Adalimumab

TNF-α inhibitor, Biologic, DMARD, Immunosuppressant, Monoclonal antibody (fully human IgG1)

Adalimumab

Humira; biosimilars Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yusimry, Abrilada

Experience

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Titration strategies

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Effects

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Summary

Classes

TNF-α inhibitor, Biologic, DMARD, Immunosuppressant, Monoclonal antibody (fully human IgG1)

Common uses

Rheumatoid arthritis0, Psoriatic arthritis0, Ankylosing spondylitis0, Crohn's disease0, Ulcerative colitis0, Moderate-to-severe plaque psoriasis0, Hidradenitis suppurativa0, Non-infectious uveitis0, Juvenile idiopathic arthritis0

Pharmacy

Starting dose

40 mg SC every other week (most adult indications); IBD induction 160 mg week 0, 80 mg week 2, then 40 mg every other week

Preparations

40 mg/0.4 mL or 40 mg/0.8 mL prefilled syringe and autoinjector pen; 10, 20, 80 mg pediatric/induction strengths

US FDA Max

40 mg every week (selected indications); otherwise 40 mg every other week

Pharmacology

Routes

Subcutaneous

Onset

Symptomatic effect within weeks; full response by 12-24 weeks

Duration

2 weeks per dose

Half-life

~14 days^[1]

Bioavailability

~64% from SC depot^[1]

Pregnancy

Generally continued through pregnancy when needed for disease control; placental transfer is minimal in the first trimester but increases in third trimester, so dose timing around delivery and considerations for live-vaccine schedule in the infant are standard.^{[citation needed]}

Legal status

Rx-only in US. Carries Boxed Warnings for serious infections (TB reactivation, invasive fungal, opportunistic bacterial/viral) and malignancy (lymphoma, including rare hepatosplenic T-cell lymphoma in young patients with IBD on combination immunosuppression)^[1]

Purported mechanism

Adalimumab is a fully human recombinant IgG1 monoclonal antibody that binds tumor necrosis factor α (TNF-α), neutralizing its interaction with TNF receptors 1 and 2 and lysing TNF-α-expressing cells via Fc-mediated complement and ADCC; the net effect is broad suppression of TNF-driven inflammatory signaling in immune-mediated diseases.0 Pre-treatment screening for latent TB (PPD or IGRA) and chronic hepatitis B is standard. Anti-drug antibody formation is a recognized cause of secondary loss of response^[1].

References

↑ ^1.0 ^1.1 ^1.2 ^1.3 FDA Prescribing Information, Humira (adalimumab), AbbVie, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s415lbl.pdf

[humira-label-1] 1.0 ^1.1 ^1.2 ^1.3 FDA Prescribing Information, Humira (adalimumab), AbbVie, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s415lbl.pdf

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