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 September 2013

Specific Treatments:

active psoriatic arthritis

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General Information

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

Cimzia is specifically indicated for the treatment of adult patients with active psoriatic arthritis.

Cimzia is supplied as a solution for subcutaneous administration. The recommended dose of Cimzia for adult patients with psoriatic arthritis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at week 2 and 4, followed by 200 mg every other week. For maintenance dosing, Cimzia 400 mg every 4 weeks can be considered. 

Clinical Results

FDA Approval

The FDA approval of Cimzia for psoriatic arthritis was based on a multi-center, randomized, double-blind, placebo controlled trial (PsA001) in 409 patients aged 18 years and older with active psoriatic arthritis despite DMARD therapy. Patients in this study had ≥ 3 swollen and tender joints and adult-onset PsA of at least 6 months’ duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria, and increased acute phase reactants. Patients had failed one or more DMARDs. Previous treatment with one anti-TNF biologic therapy was allowed. Patients received a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either Cimzia 200 mg every other week or Cimzia 400 mg every 4 weeks or placebo every other week. Patients were evaluated for signs and symptoms and structural damage using the ACR20 response at Week 12 and modified Total Sharp Score (mTSS) at Week 24. ACR20 at Week 12 was reached by 24% of the placebo arm, 58% of the Cimzia 200 mg every other week and 52% of the Cimzia every 4 weeks treatment arms. Patients treated with Cimzia 200 mg every other week demonstrated greater reduction in radiographic progression compared with placebo-treated patients at Week 24 as measured by change from baseline in total modified mTSS Score (estimated mean score was 0.18 in the placebo group compared with -0.02 in the Cimzia 200 mg group). Patients treated with Cimzia 400 mg every four weeks did not demonstrate greater inhibition of radiographic progression compared with placebo-treated patients at Week 24. 

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 psoriatic arthritis, please visit https://www.cimzia.com/