Bimzelx (bimekizumab-bkzx) / UCB, BRL Medicine - LARVOL DELTA

O07 Serious infection risk with systemic treatments for psoriasis: a cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). (PubMed, Br J Dermatol) - "Inclusion criteria were adults who received at least one of the biologics, apremilast or conventional nonbiologics (acitretin, ciclosporin and methotrexate) for ≥ 6 months. All biologics licensed for psoriasis were analysed except for infliximab, which had higher prescription criteria...The certolizumab group had a low mean age of 37.4 years (SD 10.3), the ustekinumab group had a significantly longer median treatment duration of over 4 years (IQR 1.83-6.73), and more patients in the ixekizumab (42.6%) and certolizumab (40.6%) groups had concomitant psoriatic arthritis...IRs (95% CIs) of other tumour necrosis factor-α inhibitors were 15.7 (14.5-17.1) for adalimumab and 16.7 (13.8-20.0) for etanercept. For interleukin-17 inhibitors the IRs (95% CIs) were 18.4 (15.9-21.2) for secukinumab, 7.63 (0.92-27.6) for bimekizumab, 14.5 (7.73-24.8) for brodalumab and 18.5 (14.0-24.0) for ixekizumab. For interleukin-23 inhibitors the IRs (95% CIs) were 13.5 (9.97-17.8) for guselkumab,..."

Journal • Observational data • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

P116 Patient characteristics of biologic-experienced and biologic-naive patients with chronic plaque psoriasis receiving bimekizumab. (PubMed, Br J Dermatol) - "Further analysis might clarify whether these differences impact patient outcomes following bimekizumab treatment.TablePatient characteristics of biologic-experienced and biologic-naive patients with chronic plaque psoriasis treated with bimekizumab in BADBIRPatient characteristicsBiologic experiencedBiologic naiveP-valueNumber of patients, n (%)260 (79.8)66 (20.2)Age (years)44.0 (12.3)49.5 (14.4)< 0.001Male, n (%)156 (60.0)43 (65)0.44Disease duration (years)20.5 (12.6)21.5 (15.6)0.47Number of comorbidities2.0 (1.7)1.8 (1.7)< 0.001Age of psoriasis onset (years)23.5 (13.9)28.0 (16.1)0.10PASI score12.2 (9.1); n = 19616.9 (6.5); n = 630.001DLQI total score13.4 (8.0); n = 8219.8 (7.1); n = 360.005Psoriatic arthritis, n (%)89 (34.2)15 (23)0.07High-impact site involvement Scalp, n (%)189 (72.7)43 (65)0.23 Nail, n (%)130 (50.0)38 (58)0.27The results are the mean (SD), and from all patients in the subgroup unless indicated otherwise. DLQI, Dermatology Life Quality..."

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

Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Bimekizumab treatment resulted in consistent, sustained efficacy to 52 weeks in biologic-naïve and TNFi-IR individuals with PsA and baseline plaque-type psoriasis and nail involvement. Bimekizumab was well tolerated, with a safety profile consistent with previous reports. Graphical abstract available for this article."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Disproportionality analysis of adverse events associated with bimekizumab: a real-world study based on FDA Adverse Event Reporting System (FAERS) Database. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This pharmacovigilance study corroborates established safety profiles of bimekizumab while uncovering previously unreported AE signals. These findings underscore the need for vigilant post-marketing surveillance to refine risk-benefit assessments in clinical practice."

Adverse events • Journal • Real-world evidence • Candidiasis • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Pneumonia • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Forty-eight-week safety of bimekizumab in psoriasis: focus on infectious comorbidities. (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Bimekizumab provided greater improvements in PROs versus comparators, with durable effects over 4 years. These findings reinforce bimekizumab's role in effective psoriasis management, linking clinical efficacy with sustained patient-reported benefits."

Journal • Dermatology • Immunology • Pain • Psoriasis

Safety and Efficacy of Bimekizumab in Patients With Moderate-to-Severe Hidradenitis Suppurativa: A Multicenter Retrospective Cohort Study. (PubMed, Actas Dermosifiliogr) - "Bimekizumab is effective for the treatment of HS in real-world clinical practice, with a manageable safety profile over the 24-week period. Our findings are consistent with those reported in phase 3 clinical trials."

