Bimzelx (bimekizumab-bkzx) / UCB - LARVOL DELTA

Evaluating the Effectiveness of Switching Treatments in Chronic Psoriasis: A Targeted Literature Review (ISPOR-EU 2024) - "Participants with PASI<75 achieved PASI≥75 when switched from etanercept to ixekizumab (77.6%) or tildrakizumab (53.8%). Participants with PASI<90 achieved PASI≥90 when ustekinumab, adalimumab and secukinumab were switched to bimekizumab (90.0%, 91.0% and 79.0%, respectively), or when adalimumab was switched to guselkumab (66.1%). Switching adalimumab to risankizumab increased the proportion with PASI≥90 (21.0% vs 66.0%), as did switching ustekinumab to guselkumab (24.0% vs 50.0%), a fumaric acid ester to guselkumab (50.0% vs 80.0%), and a phosphodiesterase 4 inhibitor (apremilast) to risankizumab (2.6% vs 72.3%)... Switching biologic treatments can enhance psoriasis disease control, but it is unclear if this is because of desensitization to the initial treatment or the introduction of newer, more effective treatments. To address this research gap, studies that swap between parallel treatment arms should be conducted to determine the most effective treatment strategy."

Review • Dermatology • Immunology • Psoriasis

Induction Cost Per Responder of Brodalumab Compared With Other Biologic Therapies for Patients With Moderate to Severe Plaque Psoriasis in Canada (ISPOR-EU 2024) - "The CPR was estimated as the drug acquisition costs during the induction period multiplied by the number needed to treat (NNT) for achieving PASI 75, 90, or 100 for the following treatments: adalimumab (innovator and SEB), brodalumab, bimekizumab, certolizumab pegol, etanercept (innovator and SEB), guselkumab, infliximab (innovator and SEB), ixekizumab, risankizumab, secukinumab, tildrakizumab, ustekinumab (innovator and SEB). These results demonstrate that brodalumab has the lowest induction CPR across all PASI outcomes compared to other biologic therapies, including SEB therapies, thus providing the best value for money for patients, prescribers, and payers."

Clinical • Dermatology • Immunology • Psoriasis

Lichen planus-like reaction following bimekizumab treatment in a psoriatic patient with HCV infection. (PubMed, Eur J Dermatol) - No abstract available

Journal • Dermatology • Dermatopathology • Hepatitis C • Immunology • Infectious Disease • Lichen Planus

G-BA Assigns "Not Proven" Added Benefit Rating to UCB Pharma’s Bimzelx for Hidradenitis Suppurativa (NAVLIN DAILY) - "The Federal Joint Committee (G-BA) has given UCB Pharma’s Bimzelx (bimekizumab) 'Not Proven' added benefit rating for the treatment of adult patients with active moderate to severe hidradenitis suppurativa (acne inversa) who have had an inadequate response to conventional systemic therapy. G-BA assessed Bimzelx based on the clinical data from the approval studies BE HEARD I and BE HEARD II; however, no conclusions regarding the additional benefit could be derived from these studies. In its appraisal document, G-BA noted the list price of Bimzelx 350mg as EUR 5,146.71 after deducting statutory discounts."

Reimbursement • Hidradenitis Suppurativa

A Systematic Review of Pharmacological Interventions for Hidradenitis Suppurativa: A Focus on Clinical Response, Quality of Life, and Safety (ISPOR-EU 2024) - "Adalimumab, anakinra, apremilast, avacopan, bimekizumab, doxycycline, guselkumab, IFX-1, MABp1, PF-06650833, PF-06700841, PF-06826647, povorcitinib, risankizumab, RIST4721, secukinumab, upadacitinib all reported notable clinical benefits, with Hidradenitis Suppurativa Clinical Response (HiSCR) ranged from 10% (anakinra at week 24) to 88% (povorcitinib-90 mg at week 8)...In contrast, no SAEs were detected in spesolimab or anakinra, while bimekizumab had similar safety profiles to adalimumab. The results of this review demonstrate the possibility of highly personalized treatment approaches for HS management, including adalimumab and povorcitinib. The optimization of HS care requires further research on long-term outcomes."

