"A significant number of patients treated with ENBREL in this study saw a marked improvement in as early as two weeks after initiation of treatment. Patients reached maximum relief within the first two months of the study and experienced sustained results for the remainder of the six-month study," said Dr. John Davis, assistant professor of medicine at the University of California-San Francisco and associate director of the Department of Medicine Clinical Trials Center. "I am excited about these encouraging results with ENBREL, especially since it is the first treatment to show improvement in AS patients' range of spinal motion in a phase 3 study."
The multi-center, double-blind, placebo-controlled study randomized 277 patients to receive either ENBREL (25 mg twice weekly; n=138) or placebo (n=139) over a 6-month period. The primary endpoint of the pivotal Phase 3 study was the percentage of patients at 12 weeks and 24 weeks achieving a 20 percent improvement in the Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20), a composite measure that includes back pain, inflammation and physical function.
At week 12, 60 percent of patients treated with ENBREL achieved the ASAS 20 compared with 27 percent of patients in the placebo group. At 24 weeks, 58 percent of patients treated with ENBREL achieved the ASAS 20 compared with 23 percent of the placebo pati
Contact: Rebecca Hamm, Amgen