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June 14, 2022
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Bimzelx shows consistent safety profile compared with similar psoriasis treatments

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Analysis of multiple trials showed that treatment with Bimzelx for moderate to severe psoriasis was well-tolerated, aside from an increased incidence of mild to moderate oral candidiasis.

“The chronic nature of psoriasis can place a substantial burden on patients’ health and quality of life,” Kenneth B. Gordon, MD, of the Medical College of Wisconsin, and colleagues wrote in their study published in JAMA Dermatology.

To evaluate the 2-year safety profile of Bimzelx (bimekizumab, UCB), the researchers reviewed reports of 1,789 patients who were treated with one or more doses during either a phase 2 or phase 3 trial.

Treatment emergent adverse events occurred at an exposure-adjusted incidence rate of 202.4 per 100 person-years between the trials and did not increase with longer treatment duration.

Serious treatment emergent adverse events occurred at a rate of 5.9 per 100 person-years and the exposure-adjusted incident rate was consistent.

The most frequently reported treatment emergent adverse events based on 100 person-years included nasopharyngitis at a rate of 19.1 (95% CI, 17.4-20.9), oral candidiasis at a rate of 12.6 (95% CI, 11.3-14) and upper respiratory tract infection at a rate of 8.9 (95% CI, 7.8-10.1).

The exposure-adjusted incidence rate of infections was 96.7 per 100-person years in total, although the rate of serious infections was low, at a rate of 1 per 100-person years (95% CI, 0.7-1.4). The rate of serious infections was even lower in the phase 3 trial specifically, at a rate of 0.3 per 100 person-years (95% CI, 0.1-1), and the incidence rate did not increase with longer treatment duration.

The researchers noted that the risk for infection among patients with psoriasis is higher than the general population, and that treatment with anti-interleukin-17 biologics may increase the risk. Based on this data, they wrote that the infection rate for those treated with bimekizumab was comparable with patients listed in the Psoriasis Longitudinal Assessment and Registry as well as other clinical studies focused on treatment with interleukin-17 biologics.

Finally, they noted that life with psoriasis can lead to an increased risk for depression and suicidal ideation and behavior (SIB), but their analysis of the phase 2 and phase 3 studies showed that the incidence of adjudicated SIB was low and within the background rate for patients with psoriasis.