Journal • Retrospective data • Candidiasis • Dermatology • Hidradenitis Suppurativa • Immunology • Pain • IL17A

Real-World Evidence of Secukinumab and Bimekizumab in Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis. (PubMed, Actas Dermosifiliogr) - "IL-17 inhibitors provide moderate response rates and are valuable options for patients refractory to other therapies, with low incidences of mild adverse events. More RWE studies are essential to better understand their safety and efficacy profile."

Clinical • HEOR • Journal • Real-world evidence • Retrospective data • Dermatology • Hidradenitis Suppurativa • Immunology • Pain • IL17A

BeSeen: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: UCB Biopharma SRL | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Psoriasis

HSE approves new treatment for hidradenitis suppurativa and axial spondyloarthritis (PharmaTimes) - "The decision provides a new treatment option for patients who have not responded adequately to conventional therapies....The approval is supported by data from two phase 3 studies, BE HEARD 1 and BE HEARD 2, which assessed 1,014 adult patients with moderate-to-severe HS."

Reimbursement • Ankylosing Spondylitis • Hidradenitis Suppurativa

Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies. (PubMed, RMD Open) - P3 | "Bimekizumab treatment resulted in sustained improvements in patient-reported symptoms and their impacts across the full disease spectrum of axSpA over 2 years, underscoring its long-term potential for improving patients' daily lives."

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

Biologic Breakthroughs: Comparing the Safety and Efficacy of Risankizumab and Bimekizumab in Psoriasis (ISDS 2025) - "The significantly higher rate of any adverse event with Bimekizumab use provides an important consideration for clinicians when choosing treatment for patients with psoriasis, while Risankizumab's significantly decreased risk of severe adverse events, could indicate favorable use."

Clinical • Dermatology • Immunology • Psoriasis • IL17A • IL23A

Characterization of ORKA-002, a Novel Extended Half-life Monoclonal Antibody Targeting IL-17A/F for the Treatment of Psoriasis and Other Indications (ISDS 2025) - "Recently, a biologic targeting both IL-17A and IL-17F, bimekizumab (BIME), has demonstrated high efficacy that exceeds therapies targeting IL-17A only. ORKA-002 exhibits high selectivity and affinity for IL-17A and IL-17F in vitro, potent inhibition of downstream cellular signaling ex vivo, and an extended half-life in non-human primates compared to BIME. These characteristics could result in comparable or increased efficacy compared to BIME with just two to three doses of ORKA-002 a year. Clinical studies are planned to explore this potential."

Dermatology • Immunology • Psoriasis • IL17A • IL6

Impact of Biologic Class on Ocular Outcomes in Psoriasis: Insights from a Multi-Institutional Database Study (ISDS 2025) - "Adults aged 18–89 years with psoriasis who initiated either TNFα inhibitors (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab) or IL-17 inhibitors (secukinumab, ixekizumab, brodalumab, bimekizumab) within one year of diagnosis were identified. In this large, multi-institutional analysis, psoriasis patients treated with TNFα inhibitors experienced higher rates of several ocular inflammatory and degenerative conditions compared to those treated with IL-17 inhibitors. These findings highlight the importance of considering ocular comorbidity risk when selecting biologic therapy for psoriasis."

Clinical • Cataract • Conjunctivitis • Dermatology • Dry Eye Disease • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Psoriasis • Uveitis • IL17A

EARLYPSO: Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation? (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Centre Hospitalier Universitaire de Nice | Trial completion date: Oct 2028 ➔ Jan 2029 | Trial primary completion date: Apr 2028 ➔ Jul 2028

Trial completion date • Trial primary completion date • Dermatology • Immunology • Inflammation • Psoriasis

Successful treatment of pustulotic arthro-osteitis with bimekizumab: A case report. (PubMed, Mod Rheumatol Case Rep) - "Despite treatment with nonsteroidal anti-inflammatory drugs, methotrexate, adalimumab, and upadacitinib, his symptoms and systemic inflammation persisted. The patient became afebrile the day after switching to BKZ, and both joint and skin symptoms gradually improved thereafter, along with normalization of laboratory markers. This case highlights the potential utility of BKZ in the treatment of refractory PAO, particularly in cases with systemic inflammation and fever."

