Clinical trials and postmarketing surveillance suggest secukinumab has a favorable safety profile and low rates of discontinuation. A new study evaluated those metrics in a real-world setting in axial spondyloarthritis (AxSpA) and psoriatic arthritis (PsA).
About two-thirds of patients who are prescribed secukinumab (Cosentyx) for axial spondyloarthritis (AxSpA) and psoriatic arthritis (PsA) remained on the drug after a year, according to a new report based on real-world evidence.
The report, published in Frontiers in Medicine, offers new context as to when and why patients stop taking the biologic, which, like other biologics, can be associated with adverse effects (AEs) such as infections and hypersensitivity reactions in some patients.
Corresponding author Rubén Queiro, MD, PhD, of the Central University Hospital of Asturias, in Spain, and colleagues explained that secukinumab (SEC), a human monoclonal antibody targeting interleukin 17A, had a favorable safety profile in clinical trials. In addition, postmarketing surveillance has shown the therapy has a low frequency of discontinuation.
“However, we currently have no consistent data on long-term survival of SEC in patients with AxSpA and PsA in routine clinical practice,” the investigators wrote.
They therefore performed a multicenter retrospective observational study of patients with AxSpa or PsA who were prescribed and received at least 1 dose of SEC. The primary end points were AEs and drug retention rates.
Altogether, 154 patients were included in the study: 59 had PsA and the remaining 95 patients had AxSpA. The overall disease duration was 6.5 years, and most of the enrollees (61%) had previously been treated with at least 2 biologics before being prescribed SEC.
After 1 year, the data showed that 66% of patients were still taking SEC. However, by the end of the second year, the retention rate was 43%. Those who quit primarily stopped taking SEC due to lack of efficacy (59%), and 36% said they stopped the therapy because of AEs. Nearly three-quarters (71%) of patients who quit the therapy due to AEs did so in the first 6 months of treatment.
The most common AEs were gastrointestinal (GI) disorders, which occurred in 6 patients and included symptoms such as nausea, vomiting, and abdominal pain. There were 2 cases of Crohn disease. All 6 patients with GI AEs withdrew, as did 4 of 5 patients who reported infections. Five patients had disorders of the skin and subcutaneous tissue, and all 5 withdrew as well.
Queiro and colleagues found a number of factors that made a patient less likely to discontinue SEC, and these included male gender, obesity, hypertension, and diabetes. The investigators said the finding that obesity was linked with better drug survival was interesting, since previous reports have suggested patients who are obese and who have psoriasis tend to have a poor therapeutic response to SEC.
“However, we found that obesity, and other components of metabolic syndrome, were predictors of longer survival for SEC therapy,” they wrote. “Therefore, SEC could be a good therapeutic choice in obese patients with AxSpA and PsA as opposed to [tumor necrosis factor inhibitor] agents.”
Factors associated with discontinuation included number of previous biologics and depression.
Queiro and colleagues acknowledged some limitations, including the relatively small sample size and the retrospective nature of the study. They said their findings ought to be replicated in larger cohorts, but that they still show SEC appears to be performing well in clinical practice.
“Treatment persistence has been optimal even in third line treatment, independent of underlying disease, and obesity does not seem a marker of poor treatment response,” they concluded.
Alonso S, Villa I, Fernández S, et al. Multicenter study of secukinumab survival and safety in spondyloarthritis and psoriatic arthritis: SEcukinumab in Cantabria and ASTURias study. Front Med (Lausanne). Published online May 26, 2021. doi:10.3389/fmed.2021.679009