Last reviewed 2026-05-14 · How we verify

Humira (ADALIMUMAB)

Adalimumab binds TNF-alpha and blocks interaction with p55 and p75 cell surface receptors.

IDACIO (adalimumab) is a TNF-alpha blocking monoclonal antibody indicated for nine inflammatory conditions including RA, JIA, PsA, AS, CD, UC, plaque psoriasis, hidradenitis suppurativa, and uveitis. The drug demonstrates linear pharmacokinetics with approximately 64% bioavailability, 2-week half-life, and 12 mL/hr clearance, with steady-state trough concentrations ranging from 5-12 mcg/mL depending on indication and concomitant MTX use. Serious risks include increased infection when combined with abatacept or anakinra, and live vaccines should be avoided. IDACIO represents a well-established TNF-blocking therapy with extensive clinical experience across multiple inflammatory indications.

At a glance

Mechanism of action

Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine involved in normal inflammatory and immune responses. Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased concentrations of TNF are also found in psoriasis plaques. Adalimumab products modulate biological responses induced or regulated by TNF, including changes in the concentrations of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10 M).

Approved indications

• Ankylosing spondylitis
• Axial spondyloarthritis
• Behcet's disease
• Crohn's disease
• Hidradenitis suppurativa
• Juvenile idiopathic arthritis
• Non-infectious anterior uveitis
• Non-infectious intermediate, posterior and panuveitis
• Plaque psoriasis
• Psoriasis with arthropathy
• Psoriatic arthritis
• Pustular psoriasis
• Pyoderma gangrenosum
• Rheumatoid arthritis
• Ulcerative colitis

Boxed warnings

• WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including IDACIO are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue IDACIO if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before IDACIO use and during therapy. Initiate treatment for latent TB prior to IDACIO use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti- fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with IDACIO prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with IDACIO, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions ( 5.2 )] . Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6‑mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 )] WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • Discontinue IDACIO if a patient develops a serious infection or sepsis during treatment. • Perform test for latent TB; if positive, start treatment for TB prior to starting IDACIO. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. • Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

Common side effects

• Nasopharyngitis
• Injection site erythema
• HEADACHE
• Injection site pain
• COLITIS ULCERATIVE
• PYREXIA
• NASOPHARYNGITIS
• PHARYNGITIS
• ANAEMIA
• ABDOMINAL PAIN UPPER
• PERIPHERAL SWELLING
• ARTHRALGIA

Drug interactions

• Abatacept
• Anakinra
• Live vaccines
• Methotrexate (MTX)
• CYP450 substrates with narrow therapeutic index

Key clinical trials

• Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
• Subconjunctival Humira for Boston Keratoprosthesis (PHASE1)
• Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission (NA)
• Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases (PHASE1,PHASE2)
• Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
• Treatment Tapering in JIA With Inactive Disease (PHASE3)
• Preventing Structural Damage in Early Psoriatic Arthritis (PHASE4)
• A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis (PHASE3)

Primary sources

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