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 October 2013

Specific Treatments:

active ankylosing spondylitis

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General Information

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

Cimzia is specifically indicated for the treatment of adults with active ankylosing spondylitis.

Cimzia is supplied as a solution for subcutaneous injection. The recommended dose of Cimzia for adult patients with ankylosing spondylitis 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 for active ankylosing spondylitis was based on one multicenter, randomized, double-blind, placebo controlled study (AS-1) in 325 patients ≥18 years of age with adult-onset active axial spondyloarthritis for at least 3 months. Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, and spinal pain ≥4 on a 0 to 10 Numerical Rating Scale (NRS). Patients must have been intolerant to or had an inadequate response to at least one NSAID. Patients were treated with a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either 200 mg of Cimzia every 2 weeks or 400 mg of Cimzia every 4 weeks or placebo. Concomitant NSAIDs were received by 91% of the AS patients. The primary efficacy variable was the proportion of patients achieving an ASAS20 response at Week 12. A greater proportion of patients treated with Cimzia 200 mg every 2 weeks or 400 mg every 4 weeks achieved ASAS 20 response compared to patients treated with placebo. Responses were similar in patients receiving Cimzia 200 mg every 2 weeks and 400 mg every 4 weeks. 

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 active ankylosing spondylitis, please visit https://www.cimzia.com/