No Increased Malignancy Risk with Ixekizumab Save

This study assessed the risk of malignant neoplasms in PsO, PsA, or axSpA patients treated with up to 6 years of IXE treatment, by comparison with the US general population.

A global pooled analysis examined data from 25 randomized clinical trials (RCTs) in patients with PsO, PsA, or axSpA receiving at least 1 dose of IXE over 5 years (PsO) or 3 years (PsA and axSpA). Most of the patients were naive to biologic treatments. The primary outcomes was the Incidence rates of malignant neoplasms and standardized incidence ratios (SIRs).

The study included PsO/PsA/axSpA patiens with a mean age of 46 years and included: 

• 6892 PsO patients exposed for 22 371.1 patient-years (PY) (18 025.7 PY for PsO 
• 1401 PsA patients exposed for 2247.7 PY for PsA
• 932 axSpA patients exposed for 2097.7 PY for axSpA

Reported Malignancy risks were not elevated and were significanly lower than the general population for PsO and axSpA patients on IXE:

• PsO (incidence rate [IR], 0.8 per 100 PY [95% CI, 0.7-0.9])
• PsA (IR 0.7 per 100 PY [95% CI, 0.4-1.1])
• axSpA (IR, 0.4 per 100 PY [95% CI, 0.2-0.8]). IRs of malignant neoplasms at 1-year intervals remained low (≤1.2 per 100 PY) and constant over time. 
• SIRs with 95% CIs were below or near 1 (PsO, 0.89 [95% CI, 0.71-1.08]; PsA, 0.49 [95% CI, 0.13-0.85]; axSpA, 1.07 [95% CI, 0.37-1.77]).

This risk of malignant neoplasms in PsO, PsA and axSpA patients treated with IXE is similar to the US general population. Thes data do not include conclusions regarding nonmelanoma skin cancer.