Cimzia® (certolizumab pegol) Now Approved for Plaque Psoriasis

Cimzia was recently approved by the U.S. Food and Drug Administration (FDA) to treat moderate to severe plaque psoriasis. Cimzia has been previously approved to treat other inflammatory conditions, including psoriatic arthritis, rheumatoid arthritis, and Crohn’s disease, but the approval in dermatology provides those living with psoriasis a new option for treating their skin condition.1

About Cimzia

Cimzia is a biologic medication which targets and blocks tumor necrosis factor (TNF), a protein involved in the inflammatory response. In autoimmune diseases like psoriasis, the immune system is abnormally triggered and causes an increase in inflammation, which causes the inflamed patches on the skin. By blocking TNF, Cimzia can reduce the symptoms of psoriasis. Cimzia is a PEGylated TNF inhibitor. PEG is polyethylene glycol, a substance that is attached to a protein to make it stay in the body longer.1,2

Cimzia is administered by an injection given under the skin (subcutaneously). The recommended dose for adults with moderate-to-severe psoriasis is 400 mg, given as two subcutaneous injections of 200 mg each, every other week. For people who weigh less than 90 kg (approximately 198 pounds), the dosage may be decreased to 200 mg every other week after the initial two doses.1

Research on Cimzia

The FDA approval for Cimzia for psoriasis was based on several Phase III clinical trials that included over 1,000 people with psoriasis. Most of the participants in the trials had never taken a biologic medication before (biologic naïve), and about a third of the participants had tried other biologics for their condition. In all three trials, Cimzia demonstrated a statistically significant improvement compared to placebo. The trials used the Psoriasis Area and Severity Index (PASI), a tool which expresses the extent and severity of psoriasis.1

In the first two trials, named CIMPASI-1 and CIMPASI-2, 75% and 82% of patients receiving 400 mg of Cimzia every two weeks achieved an improvement in their PASI score of at least 75% by week 16. A lower dose of Cimzia was also evaluated, and 65% and 81% of patients receiving 200 mg of Cimzia every two weeks also saw at least a 75% improvement in their PASI score. These results were convincing, as those who received placebo only had a 7% and 13% response. Some patients also had an even greater improvement – 90% improvement in their PASI score: 44% and 52% of those receiving 400 mg of Cimzia every two weeks, and 36% and 50% of those receiving 200 mg of Cimzia every two weeks, compared to 0% and 5% of those receiving placebo.1

In the third trial, named CIMPACT, 69% of those receiving 400 mg of Cimzia every two weeks and 75% of those receiving 200 mg of Cimzia every two weeks had an improvement in their PASI score of at least 75% by week 16, compared to 4% of those who received placebo. An improvement of 90% in their PASI score was seen in 49% of those receiving 400 mg of Cimzia every two weeks and 40% of those receiving 200 mg of Cimzia every two weeks, compared to 0% of those receiving placebo.1

Possible side effects of Cimzia

The most common documented side effects of Cimzia include redness or pain at the injection site, upper respiratory infections, rash, and urinary tract infections. Cimzia may cause serious side effects, such as new or worsening of infections, which may require hospitalization.1,2

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