TY - JOUR
T1 - Do we need new trial designs in spondyloarthritis?
AU - Landewé, Robert B. M.
PY - 2019
Y1 - 2019
N2 - In the last two decades drug trials in ankylosing spondylitis (AS) have been extremely successful and many effective new drugs have been approved for the treatment of patients with AS. In 2009, new classification criteria for axial spondyloarthritis (axSpA) have been released that capture not only AS, but also patients with presumably earlier non-radiographic axSpA. These criteria have served as inclusion criteria for patients to be enrolled in drug trials for the indication of nr-axSpA. The theme to be discussed in this article pertains to changes in the design of clinical trials required to optimize the process of drug-testing and -approval in a changed environment. Additional treatment criteria (MRI-and CRP-positivity), better response measurement (ASDAS) and trial homogeneity will be addressed against the background of the expansion of the disease spectrum of axSpA which has been the consequence of the new classification criteria for axSpA.
AB - In the last two decades drug trials in ankylosing spondylitis (AS) have been extremely successful and many effective new drugs have been approved for the treatment of patients with AS. In 2009, new classification criteria for axial spondyloarthritis (axSpA) have been released that capture not only AS, but also patients with presumably earlier non-radiographic axSpA. These criteria have served as inclusion criteria for patients to be enrolled in drug trials for the indication of nr-axSpA. The theme to be discussed in this article pertains to changes in the design of clinical trials required to optimize the process of drug-testing and -approval in a changed environment. Additional treatment criteria (MRI-and CRP-positivity), better response measurement (ASDAS) and trial homogeneity will be addressed against the background of the expansion of the disease spectrum of axSpA which has been the consequence of the new classification criteria for axSpA.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85075408683&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31779854
U2 - https://doi.org/10.1016/j.semarthrit.2019.09.016
DO - https://doi.org/10.1016/j.semarthrit.2019.09.016
M3 - Article
C2 - 31779854
SN - 0049-0172
VL - 49
SP - S8-S10
JO - Seminars in Arthritis and Rheumatism
JF - Seminars in Arthritis and Rheumatism
IS - 3
ER -