Favourable safety profile of long-term use of ixekizumab

Ixekizumab (IL-17A blocker) shows a consistent long-term safety profile in treating psoriasis with 5+ years of drug exposure in a large pooled database including 17,003 patient-years of exposure [1].

Results of this integrated analysis of 11 clinical trials were presented by Prof. Kristian Reich (Georg-August-University Göttingen, Germany), who pointed out that when it comes to drugs with which we only have limited experience, it is essential to capture data about safety as early as possible from as many patients as possible. A pooled analysis was performed of 11 controlled and uncontrolled phase 1-3 studies using ixekizumab in psoriasis totalling >17,000 patient years of exposure.

Prof. Reich: “The absolute numbers of safety events are actually very low here; infections are among the most frequent, but you have to treat 100 patients for 1 year to see 1 event, and this is in the ballpark with other targeted therapies.” The incidence rate of serious adverse events, infections, major adverse cardiovascular events, malignancy, and depression did not increase with longer ixekizumab exposure. No unexpected safety outcomes were reported up to 5 years and the safety profile was consistent with previous reports in ixekizumab-treated patients. Allergic reactions or hypersensitivities were the most frequently reported adverse event. The authors concluded this data does not suggest that safety events are increasing over time, although they also warned that patients at very high risk may no longer take part in the in the study after long periods. Interestingly, the psychiatric comorbidity (i.e. depression/anxiety) of patients on ixekizumab appears to steadily reduce over time. To summarise, there is a good benefit-risk ratio for ixekizumab, class-specific safety, and target-specific safety. Candida infections were within the range of 2-3 events per 100 patient years, and there is no evidence that ixekizumab exacerbates inflammatory bowel disease.

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   1. Langley RG, et al. J Eur Acad Dermatol Venereol. 2019 Feb;33(2):333-339. 

Posted on 21 June, 201924 March, 2021