FDA Approves Bimekizumab for Treatment of Psoriatic Arthritis, Non-Radiographic AxSpA, and Ankylosing Spondylitis

The FDA today approved bimekizumab-bkzx (Bimzelx), an IL-17A and IL-17F inhibitor, for the treatment of adults with active psoriatic arthritis, people with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation, and adults with active ankylosing spondylitis (AS), UCB announced in a press release.1

The approvals are based on results from the Phase 3 BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials in psoriatic arthritis, the Phase 3 BE MOBILE 1 study (NCT03928704) in nr-axSpA, and the BE MOBILE 2 study (NCT03928743) in AS.

Bimekizumab has been approved by the FDA for three new indications. | Photo credit: wladimir1804 – stock.adobe.com

The approval of [bimekizumab] The U.S. study in three new indications – active psoriatic arthritis, active non-radiographic axSpA with objective signs of inflammation, and active ankylosing spondylitis – highlights the clinical benefit of dual IL-17A and IL-17F inhibition for patients and provides an opportunity for more people with chronic inflammatory diseases to achieve meaningful outcomes, said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer of UCB, in a statement. In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the U.S. have highlighted that [bimekizumab] may help patients achieve high thresholds of clinical response that are rapid in onset and maintained for up to 2 years.

In the BE OPTIMAL and BE COMPLETE trials, bimekizumab met the primary endpoint of American College of Rheumatology 50 (ACR50) responses at 16 weeks compared with placebo.2,3

The BE OPTIMAL study included 852 patients randomized to receive either bimekizumab (n = 431), placebo (n = 281), or reference adalimumab (n = 140).2 At 16 weeks, 44% of the bimekizumab group achieved an ACR50 response compared with 10% of the placebo group (OR, 7.1; 95% CI, 4.6-10.9; P < .0001). All secondary endpoints were also met. In the BE COMPLETE study, 400 patients were randomized to receive either bimekizumab (n = 267) or placebo (n = 133), also with a primary endpoint of ACR50 at week 16. 3 In the bimekizumab cohort, 43% of patients achieved ACR50 versus 7% in the placebo group (adjusted OR, 11.1; 95% CI, 5.4-23.0; P < .0001).

In phase 3 clinical studies, clinically meaningful and consistent clinical response in patients who had previously had an inadequate response to TNF [tumor necrosis factor] Serotonin reuptake inhibitors and biologic-naïve patients suggest that bimekizumab-bkzx has the potential to be an important new treatment option in our armamentarium for adults with psoriatic arthritis, Joseph F. Merola, MD, MMSc, ​​professor, dermatologist, rheumatologist and investigator of BE OPTIMAL and BE COMPLETE, said in a statement.1 The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities.

In nr-axSpA and AS, bimekizumab met the primary endpoint of Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 16 compared with placebo in the parallel BE MOBILE 1 and BE MOBILE 2 trials, respectively.4,5

Patients with nr-axSpA in the BE MOBILE 1 trial were randomized 1:1 to receive either bimekizumab or placebo every 4 weeks, and the BE MOBILE 2 trial randomized patients with AS 2:1 to receive either bimekizumab or placebo. After 16 weeks, all patients received bimekizumab every 4 weeks.

In phase 3 clinical studies, patients treated with bimekizumab-bkzx experienced improvements in signs and symptoms and key measures of disease activity at week 16 that were sustained through one year and remained consistent in patients with nonradiographic axial spondyloarthritis and ankylosing spondylitis, said Atul Deodhar, MD, professor of medicine and medical director of the rheumatology clinics in the Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, Oregon.1 The U.S. rheumatology community applauds the approval of bimekizumab-bkzx for use across the spectrum of axial spondyloarthritis, especially since there are few currently approved options to treat both nonradiographic axial spondyloarthritis and ankylosing spondylitis.

In October 2023, bimekizumab was approved for moderate-to-severe plaque psoriasis in adults eligible for systemic therapy or phototherapy.6 With the new indications, bimekizumab is the first and only IL-17A and IL-17F inhibitor approved by the FDA for 4 chronic immune-mediated inflammatory diseases.1

References

1. UCB Announces US FDA Approval of Bimzelx (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis. Press Release. UCB. September 23, 2024. Retrieved September 23, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-US-FDA-approvals-for-BIMZELXR-bimekizumab-bkzx-for-the-treatment-of-psoriatic-arthritis-non-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis

2. McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis not treated with biologics: a phase 3 randomized, double-blind, placebo-controlled trial (BE OPTIMAL). Lancet. 2023;401(10370):25-37. doi:10.1016/S0140-6736(22)02302-9

3. Merola JF, Landew R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis who have had an inadequate response to or intolerance to tumor necrosis factor inhibitors: a randomized, double-blind, placebo-controlled phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):38–48. doi:10.1016/S0140-6736(22)02303-0

4. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results from two parallel phase 3 randomized controlled trials. Ann Rheum Dis. 2023;82(4):515–526. doi:10.1136/ard-2022-223595

5. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab treatment in patients with active axial spondyloarthritis: efficacy and safety at 52 weeks from the randomized, parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2024;83(2):199-213. doi:10.1136/ard-2023-224803

6. Myshko D. Bimekizumab-bkzx, the newest psoriasis treatment, is now available. AJMC. November 30, 2023. Accessed September 23, 2024. https://www.ajmc.com/view/bimekizumab-bkzx-the-newest-psoriasis-treatment-is-now-available

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