Last reviewed 2026-05-13 · How we verify

OLE BSA Adalimumab +/- MTX

Adalimumab is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha signaling to reduce inflammation, with optional methotrexate co-administration to enhance efficacy.

Adalimumab is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha signaling to reduce inflammation, with optional methotrexate co-administration to enhance efficacy. Used for Rheumatoid arthritis (with or without methotrexate), Ankylosing spondylitis, Psoriatic arthritis.

At a glance

Mechanism of action

Adalimumab is a fully human monoclonal antibody that binds to and neutralizes TNF-alpha, a key pro-inflammatory cytokine. By blocking TNF-alpha, it suppresses the inflammatory cascade underlying autoimmune diseases. The addition of methotrexate (MTX) provides synergistic immunosuppression and is commonly used in combination therapy for rheumatoid arthritis and other inflammatory conditions.

Approved indications

• Rheumatoid arthritis (with or without methotrexate)
• Ankylosing spondylitis
• Psoriatic arthritis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis

Common side effects

• Injection site reactions
• Upper respiratory tract infections
• Headache
• Tuberculosis reactivation
• Serious infections
• Malignancy risk (increased)

Key clinical trials

• Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA) (PHASE3)

Primary sources

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