Therapeutic Indications

Adalimumab is indicated for:

Paediatric Uveitis

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Adalimumab is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 20-40 mg every other week in combination with methotrexate

Paediatric plaque psoriasis

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Adalimumab is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - Initial dose of 20-40 mg, followed by 20-40 mg given every other week

Paediatric Crohn's disease

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Adalimumab is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 40-80 mg at week 0 and 20-40 mg at week 2, 20-40 mg every other week

Polyarticular juvenile idiopathic arthritis

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Adalimumab in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than 2 years.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 20 - 40 mg every other week

Enthesitis-related arthritis

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Adalimumab is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 20-40 mg every other week

Uveitis

Irrespective of gender only Adults (18 years old or older)

Adalimumab is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - Initial dose of 80 mg, followed by 40 mg given every other week

Ankylosing spondylitis, axial spondyloarthritis, psoriatic arthritis

Irrespective of gender only Adults (18 years old or older)

Ankylosing spondylitis (AS)

Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic evidence of AS

Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.

Psoriatic arthritis

Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 40 mg every other week

Moderate to severe chronic plaque psoriasis

Irrespective of gender only Adults (18 years old or older)

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - Initial 80 mg, followed by 40 mg given every other week

Crohn's disease

Irrespective of gender only Adults (18 years old or older)

Adalimumab is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 80-160 mg at Week 0, 40-80 mg at Week 2, 40-80 mg every other week

Hidradenitis suppurativa (HS)

Irrespective of gender only Adults (18 years old or older)

Adalimumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 160 mg initially, followed by 80 mg every other week

Ulcerative colitis

Irrespective of gender only Adults (18 years old or older)

Adalimumab is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 160 mg at Week 0 and 80 mg at Week 2, 40 - 80 mg every other week

Rheumatoid arthritis

Irrespective of gender only Adults (18 years old or older)

Adalimumab in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Adalimumab can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 40 mg as a single dose every other week

Contraindications

Active ingredient Adalimumab is contraindicated in the following cases:

Severe infections such as sepsis, and opportunistic infections

No gender/age discrimination

Adalimumab is contraindicated in severe infections such as sepsis, and opportunistic infections.

Biologic DMARDS

No gender/age discrimination

Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.

Moderate to severe heart failure (NYHA class III/IV)

No gender/age discrimination

Adalimumab is contraindicated in moderate to severe heart failure (NYHA class III/IV).

Anakinra

No gender/age discrimination

Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone. Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists. Therefore, the combination of adalimumab and anakinra is not recommended.

Active tuberculosis

No gender/age discrimination

Adalimumab is contraindicated in active tuberculosis.