Real-World Data Suggest Long-Term Treatment With Secukinumab Is Safe, Effective

New research details the long-term safety and efficacy of secukinumab in bio-naïve patients with moderate to severe cutaneous psoriasis.

Writing in Journal of the European Academy of Dermatology and Venerology, study authors explained, “the high efficacy and long-term survival rates observed and the low prevalence of arthritis and comorbidities might suggest that early intervention could contribute to modify the course of the disease, but further studies are needed.”

Secukinumab is a monoclonal antibody that neutralizes interleukin-17A. Previous studies have found the treatment is effective and safe in patients with psoriatic arthritis and pustular, erythrodermic and moderate to severe cutaneous psoriasis.

However, real-world studies on the long-term efficacy and survival in bio-naïve patients are limited, the present study authors said. To address this knowledge gap, they conducted a retrospective, multicenter study in a Spanish cohort of patients with psoriasis. All included patients were naïve to biological therapies and followed for up to 8 years.

Participants were recruited from 8 Spanish hospitals between January 2014 and January 2022. At baseline, patients received 300 mg of secukinumab weekly during the first 4 weeks and then on a monthly basis. During the follow-up period, some went on to receive an intensified or optimized regimen.

Researchers monitored the cohort at baseline; weeks 4, 12, and 24; and every 12 plus or minus 4 weeks until week 416. There were 128 patients included in the study.

Analyses revealed these findings:

• The overall secukinumab survival rate was 81.9% for an average treatment exposure of 147.9 weeks
• The approved posology was the most commonly prescribed regimen (78.7%), and 17.7% could be optimized
• An absolute Psoriasis Activity and Severity Index ≤3 was reached by 86.6%, 82.6% and 91.7% at weeks 48, 156, and 264, respectively
• The incidence of arthritis- or psoriasis-related comorbidities was low
• The response was not influenced by weight, age (older than 65 years), gender, or the presence of arthritis
• No severe adverse events were reported

The mean (SD) patient age was 50.9 (13.95) years, and 18.8% of participants had psoriatic arthritis. In addition, nearly 30% had arterial hypertension, 15% had diabetes, and 35% had dyslipidemia.

Forty-seven percent of participants were obese, and the mean duration of psoriasis prior to treatment was 16.1 (11.8) years. Most patients (92.2%) also had classical psoriasis plaques.

The current study marks one of the largest multicentric long-term cohort reports on real-world experience of secukinumab in bio-naïve psoriatic patients, the authors said.

The overall efficacy in bio-naïve patients reported was similar to that observed in previous reports, they added.

“In our study, both secukinumab response and drug survival in nonbiologic-experienced patients were found to be independent of weight, age, sex, and the presence of psoriatic arthritis, in contrast with some previously reported series, which also included biological-experienced subjects, [that] could explain these facts,” the researchers explained.

The low incidence of psoriatic arthritis, diabetes, and cardiac failure in the current analysis may reinforce theories claiming early intensive treatment with secukinumab might modify the natural course of the disease and even prevent psoriatic arthritis development or psoriasis-related comorbidities.

The absence of a control group and the study’s retrospective design mark limitations. Some baseline characteristics were also not fully documented.

“As observed in our cohort, the high long-term efficacy and survival of secukinumab in bio-naïve patients and the low prevalence of arthritis and psoriasis-related comorbidities might suggest that managing severe psoriasis as a systemic disease, introducing advanced treatments early, could potentially modify the march of this disease, but further studies are needed,” the authors concluded.

Reference

Ramos FJM, Puchades AM, Climent SG, et al. Long-term secukinumab efficacy and safety in bio-naïve patients with moderate-to-severe cutaneous psoriasis: a real-world retrospective noninterventional multicentric experience (128 patients). J Eur Acad Dermatol Venereol. Published online May 27, 2023. doi:10.1002/jvc2.185