Bimekizumab Explained

Bimekizumab, sold under the brand name Bimzelx, is a humanized anti-IL17A, anti-IL-17F, and anti-IL17AF monoclonal antibody^[7] that is used to treat plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis and hidradenitis suppurativa.

The most common side effects include upper respiratory tract infections (nose and throat infection) and oral candidiasis (thrush, a fungal infection in the mouth or throat). Injection site reactions were also common, reported in 3% of subjects.

Bimekizumab was approved for medical use in the European Union in August 2021,^{[8] [9]} and in the United States in October 2023.^{[10] [11]}

In November 2024, bimekizumab was approved by the US Food and Drug Administration for the treatment of active moderate-to-severe hidradenitis suppurativa in adults.^[12]

Medical uses

In the EU, bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, non-radiographic axial spondyloarthritis, and active ankylosing spondylitis.

Society and culture

Names

Bimekizumab is the international nonproprietary name (INN).^[13]

Research

Phase III trials have demonstrated that bimekizumab is superior to not only adalimumab^[14] but also secukinumab^[15] and ustekinumab^[16] for the treatment of plaque psoriasis.

The approval for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) in adults was supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab in the treatment of adults with moderate-to-severe HS.^{[17] [18] [19]}

Further reading

• Reis J, Vender R, Torres T . Bimekizumab: The First Dual Inhibitor of Interleukin (IL)-17A and IL-17F for the Treatment of Psoriatic Disease and Ankylosing Spondylitis . BioDrugs . 33 . 4 . 391–399 . August 2019 . 31172372 . 10.1007/s40259-019-00361-6 . 174812750 .

Notes and References

1. Web site: Updates to the Prescribing Medicines in Pregnancy database . Therapeutic Goods Administration (TGA) . 21 December 2022 . 2 January 2023 . 3 April 2022 . https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database . live .
2. Web site: Bimzelx APMDS . Therapeutic Goods Administration (TGA) . 7 April 2022 . 24 April 2022 . 24 April 2022 . https://web.archive.org/web/20220424055637/https://www.tga.gov.au/apm-summary/bimzelx . live .
3. Web site: Bimzelx Product information . Health Canada . 25 April 2012 . 29 June 2022 . 29 June 2022 . https://web.archive.org/web/20220629032157/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=101427 . live .
4. Web site: Regulatory Decision Summary for Bimzelx . Drug and Health Products Portal . 23 February 2024 . 1 April 2024.
5. Web site: Bimzelx- bimekizumab injection, solution . DailyMed . 20 October 2023 . 10 November 2023.
6. Web site: Bimzelx EPAR . European Medicines Agency (EMA) . 23 June 2021 . 24 August 2021 . 25 August 2021 . https://web.archive.org/web/20210825042145/https://www.ema.europa.eu/en/medicines/human/EPAR/bimzelx . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
7. Lim SY, Oon HH . Systematic review of immunomodulatory therapies for hidradenitis suppurativa . Biologics: Targets and Therapy. 13 . 53–78 . 13 May 2019 . 31190730 . 6526329 . 10.2147/BTT.S199862 . free .
8. Web site: Bimzelx Product information . Union Register of medicinal products . 3 March 2023 . 4 March 2023 . https://web.archive.org/web/20230304104806/https://ec.europa.eu/health/documents/community-register/html/h1575.htm . live .
9. UCB Announces European Commission Approval of Bimzelx (bimekizumab) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis . UCB . 24 August 2021 . 24 August 2021 . 25 August 2021 . https://web.archive.org/web/20210825043245/https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-European-Commission-Approval-of-BIMZELX-bimekizumab-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis . live .
10. Web site: Frellick M . FDA Approves Bimekizumab for Plaque Psoriasis in Adults . . 18 October 2023 . 28 October 2023 . 28 October 2023 . https://web.archive.org/web/20231028071500/https://www.medscape.com/viewarticle/997490 . live .
11. Bimzelx Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis . UCB . 18 October 2023 . 28 October 2023 . 28 October 2023 . https://web.archive.org/web/20231028071447/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 . live .
12. Web site: UCB . UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa . 2024-11-20 . www.prnewswire.com . en.
13. ((World Health Organization)) . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 72 . WHO Drug Information . 28 . 3 . 2014 . 10665/331112 . free . World Health Organization .
14. Warren RB, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, Langley RG, Vanvoorden V, De Cuyper D, Cioffi C, Peterson L, Cross N, Reich K . Bimekizumab versus Adalimumab in Plaque Psoriasis . The New England Journal of Medicine . 385 . 2 . 130–141 . July 2021 . 33891379 . 10.1056/NEJMoa2102388 . 233372177 . doi . free .
15. Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A . Bimekizumab versus Secukinumab in Plaque Psoriasis . The New England Journal of Medicine . 385 . 2 . 142–152 . July 2021 . 33891380 . 10.1056/NEJMoa2102383 . 233370455 . doi . free .
16. Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, Gordon KB, Merola JF, Okubo Y, Madden C, Wang M, Cioffi C, Vanvoorden V, Lebwohl M . 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 . 397 . 10273 . 487–498 . February 2021 . 33549193 . 10.1016/S0140-6736(21)00125-2 . 231809826 .
17. Kimball AB, Jemec GB, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC . Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials . Lancet . 403 . 10443 . 2504–2519 . June 2024 . 38795716 . 10.1016/S0140-6736(24)00101-6 .
18. Web site: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I) . 2024-11-20 . clinicaltrials.gov.
19. Web site: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II) . 2024-11-20 . clinicaltrials.gov.