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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
来源： ClinicalTrials.gov, Shanghai Celgen

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

PubMedJournal of reproductive immunology2026-08-02

Safety and efficacy of immunosuppressants for recurrent reproductive failure: A systematic review and meta-analysis.

Gao Yv Y, Xu Ke K, Yang Shuangshuang S, Hou Ning N

Recurrent reproductive failure impairs women's health, and the efficacy of immunosuppressants for this condition remains uncertain. This study aimed to explore the clinical application of common immunosuppressive agents including cyclosporine A, tacrolimus, etanercept and adalimumab for recurrent reproductive failure, which covers recurrent spontaneous abortion and recurrent implantation failure after IVF/ICSI, and to assess their efficacy and safety so as to provide evidence-based references for clinical practice. We retrieved eligible randomized controlled trials and cohort studies published from January 1, 2005 to February 28, 2025 from PubMed, Web of Science, CNKI and Wanfang databases, and conducted a systematic review and meta-analysis. This study was registered on PROSPERO (ID: CRD420251057130). A total of 13 randomized controlled trials and 7 cohort studies involving 2266 patients were finally included. Meta-analysis revealed that compared with the control group, immunosuppressive therapy significantly elevated live birth rate (RR=1.33, 95%CI:1.20-1.47, P < 0.00001) and clinical pregnancy rate (RR=1.24, 95%CI:1.11-1.39, P = 0.0001), while lowering miscarriage rate (RR=0.45, 95%CI:0.37-0.54, P < 0.00001). No significant differences were found in the incidence of adverse events (RR=0.96, 95%CI:0.69-1.34, P = 0.83) and birth defect rate (RR=0.63, 95%CI:0.19-2.07, P = 0.45) between the two groups. In conclusion, the above immunosuppressive drugs can improve pregnancy outcomes in patients with recurrent reproductive failure and do not obviously increase adverse reactions and birth defects. Considering the limited quality of existing evidence and potential publication bias, the results should be interpreted cautiously, and the use of these drugs is recommended to be limited to clinical trials until verified by more large-scale and high-quality randomized studies.

PMID 42541852
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PubMedMedComm2026-07-31

PD-1hiCXCR5-CD4+T Peripheral Helper Cells Were Enriched and Potentially Predicted Clinical Response to Etanercept Therapy in Rheumatoid Arthritis.

Xu Haojie H, Ho Wanki W, Cao Lulu L, Fu Dongdong D et al.

Rheumatoid arthritis (RA) remains a challenging autoimmune disease with variable treatment responses to tumor necrosis factor-α (TNF-α) inhibitors. This study investigates the clinical significance of PD-1hiCXCR5-CD4+T peripheral helper (Tph) cells in RA and their potential utility as biomarkers for predicting etanercept (ETN) therapy response. We enrolled 58 RA patients, 12 age- and sex-matched osteoarthritis patients, and 15 healthy controls, with Tph cells quantified by flow cytometry. Among 25 RA patients with inadequate response to conventional synthetic disease-modifying antirheumatic drugs receiving ETN therapy, treatment outcomes were stratified by ACR20 response criteria. Tph cell frequency was significantly elevated in RA patients and correlated positively with multiple disease activity indicators. At baseline, ETN nonresponders exhibited higher Tph proportions than responders (13.23 ± 2.60% vs. 10.82 ± 3.08%, p = 0.0467). Following ETN treatment, responders demonstrated significant Tph reduction (10.82% decreased to 7.97%, p = 0.0105), paralleling serum IL‑21 dynamics. In an exploratory analysis, baseline Tph levels showed an association with ETN response. These findings suggest that circulating Tph cells may serve as a candidate biomarker for RA disease activity and therapeutic response monitoring, warranting further validation in larger prospective cohorts.

PMID 42534265
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PubMedClinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology2026-07-30

Neurobehavioral Consequences of Obesity: The Role of Inflammation.

Celebi Gulsen G, Gocmez Semil Selcen SS, Tufekci Gozde G, Furat Selenay Humeyra SH et al.

