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etanercept (Qiangke)

✓ Approved

Shanghai Celgen · TNF · 重组蛋白

什么是 etanercept?

etanercept 是一种重组蛋白,由Shanghai Celgen研发。该药已获批,用于治疗相关适应症,给药途径:Injectable (Others)、Intraarticular Injection、Intravenous (IV)、Subcutaneous Injection。

药物档案

商品名Qiangke
公司Shanghai Celgen
药物类别重组蛋白
分子靶点TNF
给药途径Injectable (Others), Intraarticular Injection, Intravenous (IV), Subcutaneous Injection
状态Approved

作用机制

分子靶点

etanercept 作用于 1 个分子靶点:

TNFtumor necrosis factor (TNFA, TNF-alpha)
需要更深入的分析?Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

etanercept 针对 5 个适应症,涉及 2 个治疗领域。

治疗领域疾病/病症分期
Musculoskeletal and connective tissue disordersAnkylosing spondylitis✓ Approved
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Musculoskeletal and connective tissue disordersPsoriatic arthropathy✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved
Musculoskeletal and connective tissue disordersJuvenile idiopathic arthritis✓ Approved

相关研究文献

PubMedCureus2026-06-10

Drug Retention of First-Line Biologic Therapies in Rheumatoid Arthritis: Real-World Evidence From a Moroccan Cohort.

El Kacem El Marbouh EM, Majjad Abderrahim A, Belhadj Wissal W, Toufik Hamza H et al.

Drug retention is a meaningful real-world composite endpoint reflecting both long-term effectiveness and tolerability of biologic therapies in rheumatoid arthritis (RA). Data from North African cohorts remain scarce, and sociocultural determinants of treatment persistence are poorly explored. We conducted a retrospective observational study including RA patients who initiated first-line biologic therapy at a Moroccan tertiary center. Drug retention was defined as the time from initiation to permanent discontinuation for any reason. To compare drug retention across biologic agents, the Kaplan-Meier method was applied alongside the log-rank test. Cox proportional hazards regression was subsequently used to determine baseline factors independently associated with treatment discontinuation. One hundred and thirty patients met the inclusion criteria, with a clear female predominance (n = 112, 86.2%) and a mean age of 58.7 ± 12.9 years. Rituximab was the most frequently prescribed first-line biologic (n = 72, 56.1%), followed by Etanercept and Tocilizumab (n = 21, 16.2% each). Drug retention differed significantly across biologics (log-rank p = 0.018). Taking Adalimumab as the reference, three biologics showed significantly better retention: Etanercept (hazard ratio (HR) = 0.14, p = 0.001), Rituximab (HR = 0.26, p = 0.006), and Tocilizumab (HR = 0.07, p < 0.001). Additional independent predictors of better retention included concomitant conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy (HR = 0.39, p = 0.014), lower baseline Simplified Disease Activity Index (SDAI) (HR = 0.96, p = 0.020), and primary education level (HR = 0.32, p = 0.033). In this real-world Moroccan cohort, non-TNF (tumor necrosis factor) biologics demonstrated favorable retention compared to Adalimumab. Beyond treatment type, both clinical and sociocultural factors were associated with persistence. Given the retrospective observational design and the inherent risk of channeling bias, these results should be interpreted with appropriate caution.

PMID 42266298
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PubMedCurrent rheumatology reviews2026-06-09

Antidrug Antibodies and Serum Etanercept Levels in Rheumatoid Arthritis: A Narrative Review.

Abdulla Anfal A AA, Younis Ali A AA, Aladul Mohammed I MI

Etanercept is a tumor necrosis factor inhibitor used widely for rheumatoid arthritis. Because patients respond differently, clinicians have increasingly explored whether measuring drug levels and antidrug antibodies could help guide treatment. This review brings together what is currently known about etanercept immunogenicity, serum concentrations, and the role of therapeutic drug monitoring, with a particular focus on practice in resource-limited settings such as Iraq. Major databases were searched (January 2010-June 2025) for clinical trials, observational studies, and systematic reviews of adults with rheumatoid arthritis receiving originator or biosimilar etanercept that reported antidrug antibodies, serum levels, or outcomes related to monitoring. Across randomized and real-world studies, etanercept generally showed low immunogenicity, with reported antidrug antibodies mostly below 15% and neutralizing antibodies rarely detected. Serum levels varied considerably between patients, and no robust therapeutic range could be defined. In most studies, etanercept concentrations did not consistently predict clinical response, and originator and biosimilar products appeared similar in terms of effectiveness and safety. Overall, these findings suggest that immunogenicity is not a major reason for etanercept treatment failure and that routine therapeutic drug monitoring is unlikely to help most patients. However, the evidence is heterogeneous, and real-world data from low- and middleincome countries, including Iraq, are still limited. Current evidence supports etanercept and its biosimilars as low-immunogenic options for rheumatoid arthritis, where routine monitoring is usually unnecessary. A more practical strategy may be to reserve targeted testing for selected non-responders while strengthening pharmacovigilance and local real-world research.

PMID 42261172
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PubMedJAAD case reports2026-06-03

Vancomycin-induced linear IgA bullous dermatosis mimicking Stevens-Johnson syndrome/toxic epidermal necrolysis treated with etanercept.

