Bimzelx (bimekizumab-bkzx) / UCB, Zhejiang Hisun - LARVOL DELTA

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (clinicaltrials.gov) - P4 | N=10 | Not yet recruiting | Sponsor: University of California, San Francisco

New P4 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Dual IL-17A/F Blockade for Acrodermatitis Continua of Hallopeau: A Clinical Response to Bimekizumab. (PubMed, J Drugs Dermatol) - "We present the case of a 67-year-old male with ACH who failed multiple therapies, including corticosteroids, topical tapinarof, and oral deucravacitinib, before achieving rapid and sustained improvement with bimekizumab, a monoclonal antibody targeting interleukin-17A and IL-17F. As more case reports document favorable outcomes, bimekizumab may emerge as a valuable treatment option for patients with refractory ACH, offering targeted cytokine blockade in a condition with few effective therapies. &nbsp."

Journal • Dermatitis • Dermatology • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Psoriasis • Pustular Psoriasis • IL17A

Three-year BE HEARD data show bimekizumab sustains HS lesion clearance, cuts draining tunnels, and improves severity and quality of life. (Patient Care) - "The long-term findings, presented at the 15th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), extend previously reported efficacy through 48 weeks and offer insight into sustained outcomes with continued interleukin-17 (IL-17) pathway inhibition...At three years, 40.1% of assessed patients achieved complete resolution of inflammatory lesions, defined as a 100% improvement in the International Hidradenitis Suppurativa Severity Score System (IHS4-100). Additionally, 59.1% and 77.4% achieved IHS4-90 and IHS4-75 responses, respectively...The proportion of patients classified as having severe HS by IHS4 decreased from 87.4% at baseline to 14.7% at year three, while 59.4% were categorized as having mild or inactive disease."

P3 data • Hidradenitis Suppurativa

Drug Survival of Biologics in Bionaive and Bioexperienced Patients With Psoriasis. (PubMed, JAMA Dermatol) - "Adalimumab, secukinumab, and ustekinumab among bionaive patients and adalimumab, bimekizumab, brodalumab, guselkumab, ixekizumab, risankizumab, secukinumab, and ustekinumab among bioexperienced patients. In this cohort study in Denmark, among bionaive patients with psoriasis, ustekinumab had superior drug survival compared with adalimumab and secukinumab, and among bioexperienced patients with psoriasis, bimekizumab, guselkumab, and risankizumab had superior drug survival. These results offer insight into the performance of different biologics in the treatment of psoriasis in a routine clinical practice setting."

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

The Pathophysiological Significance of Dual Inhibition of IL-17A and IL-17F in Psoriatic Arthritis and Axial Spondyloarthritis. (PubMed, Mediterr J Rheumatol) - "Conducting a search through PubMed/MEDLINE, Scopus, and Web of Science, using keywords and Medical Subject Headings (MeSH) terms such as "spondyloarthritis", "psoriatic arthritis", "IL-17A", "IL-17F", "IL-23", "IL-23 independent mechanisms", "dual inhibition", "pathogenesis", "gut-joint axis", "secukinumab", "ixekizumab", "bimekizumab", "sonelokimab", we select the relevant literature for this comprehensive pathophysiological narrative...Inhibiting both IL-17A and IL-17F signifies not only a significant therapeutic advancement but also a vital strategy towards overcoming the limitations of our current armamentarium in achieving deeper and more sustained remission in SpA. Future studies and long-term data will be essential in determining the position of dual IL-17A/F inhibitors within treatment guidelines."

Journal • Review • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A • IL23A

Beyond Clinical Trials: Experience with Bimekizumab in 3 Challenging Cases of Psoriatic Arthritis. (PubMed, Mediterr J Rheumatol) - "The first case involved a woman with isolated axial PsA presenting as inflammatory cervical pain, who achieved remission after intolerance to adalimumab. These real-world cases support the efficacy and tolerability of bimekizumab across diverse and complex PsA presentations. Dual IL-17A/F inhibition may provide a valuable therapeutic option for patients with refractory disease, comorbidities, or rare phenotypes."

Journal • Dermatology • Genetic Disorders • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Obesity • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Emerging Targets in Psoriatic Arthritis: Dual IL-17A/F and Selective TYK2 Inhibition in a Clinical Perspective. (PubMed, Mediterr J Rheumatol) - "Phase II and preliminary phase III data in PsA show significant improvements in joint and skin symptoms, with a safety profile from long-term psoriasis studies that appears favourable, showing minimal hematologic or laboratory abnormalities. The advent of bimekizumab and deucravacitinib enriches the PsA treatment arsenal and their introduction will help with more personalised management strategies for patients with PsA."

