Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
NEW YORK (Reuters Health)—Secukinumab appears to improve clinical and radiographic outcomes of ankylosing spondylitis (AS) through two years of therapy, according to new results from the MEASURE 1 study. Secukinumab is a fully human monoclonal antibody against interleukin-17A, which is implicated in various pathophysiological features of spondyloarthritis. In a report online Dec. 13 in the…
Abaloparatide for Osteoporosis Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily…
In a clinical trial, subcutaneous abaloparatide has proved effective in treating postmenopausal women with osteoporosis. Also in the U.K., draft guidelines for treating ankylosing spondylitis will recommend the use of secukinumab…
Psoriatic arthritis (PsA), a chronic inflammatory arthritis characterized by structural damage to the joints, has been associated with reduced health-related quality of life, disability and reduced life expectancy. The joint changes in PsA are characterized radiographically by a combination of erosive and proliferative bone changes, including erosive joint destruction, fluffy periostitis and pencil-in-cup deformities. Radiographic…
In a 52-week clinical trial, patients with plaque psoriasis who took secukinumab achieved greater sustained skin clearance then those taking ustekinumab. Also, three clinical trials showed ixekizumab improves work productivity in patients with plaque psoriasis…
Secukinumab, an anti-interleukin-17A monoclonal antibody, has successfully completed multiple clinical trials, which found the intravenous treatment may be safe and effective for treating patients with active ankylosing spondylitis…