Bimekizumab Therapy Tolerated in Moderate to Severe Plaque Psoriasis
Despite this, an increased incidence of mild to moderate oral candidiasis was also observed in the pooled data from 8 trials.
Kenneth B. Gordon, MD
New analyses of 2-year treatment data from 8 randomized clinical trials found bimekizumab therapy to be well tolerated among patients with plaque psoriasis, demonstrating a favorable safety profile and no safety signals.
Additionally, no increased risk of adverse events with longer duration of exposure was observed.
Much like other biologic therapies, bimekizumab- a monoclonal IgG1 antibody- has a well-established safety profile, and has remained a mainstay of treatment for patients with moderate to severe plaque psoriasis.
An investigative team led by Kenneth Gordon, MD, Medical College of Wisconsin, reported safety data from 4 phase 2 randomized clinical trials and 4 phase 3 RCTs to assess the longer-term safety profile of the biologic in these patients.
The phase 2 trials included BE ABLE 1 and 2, PS0016 and PS0018, and the phase 3 trials consisted of BE VIVID, BE READY, BE SURE, and BE BRIGHT.
Eligible patients included adults with moderate to severe disease with a baseline Psoriasis Area and Severity Index. (PASI) score greater than or equal to 12, in addition to 10% or more of their body surface area affected by psoriasis and an Investigator’s Global Assessment score greater than or equal to 3 on a 5-point scale.
Patients with active symptomatic inflammatory bowel disease (IBD), a recent myocardial infarction or stroke, an active tuberculosis infection, or higher risk of TB infection were excluded.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that occurred during exposure to treatment including less than or equal to 140 days after the last dose, while serious adverse events were defined as any adverse event that led to either death, a life-threatening event, substantial or persistent disability or incapacity, congenital anomaly, or birth defect, and initial or prolonged hospitalization.
Across all trials, a total of 1789 patients received 1 or more doses of bimekizumab, 1252 of whom were women (70%) while 537 were men (30%). The mean age of participants was 45 years, and baseline characteristics and characteristics were similar between all dose groups.
Total bimekizumab exposure was 3109.7 person-years, and the analyses indicated that TEAEs occurred at an exposure-adjusted incidence rate (EAIR) of 202.4 per 100 person-years and did not increase with longer exposure duration.
Additionally, the most commonly reported TEAEs included nasopharyngitis (19.1 per 100 person-years, 95% CI, 17.4-20.9 per 100 person-years), oral candidiasis (12.6 per 100 person-years, 95% CI, 11.3-14.0 per 100 person-years), and upper respiratory tract infection (8.9 per 100 person-years, 95% CI, 7.8-10.1 per 100 person-years).
While most events of oral candidiasis were mild or moderate, 3 of these events led to discontinuation.
Meanwhile, incidences of inflammatory bowel disease, adjudicated suicidal ideation and behavior, and adjudicated major adverse cardiac events were comparably low.
“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 team wrote.
The study, "Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials," was published online in JAMA Dermatology.