Journal • Review • Candidiasis • Dermatology • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A • TYK2

Relative Efficacy of Immunomodulatory Monotherapies for Psoriasis of the Scalp: A Network Meta-Analysis Study. (PubMed, J Cosmet Dermatol) - "We are the first to provide comparative evidence on the efficacy of newly investigated agents such as deucravacitinib, tildrakizumab, roflumilast and icotrokinra. In general, the IL-17 inhibitors (bimekizumab, ixekizumab, secukinumab, brodalumab) and IL-23 inhibitors (icotrokinra, guselkumab, tildrakizumab) were effective depending upon the outcome and time-point being considered. At 16 weeks, for PSSI-100, ixekizumab 150 mg at weeks 0, 2, 4, 8, and 12 ranked highest; at 16 weeks, for Sc-PGA 0/1 bimekizumab 320 mg every 4 weeks ranked highest; at 8 weeks, for PSSI-100 ixekizumab 80 mg every 2 weeks ranked highest; at 8 weeks, for Sc-PGA 0/1 secukinumab 300 mg at weeks 1, 2, 3 and then every 4 weeks ranked highest. Small-molecule therapies (apremilast, deucravacitinib, roflumilast) improved scalp psoriasis modestly. Our work would guide the design of future studies and clinical decision-making."

Clinical • Journal • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A • IL23A

Case Report: Refractory hidradenitis suppurativa complicated by IgA vasculitis with nephritis: successful long-term control with surgery and bimekizumab. (PubMed, Front Immunol) - "We report a 41-year-old woman with severe HS refractory to adalimumab who developed fever, palpable purpura, and renal involvement...She was treated with corticosteroids, rituximab, and surgery, but proteinuria persisted...Over more than one year of follow-up, she achieved sustained HS control without recurrence of vasculitis or treatment-related adverse events. This case highlights the potential role of dual IL-17A/F inhibition in managing refractory HS complicated by IgA vasculitis and nephritis."

Journal • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Nephrology • Renal Disease • Vasculitis • IL17A

Appearance of alopecia areata during treatment with tildrakizumab for severe palmoplantar psoriasis. (PubMed, Dermatol Reports) - "Tildrakizumab was discontinued, and the patient was treated with topical corticosteroids and low-dose oral methylprednisolone, achieving complete hair regrowth within 6 months. Psoriasis subsequently recurred, and treatment was successfully switched to bimekizumab, with sustained remission and no adverse events...The temporal correlation, lack of confounding risk factors, and resolution upon drug withdrawal suggest a causal relationship. This case expands the spectrum of paradoxical reactions (PRs) to biologic therapies and highlights the need for vigilance regarding autoimmune manifestations during interleukin (IL)-23 inhibition."

Journal • Alopecia • Dermatology • Immunology • Psoriasis

Long-term efficacy of biologics in moderate-to-severe hidradenitis suppurativa: A systematic review and MAIC. (PubMed, J Eur Acad Dermatol Venereol) - "Compared with other approved biologics, bimekizumab showed favourable efficacy across the majority of outcomes assessed at Week 48-52, indicating its potential as a durable long-term therapeutic option for patients with moderate-to-severe HS."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology

Delphi consensus: First-line use of biologics and small molecules in hidradenitis suppurativa. (PubMed, J Eur Acad Dermatol Venereol) - "This consensus provides evidence-based criteria for upgrading HS patients to first-line biologic therapy, reflecting expert practices across Europe aimed at preventing irreversible disease progression. The results support a 'hit hard and early' approach to minimize scarring and tunnel formation, although prospective studies are still needed to validate these expert-driven recommendations."

Journal • Review • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Rheumatology

Clinical and Transcriptomic Response to Secukinumab in Korean Patients with Moderate-to-Severe Hidradenitis Suppurativa. (PubMed, Dermatology) - "Secukinumab demonstrated substantial clinical efficacy and modulated disease-relevant molecular pathways in Korean patients with moderate-to-severe HS. These findings support its therapeutic potential in Asian populations and provide mechanistic insights into IL-17 blockade in HS."

Journal • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain

Successful Treatment of Pyoderma Gangrenosum Associated With Hidradenitis Suppurativa With Bimekizumab. (PubMed, Australas J Dermatol) - No abstract available

Journal • Dermatology • Hidradenitis Suppurativa • Immunology • Pyoderma Gangrenosum

Effectiveness of Bimekizumab in Multi-Failure Psoriatic Patients: A Retrospective, Real-World Multicenter Study. (PubMed, J Pers Med) - " Bimekizumab demonstrated rapid, marked, and sustained clinical improvements with a favorable safety profile in multi-failure psoriasis patients. These findings support its role as an effective and well-tolerated therapeutic option for individuals with highly refractory disease in real-life practice."

Clinical • Journal • Real-world evidence • Retrospective data • Dermatology • Immunology • Psoriasis

Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. (PubMed, J Allergy Clin Immunol) - "The strong durability and high response level observed with bimekizumab may be associated with normalization of pathogenic TRM cells. A plain language summary of this article can be found in the Supplementary Information."

Journal • Dermatology • Immunology • Psoriasis • IL17A • IL7R

A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for bimekizumab. (PubMed, Front Pharmacol) - "We identified potential new adverse events associated with bimekizumab through disproportionate analysis of extensive real-world data from the FAERS database. These findings enable healthcare professionals and pharmacists to prioritize effective management of high-risk adverse events, optimize drug utilization in clinical settings, and enhance patient medication safety."

