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

PA0019: A study to learn if bimekizumab given in different ways is safe and moves similarly throughout the body over time in adults (clinicaltrialsregister.eu) - P1 | N=293 | Not yet recruiting | Sponsor: UCB Biopharma

New P1 trial

Comparison of the Effects and Safety of Planned Limited-Time Withdrawal Versus Continuous Maintenance of Interleukin Inhibitors in Patients with Psoriasis: A Systematic Review and Network Meta-Analysis. (PubMed, Dermatol Ther (Heidelb)) - "Compared with continued treatment, planned withdrawal of anti-IL therapy is associated with a largely superior risk of relapse, without any reduction in the incidence of adverse events. Moreover, bimekizumab withdrawal demonstrated better outcomes than ixekizumab withdrawal did according to the PASI90 outcome."

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

Double Trouble… or Double Triumph? Dual Biologic Therapy in Refractory Hidradenitis Suppurativa (AAD 2026) - "Adalimumab, secukinumab, and bimekizumab are currently FDA-approved for moderate-to-severe HS, with adalimumab demonstrating response rates of 42–59%...He had minimal response to doxycycline, benzoyl peroxide wash, and clindamycin, and subsequently failed adalimumab, secukinumab, acitretin, dapsone, cefadroxil, prednisone, laser hair removal, and topical agents over two years. Given inadequate disease control, infliximab was added to ongoing secukinumab... Dual biologic therapy may represent a promising option for patients with severe, refractory HS unresponsive to monotherapy with currently available systemic treatments, including FDA-approved biologics used individually. Larger studies are needed to clarify long-term efficacy and safety."

Acne Vulgaris • Aesthetic Medicine • Conjunctivitis • Dermatology • Dry Eye Disease • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Flare Prevention and Safety of Secukinumab vs Bimekizumab in Hidradenitis Suppurativa: A Matched Adjusted Indirect Comparison Analysis of Phase 3 Trials (AAD 2026) - "Secukinumab treatment for HS shows better flare prevention and lower Candida infection rates compared with bimekizumab for the treatment of moderate-to-severe HS at both Weeks 16 and 48."

Clinical • P3 data • Candidiasis • Dermatology • Hidradenitis Suppurativa • Immunology • Infectious Disease

BIMEKIZUMAB FOR REFRACTORY HIDRADENITIS SUPPURATIVA AND ASSOCIATED INFLAMMATORY ARTHROPATHIES (AAD 2026) - "We describe a case series of four patients with longstanding HS and IA refractory to multiple systemic agents, including TNF-α inhibitors, IL-17A inhibitors, IL-12/23 inhibitors, methotrexate, and upadacitinib, alone or in combination. Consolidating therapy into a single targeted agent may reduce the need for combination regimens, improve adherence, and minimize treatment-related toxicity. These observations suggest that bimekizumab may represent a promising therapeutic strategy for patients with HS and IA refractory to conventional biologics and immunosuppressants"

Ankylosing Spondylitis • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL12A • IL17A

Comparative Analysis of Drug Adverse-Events from Biologics in Hidradenitis Suppurativa versus Psoriasis (AAD 2026) - "Currently, the only three FDA-approved treatments are monoclonal antibodies targeting IL-17 (secukinumab, bimekizumab) or TNF-α (adalimumab). This study is limited by its reliance on surveillance data. Further studies with extended longitudinal follow up and alternative methods of data collection are needed to verify these observations."

Adverse events • Dermatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Musculoskeletal Pain • Psoriasis • IL17A • TNFA

Bimekizumab demonstrates sustained improvements in pain, morning stiffness, and fatigue in axial spondyloarthritis: 3-year results from two phase 3 studies (AAD 2026) - P3 | "Improvements across pain, morning stiffness, and fatigue were observed in patients with axSpA treated with bimekizumab, with sustained efficacy from Week52 to Week164 reflecting a long-term positive impact of bimekizumab on symptom severity."

P3 data • Ankylosing Spondylitis • Fatigue • Hidradenitis Suppurativa • Immunology • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Comparative Efficacy and Safety of Novel Biologics and Small-Molecule Therapies for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis (AAD 2026) - "Background Current FDA-approved systemic therapies for moderate-to-severe hidradenitis suppurativa (HS) include TNF-α inhibitors (adalimumab) and IL-17 inhibitors (bimekizumab, secukinumab) (1). Conclusions This NMA identifies JAK1 (porvocitinib, brepocitinib, and upadacitinib) and C5a (vilobelimab) inhibitors as promising investigational treatments for moderate-to-severe HS, representing potential future treatment alternatives for patients refractory to or intolerant of current therapies. However, the small-to-moderate sample sizes and short-term follow-up of such studies highlight the need for future larger, longer-term trials."

