For patients with moderate to severe plaque psoriasis, bimekizumab was well tolerated, according to a study published in JAMA Dermatology. Kenneth B. Gordon, MD, and colleagues evaluated the 2-year safety profile of bimekizumab in patients with moderate to severe psoriasis from a cohort of four phase II clinical trials and four phase III randomized clinical trials. Data were examined for adults with psoriasis (PASI level ≥12; ≥10% BSA affected by psoriasis; IGA score ≥3 on a five-point scale) who were eligible for systemic psoriasis therapy and/ or phototherapy.
“Bimekizumab has the highest rate of efficacy seen in clinical trials for the treatment of moderate to severe psoriasis,” Dr. Gordon notes. “That being said, examination of the long-term safety is critical in understanding the therapeutic utility of this medication. Our understanding of the safety related to longer exposures to the medication is of particular importance.”
Most Cases of Oral Candidiasis Were Mild or Moderate
Across the phase II/III trials, 1,789 patients (70.0% men; mean [SD] age, 45.2 [13.5] years) were treated with one or more doses of bimekizumab and were included in these analyses.
Most cases of oral candidiasis were mild or moderate; three events led to medication discontinuation. The EAIRs of inflammatory bowel disease (0.1 per 100 person year), adjudicated major adverse cardiac events (0.5 per 100 person-years), and adjudicated suicidal ideation and behavior (0.0 per 100 person-years) were low.
No Increased Serious Infection or Cancer Risks
“The key findings of our study are mostly concerns associated with medications that modulate the immune system,” Dr. Gordon notes. “Encouragingly, there seem to be no increased risks for serious infections or cancer while patients are on bimekizumab. Importantly, longer-term studies are on-going to look at even greater exposure, but to date, the safety record is promising.”
However, the one area where bimekizumab does increase the likelihood of infection is with oral candidiasis, he adds. “These cases are overwhelmingly mild and are straightforward to treat,” he says. “Moreover, the number of cases seems to diminish with more prolonged exposure to the medication. Finally, very few patients dropped out of the studies due to candidiasis. That said, this is an issue that is more pronounced with bimekizumab than other medications for psoriasis, so clinicians need to be aware and counsel patients accordingly.”
Dr. Gordon and colleagues note that it is critical to effectively treat patients with moderate to severe plaque psoriasis. “Bimekizumab, when approved, will likely be an important therapeutic choice for physicians,” Dr. Gordon says. “It is centrally important for dermatologists to have a good understanding of not only the efficacy, but also safety, of all of medications that can help our patients.”
Originally Published By 2 Minute Medicine®. Reused in Physician’s Weekly with permission. ©2022 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.