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FDA OKs Cimzia for Rheumatoid Arthritis
May 19, 2009 -- The FDA has approved the Crohn's disease drug Cimzia to treat moderate to severe rheumatoid arthritis in adults who have had an inadequate response to conventional therapy.
That news comes from UCB, the drug company that makes Cimzia.
Cimzia targets an inflammatory compound called TNF-alpha. It's given by injection at intervals of every two weeks or every four weeks, alone or with another drug called methotrexate.
The FDA first approved it in April 2008 to treat Crohn's disease in adults who haven't responded to other treatments.
In a news release, UCB states that the FDA approved Cimzia to treat rheumatoid arthritis based on clinical trials in which more than 2,300 rheumatoid arthritis patients taking Cimzia with another drug, methotrexate, had a greater reduction in signs and symptoms of RA after 24 weeks of treatment, compared to patients only taking methotrexate. Some patients showed clinical responses to Cimzia plus methotrexate within one to two weeks.
Patients taking Cimzia and methotrexate also had a slower progression of joint damage during the trial than patients only taking methotrexate, according to UCB.
Adverse events seen in Cimzia's clinical trials included infections such as tuberculosis and malignancies such as lymphoma. Both of those risks are noted on Cimzia's label.
The most commonly reported adverse events in Cimzia's clinical trials were upper respiratory tract infections, rash, and urinary tract infections.
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