Clinical • HEOR • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

Real-world Experience of Bimekizumab for Plaque Psoriasis in Adult Patients with Prior Exposure to Interleukin-17 Inhibitors: A 16-week Multicenter Retrospective Review (ACR Convergence 2024) - "Prior IL-17i agents included secukinumab (62.8%, 27/43), ixekizumab (39.5%, 17/43), and brodalumab (37.2%, 16/43); 32.6% (14/43) utilized ³2 IL-17i agents. In the BE RADIANT open-label extension study, IGA 0/1, PASI90, and PASI100 responses were 95.7%, 50.9%, and 20.8%, respectively, at week 4 for secukinumab PASI90 non-responders who switched to bimekizumab following a 48-week randomization period. Our results at week 16±6 are comparable for IGA 0/1 (96.8%) and superior for PASI90 (83.7%) and PASI100 (62.8%). Notably, our real-world study included prior IL-17i primary non-responders, while phase III clinical trials excluded this population."

Real-world • Real-world evidence • Retrospective data • Review • Candidiasis • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Psychiatry • Rheumatology • Seronegative Spondyloarthropathies • Suicidal Ideation • IL17A

Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. (PubMed, Dermatol Ther (Heidelb)) - P3 | "In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas."

Journal • P3 data • Dermatology • Immunology • Psoriasis

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: UCB Biopharma SRL | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

Bimekizumab Efficacy and Safety Through 4 Years in Moderate to Severe Plaque Psoriasis: Long-Term Results from a Phase 3 Study and Open-Label Extension (ACR Convergence 2024) - P3 | "Background/Purpose: Clinical improvements through Week 152, with no unexpected safety findings, were previously reported with bimekizumab (BKZ) in the BE SURE phase 3 trial and BE BRIGHT open-label extension.1,2 Here, we evaluate long-term efficacy of BKZ, as measured by complete (100% improvement from baseline in Psoriasis Area and Severity Index [PASI 100]) or near-complete skin clearance (PASI 90), in addition to safety of BKZ, through 4 years of treatment. In BE SURE (NCT03412747), patients with moderate to severe plaque psoriasis were randomized 1:1:1 to either BKZ 320 mg every 4 weeks (Q4W) to Week 16 then Q8W to Week 56 (BKZ Q4W/Q8W), BKZ Q4W to Week 56 (Q4W/Q4W), or adalimumab (ADA) 40 mg Q2W to Week 24 then BKZ Q4W to Week 56 (ADA/BKZ).1At Week 56, patients could enroll in BE BRIGHT (NCT03598790) to receive open-label BKZ Q4W or Q8W; 3 all received BKZ Q8W from Week 104 or next scheduled visit.Efficacy data are reported through Week 200 by initial..."

Clinical • P3 data • Candidiasis • Dermatology • Immunology • Infectious Disease • Psoriasis • Respiratory Diseases

Low Uveitis Rates in Patients with Axial Spondyloarthritis or Psoriatic Arthritis Treated with Bimekizumab: Long-Term Results from Phase 2b/3 Trials (ACR Convergence 2024) - "Across 2,514 PY in pts with axSpA and 3,656 PY in pts with PsA, the long-term data suggest that the incidence of uveitis in pts treated with BKZ remains low."

Clinical • P2/3 data • P2b data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Ocular Inflammation • Ophthalmology • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis • IL17A

Bimekizumab Treatment Was Efficacious to 2 Years Regardless of Duration of axSpA Symptoms: Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "BKZ treatment was efficacious to 2 yrs, regardless of DoS. Overall, no difference in Wk 16 treatment effect of BKZ vs PBO between pts with shorter vs longer DoS was found."

