FDA approved Enbrel (etanercept) for Rheumatoid Arthritis and Other Inflammatory ConditionsFDA approved Enbrel for Several Long-Term Inflammatory Conditions

FDA From the archive Source published November 2, 1998 Summary added October 16, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note: Evaluate for latent TB and complete vaccinations before starting Enbrel.

The U.S. Food and Drug Administration has approved Enbrel (etanercept) for the treatment of several chronic inflammatory diseases. In adults, Enbrel is indicated for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and chronic moderate to severe plaque psoriasis (PsO). In pediatric patients, it is approved for polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (JPsA) in patients 2 years of age and older, and for plaque psoriasis in patients 4 years of age and older.

Enbrel is a tumor necrosis factor (TNF) blocker administered by subcutaneous injection. For adult RA, PsA, and AS, the recommended dose is 50 mg once weekly. For adult PsO, the recommended starting dose is 50 mg twice weekly for 3 months, followed by 50 mg once weekly. Pediatric dosing is weight-based: 0.8 mg/kg weekly (maximum 50 mg per week) for patients weighing less than 63 kg, and 50 mg weekly for those weighing 63 kg or more.

Clinicians should note that patients must be evaluated for latent tuberculosis and receive age-appropriate vaccinations before initiating therapy. Enbrel can be used alone or in combination with methotrexate in RA and PsA. The approval provides an additional treatment option for patients with these inflammatory conditions.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Enbrel is a tumor necrosis factor (TNF) blocker. The exact mechanism of action is not fully described in the label.

Indication & Patient Population

Enbrel is indicated for: - Adult patients with rheumatoid arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting progression of structural damage, and improving physical function in moderately to severely active RA. Can be initiated with methotrexate (MTX) or alone. - Adult patients with psoriatic arthritis (PsA): reducing signs and symptoms, inhibiting progression of structural damage of active arthritis, and improving physical function. Can be used with or without MTX. - Adult patients with ankylosing spondylitis (AS): reducing signs and symptoms in active AS. - Adult and pediatric patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. - Pediatric patients 2 years or older with polyarticular juvenile idiopathic arthritis (pJIA): reducing signs and symptoms of moderately to severely active pJIA. - Pediatric patients 2 years or older with juvenile psoriatic arthritis (JPsA): treatment of active JPsA.

Dosing & Administration

Enbrel is administered by subcutaneous injection. - Adult RA, AS, and PsA: 50 mg once weekly. - Adult PsO: 50 mg twice weekly for 3 months, then 50 mg once weekly. - Pediatric pJIA, PsO, and JPsA: 0.8 mg/kg weekly (maximum 50 mg per week) for patients weighing less than 63 kg (138 pounds); 50 mg weekly for those weighing 63 kg or more. Doses higher than 50 mg per week are not recommended in RA. For pediatric doses other than 25 mg or 50 mg, use the single-dose vial or reconstituted lyophilized powder. Inject subcutaneously in the thigh, abdomen, or outer upper arm. Prior to initiating therapy, evaluate for active tuberculosis and test for latent infection; complete age-appropriate vaccinations.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

The label includes warnings and precautions regarding tuberculosis and vaccinations. Contraindications are not specified in the provided label text.

Place in Therapy

Enbrel is a TNF blocker approved for multiple inflammatory conditions. It can be used as monotherapy or in combination with methotrexate in RA and PsA. The label does not provide guidance on place in therapy relative to other agents.

Enbrel is a medicine given as a shot under the skin. The FDA has approved it for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis. It is also approved for some children with certain types of arthritis and psoriasis.

Enbrel works by blocking a protein in the body that drives inflammation. It can be used alone or with another medicine called methotrexate for rheumatoid arthritis and psoriatic arthritis. Adults with most of these conditions usually take one shot of 50 mg each week. Adults with plaque psoriasis start with two shots a week for three months, then one shot a week. Doses for children are based on weight.

Before starting Enbrel, doctors check patients for hidden tuberculosis and make sure their vaccines are up to date. This approval gives patients and families another option to discuss with their care team. It does not mean Enbrel is right for everyone.

These conditions are chronic, and Enbrel is not a cure. It may help control symptoms and inflammation, but it also has risks. Patients should talk with their doctor about whether it fits their situation, and should not start or stop any medicine on their own.

What this means for you:

Enbrel is now approved for several inflammatory conditions, but ask your doctor if it is right for you.

Study Details

Study typeFda approval

PublishedNov 1998

View Original Abstract ↓

1 INDICATIONS AND USAGE Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older ( 1.2 ) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) ( 1.6 ) Plaque Psoriasis, 4 years of age or older ( 1.5 ) 1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone. 1.2 Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older. 1.3 Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA). Enbrel can be used with or without methotrexate. 1.4 Ankylosing Spondylitis Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). 1.5 Plaque Psoriasis Enbrel is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. 1.6 Juvenile Psoriatic Arthritis Enbrel is indicated for the treatment of active juvenile psoriatic arthritis (JPsA) in pediatric patients 2 years of age and older.

FDA approved Enbrel (etanercept) for Rheumatoid Arthritis and Other Inflammatory ConditionsFDA approved Enbrel for Several Long-Term Inflammatory Conditions

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