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Adalimumab

AEMPS

Biologic – tumor necrosis factor alpha (TNFα) inhibitor

ATC code: L04AB04

Brand names: Humira, Amgevita, Imraldi

Updated · Methodology

Indications

A

Crohn's disease

Second line

Biologic (TNF-alpha inhibitor) for moderate-to-severe Crohn's disease in patients with inadequate response or intolerance to corticosteroids and immunomodulators (azathioprine, 6-mercaptopurine) per 2020. Induction 160 mg subcutaneously, 80 mg at week 2, then 40 mg every 2 weeks. Reduces hospitalizations and surgery and maintains remission (registrational CLASSIC-I and CHARM trials). Mandatory pre-treatment screening for latent tuberculosis and hepatitis B.

Sources

  1. Journal of Crohn's and Colitis: ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment (2020)
  2. AEMPS: Ficha técnica de Adalimumab (2024)
  3. Gastroenterology: Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial (2007)
  4. Gastroenterology: Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial (2006)

ICD-10: K50.9 · ICD-11: DD70

A

Hidradenitis suppurativa

Second line

Biologic (TNF-alpha inhibitor) and the first approved biologic for moderate-to-severe hidradenitis suppurativa in patients with inadequate response to systemic therapy (antibiotics such as clindamycin plus rifampicin). HS regimen: 160 mg subcutaneously at start, 80 mg at week 2, then 40 mg weekly. Reduces inflammatory nodules and abscesses (PIONEER I and II trials). Mandatory pre-treatment screening for latent tuberculosis and hepatitis B.

Sources

  1. New England Journal of Medicine: Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa (PIONEER I and II) (2016)
  2. Journal of the European Academy of Dermatology and Venereology: European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa (2015)
  3. AEMPS: Ficha técnica de Adalimumab (2024)

ICD-10: L73.2 · ICD-11: ED92.0

A

Psoriasis

Second line

Biologic for moderate-to-severe plaque psoriasis with PASI over 10, BSA over 10%, or DLQI over 10 per AEDV 2022 and EuroGuiderm. Used after systemic therapies (methotrexate, cyclosporine, acitretin) fail or are intolerable. Starting dose 80 mg subcutaneously, 40 mg one week later, 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.

Sources

  1. AEMPS: Ficha técnica de Adalimumab (2024)
  2. AEDV: [Translated article] Practical Update of the Recommendations Published by the Psoriasis Group of the Spanish Academy of Dermatology and Venereology (GPs) on the Treatment of Psoriasis with Biologic Therapy. Part 1. Concepts and Ge (2022)
  3. J Am Acad Dermatol: Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial (2008)
  4. J Eur Acad Dermatol Venereol: EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 1: treatment and monitoring recommendations (2020)
  5. Br J Dermatol: Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION) (2008)

ICD-10: L40 · ICD-11: EA90

A

Rheumatoid arthritis

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.

Sources

  1. AEMPS: Ficha técnica de Adalimumab (2024)
  2. EULAR: EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological DMARDs (2022)

ICD-10: M06.9 · ICD-11: FA20

A

Ulcerative colitis

Second line

Biologic for moderate-to-severe ulcerative colitis in patients with corticosteroid and immunomodulator (azathioprine, 6-mercaptopurine) failure or intolerance per 2022. Induction: 160 mg subcutaneously, then 80 mg at week 2, then 40 mg every 2 weeks. Less effective than infliximab in severe active colitis but more convenient via subcutaneous injection.

Sources

  1. AEMPS: Ficha técnica de Adalimumab (2024)
  2. Gastroenterology: Adalimumab Induces and Maintains Clinical Remission in Patients With Moderate-to-Severe Ulcerative Colitis (2012)
  3. Gut: Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial (2011)
  4. BioDrugs: Adalimumab for Moderately to Severely Active Ulcerative Colitis: A Systematic Review and Meta-Analysis (2016)
  5. J Crohns Colitis: ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment (2022)

ICD-10: K51 · ICD-11: DD71

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Anti-aging and longevity

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 (approved indications per AEMPS and ). 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), injection site reactions, and demyelinating diseases. If adalimumab was recommended to suppress aging-related inflammation in a healthy person, seek a second opinion immediately.

Sources

  1. AEMPS: Ficha técnica de Adalimumab (2024)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

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.

Safety

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.

