FDA Approves Bimekizumab for Psoriatic Arthritis, Nonradiographic AxSpA, 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, those with active nonradiographic 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 were based on findings 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 was FDA approved for 3 new indications. | Image credit: wladimir1804 - stock.adobe.com

“The approval of [bimekizumab] in the U.S. across 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 inhibition of both IL-17A and IL-17F for patients, and provides an opportunity for more people living with chronic inflammatory diseases to achieve meaningful outcomes,” Emmanuel Caeymaex, executive vice president, Head of Patient Impact, and chief commercial officer at UCB, said in a statement. “In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that [bimekizumab] can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to 2 years.”

In the BE OPTIMAL and BE COMPLETE trials, bimekizumab met the primary end point of American College of Rheumatology 50 (ACR50) responses at 16 weeks vs a placebo.^2,3

BE OPTIMAL 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 experienced ACR50 response vs 10% of the placebo group (OR, 7.1; 95% CI, 4.6-10.9; P < .0001). All secondary ranked end points were also met. In BE COMPLETE, 400 patients were randomized to receive either bimekizumab (n = 267) or placebo (n = 133), also with a primary end point of ACR50) at week 16.³ In the bimekizumab cohort, 43% of patients reached ACR50 vs 7% of the placebo group (adjusted OR, 11.1; 95% CI, 5.4-23.0; P < .0001).

“In Phase 3 clinical studies, the clinically meaningful and consistent clinical response in patients who had a previous inadequate response to TNF [tumor necrosis factor] 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,” 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 end point of Assessment of SpondyloArthritis international Society 40 (ASAS40) response at week 16 vs 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 BE MOBILE 2 randomized patients with AS 2:1 to either bimekizumab or placebo. After 16 weeks, all patients received bimekizumab every 4 weeks.

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

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

References

1. UCB announces U.S. 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.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, naïve 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

3. 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

4. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised 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: 52-week efficacy and safety from the randomised 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