Obesity is a global health concern linked to neuroinflammation, cognitive decline, and depression. Tumor necrosis factor-α (TNF-α) is a key mediator of these effects, and its inhibition may offer therapeutic benefits. This study investigated whether etanercept (ETN), a TNF-α inhibitor, prevents neurobehavioral alterations induced by a cafeteria (CAF) diet in rats. Male rats were assigned to control, CAF, or CAF + ETN groups for 12 weeks. Cognitive and affective behaviors were assessed by the Morris water maze, passive avoidance, forced swimming, and sucrose preference tests. Hippocampal TNF-α, interleukin-1β, and brain-derived neurotrophic factor (BDNF) levels were measured. CAF-fed rats developed obesity, memory impairment, and depression-like behaviors, accompanied by increased proinflammatory cytokines and reduced BDNF immunoreactivity. ETN attenuated weight gain and improved cognitive and emotional performance with normalized hippocampal proinflammatory cytokines levels. After ETN treatment, BDNF levels significantly increased compared to the CAF group but still remained lower than the controls. The results of the study indicate that TNF-α inhibition alleviates obesity-induced neuroinflammation and rescues cognitive and emotional behavioral impairments, while only partially restoring hippocampal BDNF levels. These results suggest a potential link between TNF-α inhibition and the mitigation of obesity-associated neurobehavioral dysfunction through the suppression of hippocampal neuroinflammation.

PMID 42528346
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PubMedThe spine journal : official journal of the North American Spine Society2026-07-18

TNF-α Modulation in Spinal Fusion: High-Dose TNF-α Is Associated With Failed Arthrodesis, While Etanercept Is Associated With Successful Fusion in a Rat Model.

Koerner John D JD, Ng Mitchell K MK, Dalton Jonathan J, Eichbaum Yasmine K YK et al.

TNF-α has been studied in fracture healing; modulation of its activity, either by supraphysiologic exposure or pharmacologic inhibition, may alter the likelihood of pseudarthrosis in spinal fusion. Our main objective is to determine the effects of high- and low-dose tumor necrosis factor-α (TNF-α) and the TNF-α inhibitor Etanercept on spinal fusion outcomes. Laboratory Study METHODS: Seventy-five Wistar rats underwent L4-L5 posterolateral fusion with demineralized bone matrix and received either high-dose TNF-α, low-dose TNF-α, local Etanercept, systemic Etanercept, or carrier alone. At 2, 4, and 28 days, serum and local fusion masses were analyzed with ELISA for IGF-1 and VEGF. Fusion was assessed at 4 weeks by manual palpation and microCT. The study was funded by the ***, no study specific conflicts of interest to report. In vivo, high-dose TNF-α significantly elevated local IGF-1 (22.1 ± 2.1 ng/mg) and VEGF (539 ± 177 pg/mg) at day 2 compared with controls (IGF-1: 6.2 ± 1.2; VEGF: 112 ± 12; P < 0.001). By day 28, only VEGF was reduced in all treatment groups compared with controls (P < 0.001). At 4 weeks, fusion was present in 4/5 controls, 0/5 high-dose TNF-α animals (P = 0.048), 5/5 low-dose TNF-α, 3/5 local Etanercept, and 4/5 systemic Etanercept. MicroCT demonstrated bilateral fusion in 5/5 systemic Etanercept animals, 2/5 controls, and 0/5 high-dose TNF-α (P = 0.016). High-dose TNF-α impaired fusion and was consistently associated with pseudarthrosis despite early increases in growth factor expression. Low-dose TNF-α and Etanercept, administered locally or systemically, did not compromise fusion, with systemic Etanercept showing the highest bilateral fusion rate. These findings indicate that TNF-α modulation significantly influences spinal fusion, and that TNF-α inhibition does not adversely affect arthrodesis. Modulating TNF-α appears to affect fusion success and implementing anti-TNF-α could decrease pseudoarthrosis rates among patients who have elevated TNF-α disease states.

PMID 42468831
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PubMedCureus2026-07-17

Incidence and Clinical Characteristics of Herpes Zoster in Patients With Spondyloarthritis Receiving Biologic Therapy: A 36-Month Multicenter Registry-Based Study.

