Etanercept

(Enbrel®)

Enbrel®

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 25 mg/0.5 mL, 50 mg/mL)
Drug ClassTumor necrosis factor (TNF) blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of rheumatoid arthritis (RA).
  • Indicated for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older.
  • Indicated for the treatment of Psoriatic Arthritis (PsA).
  • Indicated for the treatment of ankylosing spondylitis (AS).
  • Indicated for the treatment of plaque psoriasis (PsO) in patients 4 years or older.

Latest News

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Summary
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  • Enbrel (etanercept) is indicated for the treatment of rheumatoid arthritis (RA), the treatment of polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older, the treatment of psoriatic arthritis (PsA), the treatment of ankylosing spondylitis (AS), and the treatment of plaque psoriasis (PsO) in patients 4 years or older.
  • This summary is based on the review of 40 systematic review(s)/meta-analysis(es). [1-40]
  • Dementia Risk in RA Patients: Biological DMARDs, including TNF inhibitors, are associated with a reduced risk of developing dementia in RA patients (RR 0.76, 95% CI 0.72 to 0.80). Specific reductions observed for etanercept (RR 0.58, 95% CI 0.53 to 0.65), adalimumab (RR 0.65, 95% CI 0.59 to 0.72), and infliximab (RR 0.80, 95% CI 0.72 to 0.88).
  • Primary Autoimmune Inner Ear Disease (AIED): DMARDs, including etanercept, significantly improved auditory outcomes in AIED patients, with mean differences in pure-tone audiometry (-2.1 dB) and speech discrimination scores (13.9%). 38 adverse events were reported across 7 studies, with 4 classified as serious.
  • Switching Between Biologics and Biosimilars for RA: The effectiveness of switching to biosimilars in RA patients is comparable to continuing biologics, with ACR20 (RR 0.98, 95% CrIs 0.93 to 1.03) and HAQ-DI (SMD -0.07, 95% CrIs -0.23 to 0.1) showing no significant differences. Safety results were comparable between switching to biosimilars and continuing biologics, though results were imprecise, and long-term safety effects were not well-established.
  • Juvenile Idiopathic Arthritis (JIA): Etanercept is effective in juvenile idiopathic arthritis, with response rates for JIA-ACR30 (73-94%), JIA-ACR50 (53-78%), JIA-ACR70 (36-59%), and JIA-ACR90 (28%), comparable to other TNF inhibitors like adalimumab and infliximab. The incidence of serious adverse events (SAEs) for etanercept ranged from 0 to 20.0 SAE/100 patient-years.
  • Reduced dementia risk in RA patients using biological DMARDs, effective response and safety in juvenile idiopathic arthritis patients, and prevention of radiographic progression in psoriatic arthritis with anti-TNF agents are notable findings.

