Bimekizumab Approved for Psoriatic Arthritis, Ankylosing Spondylitis, AxSpA

The FDA has approved bimekizumab-bkzx (BIMZELX) for treating active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS) in adults.¹

"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," trial investigator Joseph F. Merola, MD, MMSc, Chair of Dermatology, and Professor, Dermatology and Rheumatology, UT Southwestern Medical Center, Dallas, 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."

The approval adds to BIMZELX’s previously approved indication for adults with moderate-to-severe plaque psoriasis² in October 2023 and follows the approval for PsA and AxSpA in Canada in March 2024.³

The FDA recommended dosage of BIMZELX for adult patients with these newly approved indications is 160 mg by subcutaneous injection every 4 weeks.1 For PsA patients with coexistent plaque psoriasis, the dosage and administration is the same as for patients treated for plaque psoriasis. The therapy is currently available for eligible patients.¹

"Psoriatic arthritis can severely impact a person's quality of life. With joint pain and stiffness, daily activities can become burdensome. New treatment options are always a welcome addition, and they offer some renewed hope for relief from the symptoms and health impacts of PsA," Leah M. Howard, JD, President and CEO, National Psoriasis Foundation, added.¹

BIMZELX’s approval for active PsA was supported by data from the phase 3 the BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials, in which BIMZELX met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints, with consistency across both biologic-naïve and TNF inhibitor‑inadequate responder (TNFi-IR) patients. These responses on ACR50, Psoriasis Area and Severity Index 90 (PASI90), minimal disease activity (MDA), and PASI100, were sustained to week 52.^4,5

BIMZELX’s approval for active nr-axSpA with objective signs of inflammation, and active ankylosing spondylitis was supported by data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, respectively. BIMZELX met the primary endpoint of Assessment of SpondyloArthritis international Society 40 (ASAS40) response at Week 16 compared with placebo, and all ranked secondary endpoints, in these studies, with consistency across TNFi-naïve and TNFi-inadequate responder patients. These responses were sustained to week 52.^6,7

"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 AxSpA and ankylosing spondylitis," Atul Deodhar, MD, Professor of Medicine and Medical Director, Rheumatology Clinics, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, added.¹ "The U.S. rheumatology community welcomes the approval of bimekizumab-bkzx for use across the entire spectrum of AxSpA, especially given that there are few options approved currently to treat both nr-AxSpA and ankylosing spondylitis."

REFERENCE

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.

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

3. BIMZELX® (bimekizumab) Now Approved for Adults with Active Psoriatic Arthritis and for Adults with Axial Spondyloarthritis. News release. UCB. March 14, 2024. https://www.newswire.ca/news-releases/bimzelx-r-bimekizumab-now-approved-for-adults-with-active-psoriatic-arthritis-and-for-adults-with-axial-spondyloarthritis-893359005

4. Ritchlin CT, Coates LC, McInnes IB, et al. Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023;82:1404–14.

5. Coates LC, Landewé R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10:e003855.

6. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomized controlled trials. Ann Rheum Dis. 2023;82:515–26.

7. 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.