Etanercept

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 31.03.2021

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Definition
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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 tumour necrosis factor-alpha (TNF-α) in the blood. This significantly reduces the concentration of TNF-α in the blood.

Furthermore, Etanercept reduces the levels of Interleukin-5, CCL20, CXCL10 and, in the case of theapier responders, also Interleukin-17A.

Indication
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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).

Interactions
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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.

Contraindication
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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.

Preparations
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Enbrel®

Note(s)
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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.

Literature
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  1. Asgari MM et al (2017) Malignancy rates in a large cohort of patients with systemically treated psoriasis in a managed care population. J Am Acad Dermatol 76:632-638.
  2. Bardazzi F et al (2014) Autoantibodies in patients with psoriasis under anti-TNF-alpha therapy.JDDG 12: 401-407
  3. Craig L et al (2003) Ethernacept as monotherapy in patients with psoriasis. N Engl J Med 349: 2114-2022
  4. Davison SC (2002) Etanercept for severe psoriasis and psoriatic arthritis: observations on combination therapy. Br J Dermatol 147: 831-832
  5. Day R (2002) Adverse reactions to TNF-alpha inhibitors in rheumatoid arthritis. Lancet 359: 540-541
  6. Girolomoni G (2001) Anti-tumor necrosis factor alpha therapy in psoriatic arthritis and psoriasis. Arch Dermatol 137: 784-785
  7. Gottlieb AB et al (2003) A randomized trial of Etarnercept as monotherapy of psoriasis. Arch DErmatol 139: 1627-1632
  8. Horneff G et al (2000) Recommendations by the Pediatric and Adolescent Rheumatology Study Committee on therapy with Etanercept (p75 TNF-alpha receptor immunoglobulin fusion protein). Z Rheumatol 59: 365-369
  9. Hsu L et al (2014) Antidrug antibodies in psoriasis: a systematic review. Br J Dermatol 170:261-273.
  10. Farewell M (2003) Psoriasis. Lancet 361: 1197-1204
  11. Melikoglu M et al (2005) Short-term trial of etanercept in Behcet's disease: a double blind, placebo controlled study. J Rheumatol 32: 98-105
  12. Paler AM et al (2008) Etanercept therapy in children and adolescents with plaque psoriasis. N Engl J Med 358: 241-251
  13. Russo RA et al (2002) Etanercept in systemic juvenile idiopathic arthritis. Clin Exp Rheumatol 20: 723-726
  14. Segnitz A et al (2010) Afebrile erysipelas under Etanercept. Nude Dermatol 35: 444-446
  15. Seneschal J et al (2007) Psoriasiform drug eruptions under anti-TNF treatment of arthritis are not true psoriasis. Acta Derm Venereol 87: 77-80
  16. Weinberg JM, Saini R (2003) Biologic therapy for psoriasis: the tumor necrosis factor inhibitors infliximab and etanercept. Cutis 71: 25-29

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Last updated on: 31.03.2021