Efleira (netakimab) / Biocad - LARVOL DELTA

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

Course of Uveitis in Patients with Ankylosing Spondylitis during the Interleukin17 Inhibitors Therapy. (PubMed, Dokl Biochem Biophys) - "The study involved 73 patients with AS (New York criteria, 1984), who received IL17-i (57-secukinumab (SEC), 22-netakimab (NTK)) for at least 1 year. There were no significant differences in the incidence rates of uveitis during IL17-i therapy compared with non-biological therapy. IL17-i therapy have not demonstrated a significant effect on the course of uveitis in AS in the study group."

Journal • Ankylosing Spondylitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Ocular Inflammation • Ophthalmology • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Uveitis • IL17A • IL7

Current treatment for spondyloarthritis: focus on netakimab. A review (PubMed, Ter Arkh) - "The drug has low immunogenicity, which allows us to count on the possibility of many years of effective use. Resolutions of expert councils on the use of NTK in AS and PsA support the inclusion of this drug in clinical guidelines."

Clinical • Journal • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Real-world experience with netakimab in the treatment of spondyloarthritis (PubMed, Ter Arkh) - "The obtained data confirm the effectiveness and safety of netakimab in treating AS and PsA in real-world practice."

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

NEUROPROTECTIVE AND ANTIOXIDANT POTENTIAL OF MONTELUKAST-ACETYLCYSTEINE COMBINATION THERAPY FOR BRAIN PROTECTION IN PATIENTS WITH COVID-19 INDUCED PNEUMONIA. (PubMed, Georgian Med News) - "No patient in Group 3 received JAK inhibitors (tofacitinib and baricitinib), IL-6 (olokizumab), IL-17A (netakimab) and glucocorticosteroids, however, recovery rates were completely good. Thus, based on the data given, it can be concluded that the high efficacy of the acetylcysteine/montelukast combination (as neuroprotectors) in pneumonia caused by COVID-19 is due to the effect of drugs on key mechanisms of pathogenesis: reduction of oxidative stress as drugs (combination) ensuring the free radical scavenging; stimulation of glutathione synthesis; suppression of cytokine storm; reduction of bronchospasm, mucus secretion and airway edema; lowering of BBB permeability and the ability to improve cerebral microcirculatory perfusion in the presence of antiplatelet agents. In conclusion, the combination of montelukast and acetylcysteine may provide an effective, safe, multicomponent approach to the prevention of hypoxic brain injury in patients with COVID-19 pneumonia."

Combination therapy • Journal • Acute Respiratory Distress Syndrome • Cardiovascular • CNS Disorders • Coronary Artery Disease • Diabetes • Heart Failure • Hematological Disorders • Hypertension • Infectious Disease • Leukopenia • Mental Retardation • Metabolic Disorders • Novel Coronavirus Disease • Oncology • Pneumonia • Psychiatry • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Type 2 Diabetes Mellitus • Vascular Neurology • IL17A • IL6 • TNFA

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 | Active, not recruiting | Sponsor: Biocad | Trial completion date: Mar 2022 ➔ Apr 2023

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

Two Epitope Regions Revealed in the Complex of IL-17A and Anti-IL-17A VH Domain. (PubMed, Int J Mol Sci) - "Netakimab is an IL-17A-specific antibody containing a Lama glama VH derivative domain and a VL variable domain...The β-turn of IL-17A, which forms the so-called epitope-1, appears to be the main region of IL-17A interaction with the antibody. Contacts formed by the IL-17A mobile C-terminal region residues (epitope-2) further stabilize the antibody-antigen complex."

Journal • CNS Disorders • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Psoriasis • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • IL17A

Efficacy of Targeted Drugs for the Treatment of Adults With Moderate-to-Severe Plaque Psoriasis in the Russian Federation: A Systematic Literature Review Update (ISPOR-EU 2022) - "Evidence synthesis included RCTs evaluating the efficacy of adalimumab (ADA), infliximab (INF), etanercept (ETN), certolizumab pegol (CZP), ixekizumab (IXE), netakimab (NTK), secukinumab (SEC), risankizumab (RIS), guselkumab (GUS), ustekinumab (UST), tofacitinib (TOFA), and apremilast (APR) after 12 weeks of therapy. The addition of head-to-head trials and increased statistical power of the network revealed previously unidentified significant differences between treatment options for moderate-to-severe plaque psoriasis."

