Secukinumab Demonstrates Long-Term Safety for Psoriasis and PsA

New findings from a real-world study has demonstrated long-term safety of secukinumab in people with psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).1

“Patients with immune-mediated inflammatory diseases such as PsO, PsA and AS, require prolonged treatment and are more susceptible to developing AEs as observed in clinical studies and case reports. Therefore, there is the need to continuously collect safety data to monitor the long-term usage of secukinumab, particularly in a real-world setting where patient selection is not strictly performed as is the case for clinical trials. Safety data deriving from long-term real-world experience may have greater value, where patient selection is less stringent than in clinical trials,” lead investigator Elena Ippoliti, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica Del Sacro Cuore, Rome, Italy, and colleagues wrote.1

Ippoliti and colleagues conducted a bicentric observational study that enrolled 332 patients with PsO (n = 142; 43%), PsA (n = 152; 46%) and AS (n = 38; 11%) who received subcutaneous injections of secukinumab for up to 9 years at University Hospitals based in Rome. The study collected adverse event (AE) data as exposure-adjusted incidence rates (EAIRs) per 100 patient-years (pt-y). Participants had a mean age of 55.45 years (standard deviation [SD], 16.14) at baseline and around half (n = 194; 58%) were male.

Participants had a total secukinumab exposure of 1129 pt-y and a retention rate of 73%, with 16 (4.8%) of patients discontinuing due to AEs. There were a total of 108 AEs observed and 76 (23%) participants reported experiencing at least 1 AE. The investigators found that most AEs were reported within the first 2 years, and overall, incidence was low and decreased over time. Accordingly, the EAIR of any AEs was the highest in the first 6 months (32.72/100 pt-y; cumulative incidence [CI], 15.96%), followed by year 1 (7.62/100 pt-y; CI, 7.44%), and year 2 of treatment (3.01/100 pt-y; CI, 7.39%). The most common AEs were respiratory and urinary tract infections, candidiasis, and diarrhea. Investigators also stratified the study by PsO and PsA but found no significant differences between AE incidence or type between subgroups.

“The current study investigated the safety profile of secukinumab across its different indications, identifying respiratory, candida and urinary tract infections and diarrhea as the most common AEs. The rates of occurrence of these AEs were relatively low in secukinumab-exposed patients and resolved during treatment. Based on our findings, long-term usage of secukinumab was not associated with the persistence of AEs or treatment interruption, confirming its valuable safety profile. In conclusion, this clinical experience confirmed the sustained safety of secukinumab for an extended 9-year exposure period and supported its use in the decision-making for the long-term management of these chronic immune-inflammatory disorders,” Ippoliti and colleagues concluded.1

Although the study contained a long observation period, Ippoliti and colleagues noted that it did have a small, localized sample size. Another limitation is the tendency of underreporting AEs over time due to recall bias. They further acknowledged that the study did not compare the risk of AEs with different secukinumab dosages or compare AEs by age.

“Thereby, future studies including a larger cohort of patients could be of great interest for comparisons across secukinumab indications and populations,” Ippoliti and colleagues wrote.1

REFERENCES

1. Ippoliti E, Falco GM, Torres T, et al. Long-Term Real-World Safety Profile of Secukinumab Assessed Through a 9-Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study. Derm Ther. Published online May 24, 2025. doi.org/10.1155/dth/9618241.

2. Liang J., Zhang S., Li Q., Yu Y., Chen X., and Zhang X., Review of Secukinumab-Induced Adverse Events of Special Interest and its Potential Pathogenesis. Derm Ther. (2022) 35, no. 8, doi: 10.1111/dth.15599.