Indications for Use:

Adults

• Moderate to severe active rheumatoid arthritis (as monotherapy or in combination with methotrexate or other basic anti-inflammatory drugs). In combination with methotrexate, adalimumab reduces the rate of joint damage progression (as shown by radiographic data) and improves functional activity.
• Active ankylosing spondylitis.
• Severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, but with objective signs of inflammation (elevated CRP levels and/or MRI data) in cases where there is an inadequate response to NSAIDs or intolerance.
• Active psoriatic arthritis (as monotherapy or in combination with methotrexate or other basic anti-inflammatory drugs).
• Chronic plaque psoriasis (moderate to severe), nail psoriasis requiring systemic therapy.
• Active moderate to severe hidradenitis suppurativa (acne inversa) in adults when there is an inadequate response to standard systemic therapy.
• Moderate to severe Crohn’s disease:
  • Inadequate response to traditional therapy, intolerance, or contraindications to traditional therapy.
  • Ineffectiveness or decreased effectiveness, or intolerance to infliximab.
• Moderate to severe ulcerative colitis when there is an inadequate response to traditional therapy, including corticosteroids and/or 6-mercaptopurine or azathioprine, or intolerance or contraindications to traditional therapy.
• Non-infectious uveitis (intermediate, posterior, and panuveitis) in adults inadequately responding to corticosteroid therapy, in situations where dose limitation or discontinuation of corticosteroids is necessary, or when corticosteroid therapy is contraindicated.
• Behçet’s disease (intestinal form) in patients with inadequate response to standard therapy.

Children

• Juvenile idiopathic arthritis in patients from 2 years old, as monotherapy or in combination with methotrexate.
• Active enthesitis-related arthritis in patients aged 6 years and older with inadequate response to standard therapy or intolerance.
• Severe chronic plaque psoriasis in children from 4 years old with inadequate response to topical therapy or phototherapy, or when topical therapy and phototherapy are contraindicated.
• Moderate to severe Crohn’s disease in patients from 6 years old with inadequate response to traditional therapy (including full enteral nutrition and corticosteroids and/or immunosuppressants), or intolerance or contraindications to traditional therapy.
• Non-infectious anterior uveitis in children from 2 years old with inadequate response to standard therapy or when standard therapy is not suitable.
• Active moderate to severe hidradenitis suppurativa (acne inversa) in children from 12 years old with inadequate response to standard systemic therapy.
• Moderate to severe ulcerative colitis in children from 5 years old with inadequate response to traditional therapy, including corticosteroids and/or 6-mercaptopurine or azathioprine, or intolerance or contraindications to traditional therapy.

This product is included in the Essential Medicines List (EML).