Clinical • Review • Dermatology • Immunology • Oncology • Psoriasis • IL12A • IL17A • IL23A

Efficacy of Targeted Drugs for the Treatment of Adults With Moderate-to-Severe Plaque Psoriasis in the Russian Federation: Number Needed to Treat and Costs Per Responder (ISPOR-EU 2022) - "OBJECTIVES: To reassess the number of adults with moderate-to-severe plaque psoriasis needed to treat (NNT) to achieve one Psoriasis Area and Severity Index (PASI) 75/90 response and costs per responder (CpR) after 12 weeks for adalimumab (ADA), infliximab (INF), etanercept (ETN), ixekizumab (IXE), netakimab (NTK), secukinumab (SEC), ustekinumab (UST), tofacitinib (TOFA), and apremilast (APR) and after 16 weeks for certolizumab pegol (CZP), risankizumab (RIS) and guselkumab (GUS) and 1 year of therapy for each drug analyzed. This study complements the systematic review and meta-analysis of the efficacy of targeted drugs to treat adults with moderate-to-severe plaque psoriasis in the Russian Federation. The results may become a useful tool for treatment decision-making."

Clinical • Dermatology • Immunology • Oncology • Psoriasis • IL17A • IL23A

Efficacy and Safety of Biological DMARDs: A Systematic Literature Review Informing the 2022 Update of the ASAS-EULAR Recommendations for the Management of Axial Spondyloarthritis (ACR Convergence 2022) - "Efficacy of golimumab and certolizumab was confirmed in r-axSpA and nr-axSpA, respectively. Equivalence between adalimumab/etanercept/infliximab biosimilars and originators was demonstrated (n=1 each). Fourteen placebo-controlled RCTs investigated efficacy of interleukin-17 inhibitors (IL-17i: secukinumab [n=7], ixekizumab [n=3], netakimab [n=2], brodalumab [n=1], bimekizumab [n=1]) and found clinically relevant effects (RR versus placebo to achieve ASAS40 response 1.3-15.3 [r-axSpA, n=9], 1.4-2.1 [nr-axSpA, n=2]; Figure 1)...Trials of IL-23 and IL-12/23 inhibitors (IL-23i: risankizumab [n=1]; IL-12/23i: ustekinumab [n=3]) failed to show relevant benefits compared to placebo and were stopped... New evidence supports the efficacy and safety of TNFi (originators/biosimilars) and IL-17i in r-axSpA and nr-axSpA, while IL-12/23i and IL-23i failed to show relevant effects. This systematic review provides important new insights into the management of patients with bDMARDs,..."

Clinical • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Ocular Inflammation • Ophthalmology • Rheumatoid Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis • IL12A • IL17A • IL23A

Biological treatment for erythrodermic psoriasis. (PubMed, Expert Opin Biol Ther) - "Novel biologics such as bimekizumab and mirikizumab, and nanobodies such as netakimab and sonelokimab have shown promise in management of plaque psoriasis and potential of these molecules in management of EP should be explored. Management of patients with prior biologic failure remains a challenge. Guidelines for the management of EP need to be revisited in light of the recent advances."

Journal • Dermatology • Dermatopathology • Immunology • Psoriasis • IL12A • IL17A • IL23A

Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study. (PubMed, Clin Exp Rheumatol) - P3 | "Subcutaneous netakimab is effective in patients with r-axSpA irrespective of baseline CRP and inflammation on SIJ MRI. The benefit in patients with high CRP (>20 mg/L) was more pronounced."

Journal • Retrospective data • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP • IL17A

Tocilizumab, netakimab, and baricitinib in patients with mild-to-moderate COVID-19: An observational study. (PubMed, PLoS One) - "In hospitalized patients with mild-to-moderate COVID-19, the combination of SOC with anti-IL-17A or anti-IL-6R therapy were superior or comparable to the combination with JAK1/JAK2 inhibitor, and all three were superior to SOC alone. Whereas previous studies did not demonstrate significant benefit of anti-IL-17A therapy for severe COVID-19, our data suggest that such therapy could be a rational choice for mild-to-moderate disease, considering the generally high safety profile of IL-17A blockers. The significant increase in blood neutrophil count in the netakimab group may reflect efflux of neutrophils from inflamed tissues. We therefore hypothesize that neutrophil count and neutrophil-to-lymphocyte ratio could serve as markers of therapeutic efficiency for IL-17A-blocking antibodies in the context of active inflammation."

Journal • Observational data • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CRP

Cardiovascular risk assessment in patients with psoriasis. (EADV-Sp 2022) - "13% received methotrexate, 10% - biologicals (netakimab), 77% of volunteers used topical treatment and ​phototherapy. Moreover, a direct relationship between the severity of psoriasis and cardiovascular risk was observed. However, further prospective randomized trials as well as a multidisciplinary therapeutic approach and biobanking will help assess the probability of CVD development in patients with psoriasis."

