Adalimumab

This medication is indicated for the treatment of:

ADULTS:

Rheumatoid Arthritis
Adalimumab is indicated to reduce the signs and symptoms, induce a clinical response and major clinical remission, inhibit the progression of structural damage, and improve physical function in adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARD).
Adalimumab is also indicated for the treatment of severe, active, and progressive rheumatoid arthritis in patients who have not previously been treated with methotrexate.  Adalimumab may be used as monotherapy or in combination with methotrexate or another DMARD.

Psoriatic Arthritis
Adalimumab is indicated to reduce the signs and symptoms of psoriatic arthritis.  Adalimumab may be used as monotherapy or in combination with disease-modifying antirheumatic drugs (DMARDs). 

Axial Spondyloarthritis
– Ankylosing Spondylitis (AS)
Adalimumab is intended for the treatment of active ankylosing spondylitis in patients with an inadequate response to conventional therapy.

– Non-radiographic axial spondyloarthritis (axial spondyloarthritis without radiographic evidence of AS)
Adalimumab is indicated for the treatment of adult patients with severe axial spondyloarthritis without radiographic evidence of AS who have objective signs of inflammation (elevated CRP and/or MRI findings) and who have had an inadequate response or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Crohn’s Disease
Adalimumab is indicated to reduce the signs and symptoms, induce and maintain clinical remission in adult patients with moderate to severe active Crohn’s Disease who have had an inadequate response to conventional therapy.
Adalimumab is also indicated to reduce signs and symptoms and induce clinical remission in patients who have become unresponsive or intolerant to infliximab.

Ulcerative Colitis or Ulcerative Rectocolitis
Adalimumab is indicated for the treatment of moderate to severe active ulcerative colitis or ulcerative rectocolitis in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have contraindications to these therapies.
Adalimumab induces and maintains mucosal healing in these patients, reduces disease-related hospitalization and its causes, and improves quality of life. Corticosteroid use may be reduced or discontinued.

Plaque Psoriasis
Adalimumab is intended for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are indicated for systemic therapy.

Hidradenitis Suppurativa
Adalimumab is indicated to reduce the signs and symptoms of moderate to severe active hidradenitis suppurativa in adult patients for whom antibiotic therapy has been inadequate, including treatment of inflammatory lesions and prevention of worsening abscesses and fistulas.

Uveitis
Adalimumab is indicated for the treatment of non-infectious intermediate, posterior, or panuveitis in adult patients who have had an inadequate response to corticosteroids, who require corticosteroid-sparing therapy (corticosteroid reduction/withdrawal), or for whom corticosteroid use is inappropriate.

PEDIATRIC USE:

Polyarticular Juvenile Idiopathic Arthritis
Adalimumab, in combination with methotrexate, is indicated to reduce the signs and symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis in pediatric patients over 2 years of age who have had an inadequate response to at least one DMARD.  Adalimumab may be used as monotherapy in individuals who are intolerant to methotrexate or when concomitant use with methotrexate is inappropriate.

Enthesitis-Related Arthritis
Adalimumab is indicated for the treatment of enthesitis-related arthritis in pediatric patients over 6 years of age who have had an inadequate response to or are intolerant to conventional therapy.

Crohn’s Disease
Adalimumab is indicated to reduce signs and symptoms, induce and maintain clinical remission in pediatric patients over 6 years of age with moderate to severe active Crohn’s Disease who have had an inadequate response to conventional therapy.

Ulcerative Colitis or Pediatric Ulcerative Rectocolitis
Adalimumab is indicated for the treatment of moderate to severe active ulcerative colitis or ulcerative rectocolitis in pediatric patients (6 years of age and older) who have had an inadequate response to conventional therapy, including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications to these therapies.

Pediatric Uveitis
Adalimumab is indicated for the treatment of non-infectious, chronic, anterior uveitis in pediatric patients aged 2 years and older who have had an inadequate response to or are intolerant to conventional therapy, or when conventional therapy is inappropriate.

Hidradenitis Suppurativa in Adolescents

Adalimumab is indicated for the treatment of moderate to severe active hidradenitis suppurativa (acne inversa) in adolescents aged 12 years and older who have had an inadequate response to conventional systemic therapy for hidradenitis suppurativa (HS).