Journal • Immunology • Inflammation • Psoriasis • CRP • IL17A • IL23A

Rare coexistence of generalized pustular psoriasis and discoid lupus erythematosus with worsening of lupus lesions after bimekizumab therapy: a case report. (PubMed, Eur J Dermatol) - No abstract available

Journal • Dermatology • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Psoriasis • Pustular Psoriasis

Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension. (PubMed, J Am Acad Dermatol) - "Bimekizumab was well-tolerated up to 2 years; no new safety signals were identified with longer exposure. Bimekizumab provided deep, durable improvements in clinical and HRQoL outcomes."

Journal • P3 data • Candidiasis • Dermatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pain • Respiratory Diseases

Towards the development of upgrade criteria for the treatment of hidradenitis suppurativa with biologics. (PubMed, J Eur Acad Dermatol Venereol) - "Current treatment practice may delay optimal intervention, potentially leading to missed therapeutic windows. A significant proportion of respondents expressed a preference for earlier biologic intervention, especially in cases of severe disease or frequent flares. The findings underscore the need for a consensus statement defining upgrade criteria for biologics as a first-line therapy, potentially improving patient outcomes and reducing healthcare burdens."

Journal • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IL17A

Hidradenitis suppurativa and bimekizumab: Looking to the future. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Dermatology • Hidradenitis Suppurativa • Immunology

External Reference Pricing (ERP) Availability vs. Reimbursement Timelines in Poland and Other European Countries: The Analysis of EURIPID Database (ISPOR-EU 2025) - "20 MPs (INN, strength, dosage form) with 11 active substances were selected for the analysis: abrocitinib, acalabrutinib, asciminib, avatrombopag, bimekizumab, larotrectinib, pegcetacoplan, siponimod, trastuzumab deruxtecan, tucatinib, zanubrutinib. Shorter time to launch was associated with higher prices of reimbursed MPs and lower availability of ERP information. The EURIPID database served as a useful source of information and a tool for pricing analysis."

Pricing • Reimbursement • US reimbursement

Bimekizumab Led to Sustained Improvements in Health-Related Quality of Life and Work Productivity in Patients With Axial Spondyloarthritis: 3-Year Results From Two Phase 3 Studies (ISPOR-EU 2025) - P3 | "BKZ resulted in sustained improvements in patient-reported measures of HRQoL and work productivity to 3 years, across the full disease spectrum of axSpA."

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

Bimekizumab's Synergistic Economic Impact Across Four Indications in France (ISPOR-EU 2025) - "The budget impact with bimekizumab in France was lower using a cross-indication modelling approach capturing synergistic benefits compared with a single-indication analysis, highlighting the economic benefits of therapies with multiple reimbursed indications. These results suggest that single-indication budget impact analyses likely overestimate the impact of therapies reimbursed for multiple diseases which can occur and be treated concurrently."

HEOR • Ankylosing Spondylitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Bimekizumab Budget Impact Analysis for the Treatment of Patients With Moderate-to-Severe Hidradenitis Suppurativa (HS) in Greece (ISPOR-EU 2025) - "Market shares for bimekizumab and its comparators—adalimumab and secukinumab—were provided by UCB estimates. The BIA concludes that the introduction of bimekizumab for HS treatment in Greece would result in an average annual budget impact of €1,570,400 over five-years. While this represents a measurable increase in healthcare spending, it is considered acceptable given the high unmet need and therapeutic benefit."

Clinical • HEOR • Dermatology • Hidradenitis Suppurativa • Immunology

Cost per Responder Analysis of Bimekizumab, a Monoclonal IgG1 Antibody Which Selectively Inhibits Il17f in Addition to Il17a Against Il17a Inhibitors in the Treatment of Axial Spondyloarthritis in Finland (ISPOR-EU 2025) - "Based on published network meta-analysis response rates and drug acquisition costs, bimekizumab demonstrated the lowest cost-per-responder outcome at Week 16 across the axSpA disease spectrum (nr-axSpA and r-axSpA) compared with approved IL-17A inhibitors in Finland, suggesting bimekizumab could be considered a preferred IL-inhibitor for treatment of axSpA."

HEOR • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A