Adalimumab

Generic Name

Adalimumab

Brand Names

Humira

Amgevita

Hyrimoz

Idacio

Yuflyma

Hadlima

Halimatoz

Abrilada

Cyltezo

Simlandi

Other biosimilars available depending on region

Drug Class

Tumor necrosis factor-alpha (TNF-α) inhibitor

Biologic disease-modifying antirheumatic drug (bDMARD)

Immunosuppressant

Monoclonal antibody

Mechanism of Action

Adalimumab is a fully human IgG1 monoclonal antibody that specifically binds to tumor necrosis factor-alpha (TNF-α)

TNF-α is a pro-inflammatory cytokine involved in systemic inflammation and plays a key role in the pathogenesis of many autoimmune diseases

By binding TNF-α, adalimumab prevents it from interacting with TNF receptors on cell surfaces

This blocks downstream inflammatory pathways, reduces the expression of adhesion molecules, and limits the migration of inflammatory cells

The result is suppression of inflammatory responses, reduction in joint destruction, and alleviation of systemic symptoms in chronic inflammatory disorders

Indications

Rheumatology

Rheumatoid arthritis

Psoriatic arthritis

Ankylosing spondylitis

Juvenile idiopathic arthritis

Non-radiographic axial spondyloarthritis

Dermatology

Moderate to severe plaque psoriasis

Hidradenitis suppurativa

Gastroenterology

Crohn’s disease (adults and children)

Ulcerative colitis (adults and children)

Ophthalmology

Non-infectious uveitis (intermediate, posterior, and panuveitis)

Dosing and Administration

Rheumatoid Arthritis

40 mg subcutaneously every other week

May increase to 40 mg weekly if not responsive

Can be used alone or with methotrexate

Crohn’s Disease and Ulcerative Colitis (Adults)

Initial: 160 mg SC on Day 1

Then: 80 mg SC on Day 15

Maintenance: 40 mg SC every other week from Day 29 onward

Psoriasis and Psoriatic Arthritis

40 mg SC every other week

In plaque psoriasis, may start with 80 mg followed by 40 mg every other week

Juvenile Idiopathic Arthritis (≥2 years)

10–40 mg depending on body weight

Administered subcutaneously every other week

Uveitis

Initial: 80 mg SC

Maintenance: 40 mg SC every other week starting 1 week after initial dose

Hidradenitis Suppurativa

Initial: 160 mg SC on Day 1

Then: 80 mg on Day 15

Then: 40 mg weekly starting on Day 29

Administration Advice

Inject into the thigh or abdomen

Rotate injection sites

Remove prefilled syringe or pen from refrigerator 15–30 minutes before injection

Do not inject into red, hard, bruised, or tender skin

Use with or without methotrexate

Pharmacokinetics

Bioavailability after SC injection ~64%

Peak serum concentration in ~5 days

Half-life: 10–20 days

Cleared via reticuloendothelial system, not renal or hepatic routes

No need for dose adjustment in renal or hepatic impairment

Contraindications

Active severe infections (e.g. sepsis, tuberculosis)

Hypersensitivity to adalimumab or formulation components

Moderate-to-severe heart failure (relative contraindication)

Precautions

Screen all patients for latent TB using skin test or interferon-gamma release assay

Test for hepatitis B virus infection prior to initiation

Avoid use in patients with demyelinating disorders (e.g. multiple sclerosis)

Avoid live vaccines during and shortly after treatment

Monitor for malignancy, especially lymphoma and nonmelanoma skin cancer

Caution in elderly due to higher risk of infections

Caution in patients with history of recurrent infections or chronic infection

Adverse Effects

Common

Injection site reactions (redness, swelling, itching)

Upper respiratory tract infections

Sinusitis

Headache

Nausea

Rash

Elevated liver enzymes

Less Common

Hypertension

Fatigue

Back pain

Urinary tract infections

Dyspepsia

Hyperlipidemia

Serious

Tuberculosis (reactivation or new)

Opportunistic infections (fungal, bacterial, viral)

Sepsis

Lymphoma and other malignancies

Demyelinating disease (e.g., MS-like symptoms)

Heart failure exacerbation

Hepatitis B reactivation

Lupus-like syndrome

Pancytopenia, aplastic anemia

Pregnancy and Lactation

Pregnancy

Category B

Human data suggest low risk when used during pregnancy

May be used in select patients after risk-benefit assessment

Transfer across placenta occurs especially in third trimester

Live vaccines should be avoided in infants exposed in utero for up to 6 months

Lactation

Present in low levels in breast milk

Limited data suggest low infant exposure

Can be considered with caution during breastfeeding

Use in Special Populations

Pediatrics

Approved for select indications (e.g., JIA, Crohn's disease, uveitis)

Dose adjusted based on weight and indication

Geriatric

Increased risk of infections

Monitor closely

Renal or Hepatic Impairment

No dose adjustment required

Drug Interactions

Live Vaccines

Contraindicated due to immunosuppressive effects

Other Biologic Immunosuppressants

Avoid concurrent use with agents like etanercept, infliximab, abatacept, or anakinra due to increased risk of infections

Methotrexate

Often used concurrently to increase efficacy and reduce antibody formation against adalimumab

Azathioprine or 6-Mercaptopurine

Used in Crohn’s and ulcerative colitis patients with close monitoring

Cyclophosphamide

Potential increased risk of hematologic toxicity

Monitoring Parameters

Tuberculosis screening before initiation

Hepatitis B screening

CBC with differential periodically

Liver function tests

CRP and ESR in inflammatory conditions

Signs of infection or malignancy

Dermatologic exam annually for skin cancer

Formulations

Prefilled syringe (10 mg, 20 mg, 40 mg)

Autoinjector (Pen – 40 mg)

Single-dose vial for pediatric use

Available in citrate-free formulation (less injection pain)

Refrigerated storage required

Patient Counseling Points

Ensure completion of TB and hepatitis B screening before therapy

Educate on proper injection technique and disposal

Report signs of infection immediately (fever, cough, painful urination)

Avoid contact with individuals with contagious illnesses

Do not receive live vaccines during or shortly after therapy

Adherence is key for maintaining remission in chronic autoimmune conditions

Report any neurologic symptoms, unexplained fatigue, persistent fever, or signs of liver dysfunction

Notify dentist or surgeon before any invasive procedure

Do not use if solution is discolored or contains particulates