Retrospective data • Review • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A • IL23A • JAK1

Bimekizumab efficacy on IHS4 response levels and lesions by HS disease duration over 2 years: Data from BE HEARD EXT (AAD 2026) - "Both disease duration quartiles showed clinically meaningful improvements over 2 years. With bimekizumab treatment over 2 years, patients with shorter disease duration had better outcomes than those with longer disease duration, particularly at higher efficacy thresholds, emphasizing the impact of earlier treatment with bimekizumab upon diagnosis."

Clinical • Hidradenitis Suppurativa • Immunology

Persistent Risk of Venous Thromboembolism in Hidradenitis Suppurativa Despite Biologic Therapy: A Retrospective Cohort Study (AAD 2026) - "Hidradenitis suppurativa (HS) is a chronic skin disease increasingly recognized as a systemic condition associated with elevated cardiovascular risk.1 While FDA-approved biologics such as adalimumab, secukinumab, and bimekizumab improve cutaneous disease activity, their impact on venous thromboembolism (VTE) risk remains unclear. Residual systemic inflammation and cumulative disease burden may contribute to ongoing vascular risk. These findings support the need for cardiovascular risk assessment in HS patients initiating biologic therapy and underscore the importance of long-term safety monitoring."

Retrospective data • Cardiovascular • Dermatology • Genetic Disorders • Glomerulonephritis • Hidradenitis Suppurativa • Immunology • Nephrology • Renal Disease • Venous Thromboembolism

Cost Effectiveness Analysis of Biological Drugs Targeting IL-17 Pathway in Plaque Psoriasis From the Perspective of the Brazilian Private Healthcare System (AAD 2026) - "For PASI 100, the estimated costs were R$160,528 for brodalumab, R$187,807 for bimekizumab, R$252,538 for ixekizumab, and R$335,867 for secukinumab. Immunobiologic therapies are effective and safe for the management of moderate-to-severe psoriasis, with IL-17 inhibitors representing an important treatment class. In this analysis, brodalumab was associated with the most favorable cost-effectiveness profile among IL-17 inhibitors. These findings suggest potential implications for optimizing clinical outcomes and healthcare resource allocation within the Brazilian Supplemental Health System."

Cost effectiveness • HEOR • Dermatology • Immunology • Psoriasis • IL17A

Efficacy, Quality-of-Life Improvement, and Predictors of Response to Bimekizumab in Moderate-to-Severe Plaque Psoriasis: A Real-World Prospective Cohort Study (AAD 2026) - "Bimekizumab achieved rapid and sustained improvements in disease severity and quality of life in this real world cohort. Diabetes mellitus was associated with lower likelihood of response, while higher BMI showed a trend toward better outcomes. Correlations with hepatic steatosis, baseline PGA, and metabolic syndrome highlight the relevance of individual factors for prognostic stratification and personalized care."

Clinical • HEOR • Real-world • Real-world evidence • Cardiovascular • Dermatology • Diabetes • Dyslipidemia • Hypertension • Immunology • Metabolic Disorders • Psoriasis • IL17A

Do biologics lower the risk of depression and anxiety in hidradenitis suppurativa? (AAD 2026) - "Adalimumab, secukinumab, and bimekizumab were each associated with lower risk of depression/anxiety, while infliximab was not. These cohorts together were associated with a lower risk compared to those on antibiotic therapy."

CNS Disorders • Depression • Dermatology • Hidradenitis Suppurativa • Immunology • Mood Disorders • Psychiatry

Association of GLP-1 Therapy with Reduced Biologic Initiation in Hidradenitis Suppurativa: A Retrospective Cohort Study (AAD 2026) - "Objective To assess whether GLP-1 therapy is associated with initiation of biologic treatment in patients with HS and obesity...The primary outcome was initiation of an HS-approved biologic (adalimumab, secukinumab, or bimekizumab) within three years...Conclusions In this large real-world cohort, GLP-1 therapy was associated with substantially reduced risk of biologic initiation in HS. These findings support further investigation of metabolic therapy as a potential disease-modifying strategy."

Retrospective data • Dermatology • Genetic Disorders • Hidradenitis Suppurativa • Immunology • Inflammation • Obesity

Bimekizumab on-treatment remission as defined by the National Psoriasis Foundation: 1-year results versus ustekinumab and secukinumab in patients with moderate to severe plaque psoriasis (AAD 2026) - "Higher proportions of bimekizumab-treated patients achieved NPF-defined on-treatment remission than ustekinumab-/secukinumab-treated patients from Week28 (earliest timepoint at which remission could be observed) through Year1."

Clinical • Dermatology • Immunology • Psoriasis

Bimekizumab treatment resulted in long-term maintenance of complete clinical resolution across skin, joint, and nail domains in patients with active psoriatic arthritis: 3-year results from two phase 3 studies (AAD 2026) - "Bimekizumab resulted in high rates of maintenance of clinical resolution across skin, joint, and nail domains at Week160/156 in biologic-naïve and TNFi-IR patients with PsA who achieved resolution at Week16/24/28."

