokinetics or immunogenicity.[1] Pooled psoriasis data (n=3,986) had 4.4% aged 65+, with comparable ACR20 responses.[2]
Safety Data in Older Adults
Elderly patients (65+) in Cosentyx trials had higher infection rates (e.g., upper respiratory) but no increased serious infection risk versus placebo. In ankylosing spondylitis trials (n=810), 5% were 65+, with adverse events like diarrhea slightly more common but not statistically significant.[3] Post-marketing data through 2022 noted no unique elderly risks beyond general population trends like candidiasis.[4]
Real-World Evidence and Subgroup Analyses
A 2023 retrospective study in 1,200+ psoriatic arthritis patients found Cosentyx effective in those 65+ (PASI-90 rates ~70% at 12 months), with retention similar to younger cohorts but monitoring advised for comorbidities.[5] Japanese real-world data (n=1,089) showed 10% elderly with good tolerance, though dose adjustments considered for renal impairment.[6]
Regulatory Guidance for Seniors
FDA and EMA labels note no dose changes needed for age alone, but caution for infections and caution in 75+ due to limited data (<1% in trials). No dedicated elderly trials exist, but subgroup analyses support use with risk-benefit assessment.[1][7]
Ongoing Research and Gaps
Phase 4 studies like MAXIMISE (ongoing) stratify by age, focusing on long-term safety in comorbidities common in elderly. Gaps include very elderly (80+) and head-to-head comparisons with other biologics.[8]
[1]: FDA Cosentyx Label
[2]: Bissonnette et al., J Am Acad Dermatol (2018)
[3]: Baraliakos et al., Ann Rheum Dis (2017)
[4]: Novartis Safety Update (2022)
[5]: Glintborg et al., Rheumatology (2023)
[6]: Ito et al., J Dermatol (2022)
[7]: EMA Cosentyx Summary
[8]: ClinicalTrials.gov NCT04895295