Efleira (netakimab) / Biocad - LARVOL DELTA

Biologic and targeted synthetic therapies in ankylosing spondylitis: a pharmacological review. (PubMed, Front Pharmacol) - "TNF inhibitors (adalimumab, infliximab, etanercept, golimumab, certolizumab pegol) typically achieve Assessment of Spondyloarthritis International Society 40% improvement (ASAS40) rates of 40%-58% at 12-24 weeks versus 13%-24% with placebo, and maintain clinical benefit in many patients over 5-8 years. IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab, brodalumab, netakimab) yield broadly similar ASAS40 responses (30%-50% versus 10%-20% placebo) and are particularly useful in patients with concomitant psoriasis with substantially reduced risk of tuberculosis reactivation. JAK inhibitors (tofacitinib, upadacitinib) represent the newest class, offering oral administration with ASAS40 responses of 40%-52% versus 13%-26% for placebo in both biologic-naïve and biologic-experienced AS, though cardiovascular safety considerations necessitate careful patient selection. Therapeutic selection should consider comorbidities (uveitis favors TNF monoclonal antibodies;..."

Journal • Review • Ankylosing Spondylitis • Back Pain • Cardiovascular • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Musculoskeletal Pain • Ocular Inflammation • Oncology • Ophthalmology • Pain • Psoriasis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Tuberculosis • Uveitis • IL17A

The efficacy of combination therapy with the IL-17 inhibitor netakimab and a dual GIP and GLP-1 receptor agonist in patients with psoriasis and metabolic syndrome (EADV 2026) - No abstract available

Clinical • Combination therapy • Dermatology • Immunology • Metabolic Disorders • Psoriasis • IL17A

The updated results of the 12-week period of the phase III, randomized, double-blind, placebo-controlled study BCD-085-16/PLANETA-KIDS: Netakimab efficacy and safety in pediatric patients with moderate-to-severe plaque psoriasis (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Pediatrics • Plaque Psoriasis • Psoriasis

To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=202 | Completed | Sponsor: SPH-BIOCAD (HK) Limited | Trial completion date: Jun 2025 ➔ Mar 2026

Trial completion date • Dermatology • Immunology • Psoriasis • IL17A

Evaluation of systemic and biologic therapies in adult erythrodermic pityriasis rubra pilaris: a 10-year single-centre study in Russia (EADV-Sp 2026) - "The treatment distribution was as follows: 38.1% (n=8) received acitretin, 14.3% (n=3) isotretinoin, 38.1% (n=8) methotrexate, 28.6% (n=6) prednisolone, 4.8% (n=1) dexamethasone, 19% (n=4) netakimab, 4.8% (n=1) ustekinumab, and 4.8% (n=1) phototherapy (PUVA, UVB-311nm). Genetically engineered biological therapy may be considered an effective adjunct for severe and treatment-resistant PRP, contributing to sustained remission and improved quality of life. However, the interpretation of these findings is limited by the small sample size, single-centre retrospective design, absence of a control group, and the purely descriptive nature of the analysis."

Clinical • Dermatopathology • Immunology • Psoriasis

Relationship of Genetic Variants of TYK2 (rs2304255) and DDX58 (rs34085293) Genes, Psoriasis Course Features and Response to Treatment with IL-17A Inhibitor (EADV-Sp 2026) - "Tо analyze the presence of TYK2 (rs2304255) and DDX58 (rs34085293) gene polymorphisms in patients with psoriasis and to evaluate the relationship of these single-nucleotide polymorphisms and therapeutic efficacy of IL-17A inhibitor netakimab...Conclusions The obtained pharmacogenomic research data – demonstrating the effectiveness of psoriasis therapy – will improve predictive diagnostics so as to assess the expected effectiveness of psoriasis therapy. In future, it could be used for the accurate interpretation of the individual patient’s profile and its genetic predictors so as to develop a personalized management plan."

Dermatology • Immunology • Plaque Psoriasis • Psoriasis • Pustular Psoriasis • DDX58 • IL17A • IL23A • TYK2

To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=202 | Completed | Sponsor: SPH-BIOCAD (HK) Limited | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Jun 2025

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis • IL17A

Real-World Retention Rate, Effectiveness, and Safety of Netakimab in the Treatment of Patients with Ankylosing Spondylitis: Two-Year Results of the Real Word Evidence LIBRA Study. (PubMed, Dokl Biochem Biophys) - "By 104 weeks 74% patients had low disease activity or inactive disease. Netakimab was well tolerated by most of patients."

Journal • Real-world evidence • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis (clinicaltrials.gov) - P3 | N=113 | Completed | Sponsor: SPH-BIOCAD (HK) Limited

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy and Safety of Biologics to Treat Adults With Active Radiographic Axial Spondyloarthritis: Systematic Review and Bayesian Network Meta-Analysis (ISPOR-EU 2025) - "OBJECTIVES: To compare efficacy and safety of IL-17 inhibitors in the treatment of adults with active radiographic axial spondyloarthritis (r-AxSpA) over a 16-week period using network meta-analysis (NMA). We conducted systematic literature search in PubMed and Embase in November 2024 to retrieve publications with results of randomized controlled trials (RCTs) evaluating efficacy and safety of IL-17 inhibitors (netakimab, secukinumab, ixekizumab, bimekizumab, brodalumab, xeligekimab, vunakizumab) in adults with active r-AxSpA... Netakimab showed the highest relative efficacy among available IL-17 inhibitors used to treat adults with active r-AxSpA over 16-week horizon and demonstrated a favorable safety profile."

Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Risk of developing a fungal nail infection during therapy with biologic drugs (EADV 2025) - "Fungal infection of the toenails (Tr.rubrum) was detected in 12 patients (10%) receiving topical and phototherapy, in 8 patients (13%) receiving methotrexate, and in 4 patients (9%) receiving a course netakimab. Fungal nail infection was not detected in patients receiving guselkumab and ixekizumab... Biologic therapy of psoriasis does not increase the risk of fungal nail infection. The rates of fungal nail infection detection during biologic therapy of psoriasis do not exceed the similar rates in other methods of therapy."

Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy of Netakimab in patients with moderate-to-severe plaque psoriasis stratified by BMI: a post-hoc analysis from the phase III PLANETA study (EADV 2025) - "The results of the post-hoc analysis showed that patients with moderate-to-severe plaque psoriasis with BMI<30 and BMI≥30 differed by demographic characteristics, but were mostly comparable by disease characteristics. NTK demonstrated efficacy and safety vs placebo regardless of patients' BMI. Table 1."

Clinical • P3 data • Retrospective data • Ankylosing Spondylitis • Dermatology • Genetic Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Obesity • Pneumonia • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Comprehensive Insights into Psoriasis: Pathophysiology, An Advanced Exploration of Current Landscape and Future Prospects in "Therapeutic Strategies". (PubMed, Recent Adv Inflamm Allergy Drug Discov) - "The focus extends to emerging targeted drugs, such as netakimab, which functions as an interleukin-17 blocker, currently undergoing clinical trials for psoriasis treatment. By synthesizing the latest research findings, this article aims to contribute to the knowledge base surrounding psoriasis, offering clinicians and researchers valuable insights into the evolving landscape of psoriasis treatment modalities."

Journal • Review • Dermatology • Immunology • Oncology • Psoriasis • IL23A

ASTERA: International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - P3 | N=228 | Completed | Sponsor: Biocad | Active, not recruiting ➔ Completed

Trial completion • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

PATERA: Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=194 | Completed | Sponsor: Biocad | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

PLANETA-KIDS: Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=140 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Biocad will study the efficacy of a psoriasis drug in children over 6 years of age (GxP News) - "The Russian biotech company Biocad has finished recruiting patients for a clinical trial of its drug, netakimab. The manufacturer’s press service told GxP News that the company plans to evaluate the drug’s effectiveness and safety in treating psoriasis in children aged six to 12."

Enrollment closed • Immunology • Psoriasis

To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=202 | Active, not recruiting | Sponsor: SPH-BIOCAD (HK) Limited

New P3 trial • Dermatology • Immunology • Psoriasis

Efficacy and Safety of IL-17 and JAK Inhibitors in Ankylosing Spondylitis: A Systematic Review and Network Meta-Analysis. (PubMed, Int Arch Allergy Immunol) - "The results of the network meta-analysis showed that netakimab 120mg ranked relatively high in outcome of ASAS20 and ASAS40. All treatments with IL-17 and JAK inhibitors were generally safe and well tolerated. However, the two included netakimab clinical studies may have limitations. Therefore, the therapeutic agents should be carefully selected in clinical treatment. Moreover, the efficacy and safety of netakimab remain to be further analyzed in studies with larger sample sizes and longer follow-up times."

Journal • Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

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

Interleukin-17: A pleiotropic cytokine implicated in inflammatory, infectious, and malignant disorders. (PubMed, Cytokine Growth Factor Rev) - "Four FDA-approved drugs-secukinumab (for ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), ixekizumab (for ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), brodalumab (for plaque psoriasis), and bimekizumab (for plaque psoriasis)-suppress the IL-17 pathway, with more in development, including netakimab, sonelokimab, izokibep, and CJM112. These agents and others are being studied across a spectrum of disorders. Understanding the complicated interplay between IL-17 and other immune mediators may yield new treatments for inflammatory/autoimmune conditions and malignancies."

Journal • Ankylosing Spondylitis • Dermatology • Genetic Disorders • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Skin Cancer • Solid Tumor • Spondylarthritis • IL17A • IL17C • IL17RA • IL23A

PLANETA-KIDS: Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children with Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Biocad

New P3 trial • Dermatology • Immunology • Psoriasis

Successful intra-class switching to novel IL-17 inhibitor netakimab in patients with plaque psoriasis in real-world practice (EADV 2024) - "This prospective, real-world study demonstrated that switching to NTK after previous ineffectiveness of other IL- 17i is a promising strategy, resulting in durable responses in the majority of patients and an improvement in quality of life."

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Efficacy and Safety of Netakimab Through 3 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the PLANETA Phase-3 Randomized Controlled Trial (EADV 2024) - P3 | "The results demonstrate NTK 120 mg maintains long-term efficacy and favorable safety profile in patients with moderate-to-severe plaque psoriasis through 3 years of treatment. Figure 1. PASI75/PASI90/PASI100 response rate during the long-term extension period (n=147) Figure 2."

Clinical • P3 data • Dermatology • Diabetes • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Leukopenia • Neutropenia • Novel Coronavirus Disease • Pneumonia • Psoriasis • Respiratory Diseases • IL17A

Real-World Retention Rate, Effectiveness, and Safety of Netakimab in the Treatment of Patients with Ankylosing Spondylitis: First Year Results of the LIBRA Post-Registration Safety Study. (PubMed, Dokl Biochem Biophys) - ": In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy."

Clinical • Journal • Real-world • Real-world evidence • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies