In an exploratory phase II trial, 175 patients whose primary disease manifestations were discoid rash, polyarthritis, or serositis were randomized to receive prednisone plus abatacept, 10 mg/kg, or placebo by intravenous infusion on days 1, 15, and 29 and then every 4 weeks for 1 year. This again was a negative trial, Dr. Manzi said, with 79% and 82% of patients in the abatacept and placebo groups experiencing flares when the steroids were tapered. Patients whose primary complaint was arthritis seemed to respond the best.
“So lupus is still a complex disease and measuring response remains incredibly challenging. We're also challenged by the fact that we have to do superiority studies, and we have to be careful about who we enter into trials,” she said.
Dr. Manzi disclosed that she receives grant research support and is on the speakers bureau for multiple companies including Aspreva Pharmaceuticals Corp., the manufacturer of MMF. SDEF and this news organization are owned by Elsevier.
'We all got very excited about [mycophenylate mofetil] when the first study came out in 2000.' DR. MANZI