According to a poster at the AAD annual meeting, from the year of exposure among patients, the safety profile of ixekizumab was favorable through year 5 without yearly increases of incidence rates.

For this study, researchers aimed to “summarize the safety outcomes from over 18,000 patient-years of exposure (over 5 years) to ixekizumab in adult patients with moderate-to-severe psoriasis.”

Using 15 randomized trials, the study team examined long-term safety of ixekizumab.

“Treatment-emergent adverse events (TEAEs) and adjusted incidence rates per 100 [patient years] within 1-year time periods through 19 March 2021 were calculated for all patients treated with ≥1 dose of ixekizumab,” they explained. Additionally, the researchers noted that they adjudicated any reported cases of major adverse cerebro-cardiovascular events (MACE) and inflammatory bowel disease (IBD).  

The study team identified 6892 adult patients with a total exposure of 18,025.7 patient years. The incident rates per 100 patient years for any TEAE and SAEs were 32.5 and 5.4, respectively.

Additional findings showed that the incident rate for treatment discontinuation because of an adverse event was 2.9.

“The predominant cause of death was MACE (n=17),” they explained. “[Incident rate] of serious infections was low (1.3). There were no confirmed cases of reactivation of tuberculosis.”

Incident rates for Candida infections was low (1.9), and there were no reported systemic cases.

Further incidence rates reported included:

• Injection site reactions (5.9);
• allergic/hypersensitivity reactions—most frequent reactions included dermatitis, eczema, urticaria (5.6).

Of note, incident rates for malignancies, depression, cytopenia, and MACE were all low (all ≤1.2).

“Across safety topics, [incidence rates] decreased or remained constant over time.”

The authors concluded “Safety profile of ixekizumab remained favorable through 5 years with no increase in yearly [incidence rates] from the first year of exposure.”

Reference:

Griffiths CEM, Gooderham M, Colombel JF, et al. Safety of Ixekizumab in Adult Patients with Moderate-to-Severe Psoriasis: data from 15 Clinical Trials with Over 18,000 Patient-Years of Exposure. Poster presented at: AAD Annual Meeting; March 25-28, 2022; Boston, MA.