AnBaiNuo (etanercept biosimilar) / Zhejiang Hisun - LARVOL DELTA

A novel single domain bispecific antibody targeting VEGF and TNF-α ameliorates rheumatoid arthritis. (PubMed, Int Immunopharmacol) - "Besides, the experiments indicated that the anti-RA activity of V5-3 was superior to Anbainuo in vivo...Mechanistically, V5-3 suppressed p65, AKT and VEGFR2 phosphorylation, as well as production of TNF-α and VEGF in joint tissues. These results demonstrated that V5-3 displayed a superior effect of anti-RA, may be a new therapy to overcome the limitations of anti-TNF-α monoclonal antibody."

Journal • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • KDR • TNFA

Comparison of Biological Agent Monotherapy and Associations Including Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis: Literature Review and Meta-Analysis of Randomized Trials. (PubMed, J Clin Med) - "This meta-analysis confirms the superiority of combination therapy over monotherapy in rheumatoid arthritis, in accordance to the usual guidelines."

Journal • Monotherapy • Retrospective data • Review • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • TNFRSF1A

Comparative Pharmacokinetics, Safety, and Immunogenicity Study of the Prefilled Syringe and Lyophilized Formulation of a Recombinant Human Tumor Necrosis Factor-α Receptor II:lgG Fc Fusion Protein in Healthy Chinese Male Subjects. (PubMed, Clin Pharmacol Drug Dev) - "Safety was comparable between the 2 formulations with low immunogenicity. rhTNFR:Fc PFS exhibited similar pharmacokinetic and safety profiles of rhTNFR:Fc LYO (Anbainuo) in healthy Chinese male subjects."

Journal • PK/PD data • Oncology • TNFA

Cost-effectiveness of Anbainuo plus methotrexate compared to conventional disease-modifying antirheumatic drugs for rheumatoid arthritis patients in China. (PubMed, Ann Transl Med) - "Further sensitivity analyses revealed that the cost-effectiveness of ABN + MTX vs. cDMARDs was relatively robust, while among all the indexes, ABN price and Health Assessment Questionnaire Disability Index (HAQ-DI) score change for the ABN + MTX group affected ICER most. Treatment with ABN + MTX offers acceptable cost-effectiveness compared to cDMARDs treatment in Chinese RA patients."

Clinical • HEOR • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Severe lupus induced by the tumor necrosis factor-alpha inhibitor Anbainuo: a case report. (PubMed, J Int Med Res) - "Subsequently, methotrexate and hydroxychloroquine were prescribed, but a reduced white blood cell count was detected. Moreover, her serum creatinine level remained high after Anbainuo withdrawal and prolonged steroid and immunosuppressive therapy. Careful and sustained monitoring for adverse reactions to Anbainuo (and other TNF-α inhibitors) is recommended."

Clinical • Journal • Alopecia • CNS Disorders • Complement-mediated Rare Disorders • Dermatology • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Oncology • Rheumatoid Arthritis • Rheumatology

[VIRTUAL] USE OF BIOLOGICAL AGENT IN MONOTHERAPY IN RHEUMATOID ARTHRITIS IN COMPARISON TO THE ASSOCIATIONS WITH D(ISEASE) M(ODIFIING) A(NTI) R(HEUMATIC) D(RUGS): REVIEW OF LITERATURE AND META-ANALYSIS OF RANDOMIZED TRIALS. (EULAR 2020) - "Currently, 9 biologic agents are approved in the RA treatment: and among them, three anti TNF agents are also approved in monotherapy (adalimumab, certolizumab and etanercept), but also abatacept, anakinra and tocilizumab. Registries of routine clinical practice treatment indicate that approximately one third of RA patients are being treated with a bDMARD in monotherapy and analyses from health care claims suggest that when methotrexate (MTX) is prescribed in combination with a bDMARD, more than half of the patients do not collect the MTX prescription and overall patients seem to taper MTX intake over time...The analysis comprises 22 trials (6358 patients), including six biological agents approved for RA (abatacept, adalimumab, etanercept, golimumab, rituximab and tocilizumab) as well as two other molecules: Clazakizumab, a humanized monoclonal antibody that binds to the interleukin-6 (IL-6) cytokine and Anbainuo, recombinant human TNFRII:Fc fusion protein. No study..."

Monotherapy • Retrospective data • Immunology • Rheumatoid Arthritis • Rheumatology • IL6

TNF-α inhibitor therapy can improve the immune imbalance of CD4+ T cells and negative regulatory cells but not CD8+ T cells in ankylosing spondylitis. (PubMed, Arthritis Res Ther) - "TNF-α inhibitor Anbainuo can not only help to inhibit disease activity but can also improve the immune imbalance of CD4+ T cells and negative regulatory cells in frequency. But CD8+ T cells have not been rescued."

Journal • Ankylosing Spondylitis • Immunology • Rheumatology • CD8 • CRP • IL10

[VIRTUAL] IMMUNE DYSFUNCTION IN ANKYLOSING SPONDYLITIS (AS) AND THE POTENTIAL OF TUMOR NECROSIS FACTOR-Α (TNF-α) INHIBITOR ANBAINUO AS AN EFFECTIVE TREATMENT (EULAR 2020) - "We found that, in terms of both innate and acquired immunity, active-stage AS patients have an immunity imbalance involving multiple types of immune cells, including CD4+T cells, CD8+T cells, Th cells, Tfh cells, Tc cells, Tregs, Bregs, and B cells. Anbainuo can not only help to inhibit disease activity and partial immune function imbalance in AS but can also increase the number of negative regulatory cells in inflammation."

Ankylosing Spondylitis • Immunology • Oncology • Rheumatology • CD8 • CRP • IL10 • TNFA

A randomized, controlled trial of efficacy and safety of Anbainuo, a bio-similar etanercept, for moderate to severe rheumatoid arthritis inadequately responding to methotrexate. (PubMed) - "Severe adverse events (SAEs) occurred in the Anbainuo group (1.3 %) and one (SAE) occurred in the control group (0.5 %) (P = 0.19). Anbainuo displays a rapid onset of efficacy as well as good tolerance and safety in MTX-IR patients having moderate to severe RA."

Journal • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

A novel etanercept biosimilar Anbainuo plus methotrexate exhibits increased cost-effectiveness compared to conventional disease-modifying anti-rheumatic drugs in treating rheumatoid arthritis patients. (PubMed, Medicine (Baltimore)) - "Sensitivity analysis reveals that rising ABN price by 20% produced an ICER of ¥130,403.6 per QALY, which was still lower than 3 times of the mean gross domestic product (GDP) per capita during the same period in China (¥165,960). Besides, ABN + MTX was more cost-effective in severe RA patients compared to moderate RA patients.ABN + MTX is cost-effective in treating moderate to severe RA patients compared with cDMARDs, although the total cost of ABN + MTX is relatively higher."

Clinical • HEOR • Journal

Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs (clinicaltrials.gov) - P4; N=100; Not yet recruiting; Sponsor: Nanfang Hospital of Southern Medical University

Clinical • New P4 trial

T2TEAS: Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis (clinicaltrials.gov) - P4; N=311; Completed; Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Clinical • New P4 trial