お知らせ • Mar 11
UCB Announces Bimzelx Demonstrates Superiority Over Skyrizi In Active Psoriatic Arthritis
UCB announced positive topline data from the BE BOLD trial assessing BIMZELX (bimekizumab) versus SKYRIZI (risankizumab) in adults with active psoriatic arthritis (PsA). Bimekizumab, the first and only approved medicine to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), demonstrated statistically significant superiority in the ACR50 primary efficacy endpoint at Week 16. Treatment with bimekizumab was generally well tolerated, with no new safety signals observed to Week 16. The results of BE BOLD add to the breadth of data for bimekizumab across a range of immune-mediated inflammatory diseases. UCB plans to submit the full BE BOLD results to a forthcoming international congress. ACR50: A 50% or greater improvement from baseline in American College of Rheumatology response criteria, including at least a 50% improvement in tender and swollen joint counts as well as 50% improvement in three additional criteria (physician global, patient global, patient pain, function, and CRP/erythrocyte sedimentation rate). This represents a stringent efficacy outcome in psoriatic arthritis. Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02% to 0.25% of the population. Of people living with psoriasis, approximately 30% progress to also develop psoriatic arthritis. It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis). The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, anxiety, and depression. In PsA, uncontrolled active disease can lead to long-term structural damage. BE BOLD is a multicenter, randomized, double-blind, risankizumab-controlled, parallel-group study designed to evaluate the efficacy and safety of bimekizumab in adult study participants (n=553) with active psoriatic arthritis (PsA). The study includes adults with active PsA who are naïve to biologic treatments or who had previous exposure to one tumor necrosis factor-inhibitor (TNFi) with an inadequate or intolerant response. The primary endpoint in BE BOLD is ACR50 at Week 16. The study has a double-blinded methodology until Week 24. In the study, participants were randomized 1:1 to receive either bimekizumab or risankizumab. BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes. The approved indications for bimekizumab in the European Union are: Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy. The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Live vaccines should not be given in patients treated with bimekizumab. BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes. Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin. The approved indications for BIMZELX in the U.S. are: Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis. Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation. Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis. Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adults with moderate to severe hidradenitis suppurativa. BIMZELX may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.
