In September, the U.S. Food & Drug Administration (FDA) approved three new indications for bimekizumab-bkzx (Bimzelx) in adults: psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).1
Bimekizumab-bkzx (Bimzelx) is a humanized interleukin (IL) 17A and F antagonist injection initially approved by the FDA on Oct. 17, 2023, for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.2 As previously reported, the FDA accepted these supplemental biologics license applications in February 2024.3,4
The recommended FDA-approved dosing for adults with these new indications is 160 mg of subcutaneous bimekizumab-bkzx every four weeks.
PsA
The approval of bimekizumab-bkzx in adults with PsA was supported by data from the phase 3 BE OPTIMAL and BE COMPLETE studies. These two trials were double blind and placebo controlled.5,6
In BE OPTIMAL, patients (N=852) who had not previously received biologic disease-modifying anti-rheumatic drugs (bDMARDs) were evaluated. In BE COMPLETE, patients (N=400) who were intolerant of or had an inadequate response to one or two tumor necrosis factor (TNF) alpha inhibitors were evaluated. The primary end point of both studies was a ACR50 response at week 16 compared with placebo. In both studies, this end point was met and was clinically and statistically significant (P<0.0001). Uniform study results were seen in both biologic-naive patients and those for whom TNF inhibitors had been inadequate.
The clinical response targets were reached at week 16 and maintained through week 52 in BE OPTIMAL and BE COMPLETE, as well as an open-label extension study, which used ACR50 as the primary end point.4,5,7,8
Additionally, all ranked secondary end points were met. These end points included Psoriasis Area and Severity Index 90 (PASI90) response rates, minimal disease activity and PASI100 response rates (e.g., complete skin clearance). These secondary end points were maintained through week 52.
The most common adverse reactions in these clinical trials were diarrhea, headache, oral candidiasis, upper respiratory tract infection and urinary tract infection.
nr-axSpA & AS
The approval of bimekizumab-bkzx for adults with nr-axSpA and objective inflammation signs was supported by data from BE MOBILE 1 (n=254). Meanwhile, the agent’s approval for |adults with active AS was supported by data from BE MOBILE 2 (n=332). Both of these clinical trials were double blind and placebo controlled.9,10
In these studies, patients taking bimekizumab achieved an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at week 16, meeting the study’s primary end point (P< 0.001) and all secondary end points.s.Uniform ASAS40 results were seen in patients who were TNF inhibitor naive and those for whom TNF inhibitors were inadequate. The clinical responses achieved at week 16 were maintained through week 52 in both patients with nr-axSpA and AS, as assessed by ASAS40 and secondary and other end points.
The most common adverse reactions in the nr-axSpA clinical trial were cough, diarrhea, headache, fatigue, musculoskeletal pain, myalgia, oral candidiasis, tonsilitis, transaminase increase, urinary tract infection and upper respiratory tract infections. The most common adverse reactions in the AS clinical trial were diarrhea, headache, injection site pain, oral candidiasis, rash, upper respiratory tract infections and vulvovaginal mycotic infection.
No new safety signals for bimekizumab-bkzx were identified. It is recommended that clinicians review important safety information in the product labeling prior to prescribing bimekizumab-bkzx.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- 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’s Global Corporate website. 2024 Sep 23.
- Highlights of prescribing information: Bimzelx (bimekizumab-bkzx) injection. U.S. Food & Drug Administration. 2023 Oct.
- UCB on growth path for a decade plus [news release]. UCB’s Global Corporate website. 2024 Feb 28.
- Kaufman M. New indications possible for bimekizumab-bkzx. The Rheumatologist. 2024 May 28.
- 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 Jan 7;401(10370):25–37.
- 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 Jan 7;401(10370):38–48.
- 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 Nov;82(11):1404–1414.
- 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 Feb 22;10:e003855.
- 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 Apr;82(4):515–526.
- 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 Jan 11;83(2):199–213.
