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How Safe Is Bimekizumab for Moderate-to-Severe Plaque Psoriasis?

In pooled analyses of data from eight randomized clinical trials, no increased risk for TEAEs seen with increased duration of exposure

By Dermsquared Editorial Team | May 11, 2022

For patients with moderate-to-severe plaque psoriasis, bimekizumab is well tolerated, according to a study published online May 11 in JAMA Dermatology .

Kenneth B. Gordon, M.D., from the Medical College of Wisconsin in Milwaukee, and colleagues examined the two-year safety profile of bimekizumab in patients with moderate-to-severe plaque psoriasis using pooled safety data from a cohort of patients from four phase 2 randomized clinical trials and four phase 3 randomized clinical trials. Data were included for 1,789 patients (mean age, 45.2 years) with moderate-to-severe plaque psoriasis who were eligible for systemic psoriasis therapy and/or phototherapy, with total bimekizumab exposure of 3,109.7 person-years.

The researchers found that treatment-emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 202.4 per 100 person-years and did not increase with a longer duration of exposure to bimekizumab. Nasopharyngitis, oral candidiasis, and upper respiratory tract infections were the most frequently reported TEAEs (19.1, 12.6, and 8.9 per 100 person-years, respectively). Oral candidiasis events were mostly mild to moderate; three led to discontinuation of bimekizumab. Low EAIRs were seen for inflammatory bowel disease, adjudicated suicidal ideation and behavior, and adjudicated major adverse cardiac events (0.1, 0.0, and 0.5 per 100 person-years, respectively).

"Overall, bimekizumab was well tolerated in patients with moderate-to-severe plaque psoriasis, and there was no increased risk of AEs with longer duration of exposure," the authors write.

Several authors disclosed financial ties to biopharmaceutical companies, including UCB Pharma, which manufactures bimekizumab and funded the study.

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