The FDA has accepted the supplemental biologics license applications (sBLA) that seek the approval of bimekizumab-bkzx (Bimzelx; Union Chimique Belge) for 3 new spondyloarthritides indications. The indications include psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). A fourth sBLA for hidradenitis suppurativa (HS) was also submitted to the FDA.1
Bimekizumab is a humanized monoclonal immunoglobulin G 1 (IgG1) antibody that is designed to selectively inhibit both interleukin (IL)-17A and IL-17F, which are 2 cytokines that are key to influencing inflammatory processes. The drug was approved by the FDA in October 2023 for the treatment of adults with moderate to severe plaque psoriasis who are eligible for systemic therapies or phototherapies. It is the first and only IL-17A and IL17F inhibitor to be approved by the FDA for this indication.1,2
The sBLA acceptances come after the approval of bimekizumab in Japan in December 2023 for the treatment of adult patients with active PsA, adult patients with active ankylosing spondylitis (AS), and adult patients with nr-axSpA.1
About the Trials
BE HEARD I
- Trial Name: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I)
- ClinicalTrials.gov ID: NCT04242446
- Sponsor: UCB Biopharma SRL
- Completion Date: February 19, 2023
BE HEARD II
- Trial Name: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II)
- ClinicalTrials.gov ID: NCT04242498
- Sponsor: UCB Biopharma SRL
- Completion Date: September 28, 2022
Recently, results from 2 phase 3 studies—BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498)—that evaluated the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe HS were presented at the Conference of the European Hidradenitis Suppurativa (EHSF). The trials were randomized, double-blind, placebo-controlled studies with a primary endpoint of a reduction from baseline in the total abscess and inflammatory nodule count by at least 50% without increase in abscess or draining tunnel count at week 16 (HiSCR50), and a secondary endpoint of HiSCR of at least 75% (HiSCR75) at week 16.2
Both trials included an initial (weeks 0-16) and maintenance treatment period (weeks 16-48). Adult patients (n = 1014) at baseline were randomly assigned to receive either 320 mg of bimekizumab every 2 weeks (Q2W)/Q2W (n = 288), bimekizumab Q2W/every 4 weeks (Q4W; n = 292), bimekizumab Q4W/Q4W (n = 288), or placebo and bimekizumab Q2W (n = 146).2
“The analyses presented at EHSF 2024 build on the phase 3 data communicated to date and reinforce our belief in the potential of bimekizumab to make a meaningful difference to patients,” said Emmanuel Caeymaex, executive vice president at Immunology Solutions and head of US at UCB, in a press release.2
The results indicated that at week 16, a greater number of patients had achieved an International Hidradenitis Suppurativa Severity Score System (IHS4) of 55 when treated with bimekizumab compared with placebo. In addition, by week 48, these responses were either sustained or increased. Patients who had switched from placebo to bimekizumab achieved comparable responses to those who received continuous bimekizumab treatment.2
Further, most patients (69.5%-74.8%) who achieved HiSCR50 at week 16 reported a quality-of-life rating of “none or mild” at week 16, and a higher proportion of patients reported this rating if they achieved HiSCR75 (77.2%-84.3%) or HiSCR90 (80.0%-89.3%) at week 16. The authors note that similar trends were also present at week 48. In addition, patients who were treated with bimekizumab in the lowest disease duration (<2.4 years) achieved HiSCR50/HiSCR75 of 67.5% (n = 133)/48.2% (n = 95) at week 16, compared with those treated with placebo (43.8% [n = 14]/21.9% [n = 7]). Patients who were treated with bimekizumab in the highest disease duration (≥10.87 years) who achieved HiSCR50/HiSCR75 of 53.8% (n = 99)/34.2% (n = 63) at week 16, compared with those treated with placebo (28.9% [n = 13)/20.0% [n = 9]).2
“Results presented re-affirm the high levels of sustained clinical response achieved with bimekizumab treatment, the positive impact on health-related quality of life as reported by patients, and the importance of timely treatment following diagnosis,” said Caeymaex in the press release.2
References
- Union Chimique Belge. UCB on Growth Path for a Decade Plus. News release. February 28, 2024. Accessed February 28, 2024. Email.
- Union Chimique Belge. Latest analyses of bimekizumab phase 3 studies in moderate to severe hidradenitis suppurativa to be presented at EHSF 2024.News release. February 9, 2024. Accessed February 28, 2024. https://www.ucb.com/stories-media/Press-Releases/article/Latest-analyses-of-bimekizumab-phase-3-studies-in-moderate-to-severe-hidradenitis-suppurativa-to-be-presented-at-EHSF-2024
