A NEW analysis has found that long-term treatment with ixekizumab (IXE), an IL-17A inhibitor, is not associated with an increased risk of malignant neoplasms in patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA). These chronic inflammatory conditions require ongoing therapy, and concerns have been raised about the long-term cancer risk linked to both the diseases themselves and their treatment with immunosuppressive agents.
This post hoc analysis included data from 25 randomised clinical trials, assessing over five years of IXE exposure in patients with PsO and three years in those with PsA and axSpA. Importantly, standardised incidence ratios (SIRs) for malignant neoplasms, excluding nonmelanoma skin cancer (NMSC), were calculated using US SEER registry data to provide context.
The findings show that cancer incidence rates remained low and stable across all patient groups. Reported rates were similar to those in long-term studies of other biologics and within the expected range for patients with PsO, PsA, or axSpA based on real-world registries and meta-analyses. For instance, the incidence rate of cancer in PsO patients was previously reported as 1.75 per 100 patient-years (PY), and 0.64 per 100 PY in PsA, figures that align with this study’s outcomes.
The study also observed a low rate (IR ≤0.4 per 100 PY) of NMSC in PsO and PsA patients and none in axSpA. Common cancers such as breast, prostate, and lung cancer were infrequent (IR ≤0.1 per 100 PY). Additionally, deaths due to cancer were low, with none reported in the axSpA group.
Overall, this comprehensive safety analysis supports the long-term use of ixekizumab in treating PsO, PsA, and axSpA, without a notable increase in cancer risk, offering reassurance to clinicians and patients managing these chronic conditions.
Reference
Merola JF et al. Ixekizumab and malignant neoplasms: a pooled analysis of data from 25 randomized clinical trials. JAMA Dermatol. 2025;DOI:10.1001/jamadermatol.2025.2056.