Clinical • Cardiovascular • CNS Disorders • Depression • Dermatology • Hypertension • Immunology • Inflammatory Arthritis • Major Depressive Disorder • Mood Disorders • Myocardial Infarction • Pruritus • Psoriasis • Psoriatic Arthritis • Psychiatry • Rheumatology • Seronegative Spondyloarthropathies • CRP

BCD-085-7: An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=213 | Completed | Sponsor: Biocad | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

COVID-19 Study at the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU (clinicaltrials.gov) - P=N/A | N=154 | Completed | Sponsor: Pirogov Russian National Research Medical University

New trial • Infectious Disease • Novel Coronavirus Disease • CRP

Immune-related adverse events (irAEs) in ankylosing spondylitis (AS) patients treated with interleukin (IL)-17 inhibitors: a systematic review and meta-analysis. (PubMed, Inflammopharmacology) - "The most common immune system-related AEs in patients treated with IL-17 inhibitors are mucosal and opportunistic infections."

Adverse events • Clinical • Journal • Retrospective data • Review • Ankylosing Spondylitis • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Nephrology • Neutropenia • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Course of COVID-19 infection in patients with arthritis receiving targeted DMARDs (data Moscow Unified Arthritis Registry) (APLAR 2021) - "Most of patients used TNF inhibitors - 92 (Adalimumab -22, Golimumab -9, Infliximab –11, Certolizumab pegol -4, Etanercept – 46), 6 patients -Ustekinumab, JAK inhibitors used 20 patients (tofacitinib-19, baricitinib-1), 13 patients was treated with Abatacept and 17 with Tocilizumab, 12 patients used Rituximab, 17 patients used inhibitor IL-17 ( 13 -sekukinumab and 2 patients Netakimab), (tab.1). COVID-19 does not look extremely dangerous in patients with rheumatic diseases, used target DMARDs. Used of tsDMARDs doesn’t reliably increase the risk of COVID-19 severity. There is reliable correlation between age and COVID-19 severity."

Clinical • Ankylosing Spondylitis • Critical care • Fibrosis • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Seronegative Spondyloarthropathies • Systemic Sclerosis • IL17A

Latest Advances for the Treatment of Chronic Plaque Psoriasis with Biologics and Oral Small Molecules. (PubMed, Biologics) - "Different classes of biologicals have been already approved, including TNF-α (etanercept, infliximab, adalimumab and certolizumab pegol), IL-12/23 (ustekinumab), IL-17 (secukinumab, ixekizumab, brodalumab) and IL-23 (guselkumab, risankizumab, tildrakizumab) inhibitors...The latest IL-17 and IL-23 inhibitors include bimekizumab, netakimab and mirikizumab as well as oral small molecules, such as deucravacitinib, a tyrosine kinase 2 selective inhibitor, and piclidenoson, an agonist of the Gi protein-associated A3 adenosine receptor. Additional molecules are in an early phase of development. Highly promising biologicals and small oral molecules are the leading edge of the systemic treatment of psoriasis."

Journal • Review • Dermatology • Immunology • Inflammatory Arthritis • Pruritus • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • TNFA • TYK2

Interleukin 17 antagonist netakimab is effective and safe in the new coronavirus infection (COVID-19). (PubMed, Eur Cytokine Netw) - "Patients received either netakimab (group NET), IL-6 antagonist tocilizumab (group TOC) or no anti-cytokine treatment (group CON). There was no difference in the incidence of side effects between groups. The IL-17 antagonist netakimab is effective and safe in the treatment of cytokine release syndrome in COVID-19."

Journal • Critical care • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CRP • IL6

[VIRTUAL] THE COURSE OF COVID-19 INFECTION IN PATIENTS WITH ARTHRITIS RECEIVING TARGETED DMARDS (EULAR 2021) - "Most of patients used TNF inhibitors - 43 (Adalimumab -10, Golimumab -4, Infliximab – 4, Certolizumab pegol -3, Etanercept – 22), JAK inhibitor tofacitinib used 13 patients, 5 patients each was treated with Abatacept and Tocilizumab, 3 patients used Rituximab and 2 patients each used Netakimab and Ustekinumab ( Table 1 ). COVID-19 does not look extremely dangerous in patients with rheumatic diseases, used target DMARDs. Used of tsDMARDs doesn’t reliably increase the risk of COVID-19 severity. There is reliable correlation between age and COVID-19 severity."

Clinical • Ankylosing Spondylitis • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Anti-IL-17 monoclonal antibodies in hospitalized patients with severe COVID-19: A pilot study. (PubMed, Cytokine) - "In hospitalized patients with severe COVID-19, anti-IL-17 therapy might mitigate the inflammatory response and improve oxygenation, but do not affect the need for mechanical ventilation and mortality."

Clinical • Journal • Critical care • Infectious Disease • Inflammation • Novel Coronavirus Disease • IL17A