Phase III study of Simponi (Merck) shows improvements in Ankylosing Spondylitis over 5 years

Five-year data from a pivotal Phase III clinical study demonstrates that once-monthly, subcutaneous injections of Simponi (golimumab), from Merck, provided sustained improvements in the signs and symptoms of patients with active Ankylosing Spondylitis (AS) over five years. According to the Assessment in SpondyloArthritis International Society criteria (ASAS) in the randomized, placebo-controlled study of 356 patients, 43 percent in the placebo group who were switched to golimumab at Week 16 or Week 24 achieved partial remission (24 of 61); 51 percent (48 of 94) of patients receiving golimumab 50 mg and 39 percent (38 of 98) of patients receiving golimumab 100 mg achieved partial remission.

Reductions in AS signs and symptoms and improvements in physical function and range of motion were sustained through five years. The findings from long-term extensions of the GO-RAISE clinical study were presented at the 2013 European League Against Rheumatism (EULAR) Annual Congress.