Ixekizumab’s safety profile ‘reassuring’ after 3-year follow-up in psoriatic arthritis
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Ixekizumab demonstrates a safety and tolerability profile that is “reassuring” and consistent with previous studies in patients with psoriatic arthritis, according to researchers.
“Ixekizumab is an approved drug to target IL-17,” Gerd-Rüdiger Burmester, MD, of Charité-Universitätsmedizin Berlin, told Healio. “It is highly efficacious both regarding the improvement of joint involvement and skin manifestations. Therefore, it is important to know the safety profile of such a reagent. Here, we could use data from four clinical trials with over 2,000 patient-years of exposure and up to 3 years of follow up. In these carefully monitored trials, the quality of data is especially helpful.”
To more fully examine the safety profile of ixekizumab (Taltz, Eli Lilly) through 3 years of follow-up, Burmester and colleagues conducted an integrated safety analysis of four clinical trials where participants received at least one dose of the drug. Researchers included the SPIRIT-P1, SPIRIT-P2, SPIRIT-P3 and SPIRIT-H2H studies. To be included in the analysis, patients were required to have active PsA with at least three of 68 tender and three of 66 swollen joints. Additionally, patients were required to have active psoriatic skin lesions or a documented history of the disease.
Patients with active Crohn’s disease or ulcerative colitis were excluded from the analysis.
Adverse events of interest included infections, injection site reactions, allergic reactions, malignancies — including non-melanoma skin cancer — inflammatory bowel disease, depression, suicidal or self-harming behavior, cytopenia and major adverse cerebrocardiovascular events. Major adverse cardiac events (MACE) and IBD events were analyzed by an external office. Depression as measured using a self-reporting survey and suicidal behavior was analyzed via the Columbia Suicide Rating Scale.
A total of 1,401 patients with a total of 2,247.7 patient-years of ixekizumab exposure were included in the analysis.
According to the researchers, who published their data in the Annals of the Rheumatic Diseases, the exposure-adjusted incidence rate (EAIR) in patients with one or more treatment-emergent adverse event was 50.3 per 100 patient years, with most events being rated as mild to moderate in severity. Serious adverse events were reported in 134 patients, with an EAIR of 6 per 100 patient-years. The most common adverse events through follow up were nasopharyngitis — with an EAIR of 9 per 100 patient years — and upper respiratory tract infections — at 8.3 per 100 patient years.
Infections as a general class and injection site reactions were the most common reported events, the authors wrote. Meanwhile, malignancy, IBD, depression and major cerebrocardiovascular events had a low prevalence overall.
“The data provide important information how to use this drug in our treatment repertoire, especially in patients with risk factors,” Burmester said. “Taken together, the overall safety profile and tolerability of ixekizumab in this very large study are consistent with the known safety profile in patients with PsA. No new or unexpected safety events were detected in a long observation period. These are very reassuring data regarding an important therapeutic principle.”
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