P3 data • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Achievement of Remission Defined by Absence of Objective Signs of Inflammation versus ASDAS ID in Patients with Active Axial Spondyloarthritis Treated with Bimekizumab: 52-Week Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "In general, a higher proportion of patients treated with BKZ achieved remission defined by the absence of OSI compared to ASDAS ID. These findings suggest that ASDAS ID could underestimate the anti-inflammatory effects of BKZ, while also highlighting a potential need for optimized endpoints to guide clinical treatment management in axSpA."

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • CRP • IL17A

How Quickly Will I Feel Better with This New Drug? – Rapidity of Treatment Response in Patients with Axial Spondyloarthritis Treated with Bimekizumab: Analysis from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "Patients across the full disease spectrum of axSpA treated with BKZ achieved rapid treatment responses, with early separation from PBO as early as 1–2 weeks after a single dose of BKZ at baseline. These results are of practical importance for counseling patients with axSpA."

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Pain • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Reporting Mental Health and Associated Disorders from Trials of Bimekizumab in Patients with Active Axial Spondyloarthritis and Psoriatic Arthritis (ACR Convergence 2024) - P3 | " Treatment-emergent adverse events (TEAEs) reported for pooled phase 2/3 axSpA/PsA trial populations (BE AGILE 1 & 2, BE MOBILE 1 & 2, BE MOVING, AS0013; BE ACTIVE 1 & 2, BE OPTIMAL, BE COMPLETE, BE VITAL)...BE OPTIMAL included an active reference arm (sc adalimumab 40 mg Q2W) to provide a reference for BKZ benefit/risk profile... Across trials of BKZ in pts with axSpA and PsA, eC-SSRS and PHQ-9 scores were low and similar to PBO to Wk 16. Adjudicated SIB, anxiety, and depression rates remained low to 1 yr, despite impacts of the COVID-19 pandemic."

Clinical • Ankylosing Spondylitis • CNS Disorders • Depression • Immunology • Infectious Disease • Inflammatory Arthritis • Mood Disorders • Novel Coronavirus Disease • Psoriatic Arthritis • Psychiatry • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Suicidal Ideation • IL17A

Updated Long-Term Safety and Tolerability of Bimekizumab in Patients with Axial Spondyloarthritis and Psoriatic Arthritis: Pooled Results from Phase 2b/3 Studies (ACR Convergence 2024) - "With an additional year of exposure, the long-term safety profile of BKZ in pts with axSpA and PsA remained consistent with prior studies; no new safety signals or concerns were raised.1"

Clinical • P2/3 data • P2b data • Ankylosing Spondylitis • Candidiasis • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Ocular Inflammation • Ophthalmology • Psoriatic Arthritis • Psychiatry • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Suicidal Ideation • Tuberculosis • Uveitis

Bimekizumab-Treated Patients with Active Psoriatic Arthritis Showed Sustained Improvements in Pain and Fatigue: Up to 2-Year Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "Both had a 16-wk double-blind, placebo (PBO)‑controlled period; BE OPTIMAL included a reference arm (adalimumab [ADA] 40 mg every 2 wks). Treatment with BKZ demonstrated sustained improvements to 2 years in patient‑reported pain and fatigue, symptoms that are associated with active PsA. Similar improvements were observed irrespective of prior bDMARD treatment. Patients who switched from ADA to BKZ at Wk 52 showed sustained improvements in pain and fatigue up to 2 years."

Clinical • P3 data • Fatigue • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Achieving Stringent Disease Control Criteria Was Associated with Greater Work Productivity Improvements in Patients with Active Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab (ACR Convergence 2024) - P3 | "Achievement of increasingly stringent disease control criteria and lower disease activity was associated with greater improvements in work productivity up to 1 year in patients with PsA. Similar improvements were observed in bDMARD-naïve and TNFi-IR patients."

Clinical • P3 data • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Bimekizumab Maintained Efficacy Responses in Patients with Active Psoriatic Arthritis: Up to 2-Year Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "BKZ demonstrated robust maintenance of response at 2 years in both bDMARD-naïve and TNFi-IR pts with PsA who responded to BKZ treatment at Wk 16. The safety profile was consistent with previous reports.2,3"

Clinical • P3 data • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Sustained Improvements with Bimekizumab in Patient-Reported Symptoms of Axial Spondyloarthritis: 2-Year Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "Results from 2 years of treatment with BKZ demonstrated consistently sustained improvements in spinal pain, morning stiffness, and fatigue in pts across the full disease spectrum of axSpA. These findings support the longer-term maintenance of BKZ benefits on clinical symptoms, which are important to pts and have a substantial impact on their daily lives."

