FDA Approves UCB's Bimekizumab-bkzx for Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved UCB's bimekizumab-bkzx (Bimzelx) for adults with active psoriatic arthritis (PsA).¹

The drug is now also approved for non-radiographic axial spondyloarthritis and ankylosing spondylitis. Bimekizumab was also approved for moderate to severe plaque psoriasis in adults in October 2023.² With the addition of these 3 new indications, bimekizumab is now the first and only US-approved inhibitor of IL-17A and IL-17F for a total of 4 chronic immune-mediated inflammatory diseases.

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The FDA's approval of bimekizumab for PsA is supported by positive clinical data stemming from the phase 3 BE OPTIMAL³ and BE COMPLETE⁴ clinical trials.

The BE OPTIMAL trial included 852 patients who were randomized to receive treatment with bimekizumab, a placebo, or a reference (adalimumab). By week 16, a significantly higher proportion of patients treated with bimekizumab (44%) achieved American College of Rheumatology 50 (ARC50) response, whereas only 10% of patients in the placebo group achieved this same response.

In BE COMPLETE, 400 patients with PsA were randomized to receive 160 mg of bimekizumab every 4 weeks or a placebo. At week 16, 43% of patients receiving treatment with bimekizumab achieved ACR50 compared to only 7% in the placebo group. Among those with psoriasis covering at least 3% of their body, 69% achieved a 90% or greater improvement in the Psoriasis Area and Severity Index (PASI90) with bimekizumab, compared to 7% with placebo.

"In phase 3 clinical studies, the clinically meaningful and consistent clinical response in patients who had a previous inadequate response to TNF inhibitors, and in patients who were new to biologics, suggest that bimekizumab-bkzx has the potential to be an important new treatment option in our armamentarium for adults with psoriatic arthritis," said Joseph Merola, MD, MMSc, in a news release.¹ Merola is a professor, board-certified dermatologist, rheumatologist, and an investigator of the BE OPTIMAL and BE COMPLETE clinical trials.

"The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities," Merola said.

Christopher Bunick, MD, PhD, associate professor of dermatology and translational biomedicine at Yale University School of Medicine in New Haven, Connecticut, and Dermatology Times’ 2024 Winter Editor in Chief, shared insights into the approval's significance.

"In an era where plaque psoriasis has numerous highly effective therapies, and standards of care of PASI-90 and -100 response, psoriatic arthritis remains a difficult to treat condition that can severely reduce a patient's daily activities and quality of life," Bunick told Dermatology Times.

"Today's US FDA approval of bimekizumab for adults with PsA, as well as for non-radiographic axial spondyloarthritis and ankylosing spondylitis, empowers the dermatology community with an advanced systemic therapy that can elevate the care of PsA patients. Our lab has shown how bimekizumab is molecularly unique,^5-6 and the dual IL-17A and IL-17F inhibition matters for PsA patients, as evidenced by bimekizumab's PsA trial data showing remarkably consistent ACR50 scores across bio-naive and bio-experienced PsA patients," Bunick said. "Moreover, the safety data in PsA patients is reassuring, with lower rates of oral candidiasis with 160 mg Q4W dosing and rates of suicidal ideation lower for bimzekizmab-treated patients than placebo. Ultimately, bimekizumab is a wonderful new opportunity to bring much needed relief to many PsA patients."

Bimekizumab is already available for eligible patients. For adults with active PsA, as well as the other indications for which bimekizumab is also now approved, the FDA recommends subcutaneous injection of 160 mg every 4 weeks. Dosage and administration recommendations are the same for patients with active PsA and concomitant moderate to severe plaque psoriasis.

References

1. UCB announces US FDA approvals for Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. News release. UCB. September 23, 2024. Accessed September 23, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-us-fda-approvals-for-bimzelxr-bimekizumab-bkzx-for-the-treatment-of-psoriatic-arthritis-non-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis
2. Bimzelx approved by the US FDA for the treatment of adults with moderate to severe plaque psoriasis. News release. UCB. October 18, 2023. Accessed September 23, 2024. 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#:~:text=Inflammatory%20Bowel%20Disease
3. McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(10370):25-37. doi:10.1016/S0140-6736(22)02302-9
4. Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):38-48. doi:10.1016/S0140-6736(22)02303-0
5. Adams R, Bunick CG, Lawson ADG, Gomez B, Shaw S. Crystal structure of bimekizumab fab fragment in complex with IL-17F provides molecular basis for dual IL-17A and IL-17F inhibition. J Invest Dermatol. 2024 Apr 16:S0022-202X(24)00288-4. doi: 10.1016/j.jid.2024.03.037. Epub ahead of print. PMID: 38631666
6. Bader K. Crystal structure of bimekizumab fab fragment supports efficacy of IL-17 dual inhibition. Dermatology Times. July 9, 2024. Accessed September 23, 2024. https://www.dermatologytimes.com/view/crystal-structure-of-bimekizumab-fab-fragment-supports-efficacy-of-il-17-dual-inhibition