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

Bimekizumab safety and sustained long-term efficacy in patients with active psoriatic arthritis and baseline psoriasis: Up to 3-year results from two phase 3 studies (AAD 2026) - "Bimekizumab resulted in sustained clinical efficacy to 3 years in biologic-naïve and TNFi-IR patients with PsA and baseline psoriasis. Bimekizumab was well-tolerated; with no new safety signals.[3,4]"

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

Phase 1 Clinical Trial of ORKA-002, a Novel Half-Life Extended IL-17 A/F Monoclonal Antibody with Potential for Twice Yearly Dosing in Psoriasis and Psoriatic Arthritis (AAD 2026) - "Introduction ORKA-002 is a novel monoclonal antibody targeting IL-17A and IL-17F that is similar to bimekizumab for potency and epitope binding, and an Fc region that has been engineered to significantly extend serum half-life. Conclusion The PK and PD results in this Phase 1 study of ORKA-002 will be used to support future clinical trials exploring twice yearly dosing. Efficacy and safety of ORKA-002 will next be evaluated in a Phase 2 study in adults with moderate-to-severe psoriasis."

Clinical • First-in-human • P1 data • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Bimekizumab efficacy by disease duration and severity in moderate to severe hidradenitis suppurativa: 3-year phase 3 results from BE HEARD EXT (AAD 2026) - "Patients in both disease duration and severity subgroups demonstrated clinically meaningful efficacy with bimekizumab treatment at Year 1, with improvements at Year 3. Bimekizumab-treated patients with shorter disease duration and moderate HS had higher achievement of each HiSCR threshold (HiSCR50/75/90/100) than those with longer duration and severe HS, especially at higher HiSCR thresholds."

Clinical • P3 data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Bimekizumab leads to sustained flare-free status in moderate to severe hidradenitis suppurativa: 3-year data from BE HEARD EXT (AAD 2026) - "The majority of bimekizumab-treated patients with moderate to severe HS who remained in the study at Year 3 remained flare-free at scheduled clinic visits through 3 years."

Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

Bimekizumab in Hidradenitis Suppurativa: Insights from Real-World Clinical Practice (AAD 2026) - "By blocking these pathways, it reduces recruitment of inflammatory cells, particularly neutrophils to the follicular epithelium. Our real-world findings support phase III trial data showing bimekizumab’s efficacy and tolerability in HS."

Clinical • Real-world • Real-world evidence • Candidiasis • Chronic Kidney Disease • Dermatology • Diabetes • Hidradenitis Suppurativa • Immunology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Psoriasis • Renal Disease • IL17A

Bimekizumab time to clinical response and achievement of clinically meaningful improvement thresholds in Chinese patients with psoriasis from the BE SHINING phase 3 trial (AAD 2026) - "Bimekizumab treatment demonstrated rapid clinical PASI responses aligned with patient treatment goals (consistent with global studies)[7,8] and treatment target BSA responses in Chinese patients with moderate to severe psoriasis."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Bimekizumab pharmacokinetics, safety, and efficacy in adolescents with moderate to severe plaque psoriasis: Data from the initial treatment period of the open-label BE CONNECTED phase 2 study (AAD 2026) - "In adolescents with moderate to severe psoriasis, bimekizumab pharmacokinetics were comparable to those in adults. Bimekizumab was well-tolerated and demonstrated efficacy consistent with adult studies.[3-6]"

Clinical • P2 data • PK/PD data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Psoriasis

Bimekizumab efficacy by patient subgroups in moderate to severe hidradenitis suppurativa: 3-year phase 3 results from BE HEARD EXT (AAD 2026) - "Patients treated with bimekizumab demonstrated efficacy in all subgroups with improvements in clinical response maintained over 3 years."

Clinical • P3 data • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

Representation of Race and Ethnicity in Randomized Control Trials of Biologic Therapies for Psoriasis: A Scoping Review (AAD 2026) - " Following Joanna Briggs Institute methodology, we searched MEDLINE (PubMed), Embase (Elsevier), and Cochrane Library in June 2024 for RCTs evaluating efficacy and/or safety of adalimumab, infliximab, etanercept, bimekizumab, ustekinumab, and guselkumab. Black and Hispanic patients remain underrepresented in psoriasis biologic RCTs despite higher disease burden, and demographic reporting is inconsistent, limiting generalizability. Trials documenting race/ethnicity appeared in higher impact, more frequently cited journals. Future biologic trials should prioritize diverse recruitment and standardized demographic reporting to strengthen equity and applicability of findings."

Clinical • Review • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Seronegative Spondyloarthropathies