Clinical • P3 data • Ankylosing Spondylitis • Fatigue • Immunology • Inflammatory Arthritis • Pain • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Bimekizumab Maintained Stringent Clinical Responses over 2 Years in Patients with Axial Spondyloarthritis: Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "Using the most critical statistical methodology (NRI or WCI; MI), BKZ maintained stringent clinical responses from Wk 16 to Wk 104 in axSpA. No new safety signals were observed."

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Bimekizumab-Treated Patients with Active Psoriatic Arthritis Showed Sustained Reductions in Disease Impact Assessed by the Psoriatic Arthritis Impact of Disease (PsAID)-12 Questionnaire: Up to 2‑Year Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "BE OPTIMAL included a reference arm (sc adalimumab [ADA] 40 mg Q2W); these pts switched to BKZ at Wk 52 (ADA/BKZ) with no washout between treatments. BKZ treatment demonstrated sustained reduction in disease impact up to 2 yrs in pts with PsA who were bDMARD-naïve or TNFi-IR. Pts who switched from ADA to BKZ at Wk 52 showed sustained reduction in disease impact up to 2 yrs."

Clinical • P3 data • Fatigue • Immunology • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Bimekizumab Impact on Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Core Domains for Patients with Psoriatic Arthritis: Results up to 2 Years of Treatment Duration (ACR Convergence 2024) - P3 | "BE OPTIMAL included a reference arm (adalimumab 40 mg Q2W); pts switched to BKZ at Wk 52 (data not shown).2,3,7From Wk 16, all PBO-randomized pts received BKZ 160 mg Q4W. Treatment with BKZ resulted in robust improvement maintained up to 2 yrs across GRAPPA domains with low rates of IBD and no uveitis for both bDMARD‑naïve and TNFi‑IR pts with PsA; results from pts with axSpA support efficacy in the axial domain."

Clinical • Ankylosing Spondylitis • Dermatology • Immunology • Inflammatory Arthritis • Ocular Inflammation • Ophthalmology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis

Efficacy and Safety of the Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (XKH004) in Patients with Active Ankylosing Spondylitis: Findings from a 24-Week, Phase 2 Multicenter, Randomized, Placebo-Controlled Study (ACR Convergence 2024) - "Background/Purpose: XKH004, the first recombinant anti-human IL-17A/F humanized monoclonal antibody in China (also known as XKH004), shares the same therapeutic target as Bimekizumab from UCB pharma, the first biologic targeting IL-17 A/F (XKH004 is the second one worldwide). In patients with active AS, various dosages of XKH004 effectively improved disease activity. The safety and tolerability profile were favorable, and no immunogenicity risk was identified for up to 24 weeks."

Clinical • P2 data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Patient-Reported Symptoms Improved with Stringent Control of Swollen Joints in Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab (ACR Convergence 2024) - P3 | "Both had a 16-week (wk) double-blind, placebo-controlled period; BE OPTIMAL included a reference arm (adalimumab 40 mg Q2W). Attaining stringent control of SJC was associated with greater improvements in pt‑reported pain and fatigue, sustained up to 2 years in pts with PsA. Notably, the most substantial improvements were observed with SJC=0, underscoring the pivotal role of complete resolution as a treatment target."

Clinical • P3 data • Dermatitis • Fatigue • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Sustained Improvements with Bimekizumab in Spinal Mobility, Physical Function and Health-Related Quality of Life in Patients with Axial Spondyloarthritis: 2-Year Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "BKZ treatment resulted in sustained improvements in spinal mobility, physical function, and HRQoL over 2 years across the full disease spectrum of axSpA."

Clinical • HEOR • P3 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A