Axial spondyloarthritis

Active Ingredient: Certolizumab pegol

Indication for Certolizumab pegol

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:

200-400 mg once every 2 weeks

Route of admnistration


Defined daily dose

200 - 400 mg

Dosage regimen

From 200 To 400 mg once every 14 day(s)

Loading dose

400 mg

Maintenance dose

200 mg

Detailed description

Loading dose

The recommended starting dose of certolizumab for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4.

Maintenance dose

After the starting dose, the recommended maintenance dose of certolizumab for adult patients with axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.

Missed dose

Patients who miss a dose should be advised to inject the next dose of certolizumab as soon as they remember and then continue injecting subsequent doses as instructed.

Dosage considerations

Suitable sites for injection would include the thigh or abdomen.

Active ingredient

Certolizumab pegol

Certolizumab pegol has a high affinity for human TNFα and binds with a dissociation constant (KD) of 90 pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol was shown to neutralise membrane associated and soluble human TNFα in a dose-dependent manner. By inhibiting the action of TNFα, certolizumab pegol reduces inflammation and other symptoms in patients with rheumatoid arthritis.

Read more about Certolizumab pegol

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