Product Monograph / Prescribing Information

Document TitleYearSource
Enbrel (etanercept) Prescribing Information.2023Immunex Corporation, Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Association between disease-modifying antirheumatic drugs for rheumatoid arthritis and risk of incident dementia: a systematic review with meta-analysis.2024Rheumatic & Musculoskeletal Diseases
Disease-modifying antirheumatic drugs in the treatment of autoimmune inner ear disease: a systematic review and meta-analysis of auditory and vestibular outcomes.2023Otology & Neurotology
Impact of switching between reference biologics and biosimilars of tumour necrosis factor inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis.2023Scientific Reports
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.2023The Cochrane Database of Systematic Reviews
Biosimilars for the treatment of psoriasis: a systematic review of clinical trials and observational studies.2023JAMA Dermatology
Therapeutic equivalence of biosimilar and reference biologic drugs in rheumatoid arthritis: a systematic review and meta-analysis.2023JAMA Network Open
Efficacy and safety of TNF inhibitors in the treatment of juvenile idiopathic arthritis: a systematic literature review.2023Pediatric Rheumatology Online Journal
Efficacy, safety and immunogenicity of etanercept biosimilars versus reference biologics in patients with rheumatoid arthritis: a meta-analysis.2023Frontiers in Pharmacology
Disease-modifying antirheumatic drugs in the treatment of autoimmune inner ear disease: a systematic review and meta-analysis of auditory and vestibular outcomes.2023Otology & Neurotology
Risk of hospitalization for serious infection after initiation of ustekinumab or other biologics in patients with psoriasis or psoriatic arthritis.2022Arthritis Care & Research
Biologic disease-modifying antirheumatic drugs for preventing radiographic progression in psoriatic arthritis: a systematic review and network meta-analysis.2022Pharmaceutics
Infection risk in psoriatic patients receiving tumour necrosis factor inhibitors: a 20-year systematic review and meta-analysis of randomized controlled trials.2022Journal of the European Academy of Dermatology and Venereology
Tumor necrosis factor (TNF) inhibitors for juvenile idiopathic arthritis-associated uveitis.2022The Cochrane Database of Systematic Reviews
Efficacy and safety of biological agents for the treatment of pediatric patients with psoriasis: a Bayesian analysis of six high-quality randomized controlled trials.2022Frontiers in Immunology
Impact of biologics on health-related quality of life in patients with Ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials.2022Seminars in Arthritis and Rheumatism
Adherence and persistence to biological drugs for psoriasis: systematic review with meta-analysis.2022Journal of Clinical Medicine
A systematic review on biological therapies in juvenile idiopathic inflammatory myopathies: an evidence gap in precision medicine.2022Clinical and Experimental Rheumatology
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year.2022The Journal of Dermatological Treatment
Systematic review and meta-analysis of biosimilar for the treatment of rheumatoid arthritis informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis.2022Modern Rheumatology
Biologics for pediatric psoriasis: a systematic review and meta-analysis.2022Pediatric Dermatology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta‐analysis.2021Cochrane Database of Systematic Reviews
Management of diffuse alveolar hemorrhage in the hematopoietic stem cell transplantation population: a systematic review.2021Pharmacotherapy
Short-term efficacy of biologic therapies in moderate-to-severe plaque psoriasis: a systematic literature review and an enhanced multinomial network meta-analysis.2021Dermatology and therapy
Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data.2021Dermatology and Therapy
Efficacy and safety of anti-tnfα therapy for uveitis associated with juvenile idiopathic arthritis: a systematic review and meta-analysis.2021Rheumatology and Therapy
Biologic drug survival in psoriasis: a systematic review & comparative meta-analysis.2021Frontiers in Medicine
Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis.2021Expert Review of Clinical Immunology
Systematic literature review of efficacy/effectiveness and safety of current therapies for the treatment of cryopyrin-associated periodic syndrome, hyperimmunoglobulin D syndrome and tumour necrosis factor receptor-associated periodic syndrome.2020Rheumatic & Musculoskeletal Diseases
Drug survival of biologics in treating ankylosing spondylitis: a systematic review and meta-analysis of real-world evidence.2020BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene therapy
Effectiveness and safety of systemic therapy for psoriasis in older adults: a systematic review.2020Journal of Cutaneous Medicine and Surgery
Reduction of biologics in rheumatoid arthritis: a systematic review and meta-analysis.2020Rheumatology International
The benefit–risk balance for biological agents in juvenile idiopathic arthritis: a meta-analysis of randomized clinical trials.2020Rheumatology
FDA approved biologics: can etanercept and ustekinumab be considered a first-line systemic therapy for pediatric/adolescents in moderate to severe psoriasis? A systematic review.2020Cureus
Comparison of cumulative clinical benefits of biologics for the treatment of psoriasis over 16 weeks: results from a network meta-analysis.2020Journal of American Academy of Dermatology
Impact of TNF-α inhibitors on body weight and BMI: a systematic review and meta-analysis.2020Frontiers in Pharmacology
Real-world evidence on etanercept biosimilar SB4 in etanercept-naïve or switching patients: a systematic review.2019Rheumatology and Therapy
Paradoxical hidradenitis suppurativa in patients receiving TNF-α inhibitors: case series, systematic review, and case meta-analysis.2019Dermatology
Biologic therapies targeting the interleukin (IL)-23/IL-17 immune axis for the treatment of moderate-to-severe plaque psoriasis: a systematic review and meta-analysis.2019Journal of the European Academy of Dermatology and Venereology
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: a systematic review and network meta-analysis.2019Seminars in Arthritis and Rheumatism
Anti-TNF drugs for chronic uveitis in adults-a systematic review and meta-analysis of randomized controlled trials.2019Frontiers in Medicine

Clinical Practice Guidelines