Highlights from

SPIN 2019

Skin Inflammation & Psoriasis International Network

Paris 25-27 April 2019

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. This good news on the long-term safety of ixekizumab was supposed to be presented by the first author Prof. Christopher Griffiths (University of Manchester, UK) but was due to circumstances given by Prof. Kristian Reich (“with an English accent”; Georg-August-University Göttingen, Germany) [1]. Prof. Reich pointed out that with 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. Prof. Griffiths and colleagues performed a pooled analysis of 13 controlled and uncontrolled phase 1-3 studies using ixekizumab in psoriasis totalling >17,000 patient years of exposure.

Prof. Reich presented the data: “The absolute numbers of safety events are actually very low here, one of the highest events here is infections, 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 more 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 longer 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.

  1. Griffiths CE, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis: Results from more than 17000 patient-years of exposure. P005, SPIN 2019, 25-27 April, Paris, France.

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