Secukinumab: Phase III data
Top-line data from the double-blind, international Phase III MEASURE 2 trial in about 220 patients with ankylosing spondylitis showed that secukinumab met the primary endpoint of a greater proportion of patients achieving ASAS20 response at week 16 vs. placebo. Novartis said secukinumab also met key secondary endpoints. Patients received 75 or 150 mg subcutaneous secukinumab once weekly at baseline and weeks 1-4 and then every 4 weeks. The trial enrolled patients who are intolerant to or have had an inadequate response to NSAIDs, DMARDS and/or tumor necrosis factor (TNF) alpha inhibitors. Novartis also reported data from the Phase III MEASURE 1 trial of subcutaneous secukinumab in the indication. Novartis plans to present additional data from MEASURE 1 and 2 by year end and plans to submit joint regulatory filings of secukinumab to treat ankylosing spondylitis and psoriatic arthritis in 2015. Last month, Novartis reported that subcutaneous secukinumab met the primary endpoint in the Phase III FUTURE 1 and FUTURE 2 trials to treat psoriatic arthritis (see BioCentury, Sept. 29). ...