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FDA Approves Cimzia for Plaque Psoriasis

Clinical trial data show drug may help you achieve clear skin.

Adults with moderate-to-severe plaque psoriasis will soon have access to a new treatment option. On May 29, 2018, the U.S. Food and Drug Administration (FDA) approved the biologic Cimzia (certolizumab pegol) for the treatment of adults with psoriasis who are eligible for systemic therapy or phototherapy.

“We have a wide range of biologics available today. They’re effective and safe and they give patients the options they need to find the treatment that works best for them,” says Andrew Blauvelt, M.D., president and investigator, Oregon Medical Research Center in Portland. “Cimzia has been FDA-approved for psoriatic arthritis for many years. This new approval, for the treatment of psoriasis, is welcome news.”

The FDA approved Cimzia for the treatment of psoriatic arthritis in adults in 2013. In March 2018, the FDA approved a label update that there is negligible to low transfer of Cimzia through the placenta and minimal transfer to breast milk from mother to infant.

The drug is given by injection under the skin. The recommended dose is 400 mg (given as two injections of 200 mg each) every other week. Another dosing option may be considered for people who weigh 198 pounds (90 kg) or less: 400 mg (given as two injections of 200 mg each) initially and at week two and week four, followed by a dose of 200 mg every other week. Always consult your health care provider about the appropriate treatment and dosage for you.

Cimzia works by inhibiting tumor necrosis factor-alpha. TNF-alpha is a cytokine, or protein, involved in systemic inflammation. Results from three Phase 3 clinical trials showed significant improvement in psoriasis symptoms through 48 weeks in adults who received Cimzia in one of two doses, 400 mg or 200 mg, compared with the placebo. Overall, improvement was greater for people who took 400 mg, which could mean that the larger dose may be more effective. No new adverse events were observed.

Since 1987, NPF has invested more than $17 million in psoriatic disease research, which has directly contributed to the wave of newly approved therapies in recent years. NPF also helps connect patients with clinical trials so that more drugs may be tested and ultimately approved.

Know your options 

If you’d like to learn more about your treatment options, such as Cimzia, contact our Patient Navigation Center. Our Patient Navigators offer free resources and personalized support to help you live your healthiest life with psoriatic disease.

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