Alanazi Rawan R, Aldahash Rawan R, Alanazi Shada Khalid SK, Almasoud Sharifah Hussain SH et al.

PMID 42232736
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PubMedThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2026-06-02

TB risk during treatment with biological agents and Janus kinase inhibitors: an umbrella review.

Alves R F RF, Hilário C C, Ferreira N B NB, Cascais M M et al.

BACKGROUNDBiological therapies and Janus kinase (JAK) inhibitors have revolutionised the management of immune-mediated and oncologic diseases, but concerns remain regarding their potential to increase TB risk.OBJECTIVETo systematically synthesise evidence from previous systematic reviews on the risk of TB disease associated with different biological classes and JAK inhibitors.METHODSFollowing Preferred Reporting Items for Overviews of Reviews guidelines, we conducted an umbrella review of systematic reviews and meta-analyses, registered in PROSPERO (CRD42024497515). Twenty-five reviews met the inclusion criteria. Data were extracted on TB incidence, risk estimates, type, and time to onset. Risk of bias was assessed using ROBIS.RESULTSAnti-TNF monoclonal antibodies (infliximab, adalimumab) were consistently associated with the highest TB risk (odds ratio commonly 3-5), with greater proportions of disseminated/extra-pulmonary disease compared to etanercept. Combination immunosuppression further increased risk. IL-6, IL-17, and IL-23 inhibitors showed low TB reactivation rates under screening and prophylaxis protocols. JAK inhibitors (notably tofacitinib) conferred geographically variable risk, higher in intermediate/high-burden countries. Immune checkpoint inhibitors, especially PD-1/PD-L1 agents, were linked to TB incidence far above background rates.CONCLUSIONTB risk varies markedly across biologic and targeted agents. Risk-based TB infection screening and tailored prophylaxis beyond anti-TNF therapy are warranted, particularly in endemic regions..

PMID 42226371
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PubMedExperimental and therapeutic medicine2026-06-01

Morphological analysis of bronchoalveolar lavage fluid in diagnosing pulmonary aspergilloma in a patient with rheumatoid arthritis: A case report.

Zhou Yuli Y, Lai Yuyi Y, Zhou Fuxian F, Wang Xinxin X et al.

Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disorder that primarily affects the joints and may be associated with systemic complications. Patients with RA have an increased susceptibility to opportunistic infections, attributable to inherent immune dysregulation as well as immunosuppressive therapies, including tocilizumab, particularly among those with comorbidities or high disease activity. Notably, the use of tumor necrosis factor inhibitors, such as adalimumab and etanercept, has been associated with a higher incidence of invasive pulmonary aspergillosis and chronic pulmonary aspergillosis. The present study reports a rare case of pulmonary aspergilloma in a 75-year-old female RA patient with prior tuberculosis and long-term tocilizumab use. The patient was diagnosed via bronchoalveolar lavage fluid morphology, fungal culture, Aspergillus galactomannan assay, metagenomic next-generation sequencing and pathology, and the patient achieved symptom resolution and improved imaging after 6 months of treatment with voriconazole. These findings underscore the need for vigilant monitoring and individualized management strategies in this patient population.

PMID 42222213
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PubMedBiosensors & bioelectronics2026-05-31

Screening molecular recognition element-based SWCNT optical sensors for the inflammatory cytokine TNF-α.

Rahman Syeda S, Israel Atara R AR, Ryan Amelia A, Williams Ryan M RM

TNF-α (Tumor Necrosis Factor) is a proinflammatory cytokine that amplifies inflammatory response and promotes leukocyte recruitment. TNF-α is primarily produced by activated macrophages, among others, in response to infection, inflammation, or tissue damage. Given its central role in normal and abnormal immune responses, it is the target of several therapeutics, such as adalimumab and etanercept. TNF-α is also a prognostic and diagnostic biomarker associated with rheumatoid arthritis, Alzheimer's disease, multiple sclerosis, several kidney diseases, cancers, type 2 diabetes, sepsis, and others. Because TNF-α levels change dynamically during inflammatory responses, tools capable of sensitive and spatially resolved detection could enable improved monitoring of immune activity and disease progression. Single-walled carbon nanotubes (SWCNT) are cylindrical carbon lattices that emit distinct near-infrared bandgap photoluminescence. In this work, we evaluated three aptamer-based sensor constructs, plus an additional two iterations of one aptamer sequence, and two antibody-based sensor constructs for TNF-α that use SWCNT near-infrared photoluminescence signal transduction. Several, but not all, of these aptamer and antibody-based sensors sensitively and selectively detected TNF-α in human and bovine serum in a physiologically relevant range, and we found that their sensing was impacted by both passivation and incorporating an exogenous quencher onto the aptamer sequence. This study highlights the importance and challenges of translating previously-validated molecular recognition elements to new detection conditions, in this case on the surface of SWCNT and in challenging serum conditions. It also validated a lead sensor, the VR11-SWCNT aptamer construct with or without quencher chemistry and with surface passivation, that builds upon constructs that failed in serum. These results demonstrate a strategy toward synthesis of nanoscale optical sensors capable of detecting TNF-α. We anticipate that the sensors evaluated here will have utility in both the diagnosis and study of inflammation-driven chronic disease, while the sensor assessment framework will help drive the broader field of molecularly specific diagnostics.

PMID 42217399
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