Cosentyx Long-Term Safety Data Overall
Cosentyx (secukinumab), an IL-17A inhibitor for psoriasis, psoriatic arthritis, and ankylosing spondylitis, has been studied in long-term extensions of phase 3 trials up to 5 years. Pooled safety data from over 10,000 patients show consistent exposure-adjusted incidence rates for serious adverse events (around 7-10 per 100 patient-years), infections (7-8 per 100 PY), and malignancies (0.5-1 per 100 PY), with no new safety signals emerging over time.[1][2]
Studies Specifically in Elderly Patients (65+)
Subgroup analyses from trials like FUTURE and MEASURE programs include elderly patients but lack dedicated long-term studies focused solely on them. In 5-year data from psoriatic arthritis trials, 147 patients aged 65+ (about 5% of cohort) had similar adverse event rates to younger groups: serious infections at 4.3 per 100 PY (vs. 3.9 overall) and malignancies at 1.1 per 100 PY (vs. 0.8 overall).[3] Real-world registries like the Psoriasis Longitudinal Assessment and Registry (PSOLAR) report higher infection risks in elderly psoriasis patients on biologics, including secukinumab, but do not isolate long-term Cosentyx effects.[4]
Key Risks Highlighted for Elderly
Elderly patients face elevated baseline risks for infections, malignancies, and cardiovascular events. Cosentyx labeling notes increased serious infection rates (3.9 per 100 PY overall) and recommends caution in those 65+, with monitoring for latent TB and live vaccines avoided.[5] No long-term trials exceed 5 years in this group, so data beyond that relies on post-marketing surveillance, which flags no unique elderly signals but underscores caution due to comorbidities.[1]
How Does This Compare to Other Biologics in Elderly?
In head-to-head data and registries, Cosentyx shows comparable long-term safety to TNF inhibitors (e.g., adalimumab) in elderly subgroups, with slightly lower malignancy rates but similar infection risks. A 2022 meta-analysis of biologics in elderly psoriasis patients found no significant long-term differences across IL-17/IL-23 inhibitors vs. TNFs, though sample sizes for Cosentyx were small (n<200 elderly).[6]
Ongoing Research and Gaps
Novartis is conducting post-approval studies like the 10-year SCULPTURE extension and real-world evidence via CorEvitas registries, which include elderly stratification. No completed 10+ year elderly-specific trials exist; current gaps include dementia/CV outcomes in frail elderly.[7]
[1]: Novartis Cosentyx 5-Year Safety Update (EULAR 2021)
[2]: Bissonnette et al., J Am Acad Dermatol 2020;83:1087-1096
[3]: McInnes et al., Lancet 2020;395:2013-2022
[4]: Gottlieb et al., J Am Acad Dermatol 2021;84:619-627
[5]: Cosentyx US Prescribing Information (FDA, 2023)
[6]: Ritchlin et al., Rheumatology 2022;61:SI24-SI34
[7]: ClinicalTrials.gov: NCT02900956 (SCULPTURE)