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

Bimekizumab as-needed dosing in patients with psoriasis: a case series. (PubMed, J Dermatolog Treat) - "No adverse events were observed. Larger prospective studies comparing efficacy and safety of this off-label, as needed, bimekizumab dosing regimen with standard on-label dosing are necessary to corroborate these findings."

Journal • Retrospective data • Dermatology • Immunology • Psoriasis

Real-World Experience of Bimekizumab in a Cohort of 109 Patients Over 48 Weeks and Identification of Predictive Factors for an Early Super Response and Risk of Adverse Events. (PubMed, Psoriasis (Auckl)) - "Baseline PASI, nail involvement, and prior biologic failures influenced early treatment response. Identifying predictors of ESR and adverse events can guide personalized therapeutic approaches, optimizing outcomes for psoriasis patients."

Adverse events • Biomarker • Journal • Real-world evidence • Allergic Rhinitis • Asthma • Atopic Dermatitis • Candidiasis • Dermatology • Immunology • Inflammation • Psoriasis • Pulmonary Disease • Respiratory Diseases • IL17A

Evaluating the Efficacy of Bimekizumab across the Different Sensitive Areas in Moderate-to-Severe Psoriasis: A 52-week Italian Multicenter Real-Life Lazio Experience. (PubMed, Dermatol Pract Concept) - "Bimekizumab demonstrates significant efficacy in reducing psoriasis severity across different body areas and improving QoL over a 52-week period. These findings support this robust treatment option for moderate-to-severe psoriasis."

Journal • Dermatology • Immunology • Psoriasis • IL17A

A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P3 | N=40 | Not yet recruiting | Sponsor: UCB Biopharma SRL

New P3 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. (PubMed, RMD Open) - P2, P2b, P3 | "Overall, BKZ demonstrated good tolerability, with TEAE EAIRs comparable between axSpA and PsA cohorts, remaining stable over extended treatment periods. No new safety signals were identified."

Journal • P2/3 data • P2b data • Ankylosing Spondylitis • Candidiasis • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Novel Coronavirus Disease • Ocular Inflammation • Ophthalmology • Psoriatic Arthritis • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Suicidal Ideation • Tuberculosis • Uveitis

bimekizumab (Bimzelx) is accepted for restricted use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. SMC restriction: for use in adult patients with active moderate to severe HS for whom adalimumab is contraindicated or otherwise unsuitable, including those who have failed to respond or have lost response to prior adalimumab treatment. In two phase III studies in patients with moderate to severe HS, significantly more patients achieved a clinical response (defined as ≥50% decrease in abscess and inflammatory nodule [AN] count with no increase in the number of abscesses and/or in the number of draining fistulae) with bimekizumab (every two weeks) compared with placebo at week 16."

Reimbursement • Hidradenitis Suppurativa

Wolf's Isotopic Response: A Rare Case of Terra Firma-Forme Dermatosis on Resolved Psoriatic Plaques. (PubMed, Australas J Dermatol) - "Wolf's isotopic response refers to the development of a new dermatosis in the same location that a previous, healed, unrelated skin condition occupied. We report the case of a patient developing Terra firma-forme dermatosis at the site of resolved psoriatic plaques."

Journal • Dermatology • Immunology • Psoriasis

“A full HTA is not recommended. The NCPE recommends that bimekizumab not be considered for reimbursement at the submitted price.” [For non-radiographic axial spondyloarthritis] (National Centre for Pharmacoeconomics, Ireland)

HEOR • Inflammation • Spondylarthritis

Cost per Response Analysis of Deucravacitinib and Biologic Treatments for Moderate to Severe Plaque Psoriasis From the Perspective of the Brazilian Private Healthcare System (ISPOR 2025) - "Deucravacitinib presented the lowest cost-per-response ratio amongst all treatments available for moderate to severe plaque psoriasis in the Brazilian private"

Dermatology • Immunology • Inflammation • Psoriasis

Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector. (PubMed, Dermatol Ther (Heidelb)) - P3 | "The 2 mL SSy and AI devices offer patients with moderate to severe plaque psoriasis two different safe and effective options for the delivery of bimekizumab, empowering individuals to select a device on the basis of personal preference. Graphical abstract available for this article."

Journal • Dermatology • Immunology • Pain • Psoriasis

Hidradenitis suppurativa (PubMed, Ugeskr Laeger) - "Data demonstrates a significant diagnostic delay, which may contribute to the long preceding treatment history with multiple drug classes and treatment series before initiation of biologic therapy. Although adalimumab, secukinumab, and bimekizumab are the only approved biologics by EMA for moderate to severe HS, many promising biologics are currently being investigated for moderate to severe HS."

