Safety of IL-17A Inhibitors in Patients With Moderate to Severe Psoriasis in a US Claims Data-Based Cohort Study.

Background: Safety outcomes from IL-17A inhibitors have not been fully evaluated.

Objective: Compare the risk of seven safety outcomes in patients with psoriasis who started treatment with either ixekizumab or secukinumab vs other biologics to treat psoriasis.

Methods: In this cohort study (Apr 2016 - Dec 2022), we used US claims data to assess the risk of infections, major adverse cardiac events (MACE), inflammatory bowel disease (IBD), malignancy, and anaphylaxis, in patients with psoriasis starting an IL-17A inhibitor vs other biologics (TNF, IL-12/23, or IL-23 inhibitors).

Results: Among 4261 IL-17A inhibitors users we observed no meaningfully increased risk of MACE (RR = 0.67, 0.27-1.63), or malignancy (RR = 0.92, 0.58-1.45) vs patients initiating other biologics. After propensity score matching IL-17A inhibitors users had a 3-fold increase in the risk of oral candidiasis (RR = 3.43; 1.48-7.84), a 19% increase in the risk of outpatient infections (RR = 1.19; 1.05-1.35) and a 40% increased risk of serious infections with wide confidence intervals (RR = 1.40; 0.72-2.71). We observed a signal for an increased risk of IBD based on very few events.

Conclusion: Patients with psoriasis using an IL-17A inhibitor had an increased risk of oral candidiasis and outpatient infections but no increase for MACE, anaphylaxis, or malignancy compared to other biologics.