Crohn's Disease (cont.)

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Certolizumab pegol (Cimzia)

Certolizumab pegol (Cimzia) is a pegylated humanized antibody fragment also directed against TNF alpha, acting similarly to infliximab and adalimumab. Although unlike other monoclonal antibodies (infliximab, adalimumab), certolizumab pegol is missing a certain portion of the molecule and, therefore, does not induce in vitro complement activation which can be toxic to normal cells. Theoretically this may result in better tolerability of certolizumab pegol in patients as compared with other TNF antibodies6.

This medication was approved in 2008 by the U.S. Food and Drug Administration for the treatment of moderate to severe Crohn's disease in patients who do not respond sufficiently or adequately to standard medical therapy. Certolizumab pegol 400 mg subcutaneously has been effective in inducing and maintaining clinical remissions for over 3.5 years without the need for increasing doses (based on the PRECiSE2 and PRECiSE3 studies)6.

The standard dose of certolizumab pegol is 400 mg subcutaneously at week 0, week 2, and then week 4 to induce remission. Maintenance dosing is 400 mg subcutaneously every 4 weeks in patients who demonstrate a clinical response.

The side effects of certolizumab (Cimzia)

Certolizumab is generally well-tolerated. The incidence of adverse events in the literature was similar between placebo and treatment groups. Nasopharyngitis, injection site pain or other injection site reaction, and infections were more common in the treatment groups.

Patients might also experience upper respiratory tract infections, urinary tract infections, or a rash. The most common adverse reactions leading to the discontinuation of the drug were abdominal pain, diarrhea, and intestinal obstruction (rarely).

Since certolizumab pegol is similar to the other biologic agents, it is reasonable to assume that it might increase the risk for serious infections including tuberculosis. However, in ongoing clinical studies (including over 5000 certolizumab-treated patients), the overall rate of TB is approximately 0.61 per 100 patient-years, the majority of cases occurring in countries with high endemic rates of TB. No cases have been reported in the US or Canada. Rare cases of opportunistic infections have been reported.

There have also been some cases of worsening heart failure, the majority of which have been mild or moderate. The reason for this effect on the heart is unclear. As a precaution, individuals with heart disease should inform their physician of this condition before receiving infliximab, adalimumab, or certolizumab.

Hypersensitivity reactions have been reported including angioedema, allergic dermatitis, dizziness, shortness of breath, hot flushes, hypotension (low blood pressure), malaise, fainting (syncope). Patients experiencing symptoms of severe allergic reactions should seek emergency care immediately.

Medically Reviewed by a Doctor on 8/27/2014

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