Yisaipu (etanercept biosimilar) / Cipla, 3SBio, Abbott - LARVOL DELTA

Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein (Yisaipu) combined with Tripterygium Wilfordii and Methotrexate for Active Rheumatoid Arthritis: A Multicenter, Prospective, Controlled Study (ChiCTR) - P4 | N=600 | Not yet recruiting | Sponsor: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine; Shanghai Guanghua Hospital of Integrated Traditional Chinese and We

New P4 trial • Immunology • Inflammatory Arthritis • Oncology • Ophthalmology • Rheumatoid Arthritis • Rheumatology

T Cell Subset Signatures Predicted Clinical Response to Etanercept-biosimilar Yisaipu in Patients with Rheumatoid Arthritis (ACR Convergence 2023) - "T cell signatures might promisingly predict the clinical response to Yisaipu in RA patients and facilitate better stratification of patients for optimal treatment choices in the future."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD8 • FOXP3

Cost-Effectiveness of Secukinumab Versus Other Biologics in the Treatment of Moderate-to-Severe Plaque Psoriasis: The Chinese Healthcare System Perspective. (PubMed, Dermatol Ther (Heidelb)) - "Secukinumab is the most cost-effective treatment option for patients with moderate-to-severe psoriasis compared with other commonly used biologics from the Chinese healthcare system perspective."

Cost effectiveness • HEOR • Journal • Dermatology • Immunology • Psoriasis

3SBio announces 2023 interim results, with revenue growing over 20% year on year and pipeline value constantly enhanced (PRNewswire) - "Sales of Yisaipu for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis were RMB 300million in the first half of 2023, up 25% year on year. The pre-filled injection of Yisaipu was approved for marketing in March this year."

Sales • Ankylosing Spondylitis • Immunology

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein in the Treatment of Acute Gout (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Lihua Duan

New trial • Gout • Inflammatory Arthritis • Oncology • Rheumatology

YISTAR: Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA (clinicaltrials.gov) - P4 | N=504 | Completed | Sponsor: Peking Union Medical College Hospital | Unknown status ➔ Completed | Phase classification: P2 ➔ P4 | Trial completion date: Jul 2020 ➔ Jul 2022 | Trial primary completion date: Jul 2020 ➔ Mar 2022

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Oncology • Ophthalmology • Rheumatoid Arthritis • Rheumatology • CRP

Neuroprotective effects of voluntary exercise and Yisaipu after traumatic brain injury in mice. (PubMed, Sheng Li Xue Bao) - "These functional improvements were accompanied by reduced systemic inflammation largely via decreased serum TNF-α, boosted autophagic flux, and mitigated lesion volume after TBI. Given these neuroprotective effects, composite approaches such as a combination of exercise and TNF inhibitor may be a promising strategy for facilitating functional recovery from TBI and are worth further investigation."

Journal • Preclinical • CNS Disorders • Immunology • Inflammation • Vascular Neurology

LORMYF: Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients (clinicaltrials.gov) - P=N/A | N=500 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

New trial • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Current Knowledge of Biologics in Treatment of Noninfectious Uveitis. (PubMed, J Ocul Pharmacol Ther) - "Other drugs include anti-CD20 inhibitors (rituximab), interleukin-6R-inhibitor (tocilizumab), Interleukin-1R-inhibitor (anakinra), Iinterleukin-2-inhibitor (daclizumab), and the list is further increasing. New advances in biologics are the biosimilar molecules, which are biological products that are highly similar to the reference product, and they include Infimab (biosimilar of infliximab), Exemptia or Adfrar (biosimilar of adalimumab), and Intacept or Etacept (biosimilar of etanercept)...Thus, biologics are the future of uveitis treatment with promising results. This article aims to summarize the current knowledge on biologics and their clinical utility in the management of NIU."

Journal • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Ocular Inflammation • Oncology • Ophthalmology • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis • IL1R1 • IL2 • IL6R

Yisaipu Provide AS Patients With an Economical Therapeutic Option While Original Biologicals are More Advantageous in the COVID-19 Epidemic Situation. (PubMed, Front Pharmacol) - "The overall impact of the COVID-19 epidemic on patients of original biological group was comparatively smaller than that on Yisaipu group. Yisaipu provided AS patients with an economical selection during regular follow-up, while original biologicals had certain advantages in the COVID-19 epidemic setting, including a longer time interval between two drug administrations and the self-injection dose form of medication."

