Adalimumab

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Definition
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Recombinant monoclonal IgG1 antibody, consisting only of human sequences, against tumor necrosis factor alpha (TNF-α) with specific binding to TNF-alpha and without affinity to other members of the human TNF family. Pharmacologically the antibody belongs to the group of "immune response modifiers".

Pharmacodynamics (Effect)
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  • Neutralization of the biological function of TNF-alpha by highly specific binding to the TNF-alpha molecules and inhibition of the interaction with the cellular p55 and p75 TNF receptors
  • Secondarily, the production and secretion of IL-1 and IL-6 as well as leukocyte migration and expression of adhesion molecules are inhibited.

Indication
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  • Moderate to severe active rheumatoid arthritis in adults with treatment failure compared to other therapies including methotrexate.
  • Active & progressive psoriatic arthritis in adults who have had an inadequate response to therapy with basic disease-modifying therapeutics. Primarily used in combination therapy with methotrexate (to prevent the formation of autoantibodies against adalimumab), also applicable as monotherapy in case of intolerance to MTX.
  • In the meantime, an approval as first-line therapy for psoriasis has also been obtained.
  • Adalimumab can also be used in children with severe plaque psoriasis who did not respond adequately to methotrexate.
  • Plaque Psoriasis
  • Off label use: Acrodermatitis continua suppurativa (see there)

Pregnancy/nursing period
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Do not use during pregnancy and lactation (insufficient experience or data available).

Dosage and method of use
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Adults/young people > 18 years: once/14 days 40 mg s.c.

Undesirable effects
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  • Often local reactions at the injection site such as redness, pain, pruritus.
  • Occasional infections of the respiratory system as well as urinary tract infections, herpes simplex, nausea, diarrhoea, headaches.
  • Immunogenicity: Anti-Adalimiúmab antibodies occur in 6-50% of patients. However, this does not exclude a good clinical response (Hsu L et al. (2014).

Contraindication
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Hypersensitivity to the active substance or excipients in the preparation. Active tuberculosis, severe infections (sepsis, opportunistic infection), heart failure (NYHA Class III/IV), concurrent therapy with live vaccines.

Preparations
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Humira

Note(s)
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  • Remember! Contraception for women during therapy until at least 5 months after the end of therapy and for men during use until 70 days after the last injection of Adalimumab!

  • New study data indicate that Adalimumab leads to a significant improvement of disease symptoms in patients with moderate to severe psoriasis. In addition, regular use of the fully human monoclonal antibody may reduce the risk of further aggravation.
  • A biosimilar has been available since 2018 (Hexal/Hyrimoz®)

Literature
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  1. Lehnen M et al (2004) New therapeutic options for psoriatic arthritis: TNF inhibitors. German Med Weekly 129: 634-638
  2. Hsu L et al (2014) Antidrug antibodies in psoriasis: a systematic review. Br J Dermatol 170:261-273.
    Menter A et al. (2008) Adalimumab therapy for moderate to severe psoriasis. A randomized, controlled phase III trial. J Am Acad Dermatol 58: 106-115
  3. Molloy E et al (2004) Morbidity and mortality in rheumatoid patients during treatment with adalimumab and infliximab. Rheumatology (Oxford) 43: 522-523
  4. Shikiar R et al (2007) Adalimumab treatment is associated with improvement in health-related quality of life in psoriasis: patient-reported outcomes from a Phase II randomized controlled trial. J Dermatolog Treat 18: 25-31
  5. Toussirot E et al (2004) The use of TNF-alpha blocking agents in rheumatoid arthritis: an overview. Expert Opinion Pharmacother 5: 581-594
  6. Wozel G, Sticherling M (2007) Systemic psoriasis therapy - the next step. dermatologist 58: 515-524

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Last updated on: 29.10.2020