Secukinumab Retention, Efficacy, Safety Confirmed by Recent Interim Analysis

Findings from a recent 3-year interim analysis of the SERENA study are providing insight the safety, efficacy, and retention of secukinumab for treating psoriatic arthritis (PsA) and ankylosing spondylitis (AS).1

SERENA is a recently completed longitudinal, observational, multinational study examining the retention, effectiveness, and safety of secukinumab in patients with moderate-to-severe plaque psoriasis, active PsA, or active AS. Patients diagnosed with any of the aforementioned diseases who had received commercial secukinumab for ≥16 weeks before registration.2

SERENA enrolled >2800 participants: of these, 1799 had psoriasis, 541 had PsA, and 460 had AS. Patients were followed up with every 6 months until discontinuation of treatment or study end – when all patients would have completed ≥2 years of follow-up or when approximately 1000 patients would have completed the 5-year final visit, whichever occurred last.1

This study solely examines patients with PsA or AS who were enrolled and observed for ≥3 years, specifically at centers in Greece. The primary objective was to evaluate long-term retention of secukinumab in routine clinical practice, which was assessed based on percentage of patients who had not discontinued treatment at specific timepoints after enrollment.1

“Chronic diseases like psoriasis, PsA and AS require long-term treatment, hence real-world retention rate is an important measure of sustained efficacy, long-term safety and patient satisfaction and can help guide clinical decisions,” wrote Andreas Bounas, MD, General Clinic of Patra, and colleagues. “Secukinumab has demonstrated sustained efficacy and safety in international clinical trials of psoriasis, PsA, and AS. However, most real-world evidence in Europe is of limited duration.”1

The study enrolled 218 patients with PsA and 82 with AS. Of these, 4 patients with PsA were excluded due to protocol deviation, while one patient with AS was excluded for not receiving ≥1 secukinumab dose. The final target and safety sets were 295 (214 with PsA and 81 with AS) and 299 (218 with PsA and 81 with AS), respectively. Mean ages were 53 and 48.2 years, respectively.1

Results showed retention rates were high after 1, 2, and 3 years, and were similar between PsA and AS patients. Retention rates for patients with PsA were 98.6% (n = 210; 95% CI; 96.7-100), 90.6% (n = 203; 95% CI, 86.4-94.9), and 79.2% (n = 197; 95% CI, 73.3-85.1), respectively. AS patients exhibited retention rates of 96.3% (n = 81; 95% CI, 91.6-100), 88.6% (n = 79; 95% CI, 81-96.3), and 84.4% (n = 77; 95% CI, 75.7-93.2), respectively. Investigators noted a total of 68 patients discontinued secukinumab treatment within 3-years post enrollment.1

At 3 years post enrollment, percentages of patients in the PsA cohort with tender or swollen joints, dactylitis, and enthesitis were reduced to 19.7%, 1.4%, and 3.4%. In the AS cohort, mean ankylosing spondylitis disease activity score was reduced to 1.7 mg/L post enrollment. 40.9% had <1.3 mg/L (inactive disease) compared with 15.2% at enrollment. Investigators observed similar trends for other outcomes in both cohorts.1

After 3 years, 28.4% of patients with PsA and 32.1% of AS patients had experienced at least 1 adverse effect and 2.3% and 6.2% experienced a severe adverse effect, respectively. No deaths were reported during the observation period.1

Retention, safety, and efficacy rates were all consistent with SERENA – however, the team indicated difficulty discussing the findings in relation to the literature, as SERENA participants were treated with secukinumab for a mean of 1 year prior to the study itself.1

Overall, the study indicated high long-term retention for secukinumab, with similar trends in patients with active PsA and AS, as well as sustained effectiveness and quality of life outcome measures. Safety data collected over the 3-year interim study maintained a favorable safety profile in the real-world setting without any new signals.1

“These outcomes enrich Greek real-world evidence of secukinumab in PsA and AS and strengthen emerging data from other European observational studies, altogether supporting the clinical utility of secukinumab in these diseases,” wrote Bounas and colleagues.1

References

1. Bounas A, Kandyli A, Katsifi G, et al. High long-term retention rates of secukinumab in psoriatic arthritis and ankylosing spondylitis: A 3-year interim analysis from the observational, prospective Serena study, in greek patients. Rheumatology International. 2025;45(5). doi:10.1007/s00296-025-05839-x

2. Augustin M, Sator PG, von Kiedrowski R, et al. Secukinumab demonstrated sustained retention, effectiveness and safety in a real-world setting in patients with moderate-to-severe plaque psoriasis: long-term results from an interim analysis of the SERENA study. J Eur Acad Dermatol Venereol. 2022;36(10):1796-1804. doi:10.1111/jdv.18329