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Bone and Cancer

Clinical Trials

Cimzia (certolizumab pegol)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

UCB

Approval Status:

Approved March 2019

Specific Treatments:

non-radiographic axial spondyloarthritis

Therapeutic Areas

General Information

Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) blocker.

Cimzia is specifically indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Cimzia is supplied as an injection for subcutaneous administration. The recommended dose of Cimzia for adult patients with non-radiographic axial spondyloarthritis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks. 

Clinical Results

FDA Approval

The FDA approval of Cimzia was based on a multicenter, randomized, double-blind, placebo controlled study in 317 subjects ≥18 years of age with adult-onset active axial spondyloarthritis for at least 12 months.  Patients were treated with a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 or placebo followed by 200 mg of Cimzia every 2 weeks or placebo. Utilization and dose adjustment of concomitant medications (including NSAIDs, DMARDs, corticosteroids, opioids) were permitted at any time. Patients were allowed to transition to use of open label Cimzia at any time at the discretion of the investigator. However, no patients transitioned before Week 12. The primary endpoint was the proportion of patients achieving an Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) response at Week 52. A greater proportion of nr-axSpA patients treated with Cimzia had ASDAS-MI response compared to patients treated with placebo (47% versus 7%, respectively).

Side Effects

Adverse effects associated with the use of Cimzia may include, but are not limited to, the following:

upper respiratory tract infection

rash

urinary tract infection

The Cimzia drug label comes with the following Black Box warning: Patients treated with Cimzia are at an increased risk of serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Cimzia should be discontinued if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting Cimzia. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member. Cimzia is not indicated for use in pediatric patients. 

Mechanism of Action

Cimzia (certolizumab pegol) binds to human TNFα with a KD of 90pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol selectively neutralizes TNFα but does not neutralize lymphotoxin α (TNFβ).

Additional Information

For additional information regarding Cimzia or non-radiographic axial spondyloarthritis, please visit https://www.cimzia.com/

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