Biologic – tumor necrosis factor alpha (TNFα) inhibitor
ATC code: L04AB04 (Adalimumab)
Brand names
Humira, Amgevita, Imraldi, Hyrimoz, Idacio
A fully human IgG1 monoclonal antibody that specifically binds soluble and membrane-bound TNFα. Neutralizes TNFα biological activity – the key pro-inflammatory cytokine in rheumatoid arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Half-life of 14 days allows injection every 2 weeks. One of the first biologics with biosimilars in Europe since 2018 (Amgevita, Imraldi, Hyrimoz, Idacio, and others) – price lower than original Humira.
Second line
Biologic for moderate-to-severe plaque psoriasis with PASI over 10, BSA over 10%, or DLQI over 10 per AEDV 2024 and EuroGuiderm. Used after systemic therapies (methotrexate, cyclosporine, acitretin) fail or are intolerable. Starting dose 80 mg subcutaneously, then 40 mg every 2 weeks. Anti-IL-17 and anti-IL-23 biologics (secukinumab, ixekizumab, guselkumab, risankizumab) achieve stronger skin responses in psoriasis and are often preferred.
Second line
Biologic for moderate-to-severe rheumatoid arthritis in patients with inadequate response to synthetic DMARDs (methotrexate, leflunomide, sulfasalazine) per 2022. Dose 40 mg subcutaneously every 2 weeks. Effective as monotherapy, but combination with methotrexate enhances response and reduces anti-drug antibody formation. Mandatory pre-treatment screening for latent tuberculosis (QuantiFERON or Mantoux, chest X-ray) and hepatitis B/C.
Second line
Biologic for moderate-to-severe ulcerative colitis in patients with corticosteroid and immunomodulator (azathioprine, 6-mercaptopurine) failure or intolerance per 2024 and GETECCU 2023. Starting dose 160 mg subcutaneously with titration. Less effective than infliximab in severe active colitis but more convenient via subcutaneous injection.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Adalimumab is a monoclonal antibody against tumor necrosis factor alpha (TNF-α). It is prescribed for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, and hidradenitis ( 2023, 2024, 2020 guidelines). In premium anti-aging circles, adalimumab is promoted as a biological for suppressing chronic inflammation of aging in healthy people. In healthy adults, no clinical studies of prophylactic use exist; international anti-aging guidelines do not include adalimumab. The drug has serious risks: severe infections (bacterial, fungal, opportunistic), reactivation of tuberculosis and hepatitis B (requires screening before start), lymphomas and other malignancies ( boxed warning), infusion reactions, and demyelinating diseases. If adalimumab was recommended to suppress aging-related inflammation in a healthy person, seek a second opinion immediately.
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Boxed warning
FDA boxed warning: increased risk of serious infections (tuberculosis, invasive fungal infections, hepatitis B reactivation, opportunistic infections) and lymphoma, including hepatosplenic T-cell lymphoma in young patients with inflammatory bowel disease. Latent tuberculosis screening is mandatory before start.
FDA category B. Adalimumab crosses the placenta in T2 and T3. Use in pregnancy when needed is acceptable – no increase in malformation rates described. In infants born to adalimumab-treated mothers, defer live vaccines for 6 months (risk of severe reactions after BCG and other live vaccines).
Compatible with breastfeeding. Adalimumab milk concentrations are low and infant GI absorption is minimal.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Adalimumab is evaluated for the following indications with varying evidence strength: Rheumatoid arthritis (evidence tier A), Psoriasis (evidence tier A), Ulcerative colitis (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Adalimumab (≥ 1 in 100): Injection site reactions (itching, erythema, swelling), Upper respiratory infections, Headache, Nausea, Rash, Elevated liver enzymes. See the Safety section for uncommon and serious reactions.
FDA category B. FDA category B. Adalimumab crosses the placenta in T2 and T3. Use in pregnancy when needed is acceptable – no increase in malformation rates described. In infants born to adalimumab-treated mothers, defer live vaccines for 6 months (risk of severe reactions after BCG and other live vaccines).
Compatible with breastfeeding. Adalimumab milk concentrations are low and infant GI absorption is minimal.
Adalimumab is contraindicated in: Hypersensitivity to adalimumab or excipients; Active tuberculosis or other severe infections (sepsis, opportunistic infections); Active hepatitis B without concomitant antiviral therapy; Heart failure NYHA IIIb–IV; Demyelinating diseases (multiple sclerosis). Full list in the Safety section.
FDA boxed warning: increased risk of serious infections (tuberculosis, invasive fungal infections, hepatitis B reactivation, opportunistic infections) and lymphoma, including hepatosplenic T-cell lymphoma in young patients with inflammatory bowel disease. Latent tuberculosis screening is mandatory before start.