Certolizumab pegol

Therapeutic indications

Certolizumab pegol is indicated for:

Rheumatoid arthritis

Population group: only adults (18 years old or older)

Certolizumab pegol, in combination with methotrexate (MTX), is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate
  • the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Certolizumab pegol 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 MTX.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Axial spondyloarthritis

Population group: only adults (18 years old or older)

Certolizumab pegol is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:

Ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis)

Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Axial spondyloarthritis without radiographic evidence of AS (also known as non-radiographic axial spondyloarthritis)

Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Psoriatic arthritis

Population group: only adults (18 years old or older)

Certolizumab pegol, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.

Certolizumab pegol can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Plaque psoriasis

Population group: only adults (18 years old or older)

Certolizumab pegol is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Certolizumab pegol is contraindicated in the following cases:

Severe infections, sepsis

at least one of
Infectious disease
Systemic infection

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

at least one of
Heart failure New York Heart Assosiation Class IΙΙ
Heart failure New York Heart Assosiation Class IV

Tuberculosis

Tuberculosis

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