Bimekizumab – Higher Chance of Complete Skin Healing in Moderate to Severe Psoriasis?
In August 2021, the European Medicines Agency (EMA) approved bimekizumab (Bimzelx LP) as the first psoriasis treatment that selectively and directly inhibits interleukins IL-17A and IL-17F. It is intended for the treatment of moderate to severe plaque psoriasis in adults for whom systemic treatment is appropriate. The approval is based on three Phase III clinical studies in which bimekizumab demonstrated a very high rate of skin healing compared to placebo and active treatments like ustekinumab and adalimumab, as well as good tolerability.
Mechanism of Action
The pathophysiology of psoriasis involves elevated levels of interleukins IL-17A and IL-17F. Bimekizumab is a humanized monoclonal IgG1/κ antibody that selectively binds with high affinity to cytokines IL-17A, IL-17F, and IL-17AF, blocking their binding to the IL-17RA/IL-17RC receptor complex. This leads to the normalization of skin inflammation and alleviation of clinical symptoms associated with psoriasis.1
Clinical Efficacy and Safety
The efficacy and safety of bimekizumab were evaluated in three Phase III clinical studies: BE READY, which compared it to placebo; BE VIVID, which compared it to both placebo and ustekinumab; and BE SURE, which compared it to adalimumab. In July 2021, the results from the BE RADIANT study were published, comparing bimekizumab with secukinumab.
The international randomized double-blind study BE READY2 included 435 adults with moderate to severe psoriasis. After 16 weeks, 91% of patients treated with bimekizumab achieved a 90% improvement in the Psoriasis Area and Severity Index (PASI90) compared to 1% of patients on placebo (p < 0.0001), and 93% vs. 1% achieved an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) (p < 0.0001). The efficacy of bimekizumab persisted throughout the 56-week follow-up. Adverse events were reported in 77% of patients receiving active treatment and 69% of those receiving placebo.
The multicenter randomized double-blind study BE VIVID3 included 567 adults with moderate to severe psoriasis (PASI ≥ 12 and ≥ 10% body surface area involvement). After 16 weeks, 85% of patients treated with bimekizumab achieved PASI90 compared to 50% with ustekinumab (p < 0.0001) and 5% with placebo (p < 0.0001). Serious adverse events were reported in 6% of patients treated with bimekizumab and 8% with ustekinumab over one year.
In the randomized study BE SURE4 involving 478 adults with moderate to severe psoriasis, PASI90 was achieved in 86% of cases in the bimekizumab group compared to 47% in the adalimumab group after 16 weeks (p < 0.0001). IGA scores of 0/1 were achieved by 85% of patients treated with bimekizumab and 57% with adalimumab after 16 weeks (p < 0.0001). The most common adverse events with bimekizumab included respiratory tract infections, oral candidiasis (mostly mild to moderate), hypertension, and diarrhea.
In the BE RADIANT5 study involving 743 patients, the primary endpoint was complete clearance of psoriatic lesions (PASI100). After 16 weeks, this was observed in 62% of patients treated with bimekizumab compared to 49% with secukinumab (p < 0.0001), and after 48 weeks, these figures were 67% and 46%, respectively (p < 0.0001). Rapid onset of action was also observed with bimekizumab, with 71% of patients achieving PASI75 after 4 weeks of treatment compared to 47% with secukinumab.
Dosage
The recommended dose of bimekizumab is 320 mg administered as two subcutaneous injections once every 4 weeks until week 16, followed by once every 8 weeks. For some patients weighing ≥ 120 kg who have not achieved complete skin clearance by week 16, continuing the 320 mg dose once every 4 weeks may improve treatment outcomes.
Bimekizumab should not be administered to patients with clinically significant infections. Tuberculosis should be excluded before starting treatment. It is not recommended for patients with inflammatory bowel disease, and live vaccines should not be administered during treatment.1
Conclusion
In clinical studies, patients with moderate to severe psoriasis treated with bimekizumab experienced significantly better skin healing compared to those in placebo, adalimumab, ustekinumab, and secukinumab groups. Approximately 60% of patients achieved complete skin clearance within 16 weeks of treatment with bimekizumab, and this effect persisted for up to one year. Bimekizumab may thus help more patients with moderate to severe psoriasis achieve their treatment goals.
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Sources:
1. SPC Bimzelx. Available at: www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_cs.pdf
2. Gordon K. B., Foley P., Krueger J. G. et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet 2021 Feb 6; 397 (10273): 475−486, doi: 10.1016/S0140-6736(21)00126-4.
3. Reich K., Papp K. A., Blauvelt A. et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet 2021 Feb 6; 397 (10273): 487−498, doi: 10.1016/S0140-6736(21)00125-2.
4. Warren R. B., Blauvelt A., Bagel J. et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med 2021 Jul 8; 385 (2): 130−141, doi: 10.1056/NEJMoa2102388.
5. Reich K., Warren R. B., Lebwohl M. et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med 2021 Jul 8; 385 (2): 142−152, doi: 10.1056/NEJMoa2102383.
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