What is the recommended use of certolizumab pegol (Cimzia) in patients with moderate to severe Crohn’s disease?

From the Guidelines

Certolizumab pegol (Cimzia) is recommended for inducing and maintaining remission in patients with moderate to severe Crohn's disease who have not responded adequately to conventional therapy, with a standard dosing regimen of 400 mg administered subcutaneously at weeks 0,2, and 4, followed by 400 mg every four weeks for maintenance therapy, as supported by the most recent evidence from 1.

Key Points to Consider

• The use of certolizumab pegol is suggested for maintenance therapy in moderate-to-severe Crohn's disease, with a weak recommendation and moderate-quality evidence, as stated in 1.
• Patients should be evaluated for response within 8-12 weeks of initiating therapy, and treatment should be discontinued if no clear benefit is observed.
• Before starting certolizumab, patients should be screened for tuberculosis, hepatitis B, and other infections, and vaccination status should be updated, with live vaccines avoided during treatment, as a precautionary measure.
• Certolizumab works as a TNF-alpha inhibitor, binding to tumor necrosis factor and preventing it from interacting with cell surface receptors, thereby reducing inflammation in the intestinal mucosa.
• The medication is particularly valuable for patients who have failed or cannot tolerate corticosteroids, immunomodulators, or other biologics.
• During treatment, patients should be monitored for infections, neurologic symptoms, hematologic abnormalities, and hypersensitivity reactions, as reported in 1.

Important Considerations

• The efficacy and safety of certolizumab for induction therapy in patients with moderately to severely active Crohn's disease was evaluated in several randomized, placebo-controlled trials, including a total of 1485 patients, as mentioned in 1.
• A Cochrane review from 2019 evaluated the efficacy and safety of certolizumab as induction therapy for Crohn's disease, showing that certolizumab was superior to placebo for induction of clinical response and clinical remission, as cited in 1.
• The rates of any serious adverse events (SAEs) were higher with certolizumab compared to placebo, highlighting the need for careful patient selection and monitoring, as reported in 1.

From the FDA Drug Label

CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. The recommended initial adult dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.

The recommended use of certolizumab pegol (Cimzia) in patients with moderate to severe Crohn’s disease is for:

• Reducing signs and symptoms of Crohn's disease
• Maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy The recommended dosing regimen is:
• Initial dose: 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4
• Maintenance dose: 400 mg every four weeks 2, 2, 2

From the Research

Recommended Use of Certolizumab Pegol in Crohn's Disease

The recommended use of certolizumab pegol (Cimzia) in patients with moderate to severe Crohn's disease is as follows:

• Induction and maintenance therapy with certolizumab pegol has been associated with a modest improvement in response rates, as compared with placebo, but with no significant improvement in remission rates 3.
• Certolizumab pegol offers rapid and sustained remission of moderate to severe Crohn's disease, and is an effective and well-tolerated therapy both in patients who have already received biologics and in patients who are anti-TNF naïve 4.
• In patients with moderate to severe Crohn's disease and secondary failure to infliximab, response to open-label induction therapy with certolizumab pegol was achieved by 62% of patients, and certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remission 5.

Dosage and Administration

• The recommended dosage of certolizumab pegol is 400 mg subcutaneously at weeks 0,2, and 4, and then every 4 weeks 3, 6.
• Certolizumab pegol can be self-administered, which may be a consideration in patient and physician preference 7.

Efficacy and Safety

• Certolizumab pegol has been shown to improve function and quality of life in patients with Crohn's disease, and may have the potential to slow or even modify disease progression 4.
• Common adverse effects of certolizumab pegol include upper respiratory tract infection, urinary tract infection, and arthralgia, and serious infection occurred in 3% of patients 7.
• Certolizumab pegol was generally well tolerated, and adverse events associated with the drug were of a mild to moderate nature, with no instances of lupus reported in any of the trials 6.