Enbrel (Etanercept): Recommended Use and Dosing
Primary Indications
Enbrel is indicated for moderate-to-severe plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis, administered as a subcutaneous injection with specific dosing regimens based on the condition being treated. 1
Adult Dosing by Indication
Plaque Psoriasis
- Starting dose: 50 mg subcutaneously twice weekly for 12 consecutive weeks 2, 1
- Maintenance dose: 50 mg once weekly after the initial 12-week period 2, 1
- Alternative for better control: Some patients may require continuation of 50 mg twice weekly for optimal disease control 2
- Clinical efficacy: 49% of patients achieve PASI-75 at 12 weeks with the 50 mg twice-weekly regimen 2, 3
Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
- Standard dose: 50 mg subcutaneously once weekly 1
- Combination therapy: May be continued with methotrexate, glucocorticoids, NSAIDs, or analgesics 1
- Important caveat: Doses higher than 50 mg per week are not recommended based on studies showing higher adverse reactions without improved ACR response rates 1
Pediatric Dosing
Polyarticular Juvenile Idiopathic Arthritis, Juvenile Psoriatic Arthritis, and Pediatric Plaque Psoriasis
- Weight ≥63 kg (138 lbs): 50 mg subcutaneously once weekly 1
- Weight <63 kg (138 lbs): 0.8 mg/kg subcutaneously once weekly (maximum 50 mg) 2, 1
- Age requirements:
- Pediatric efficacy: 57% of children achieved PASI-75 with 0.8 mg/kg weekly dosing 2
Special Clinical Scenarios
Difficult-to-Treat Areas
- Scalp psoriasis: Etanercept is recommended as monotherapy with 86.8% improvement in PSSI score at 12 weeks (Strength A) 2, 3
- Nail psoriasis: Recommended as monotherapy with 41.7% improvement in NAPSI score at 12 weeks (Strength A) 2, 3
- Pustular or erythrodermic psoriasis: Can be recommended as monotherapy (Strength B) 2
Psoriasis with Psoriatic Arthritis
- Indication: Recommended for plaque psoriasis of any severity when associated with significant psoriatic arthritis (Strength A) 2
- Dual benefit: Inhibits radiographically detected joint damage while treating skin manifestations 3
Combination Therapy Options
Strongly Recommended Combinations (Strength A-B)
- Topical corticosteroids ± vitamin D analogues: Recommended to augment efficacy (Strength A) 2
- Methotrexate: Recommended combination for enhanced efficacy (Strength B) 2
- Acitretin: May be combined for augmented efficacy (Strength B) 2
- Narrowband UVB phototherapy: May be combined (Strength B) 2
Lower Evidence Combinations (Strength C)
- Apremilast: May be combined when clinically indicated (Strength C) 2
- Cyclosporine: May be combined when clinically indicated (Strength C) 2
Mandatory Pre-Treatment Evaluation
Required Baseline Testing
- Tuberculosis screening: PPD or interferon-gamma release assay is required before initiation 2, 3, 1
- Complete blood count (CBC): Baseline required 2, 3
- Liver function tests (LFTs): Baseline required 2, 3
- Hepatitis B screening: For patients with risk factors or history of viral hepatitis 3
- Vaccinations: Complete all age-appropriate immunizations before starting therapy 1
Ongoing Monitoring
- Periodic history and physical examination while on treatment 2
- Consider yearly PPD testing even if initial test was negative 2, 3
- Periodic CBC and LFT monitoring 2, 3
- Monitor for signs of infection throughout treatment 3
Critical Safety Considerations
Absolute Contraindication
- Sepsis: Enbrel is contraindicated in patients with active sepsis 1
Serious Warnings (Boxed Warning)
- Serious infections: Increased risk of tuberculosis, bacterial sepsis, invasive fungal infections, and opportunistic infections leading to hospitalization or death 1
- Malignancies: Lymphoma and other malignancies reported, particularly in children and adolescents treated with TNF-blockers 1
- Action required: Discontinue Enbrel if serious infection or sepsis develops 1
Additional Important Warnings
- Demyelinating disease: New onset or exacerbation may occur 1
- Congestive heart failure: Worsening or new onset possible 1
- Hepatitis B reactivation: Monitor previously infected patients during and several months after therapy; consider stopping Enbrel and initiating antiviral therapy if reactivation occurs 1
- Pancytopenia/aplastic anemia: Advise patients to seek immediate medical attention if symptoms develop 1
- Lupus-like syndrome or autoimmune hepatitis: Stop Enbrel if develops 1
- Anaphylaxis: Serious allergic reactions may occur 1
Drug Interactions to Avoid
- Live vaccines: Avoid concurrent administration 3, 1
- Anakinra: Increased risk of serious infection; avoid combination 1
- Abatacept: Increased risk of serious adverse events including infections; avoid combination 1
- Cyclophosphamide: Not recommended for use with Enbrel 1
Empiric Antifungal Therapy
- Consider empiric antifungal treatment for patients at risk for invasive fungal infections (those residing in or traveling to endemic mycoses regions) who develop severe systemic illness on Enbrel 3, 1
Administration Technique
Injection Instructions
- Route: Subcutaneous injection only 1
- Sites: Thigh, abdomen, or outer area of upper arm 1
- Preparation: Allow prefilled syringe to reach room temperature for 15-30 minutes before injection for comfort; do not remove needle cover during warming 1
- Inspection: Visually inspect for particulate matter and discoloration before administration 1
- Pregnancy category: B 2
Clinical Efficacy Benchmarks
Short-Term Response (12 weeks)
Step-Down Efficacy (24 weeks)
- Patients stepped down from 50 mg twice weekly to 25 mg twice weekly: 54% maintain PASI-75 2
- Patients maintained at 25 mg twice weekly: 45% achieve PASI-75 2
Long-Term Maintenance
- Beneficial effects sustained for up to 9 years in long-term studies 4