Clinical • Journal • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Oncology • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • TNFA

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

Clinical • Phase classification • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P; N=100; Recruiting; Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Clinical • New trial • Dermatology • Immunology • Psoriasis

Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial. (PubMed, Rheumatol Ther) - P3 | "Once-weekly 50-mg or twice-weekly 25-mg prefilled liquid Yisaipu is safe and non-inferior to twice-weekly 25-mg lyophilized Yisaipu."

Clinical • Journal • P3 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Algorithms for detecting and predicting influenza outbreaks: metanarrative review of prospective evaluations. (PubMed) - BMJ Open - "Awareness of the narrative format in which results are reported is essential when interpreting algorithm evaluations from an infectious disease control practice perspective."

Journal • Biosimilar

Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis (clinicaltrials.gov) - P3; N=640; Completed; Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Clinical • New P3 trial • Ankylosing Spondylitis • Immunology • Inflammation • Rheumatology

Etanercept biosimilar (recombinant human tumor necrosis factor-α receptor II: IgG Fc fusion protein) and methotrexate combination therapy in Chinese patients with moderate-to-severe plaque psoriasis: a multicentre, randomized, double-blind, placebo-controlled trial. (PubMed, Arch Dermatol Res) - "Etanercept biosimilar recombinant human tumour necrosis factor-α receptor II: IgG Fc fusion protein (rhTNFR-Fc, trade name Yisaipu) has shown good efficacy in the treatment of moderate-to-severe plaque psoriasis. The most common AEs in the two groups were upper respiratory tract infection and abnormal liver function. The combination therapy of rhTNFR-Fc plus MTX was an effective therapy for moderate-to-severe plaque psoriasis with an acceptable safety and tolerability profile, indicating that it was feasible and well tolerated for patients."

Clinical • Combination therapy • Journal

Clinical and MRI response to dose reduction of an etanercept-biosimilar for hip arthritis in patients with ankylosing spondylitis: an observational, retrospective cohort study. (PubMed, Clin Rheumatol) - "Efficacy of Yisaipu® tapering treatment is comparable to the full-dose therapy for hip arthritis in AS patients. Both treatments maintain remission of hip arthritis after patients achieved low disease activity."

Journal • Retrospective data

Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein (clinicaltrials.gov) - P4; N=150; Completed; Sponsor: Sun Yat-sen University; Active, not recruiting ➔ Completed

Clinical • Trial completion

Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate AS (clinicaltrials.gov) - P4; N=76; Completed; Sponsor: Nanfang Hospital of Southern Medical University; Recruiting ➔ Completed; N=200 ➔ 76; Trial completion date: Dec 2019 ➔ Jul 2019; Trial primary completion date: May 2018 ➔ Jul 2019

Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Correlation between magnetic resonance imaging (MRI) findings and the new bone formation factor Dkk-1 in patients with spondyloarthritis. (PubMed, Clin Rheumatol) - "...Thirty patients with active SpA were included, all treated with recombinant human tumor necrosis factor (TNF) receptor-antibody fusion protein (YiSaiPu) injection at 50 mg/week for 6 months...Inhibition of the level of serum Dkk-1 by TNF inhibitors may be the molecular basis for inhibiting the formation of new bone in SpA patients. In addition, spinal marrow edema may have significance for predicting new bone formation."

Clinical • Journal

Full dose, half dose, or discontinuation of etanercept biosimilar in early axial spondyloarthritis patients: a real-world study in China. (PubMed, Arch Med Sci) - "To investigate the effect of dose maintenance, reduction, or discontinuation of the etanercept biosimilar Yisaipu (YSP) on early axial spondyloarthritis (axSpA) patients in remission with YSP 50 mg once weekly (QW)...Most patients who flared regained remission rapidly after resuming YSP 50 mg QW or starting adalimumab 40 mg every other week. For patients with early axSpA in remission on YSP for more than 12 weeks, continuation of YSP at full dose was superior to discontinuation of YSP, but not superior to halving the dose."

Clinical • Journal • Real-World Evidence