New Drug in the Biologic Therapy Arsenal for Plaque Psoriasis
Bimekizumab shows promising effects in clinical studies with psoriasis patients. Let's take a closer look at this recently approved drug in our brief summary.
Pathogenesis of Psoriasis and Targeted Therapy
Psoriasis affects up to 3% of adults in the western world and is associated not only with skin manifestations but also with a number of comorbidities such as psoriatic arthritis, cardiovascular and metabolic disorders, or psychological diseases.
Recent discoveries have allowed us to better understand certain processes in the pathogenesis of the disease, and consequently, several biologic drugs targeting the inflammatory pathways of IL-17 and IL-23 interleukins have been introduced to the market. Psoriasis is now one of the best-managed chronic inflammatory diseases. However, some patients do not tolerate the therapy, do not respond to it, or gradually lose response.
Promising alternatives are antibodies with a dual mechanism of action that influence the signaling of two different cytokines simultaneously, which could lead to better disease control.
Bimekizumab in Psoriasis Treatment
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively neutralizes IL-17A and IL-17F. It is currently undergoing clinical evaluation for its efficacy in treating several immune-related diseases. As of August 20, 2021, the drug has been approved in the EU for the treatment of moderate to severe plaque psoriasis requiring systemic therapy.
The efficacy and safety of bimekizumab in this indication were assessed in 4 large phase III clinical studies, which demonstrated its superiority compared to placebo, IL-12/23 inhibitor ustekinumab, tumor necrosis factor (TNF) inhibitor adalimumab, and IL-17A inhibitor secukinumab.
Efficacy
The onset of action was very rapid, with 85% of patients treated with bimekizumab in the BE VIVID clinical study achieving a 90% reduction in the Psoriasis Area and Severity Index (PASI90) by week 16, compared to 50% of patients treated with ustekinumab and 4% in the placebo arm.
Safety Profile
Bimekizumab exhibits a safety profile similar to other biologics targeting IL-17. The most common adverse events were upper respiratory tract infections, nasopharyngitis, and oral candidiasis. The incidence rate of oral candidiasis in patients on bimekizumab was higher than with other IL-17 inhibitors (10-15% vs. 1-4%), but the infections were typically localized, mild, and responded well to treatment.
The observed incidence of serious adverse events during treatment ranged from 2-5% in studies. There is currently insufficient data on long-term safety and use in real-world clinical practice.
Conclusion
Due to its different mechanism of action (dual inhibition of IL-17A/F), bimekizumab represents a new therapeutic approach for moderate to severe psoriasis. It is highly effective, with a rapid onset of action and an expected safety profile. It also shows promising results in studies with patients suffering from psoriatic arthritis.
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Sources:
1. Freitas E., Torres T. Bimekizumab: the new drug in the biologics armamentarium for psoriasis. Drugs Context 2021; 10: 2021-4-1, doi: 10.7573/dic.2021-4-1.
2. SPC Bimzelx. Available at: www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_cs.pdf
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