Psoriasis: long-term safety of ixekizumab

Takeaway

• An integrated safety analysis from 13 clinical trials including >17,000 patient-years of exposure supports a favourable safety profile of ixekizumab for the treatment of moderate to severe plaque psoriasis.

Key results

• Total ixekizumab exposure was 17,004.3 patient-years.
• Rates of treatment-emergent adverse events that led to discontinuation declined from 3.8/100 patient-years in year 1 to 2.0/100 patient-years in year 5.
• Rates of non-melanoma skin cancer declined from 0.5/100 patient-years in year 1 to 0.2/100 patient-years in years 4-5.
• Rates of injection site reactions declined from 15.5/100 patient-years in year 1 to 2.0-2.3/100 patient-years in years 3-5.
• Rates of serious adverse events (6.2-7.0/100 patient-years), serious infections (1.3-1.7/100 patient-years), other malignancies (0.4-0.6/100 patient-years), inflammatory bowel disease (0.2/100 patient-years), and major adverse cardiovascular events (0.3-0.7/100 patient-years) were stable during the study period.

Study design

• 5898 patients with moderate to severe plaque psoriasis from 13 clinical trials, 2749 with ≥4 years of exposure to ixekizumab, were analyzed.
• Funding: Eli Lilly and Company.

Limitations

• Potential recall bias.
• Lack of randomised placebo control group after the induction period.
• Follow-up time varied between included studies.