Contraindications

  • 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)
  • Pregnancy – with caution
  • Age under 2 (most indications)

Serious adverse effects

  • Serious infections (sepsis, opportunistic fungal and bacterial infections, TB reactivation)
  • Hepatitis B reactivation
  • Lymphoma and other malignancies (especially hepatosplenic T-cell lymphoma in young patients)
  • Demyelinating disease (new MS cases)
  • Heart failure worsening
  • Drug-induced lupus
  • Anaphylaxis

Common adverse effects

  • Injection site reactions (itching, erythema, swelling)
  • Upper respiratory infections
  • Headache
  • Nausea
  • Rash
  • Elevated liver enzymes

Pregnancy: can you take Adalimumab?

EMA summary of product characteristics (section 4.6): a monkey study showed no embryotoxicity or teratogenicity, and about 2,100 prospectively followed pregnancies exposed to adalimumab with known live births, including more than 1,500 exposed in the first trimester, do not indicate an increase in the rate of malformation in the newborn. In a prospective registry (257 women with rheumatoid arthritis or Crohn's disease treated with adalimumab at least during the first trimester and 120 untreated women), the adjusted odds ratio for major birth defects was 1.10 (95% CI 0.45 to 2.73), with no clear differences in spontaneous abortion, minor birth defects, preterm delivery, size at birth or serious infections, although the sample was small and the design non-randomised. Because adalimumab inhibits TNF-alpha, its use in pregnancy could affect the newborn's normal immune response, so it should be used during pregnancy only if clearly needed. Adalimumab may cross the placenta into the infant's serum, and these infants may have a higher risk of infections; live vaccines (for example, BCG) are not recommended for them until 5 months after the mother's last injection during pregnancy.

Breastfeeding: can you take Adalimumab?

Compatible with breastfeeding. Adalimumab milk concentrations are low and infant GI absorption is minimal.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Inject subcutaneously into thigh or abdomen every 2 weeks. Remove the pen or pre-filled syringe from the fridge 15–30 minutes before injection to reduce pain. Rotate injection sites. Do not inject into red, hard, bruised skin or stretch marks. Store at +2 to +8 °C; at room temperature up to 25 °C – no more than 14 days. Screen for TB before start and every 6 months. Live vaccines are contraindicated during therapy; inactivated vaccines are best completed before start.
Label mentions3 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • ModerateTheophylline
    «Cytochrome P450 Substrates: The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFα, IL-6) during chronic inflammation. It is possible for products that…»

    FDA, section 7 · Open on DailyMed

  • ModerateWarfarin
    «Cytochrome P450 Substrates: The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFα, IL-6) during chronic inflammation. It is possible for products that…»

    FDA, section 7 · Open on DailyMed

  • Methotrexate
    «Humira ha sido estudiado en pacientes con artritis reumatoide, artritis idiopática juvenil poliarticular y artritis psoriásica tratados con Humira tanto en monoterapia como con metotrexato de forma…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Adalimumab used for?

Adalimumab is evaluated for the following indications with varying evidence strength: Crohn's disease (evidence tier A), Hidradenitis suppurativa (evidence tier A), Rheumatoid arthritis (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Adalimumab?

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.

Is Adalimumab safe during pregnancy?

EMA summary of product characteristics (section 4.6): a monkey study showed no embryotoxicity or teratogenicity, and about 2,100 prospectively followed pregnancies exposed to adalimumab with known live births, including more than 1,500 exposed in the first trimester, do not indicate an increase in the rate of malformation in the newborn. In a prospective registry (257 women with rheumatoid arthritis or Crohn's disease treated with adalimumab at least during the first trimester and 120 untreated women), the adjusted odds ratio for major birth defects was 1.10 (95% CI 0.45 to 2.73), with no clear differences in spontaneous abortion, minor birth defects, preterm delivery, size at birth or serious infections, although the sample was small and the design non-randomised. Because adalimumab inhibits TNF-alpha, its use in pregnancy could affect the newborn's normal immune response, so it should be used during pregnancy only if clearly needed. Adalimumab may cross the placenta into the infant's serum, and these infants may have a higher risk of infections; live vaccines (for example, BCG) are not recommended for them until 5 months after the mother's last injection during pregnancy.

Is Adalimumab compatible with breastfeeding?

Compatible with breastfeeding. Adalimumab milk concentrations are low and infant GI absorption is minimal.

Who should not take Adalimumab?

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.

Does Adalimumab carry an FDA 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.

Official sources

Direct links to regulator labels. Open in a new tab.

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