Journal • Review • CNS Disorders • Dermatology • Dermatopathology • Hidradenitis Suppurativa • Immunology • Mental Retardation • Metabolic Disorders • Psychiatry

Psychometric Validation and Interpretation Thresholds of the Hidradenitis Suppurativa Quality of Life (HiSQOL©) Questionnaire Using Pooled Data from the Phase 3 BE HEARD I & II Trials of Bimekizumab in Hidradenitis Suppurativa. (PubMed, Br J Dermatol) - No abstract available

HEOR • Journal • P3 data • Dermatology • Hidradenitis Suppurativa • Immunology

Hot Topics 2024 and 2025 in dermatology (PubMed, Rev Med Suisse) - "Ruxolitinib cream offers new hope for vitiligo, though reimbursement remains uncertain...Concerns about a potential link between dupilumab and cutaneous T-cell lymphoma call for increased clinical vigilance. Meanwhile, bimekizumab marks a breakthrough in hidradenitis suppurativa treatment. Addressing Trichophyton indotineae resistance requires complex strategies. Finally, innovative laser targeting sebaceous glands offers new hope for acne."

Journal • Acne Vulgaris • Cutaneous T-cell Lymphoma • Dermatology • Eosinophilia • Hematological Malignancies • Hidradenitis Suppurativa • Immunology • Lymphoma • Oncology • Psoriasis • Pustular Psoriasis • T Cell Non-Hodgkin Lymphoma • Vitiligo

INHIBITION OF RADIOGRAPHIC PROGRESSION WITH BIMEKIZUMAB TREATMENT OBSERVED IN BDMARD-NAÏVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AT 2 YEARS: RESULTS FROM A PHASE 3 STUDY AND ITS OPEN-LABEL EXTENSION (EULAR 2025) - No abstract available

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

BIMEKIZUMAB, A DUAL INHIBITOR OF IL-17A AND IL-17F, DEMONSTRATED LONG-TERM SAFETY AND EFFICACY IN BIOLOGIC DMARD-NAÏVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: FINAL 3-YEAR RESULTS FROM THE PHASE 3 BE OPTIMAL STUDY AND ITS OPEN-LABEL EXTENSION (EULAR 2025) - No abstract available

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

Bimekizumab rescue therapy in a patient with relapsing polychondritis-associated aortitis (EULAR 2025) - No abstract available

Clinical

SUSTAINED IMPROVEMENTS WITH BIMEKIZUMAB IN PAIN, MORNING STIFFNESS, FATIGUE, PHYSICAL FUNCTION AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: 3-YEAR RESULTS FROM TWO PHASE 3 STUDIES (EULAR 2025) - No abstract available

Clinical • HEOR • P3 data • Ankylosing Spondylitis • Fatigue • Immunology • Pain • Seronegative Spondyloarthropathies • Spondylarthritis

DUAL INHIBITION OF IL-17A AND IL-17F WITH BIMEKIZUMAB DEMONSTRATED LONG-TERM SAFETY AND EFFICACY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND PRIOR INADEQUATE RESPONSE TO TUMOUR NECROSIS FACTOR INHIBITORS: FINAL 3-YEAR RESULTS FROM THE PHASE 3 BE COMPLETE STUDY AND ITS OPEN-LABEL EXTENSION (EULAR 2025) - No abstract available

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

ACHIEVEMENT OF REMISSION DEFINED BY ABSENCE OF OBJECTIVE SIGNS OF INFLAMMATION VERSUS ASDAS INACTIVE DISEASE IN PATIENTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS TREATED WITH BIMEKIZUMAB: 52-WEEK RESULTS FROM TWO PHASE 3 STUDIES (EULAR 2025) - No abstract available

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Inflammation • Seronegative Spondyloarthropathies • Spondylarthritis

BIMEKIZUMAB MAINTAINED STRINGENT CLINICAL RESPONSES OVER 2 YEARS IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: RESULTS FROM TWO PHASE 3 STUDIES (EULAR 2025) - No abstract available

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

BIMEKIZUMAB DEMONSTRATES COMPARABLE ONE-YEAR EFFICACY IN MALE AND FEMALE PATIENTS WITH AXIAL SPONDYLOARTHRITIS: RESULTS FROM TWO PHASE 3 STUDIES (EULAR 2025) - No abstract available

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

BIMEKIZUMAB DEMONSTRATED SUSTAINED EFFICACY AND SAFETY ACROSS THE FULL SPECTRUM OF AXIAL SPONDYLOARTHRITIS: 3-YEAR RESULTS FROM TWO PHASE 3 STUDIES AND THEIR OPEN-LABEL EXTENSION (EULAR 2025) - No abstract available

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

LOW UVEITIS RATES IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS OR PSORIATIC ARTHRITIS TREATED WITH BIMEKIZUMAB: LONG-TERM RESULTS FROM PHASE 2B/3 TRIALS (EULAR 2025) - No abstract available

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

BIMEKIZUMAB DEMONSTRATED SIMILAR EFFICACY AND SAFETY IN TWO CLINICAL ENDOTYPES OF AXIAL SPONDYLOARTHRITIS: 1-YEAR RESULTS FROM TWO PHASE 3 TRIALS (EULAR 2025) - No abstract available

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) and Questionnaire (HSSQ): Psychometric Validation and Interpretation Threshold Derivation Using Phase 3 Study Data. (PubMed, Dermatol Ther (Heidelb)) - P3 | "HSSDD and HSSQ item scores demonstrated good psychometric performance in participants with moderate to severe HS. The clinically meaningful severity thresholds defined here could be used to assess treatment efficacy."

Journal • P3 data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain