Rheumatoid arthritis

Indication for Certolizumab pegol

Population group: Suitable for both men and women, 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:

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 rheumatoid arthritis is 200 mg every 2 weeks. Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered. MTX should be continued during treatment with certolizumab where appropriate.

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 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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