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Certolizumab – Uses, Mechanism & Side Effects

Certolizumab is a biological medication used to treat chronic inflammatory conditions such as rheumatoid arthritis and Crohn's disease.

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Things worth knowing about "Certolizumab"

Certolizumab is a biological medication used to treat chronic inflammatory conditions such as rheumatoid arthritis and Crohn's disease.

What is Certolizumab?

Certolizumab (also known as certolizumab pegol, brand name: Cimzia) is a biological medication belonging to the class of TNF-alpha inhibitors. It is a PEGylated Fab fragment of a humanized monoclonal antibody that selectively targets and neutralizes tumor necrosis factor-alpha (TNF-alpha), a key mediator of chronic inflammation in the body.

Indications (Approved Uses)

Certolizumab is approved for the treatment of several chronic inflammatory conditions, including:

Rheumatoid arthritis (RA): in adults with moderate to severe active disease
Axial spondyloarthritis: including ankylosing spondylitis (Bechterew's disease)
Psoriatic arthritis: inflammatory joint disease associated with psoriasis
Crohn's disease: severe active form of inflammatory bowel disease
Plaque psoriasis: moderate to severe forms of the skin condition

Mechanism of Action

Certolizumab pegol binds specifically and with high affinity to TNF-alpha, neutralizing its biological activity and thereby blocking pro-inflammatory signaling in the immune system. Unlike other TNF inhibitors, certolizumab is not a full antibody but a Fab fragment (fragment antigen-binding) that is stabilized through PEGylation (attachment of polyethylene glycol chains). This significantly extends the half-life of the drug in the bloodstream, allowing for less frequent dosing. Importantly, the molecule lacks an Fc region, meaning it does not trigger complement-mediated cytotoxicity and is not actively transported across the placenta – a significant clinical advantage during pregnancy.

Dosage and Administration

Certolizumab is administered as a subcutaneous injection (under the skin). The dosage depends on the indication:

Induction phase: Typically 400 mg at weeks 0, 2, and 4.
Maintenance therapy: 200 mg every 2 weeks or 400 mg every 4 weeks, depending on the disease and clinical response.

Treatment is often combined with other medications such as methotrexate, particularly in rheumatoid arthritis. The exact dosage is always determined individually by the treating physician.

Side Effects

As with all biological therapies, certolizumab can cause side effects. Common and clinically relevant side effects include:

Increased susceptibility to infections: Particularly respiratory tract infections, urinary tract infections, and possible reactivation of latent tuberculosis
Injection site reactions: Redness, swelling, or pain at the injection site
Headaches and general malaise
Rare but serious side effects: Increased risk of serious infections, opportunistic infections, certain cancers (e.g., lymphoma), worsening heart failure, and demyelinating disorders

Screening for tuberculosis and hepatitis B is mandatory before initiating therapy.

Special Considerations and Contraindications

Certolizumab must not be used in patients with:

Active infections (including active tuberculosis)
Severe heart failure (NYHA class III/IV)
Known hypersensitivity to the active substance

A key clinical advantage of certolizumab over other TNF inhibitors is its suitability for use during pregnancy. Because the molecule lacks an Fc region, it is not actively transported across the placenta. Current evidence suggests that certolizumab may be used during pregnancy when clinically necessary, following a thorough benefit-risk assessment by the treating physician.

References

European Medicines Agency (EMA): Cimzia (certolizumab pegol) - Summary of Product Characteristics and EPAR. Available at: www.ema.europa.eu
Smolen JS et al. - EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Annals of the Rheumatic Diseases, 2020.
Mahadevan U et al. - Placental Transfer of Certolizumab Pegol. Alimentary Pharmacology & Therapeutics, 2017.

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