Wednesday May 9, 2012
The Arthritis Advisory Committee to the U.S. FDA has voted 8-2 to recommend approval of tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis. If approved, tofacitinib would be the first new oral disease-modifying anti-rheumatic drug (DMARD) for rheumatoid arthritis in more than 10 years and the first oral biologic drug belonging to a new class of drugs known as JAK (Janus kinase) inhibitors. The FDA is expected to make their decision on Pfizer's new drug for rheumatoid arthritis in August 2012.
Unlike other currently existing biologic drugs that target extracellular entities, such as proinflammatory cytokines, tofacitinib targets intracellular pathways that operate as hubs in the inflammatory cytokine network, according to Pfizer. Tofacitinib has been studied in about 4,800 patients. There have been five Phase III trials and two ongoing, long-term extension studies in numerous countries around the world. The drug was recommended for approval despite some concern over side effects including lymphoma, infection, and elevated cholesterol levels. Proponents believe there is a need for more treatment options, especially for rheumatoid arthritis patients who have not responded to other treatments or for those who develop antibodies to current biologic treatments and have to discontinue use.
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Wednesday May 9, 2012
The Arthritis Advisory Committee voted 11-0 against recommending FDA approval of Arcalyst (rilonacept) for the prevention of gout flares in patients starting urate-lowering treatment. Arcalyst, a drug being developed by Regeneron, is an interleukin-1 blocker. The advisory panel did not feel that benefits outweighed risks in data presented for Arcalyst. They also felt that 16 weeks, the duration of trials, was inadequate.
The committee voted 6-5 that Arcalyst is effective for treating gout flares. They also voted 8-3 that Regeneron's safety data was insufficient. The committee felt the study was too short to assess cancer risk. Regeneron studied Arcalyst on patients who were capable of taking other gout medications. It was suggested that, if patients who could not take other treatments were studied, more useful data may be produced.
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Saturday May 5, 2012
Researchers from the University of Alabama at Birmingham used U.S. Medicaid data from 2000 to 2005 to compare the incidence of bacterial infection in children with and without juvenile idiopathic arthritis (JIA). It was determined that children with juvenile idiopathic arthritis have higher rates of hospitalization for bacterial infection than children without juvenile idiopathic arthritis. The risk of bacterial infection significantly increased with the use of high-dose glucocorticoids (10 mg. prednisone or more daily), but the use of methotrexate or TNF blockers was not found to increase the risk of bacterial infection among children with JIA.
Interestingly, the findings also suggested that the inflammatory or autoimmune process of JIA itself may increase the risk of infection, no matter which treatment was used. But steroids were found to double the risk of bacterial infection among JIA patients compared to those not taking steroids. When possible, avoiding steroids in JIA patients may be the preferred treatment course.
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Friday May 4, 2012
In the U.S., one-third of adults with arthritis (45 years and older) report having anxiety or depression, according to the Centers for Disease Control and Prevention (CDC). Researchers found that anxiety is nearly twice as common as depression among people with arthritis. Previous studies have revealed a connection between arthritis and depression but anxiety seems to be under-recognized and under-treated.
In the study published online April 30, 2012 in Arthritis Care & Research, out of 1,793 study participants with doctor-diagnosed arthritis or rheumatic diseases, 18% had depression and 31% had anxiety. Of those who reported having depression, 84% also had anxiety. But, only half of the participants with either depression or anxiety sought treatment during the last year. Experts suggest that screening arthritis patients for depression and anxiety may be helpful. Treating the conditions may improve quality of life.
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