Study reports therapeutic equivalence for once-weekly etanercept in AS

Once weekly etanercept produces comparable improvements in disease activity and back pain when compared with twice-weekly treatment for patients with ankylosing spondylitis (AS), according to new findings.In their double-blind, placebo-controlled study, Dr Désirée van der Heijde (University Hospital Maastricht, the Netherlands) and colleagues have compared the efficacy, pharmacokinetics, and safety of etanercept 50mg once weekly with 25mg twice weekly in patients with AS. In total, 356 patients with active disease were randomised to etanercept 50mg once weekly, etanercept 25mg twice weekly, or placebo. The main outcome was the proportion of patients achieving a response at week 12 based on Assessment in AS Working Group criteria (ASAS 20).During the 12 weeks of investigation 9% of the patients in the once weekly treatment arm discontinued therapy compared with 9.3% of those treated twice weekly and 13.7% for placebo. Dr van der Heijde's team also report that an ASAS 20 response was achieved in 74.2% of those treated once weekly compared with 71.3% and 37.3% of those receiving once weekly and placebo, respectively.The investigators identify that significant improvements were observed as early as two weeks into treatment with reductions in measures of disease activity, back pain, morning stiffness, and C-reactive protein. The researchers also note that all three groups had a similar incidence of treatment-related adverse events, including infections, and "no unforeseen safety issues were identified."Dr van der Heijde's team concludes, "Patients with AS can expect comparable significant improvement in clinical outcomes with similar safety when treated with etanercept 50 mg once weekly or 25 mg BIW."Reference...