Long-Term Ixekizumab Use Not Linked to Increased Cancer Risk: Analysis
Key Takeaways
Long-term IXE use did not increase the incidence of malignant neoplasms across PsO, PsA, and axSpA populations, new data indicate.
Standardized incidence rates for malignancy in IXE-treated patients were comparable to the general U.S. population.
Malignancy rates were stable and in line with prior safety data.
Long-term treatment with ixekizumab (IXE) for psoriasis, psoriatic arthritis, and axial spondyloarthritis was not associated with increased risk of malignant neoplasms, according to a new analysis of pooled data from 25 randomized clinical trials.
Researchers for the post hoc pooled safety analysis looked at 9,225 patients treated with IXE [cumulative 22,371 patient-years (PY)]. Malignancy incidence rates excluding nonmelanoma skin cancer (NMSC) were consistent across study cohorts with the general U.S. population, as determined by standardized incidence ratios (SIRs) using SEER data from 2013 to 2017. 6,892 patients with PsO, 1,401 with PsA, and 932 with axSpA were included in the analysis, with a mean age of 45.9 years. Most patients were male and biologic-naive at baseline.
According to the results, malignant neoplasms were reported in 2.0% of PsO patients (IR, 0.8 per 100 PY; 95% CI, 0.7–0.9), 1.1% of PsA patients (IR, 0.7; 95% CI, 0.4–1.1), and 1.0% of axSpA patients (IR, 0.4; 95% CI, 0.2–0.8). Incidence rates did not exceed 1.2 per 100 PY at any annual interval. Prostate and breast cancers were the most frequently reported malignancies.
"These findings support the long-term safety profile of IXE in the treatment of PsO, PsA, and axSpA," the authors wrote. "Rates of malignant neoplasms were consistent with previous studies and aligned with population-level expectations, offering reassurance for continued IXE use."
Study limitations included racial homogeneity, trial setting bias, and lack of comparator arms, the consistency of IRs across cohorts and with SEER benchmarks offers substantial reassurance.
Source: Merola J, et al. JAMA Dermatology. 2025. doi:10.1001/jamadermatol.2025.2056