Is long-term treatment with ixekizumab sufficiently safe?
Psoriasis is a chronic inflammatory disease whose manifestations require long-term treatment. A poster presented at last year's European Academy of Dermatology and Venereology (EADV) congress summarizes ixekizumab safety data from monitoring lasting up to 5 years, based on nearly 18,000 patient-years (PY) in the treatment of this disease.
Ixekizumab in the treatment of psoriasis
Ixekizumab is a high-affinity antibody that selectively binds to interleukin 17A (IL-17A). In a number of clinical studies, it has achieved significant efficacy in treating moderate to severe plaque psoriasis and has been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use in adults and children over 6 years old. The short-term safety profile of ixekizumab to date is consistent with IL-17A inhibition and is comparable to etanercept.
Population of assessed patients
Data on the long-term safety profile were collected from a total of 16 clinical studies focused on the treatment of plaque psoriasis, including the UNCOVER-1, -2, and -3 studies, across both adult and pediatric populations. Patients (n = 6645) who received at least 1 dose of the medication were included in the analysis; the total exposure to the medication reached 17,902 PY. More than 5 years of ixekizumab use was recorded in 1351 patients.
Analysis results
The incidence rate [IR] of one or more treatment-emergent adverse events (TEAEs) per 100 PY was 31.4 (95% confidence interval [CI] 30.6–32.3). The most commonly reported TEAEs were nasopharyngitis (IR 8.9/100 PY; 95% CI 8.5–9.4) and upper respiratory tract infections (IR 5.7/100 PY; 95% CI 5.3–6.0).
The IR for serious adverse events (SAEs) per 100 PY was 5.4 (95% CI 5.1–5.7). The mortality rate was 0.2/100 PY (95% CI 0.1–0.3) and the IR for treatment discontinuation due to adverse events was 2.8/100 PY (95% CI 2.6–3.1).
The IR for TEAEs, SAEs, infections, injection site reactions, serious cerebro-cardiovascular events, malignancies, inflammatory bowel diseases, and depression did not increase during the treatment period (up to 5 years).
Conclusion
The analysis of long-term monitoring data did not reveal any new safety signals in patients with moderate to severe plaque psoriasis. The safety profile of long-term treatment with ixekizumab is consistent with current knowledge and does not change over time.
(eko)
Source: Griffiths C. E. M., Reich K., Gooderham M. et al. Long term safety of ixekizumab in patients with moderate-to-severe plaque psoriasis up to 5 years: pooled data from 16 clinical trials. EADV Congress, 2020 Oct 29–31.
Did you like this article? Would you like to comment on it? Write to us. We are interested in your opinion. We will not publish it, but we will gladly answer you.
