New Dosing Option for Bimekizumab Now Commercially Available for PsA, Psoriasis, HS

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Bimekizumab-bkzx (BIMZELX) has been announced by UCB as commercially-accessible within the US through prescription in a 2 mL pre-filled syringe and autoinjector, with each dose being 320 mg.¹

The January 16 announcement provides patients and clinicians with additional options for treatment of various inflammatory conditions, adding to the available option of 1 mL device administration and each dose containing 160 mg. The drug itself is a humanized monoclonal IgG1 antibody which was formulated to selectively inhibit interleukin 17A (IL-17A) as well as interleukin 17F (IL-17F) cytokines.

“With five new FDA-approved indications for [bimekizumab] in just over a year, we’ve had the opportunity to reach a wider range of people living with chronic inflammatory conditions who have long been in need of new treatment options,” Camille Lee, head of US Immunology at UCB, said in a statement.

The IL-17F cytokine is known to be over-expressed in the skin of individuals suffering from conditions such as psoriasis, psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis, and hidradenitis suppurativa (HS).

The US Food and Drug Administration announced its approval in October 2024 of the 320 mg single-injection administration option for bimekizumab.² This decision by FDA officials had been supported by research that had demonstrated the bioequivalence of a single 2 mL subcutaneous bimekizumab injection of 320 mg to 2 separate 1 mL subcutaneous injections of the same dose among healthy participants.

The new optional dosing regimen may allow for patients with inflammatory conditions such as psoriasis and HS additional convenience. The UCB announcement highlighted that for conditions such as nr-axSpA with objective signs of inflammation, active PsA without coexisting plaque psoriasis, and active ankylosing spondylitis, the standard recommendation was 160 mg.

The company noted the variation of dosage and administration of bimekizumab by condition, highlighting a set of recommendations provided:

• For those with plaque psoriasis, the recommended dosage was noted as 320 mg subcutaneously at the 0, 4, 8, 12, and 16-week marks, followed by 320 mg every 8 weeks. For those weighing 120 kg or more, the dose may be changed to 320 mg every 4 weeks following Week 16.
• For those with PsA, the recommended dosage was noted as 160 mg subcutaneously every 4 weeks, except in individuals who have coexisting moderate-to-severe plaque psoriasis, where the dosing schedule for plaque psoriasis should be followed.
• For those with nr-axSpA and ankylosing spondylitis, the recommended dosage was noted as 160 mg subcutaneously every 4 weeks.
• For those with hidradenitis suppurativa, the dosage consists of 320 mg administered subcutaneously at the 0, 2, 4, 6, 8, 10, 12, 14, and 16-week marks. This would be followed by 320 mg every 4 weeks thereafter.

UCB further highlighted that it plans to support patients with bimekizumab prescriptions by offering a patient assistance program known as ‘BIMZELX Navigate.’ Patients involved in this program will be provided personalized guidance from a Nurse Navigator on treatment-related goals, provides training on administering bimekizumab, connects eligible individuals to programs for copay assistance, and allows them to receive updates on shipments and insurance coverage.¹

“With the addition of a single-injection administration regimen, we are further expanding options and enhancing the treatment experience for individuals with moderate-to-severe plaque psoriasis, active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis, and moderate-to-severe hidradenitis suppurativa who receive a 320 mg dose of [bimekizumab],” Lee said in a statement.¹

References

1. ^{UCB Announces U.S. Availability of 320 mg/2 mL Single-Injection Administration Option for BIMZELX® (bimekizumab-bkzx). UCB. January 16, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-us-availability-of-320-mg2-ml-single-injection-administration-option-for-bimzelx-bimekizumab-bkzx. Date accessed: January 16, 2024.}
2. ^{UCB. BIMZELX® Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. Press release. Published October 18, 2023. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis. Date accessed: January 16, 2024.}