New considerations in the design of clinical trials for spondyloarthritisAuthor(s): Robert Landewe ,Desiree van der Heijde
Inflammation in spondyloarthritis (SpA) primarily affects the axial skeleton including the sacroiliac joints, the spine and the peripheral joints. Currently, axial and peripheral SpA can be distinguished, and new criteria have been developed to classify these subtypes. Ankylosing spondylitis (AS; Bechterew’s disease) belongs to the spectrum of axial SpA. To date, randomized clinical trials in this field have usually been conducted in patients with AS, showing efficacy of non-steroidal anti-inflammatory drugs and of TNF-a-inhibiting biologicals on signs and symptoms of AS, on acute phase reactants and on inflammation on MRI of the spine and sacroiliac joints. In this article, classic trial design in AS is discussed, as well as the implications of the development of the new Assessment in Spondyloarthritis international Society criteria and new outcome measures in the field of SpA on future trial designs with regard to new drug development.