Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.01.2024

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Immunoregulatory effective, genetically engineered variant (dimer fusion protein) of the TNF-alpha receptor.

Pharmacodynamics (Effect)
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Higher affinity to TNF-α than the physiological tumor necrosis factor-alpha receptor. Due to its dimer structure, etanercept binds two molecules of tumor necrosis factor-alpha (TNF-α) in the blood. This significantly reduces the concentration of TNF-α in the blood.

Etanercept also reduces the levels of interleukin-5, CCL20, CXCL10 and, in therapy responders, interleukin-17A.

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Moderate and severe forms of plaque-type psoriasis vulgaris in adult patients (in children for severe plaque psoriasis from the 8th year of life) in whom other systemic therapies including ciclosporin, methotrexate and PUVA have not responded, are contraindicated or have not been tolerated.

Psoriasis arthropathica: Aggressive, progressive psoriatic arthritis when basic therapy fails.

Active rheumatoid arthritis in adults when response to existing basic therapy (including methotrexate if not contraindicated) is inadequate.

Severe, active and progressive forms of rheumatoid arthritis in adults without prior treatment with methotrexate

Active polyarticular juvenile chronic arthritis in children (4-17 LJ) after failure of methotrexate therapy (unless contraindicated).

Off-label use (not approved) and also experimentally in pustular psoriasis, subcorneal pustulosis, Behçet's disease, possibly granuloma anulare, granuloma anulare disseminatum, bullous autoimmune dermatoses.

Pregnancy/nursing period
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Insufficient data on use during pregnancy and lactation. Should not be prescribed during pregnancy and lactation.

Dosage and method of use
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  • Psoriasis vulgaris of the plaque type: standard dose (patient > 18 years) 2 times/week 25 mg s.c. Alternatively: 2 times/week 50 mg s.c. for up to 12 weeks, then 2 times/week 25 mg s.c.

Remember! The treatment should be continued until remission. Maximum duration of treatment: 24 weeks. The therapy should be discontinued in patients who have not responded after 12 weeks.

  • Children and adolescents (4-18 LJ): twice a week 0.4-0.8 mg/kg bw (up to max. 50 mg total dose) s.c. at intervals of 3-4 days.

Undesirable effects
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Often local reactions occur at the injection site (including bleeding, haematoma, erythema, itching, pain, swelling), which are usually reversible.

Infections such as abscesses, erysipelas (also afebrile!) bacteremia, bronchitis, herpes zoster, wound infections, especially in patients with concomitant diseases such as diabetes, can occur.

Notice! The formation of autoantibodies is possible. In a study on 45 patients (21 should ticker, 24 patients with psoriatic arthritis) 12 of 45 patients (26,6 %) developed autoantibodies. In other studies between 0-18% anti-etanercept antibodies were detected (HSU L et al. 2014).

Antinuclear antibodies were detectable in 9 patients, ENA in 1 patient, anti-ds DNA-Ak in 3 patients, high-titre AK in 1 patient.

Under Etanercept, increased malignancy rates (e.g. increased lymphoma rate in patients with RA; increased squamous cell carcinoma rate in psoriasis patients) could be detected in several studies. however, the total cancer rate was not increased in these patients (Asagari M et al. 2016).

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  • To date, there are no findings from validated studies on interactions of Etanercept with other drugs.
  • Live vaccines: The immunosuppression caused by Etanercept can prevent the normal immune response to a vaccination. Instead, there is a risk of a manifest infection by the vaccine germ. Therefore, if possible, dead vaccines should be used. Especially in children and adolescents, necessary vaccinations should be completed before the start of treatment with Etanercept.

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Sepsis or risk of sepsis; active tuberculosis(Quantiferon-Tb- Gold-Test); caution with diabetics! Existing or newly appeared CNS demyelinating disease, exposure to Varicella viruses; decompensated heart failure.

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Remember! Exclusion of tuberculosis before the start of therapy is recommended (tuberculin test and chest X-ray)!

Therapy success: According to double-blind, placebo-controlled studies 50-60% of psoriasis patients under therapy with 2 times 25 mg/week s.c. show a PASI reduction of 75% after 12 and 24 weeks respectively. It is expected that 50% of the patients are clinically free of symptoms after 24 weeks.

In a double-blind, placebo-controlled study ( off-label use) 40 volunteers with M. Behçetwere treated with Etanercept 2 times/day 25 mg for 4 weeks. Already after the first week of treatment, significant clinical improvements were seen, at the end of the study, significantly fewer disease foci were documented. The question of intermittent therapy could be checked in a larger study (CRYSTAL study). According to this, interruption does not lead to resistance to therapy.

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Last updated on: 29.01.2024