Cimzia Approved as a Treatment for Rheumatoid Arthritis
May
31
Written by:
5/31/2009
In May 2009, the FDA approved the Crohn's disease drug Cimzia for adults with moderate to severe rheumatoid arthritis who have had an inadequate response to conventional therapy or who have serious side effects from long-term use of prednisone. The FDA first approved Cimzia in April 2008 to treat Crohn's disease in adults who haven't responded to other treatments.
That news comes from UCB, the drug company that makes Cimzia. As a tumor necrosis factor blociker, Cimzia targets an inflammatory compound called TNF-alpha. It's given by injection at intervals of every two to four weeks, alone or with another immunosuppressant drug called methotrexate.
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.
SOURCES: News release, UCB. WebMD Health News: "FDA OKs New Crohn's Disease Drug Cimzia."