By: Bhojranie Brahmanand, PharmD Candidate c/o 2025

On October 18, 2023, the United States Food and Drug Administration (FDA) approved Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis.¹ Psoriasis is an immune-mediated inflammatory disease that is associated with cutaneous and systemic manifestations. The pathophysiology can be characterized by abnormal keratinocyte proliferation and immune cell infiltration within the epidermis. Immune cells, specifically T-cells, mistakenly attack healthy skin cells causing inflammation. In turn, this triggers the body to create an accelerated buildup of skin cells known as plaques, which are commonly observed as elevated red patches on the elbows, knees, scalp, or lower back.²

Traditional treatments include topical agents, photo-based therapies, and biologic agents. However, bimekizumab’s recent approval marks a milestone in improving the standard of care for those who suffer from plaque psoriasis as it is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines that are responsible for causing the inflammation – interleukin (IL)-17A and IL-17F. ³

The efficacy and safety of bimekizumab was evaluated in three Phase 3 studies. For each study, the participants enrolled had chronic plaque psoriasis for at least six months prior to screening, an affected body surface area of at least 10%, a Psoriasis Area and Severity Index (PASI) of at least 12 (can range from 0-72) and an Investigator’s Global Assessment (IGA) score of at least 3 on a 5-point scale. Furthermore, the primary endpoints were a 90% or greater reduction from baseline in the PASI score (PASI 90) and an IGA score of 0 or 1 (scores range from 0 to 4 with lower scores indicating clearer skin). All three studies showed that the most common adverse event was nasopharyngitis but all cases found were mild to moderate in intensity.^4,5,6

The BE VIVID study consisted of patients treated with bimekizumab 320 mg every 4 weeks to active comparator ustekinumab 45 mg every 12 weeks or a placebo for a duration of 52 weeks. At week 16, 273 of 321 patients (85%) in the bimekizumab group had a PASI 90 versus 81 of 163 patients (50%) in the ustekinumab group and 4 of 83 patients (5%) in the placebo group. Additionally, at week 16, 84% of patients in the bimekizumab group had an IGA response score of 0 or 1 versus 53% in the ustekinumab group and 5% in the placebo group. The data showed that bimekizumab was more efficacious than a traditional drug in the treatment of moderate to severe plaque psoriasis.⁴

The BE READY study had a total of 435 participants who were randomized to either bimekizumab 320 mg or placebo every 4 weeks for a total of 56 weeks. Coprimary endpoints were met at week 16, where 317 of 349 patients (91%) receiving bimekizumab achieved a PASI 90 compared to 1 of 86 patients (1%) receiving placebo. It was also found that 323 of 349 patients (93%) receiving bimekizumab 320 mg every 4 weeks achieved an IGA score of 0 or 1 versus 1 of 86 patients (1%) receiving the placebo.⁵   It is evident to say that bimekizumab presented high levels of response which were substantial over the 56-week time period supporting its therapeutic value.

The BE SURE study compared bimekizumab to adalimumab and lasted a total of 56 weeks. There were approximately 478 participants given either 320 mg of bimekizumab every 4 weeks or 40 mg of adalimumab every 2 weeks. At week 16, a total of 275 of 319 patients (86%) who received bimekizumab achieved a PASI 90versus 75 of 159 patients (47%) who received adalimumab.⁶

Furthermore, out of 319 patients who received bimekizumab, 272 (85.3%) achieved an IGA score of 0 or 1, whereas only 91 out of 159 patients (57%) who received adalimumab attained the same score. The BE SURE study was able to demonstrate that bimekizumab was noninferior and superior to the drug adalimumab in reducing symptoms.⁶

Bimekizumab shows promising results in improving outcomes for many psoriasis patients that would help alleviate the physical and emotional burden of the condition. The three phase 3 studies assessing the effectiveness and safety of bimekizumab have shown that the drug has achieved higher levels of skin clearance compared to those who received a placebo or biologics targeting only the IL-17A cytokine. More than 8 out of 10 patients had achieved a 90% reduction from baseline and an IGA score of 0 or 1 at only 16 weeks. Today, the drug is currently being studied as a possible treatment option for other conditions such as axial spondylarthritis, rheumatoid arthritis, and ulcerative colitis.

References

1. BIMZELX[®] approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. Press release. UCB. October 18, 2023. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis
2. Campanati A, Marani A, Martina E, Diotallevi F, Radi G, Offidani A. Psoriasis as an Immune-Mediated and Inflammatory Systemic Disease: From Pathophysiology to Novel Therapeutic Approaches. Biomedicines. 2021;9(11):1511. Published 2021 Oct 21. doi:10.3390/biomedicines9111511
3. Camiña-Conforto G, Mateu-Arrom L, López-Ferrer A, Puig L. Bimekizumab in the Treatment of Plaque Psoriasis: Focus on Patient Selection and Perspectives. Patient Prefer Adherence. 2023;17:1541-1549. Published 2023 Jun 30. doi:10.2147/PPA.S350760
4. Reich K, Papp KA, 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;397(10273):487-498. doi:10.1016/S0140-6736(21)00125-2
5. Gordon KB, Foley P, Krueger JG, 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;397(10273):475-486. doi:10.1016/S0140-6736(21)00126-4
6. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141. doi:10.1056/NEJMoa2102388

Published by Rho Chi Post