Analysis: Long-Term Ixekizumab Not Linked to Higher Cancer Risk in PsO, PsA
KEY TAKEAWAYS
Malignancy rates among ixekizumab (IXE)-treated patients remained low and consistent over time, according to a new pooled analysis.
Standardized incidence ratios were comparable to those of the general U.S. population.
The data support the long-term safety of IXE across PsO, PsA, and axSpA.
A recent pooled analysis of 25 randomized clinical trials (RCTs) found no increased risk of malignant neoplasms with long-term ixekizumab (IXE) therapy in patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA).
The study included more than 9,200 patients (n = 9,225) with 22,371.1 patient-years of IXE exposure. Reported malignant neoplasms occurred in 2.0% of PsO patients (IR = 0.8 per 100 patient-years), 1.1% of PsA patients (IR = 0.7), and 1.0% of axSpA patients (IR = 0.4). Standardized incidence ratios showed no excess malignancy risk associated with IXE treatment. Nonmelanoma skin cancer (NMSC) occured most frequently in PsO and PsA patients. No NMSC cases were reported in the axSpA group. Breast, prostate, and lung cancer incidence rates were ≤0.1 per 100 PY for all cohorts. Malignancy-attributable deaths were rare (they occurred in ≤5.3% of affected participants).
"This study shows that the safety profile of IXE supports its long-term use in patients with PsO, PsA, or axSpA, without an increased risk for malignant neoplasm development," the authors concluded. "This conclusion is substantiated by SIRs of malignant neoplasms observed across the indications under study, which were comparable to those observed in the US general population."
The authors went on to say that the study results should give both clinicians and patients additional confidence in IXE as a reliable treatment option for long-term use in individuals with PsO, PsA, or axSpA.
"Further validation resides in the observed malignant neoplasm rates across indications, falling within or better than the reference benchmarks derived from data in an RCT registry and claims database," they wrote. "This is evidenced by incidences of malignant neoplasms consistent with previous reports, and with SIRs of malignant neoplasms across indications similar to the US general population."
Source: Merola J, et al. JAMA Dermatology. 2025. doi:10.1001/jamadermatol.2025.2056