Adverse events • Journal • Real-world evidence • Candidiasis • CNS Disorders • Depression • Dermatology • Fatigue • Immunology • Musculoskeletal Pain • Pain • Pruritus • Psoriasis • Psychiatry • IL17A

UCB Canada remains dedicated to helping patients and working collaboratively with CDA-AMC following draft recommendation for (Pr) BIMZELX for hidradenitis suppurativa (HS) (Cantech Letter) - "This draft recommendation for public drug plans, excluding Quebec, advises not to reimburse ^PrBIMZELX for the treatment of HS. HS is a debilitating, chronic inflammatory skin disease characterized by recurrent and painful subcutaneous nodules, abscesses, and draining sinus tracts...UCB Canada is committed to working with the CDA-AMC to address all questions raised in the draft recommendation....The draft recommendation for ^PrBIMZELX is open for feedback from eligible interested stakeholders until January 30, 2026, and may be submitted via the CDA-AMC website..."

Reimbursement • Hidradenitis Suppurativa

Impact of symptom duration on the short- and long-term efficacy of bimekizumab in axial spondyloarthritis: results up to 2 years. (PubMed, Arthritis Res Ther) - No abstract available

Journal • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Outcomes in Bimekizumab Treated Psoriasis Patients With Prior IL-17 Inhibitor Failure. (PubMed, J Psoriasis Psoriatic Arthritis) - "Previous real-world studies have reported success with intra-class switching within the IL-17 inhibitor class, but data have been limited to secukinumab, ixekizumab, and brodalumab. Using retrospective data from cases selected for moderate-to-severe psoriasis who failed prior IL-17 therapy, we report our real-world experience using bimekizumab in 50 patients who failed a prior IL-17 inhibitor, in which 82% achieved an IGA 0/1. By demonstrating achievement of stringent benchmarks, such as IGA 0/1 and sPGAxBSA 100 in these selected patients, we challenge the conventional teaching of primary vs secondary non-responders class switching, and have found bimekizumab to be a viable option in those who have failed IL-17 inhibitor therapy in the past."

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

Dual biologic therapy in a patient with severe psoriasis and psoriatic arthritis, using guselkumab and bimekizumab: A case report and review of the literature. (PubMed, SAGE Open Med Case Rep) - "This case illustrates how targeting multiple points in the interleukin-23/interleukin-17 pathway can improve outcomes in patients unresponsive to monotherapy. Dual biologic therapy may be a viable option for select patients with complex disease, though further research is needed to evaluate its long-term safety and efficacy."

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

Response of recalcitrant Blaschkoid psoriasis to bimekizumab: A case report. (PubMed, JAAD Case Rep) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

Model-Based Meta-Analysis of IL-17 A Inhibitors for Moderate-to-Severe Plaque Psoriasis: Establishing Exposure-Response Relationships to Inform Targeted Drug Development. (PubMed, Clin Rev Allergy Immunol) - "This study aimed to establish an exposure-response model for IL-17 A inhibitors to predict the clinical efficacy of novel agents based on in vitro potency and pharmacokinetic parameters, guiding the development of new IL-17 A-targeting therapies. A systematic literature search was conducted in PubMed, Cochrane Library, and Embase to identify randomized controlled trials of three FDA-approved IL-17 A inhibitors: secukinumab, ixekizumab, and bimekizumab. External validation showed high predictive accuracy for xeligekimab. A reference table was also constructed to estimate required doses based on IC50 and desired therapeutic targets, facilitating rational dose selection. Based on existing pharmacokinetic and clinical efficacy data of IL-17 A inhibitors, this study successfully developed a streamlined and accurate exposure-response model, offers a practical tool for efficacy prediction and dose optimization in the development of novel agents..."

Clinical • Journal • Retrospective data • Review • Dermatology • Immunology • Psoriasis • IL17A

PrBIMZELX (bimekizumab injection) approved in Canada for treatment of moderate to severe hidradenitis suppurativa (HS) (Canada Newswire) - "The approval was granted based on the results of two Phase III trials, BE HEARD I and BE HEARD II, which evaluated over 1,000 adult patients globally."

Canada approval • Hidradenitis Suppurativa

Erosive Oral Lichen Planus Treated With Upadacitinib Amid Systemic Psoriatic Therapy. (PubMed, Cureus) - "First-line therapies are topical corticosteroids or calcineurin inhibitors, while erosive OLP may require intralesional triamcinolone...Previous treatments, including prednisone, clobetasol gel, dexamethasone, chlorhexidine rinses, and mycophenolate, provided little relief. As her OLP remained unresponsive to treatment, her psoriasis also proved challenging, necessitating multiple therapeutic adjustments. She was started on apremilast for her PsO and PsA, which was ineffective. She transitioned to certolizumab pegol, which provided partial relief but led to recurrent infections. Bimekizumab was then initiated, clearing her PsO, but leaving her with persistent joint pain...Given the inflammatory pathway overlap between PsA and LP, JAK inhibition may mitigate the chronic inflammatory cascade that drives erosive OLP. Upadacitinib's efficacy in this case of refractory erosive OLP warrants further clinical studies to establish its therapeutic role."

Journal • Dermatology • Dermatopathology • Immunology • Infectious Disease • Inflammatory Arthritis • Lichen Planus • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • JAK3