Ben Marzouk Ilham I, Rostom Samira S, El Binoune Imane I, Ghoullam Ghizlane G et al.

Herpes zoster, caused by the reactivation of varicella-zoster virus, has been reported in patients with autoimmune inflammatory diseases receiving biologic therapies. However, data regarding its occurrence in patients with spondyloarthritis (SpA) remain limited. This study aimed to determine the incidence of herpes zoster and describe the clinical characteristics of affected patients with SpA receiving biologic therapy. A multicenter retrospective registry-based study was conducted over a 36-month period, including patients with SpA receiving biologic therapy and registered in the Moroccan Society of Rheumatology Biotherapy Registry (BRMSR). Clinical, laboratory data, including erythrocyte sedimentation rate and C-reactive protein, and therapeutic data were collected at baseline, at 36 months, and at the time of herpes zoster infection. A descriptive statistical analysis was performed. A total of 194 patients with SpA were included, with a mean age of 40.23 ± 13.68 years. The cohort included 123 males (63.4%) and 71 females (36.6%), with a mean disease duration of 11 ± 7 years. Most patients (98.5%) were treated with anti-tumor necrosis factor agents, with etanercept being the most commonly prescribed biologic therapy. The incidence of herpes zoster was 6.87 cases per 1,000 person-years (95% CI: 2.018-16.85). Four cases of herpes zoster were identified. These patients were all older than 55 years, had associated comorbidities, and had prolonged exposure to biologic therapy. The incidence of herpes zoster in patients with SpA receiving biologic therapy was low. The four reported cases shared common clinical characteristics, including older age, the presence of comorbidities, and prolonged exposure to biologic therapy. Further studies with larger populations and longer follow-up are needed to better characterize herpes zoster occurrence in this population.

PMID 42465193
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PubMedInternational journal of clinical pharmacy2026-07-17

Budget impact analysis of medication reviews by junior pharmacists in polypharmacy patients: a hospital perspective.

Hectors Toon T, Kooijman Thirza T, van Barreveld Marit M, Kuijvenhoven Marianne M et al.

Pharmacist-led medication reviews are increasingly recognised for generating cost savings within the hospital. However, no cost-analysis has investigated the budget impact of junior pharmacists conducting medication reviews under supervision of clinical pharmacists, nor included recommendations to start-, increase-, or monitor medications. To assess the budget impact of medication reviews by supervised junior pharmacists across hospital wards, explore budget impact differences between drug classes, and identify patient predictors that potentially influence the budget impact. Data of medication reviews were collected over a 19-month period in patients with polypharmacy (≥ 5 medications) who had at least one additional risk factor. We developed a cost model over a one-year horizon, from the hospital perspective. Intervention costs were derived from measured labour time per medication review and salary of junior- and clinical pharmacists. Cost avoidance from potential preventable medication-related readmissions were based on admission time, admission costs and an estimate of preventable medication-related admissions (4.8%). Costs and savings from medication recommendations were aggregated using drug price per daily defined dose and its predicted days of therapy per year, and clustered by drug class. Scenario analyses tested the robustness of medication recommendation savings to account for effectively implemented and additional monitoring recommendations. Patient predictors of budget impact related to medication recommendations were assessed using multivariable linear regression, including age, gender, eGFR, acute admission, medication count, comorbidity, expensive drugs, and ward type. We collected 271 medication reviews, including 1,689 medication recommendations. Per-patient budget impact was negative for the intervention (€104 costs), but positive for medication recommendations (€46 savings), and preventable medication-related readmissions (€239 savings). Total estimated savings were €181 per patient, and €688,000 when upscaled hospital-wide. Opiates, beta receptor agonists, corticosteroids, urological drugs, and muscarine receptor antagonists generated 43% of medication recommendation savings. Erythropoietic growth factors, SGLT2 inhibitors, etanercept, etravirine, and calcium/vitamin D formulations generated 70% of medication recommendation costs. No significant associations were found between any of the included patient characteristics and budget impact related to medication recommendations. Junior pharmacist-led medication reviews provide a modest cost-saving intervention from the hospital perspective, demonstrating savings across clinical populations with polypharmacy.

PMID 42467355
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