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Information on how to access Enbrel® (etanercept) prescribing information and adverse event reporting can be found at the bottom of the page.

Rheumatoid Arthritis

Indication

Enbrel in combination with MTX is indicated for the treatment of moderate to severe active RA in adults when the response to DMARDs, including MTX (unless contraindicated), has been inadequate.1

Enbrel can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.1

Enbrel is also indicated in the treatment of severe, active and progressive RA in adults not previously treated with MTX.1

Enbrel, alone or in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.1

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients1
  • Sepsis or risk of sepsis1
  • Treatment with Enbrel should not be initiated in patients with active infections, including chronic or localised infections1

RA dosing

Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of RA. Patients treated with Enbrel should be given the Patient Alert Card.1

25 mg Enbrel administered twice weekly is the recommended dose. Alternatively, 50 mg administered once weekly has been shown to be safe and effective.1

Clinical efficacy

Enbrel is efficacious both in combination with MTX and in monotherapy. Enbrel inhibits radiographic progression alone and in combination with MTX in moderate to severe RA.2,3

Enbrel monotherapy in RA patients

The TEMPO trial was a double-blind, randomised control trial in 686 patients with active, adult-onset RA. Subjects were randomised to receive Enbrel alone (25 mg Enbrel twice weekly + placebo); MTX alone (7.5 mg orally every week up to 20 mg within 8 weeks if the patient had any painful or swollen joints + placebo) or combination therapy (25 mg subcutaneous Enbrel injections twice a week + oral MTX capsules once a week). The primary efficacy endpoint was the numeric index of the ACR response area under the curve over the first 24 weeks. The primary radiographic endpoint was the change from baseline to Week 52 in total joint damage, assessed with the modified Sharp score and intention-to-treat analysis.3​​​​​​​

Adapted from Klareskog L et al. 2004.

Enbrel in combination with methotrexate in RA patients

The ADORE trial was a 16 week, randomised, open-label study in patients with active RA who had an inadequate response to MTX monotherapy despite taking MTX ≥12.5 mg per week for ≥3 months. Patients were randomised to receive either Enbrel 25 mg twice weekly alone (n=160) or in combination with MTX (n=155). The primary endpoint was DAS28 improvement ≥1.2 units. Primary analysis was based on the intent-to-treat population.4

There were no significant differences in ACR 20, 50 and 70 scores at Week 16 between RA patients receiving either Enbrel monotherapy or in combination with MTX.4

Proportion of patients achieving ACR 20, 50 and 70 at Week 164

Adapted from Van Riel PL et al 2006.

Summary of the safety profile

The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.1

Serious adverse reactions have also been reported for Enbrel. TNF-antagonists, such as Enbrel, affect the immune system and their use may affect the body's defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with Enbrel. Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).1

Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use. There have been rare reports of lupus, lupus-related conditions, and vasculitis.1

Before prescribing Enbrel refer to the full Summary of Product Characteristics.

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ACR=American College of Rheumatology; DAS=disease activity score; DMARD=disease modifying anti-rheumatic drug; MTX=Methotrexate; RA=rheumatoid arthritis; TEMPO=Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes.

References
  1. Enbrel (etanercept) SmPC. 50 mg solution for injection in pre-filled pen. 
  2. Emery P, et al. Lancet. 2008; 372(9636):375–382.
  3. Klareskog L, et al. Lancet. 2004; 363:675–681.
  4. Van Riel PL, et al. BMJ. 2006; 65: 1478–1483.
PP-ENB-GBR-0978. March 2021

Learn about the licensed indication of Enbrel in patients with Juvenile idiopathic arthritis.

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PP-PFE-GBR-2688. December 2020

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