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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.

Plaque Psoriasis

Indication

Enbrel is indicated for the treatment of adults with moderate to severe plaque PsO who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, MTX or PUVA.1

Enbrel is also indicated for the treatment of chronic severe plaque PsO in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.2

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

Plaque PsO dosing

Adults

The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.1

Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients. Treatment should be discontinued in patients who show no response after 12 weeks.1

If re-treatment with Enbrel is indicated, the same guidance on treatment duration should be followed. The dose should be 25 mg twice weekly or 50 mg once weekly.1

Children (age 6 years and above)

The recommended dose of Enbrel is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks.2

If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.2

There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque PsO.2

Clinical efficacy

Clinical efficacy in adult patients

The efficacy of Enbrel in plaque PsO was assessed in a randomised, double-blind, placebo-controlled study. The primary efficacy endpoint was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the PASI score from baseline) at 12 weeks.3

Patients ≥ 18 years old with active, but clinically stable, plaque PsO involving ≥ 10% of the body surface area (n=112) were randomised to receive a dose of 25 mg of Enbrel (n=57) or placebo (n=55) twice a week for 24 weeks.3

The Enbrel-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p<0.0001). At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.3  

Among patients with plaque PsO who received Enbrel, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy. In long-term (up to 34 months) open-label studies where Enbrel was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.3

Clinical efficacy in paediatric patients

The efficacy of Enbrel in paediatric plaque PsO was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4–17 years with moderate to severe plaque PsO. Eligible patients had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy.4

Patients received Enbrel 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks. At week 12, more patients randomised to Enbrel had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.4

Paediatric Plaque PsO outcomes at 12 weeks4

Adapted from Paller AS, et al. 2008.
*p<0.0001, Enbrel vs. placebo

After the 12-week double-blind treatment period, all patients received Enbrel 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks. Responses observed during the open-label period were similar to those observed in the double-blind period.

During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to Enbrel. With continued therapy, responses were maintained up to 48 weeks.4

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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MTX=methotrexate; PASI=psoriasis area and severity index; PsO=plaque psoriasis; PUVA=psoralen and ultraviolet-A light; sPGA=static Physician Global Assessment; TNF=tumour necrosis factor.

References:
  1. Enbrel (etanercept) SmPC. 50 mg solution for injection in pre-filled pen. 
  2. Enbrel (etanercept) SmPC. Enbrel 10 mg powder and solvent for solution for injection for paediatric use.
  3. Gottlieb AB, et al. Arch Dermatol. 2003; 139:1627–1632.
  4. Paller AS, et al. NEJM. 2008; 358:241–251.
PP-ENB-GBR-0982. March 2021

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PP-PFE-GBR-2688. December 2020

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