A Randomized, Double-Blind, Placebo-Controlled, Sixteen-Week Study of Subcutaneous Golimumab in Patients With Active Nonradiographic Axial Spondyloarthritis

Axial spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by inflammation of the sacroiliac (SI) joints and spine 1, 2. Patients with axial SpA experience chronic back pain and spinal stiffness as well as a reduction in mobility and quality of life (QoL) 3. Over time, permanent damage to spinal mobility and function can occur due to new bone formation in the spine 3. The term axial SpA encompasses patients with evident radiographic changes in the SI joints according to the modified New York criteria 4, also termed ankylosing spondylitis (AS), and patients who have no evident radiographic signs of structural damage but who may have evidence of sacroiliitis visible by magnetic resonance imaging (MRI) and/or share other features with AS such as spinal inflammation, chronic back pain, HLA–B27 positivity, and other nonarticular symptoms 5, 6. This latter group is described as having nonradiographic axial SpA, and nonradiographic axial SpA was recently classified by the Assessment of SpondyloArthritis international Society (ASAS) as part of axial SpA 2, 7. A late diagnosis of axial SpA frequently leads to delays in treatment 8. Adoption of the ASAS criteria has the potential to lead to earlier identification of patients with axial SpA 6, early in the disease course for many, and more timely therapeutic intervention. The current standard of care for axial SpA is nonsteroidal antiinflammatory drugs (NSAIDs) 9, 10, 11, 12, 13. If there is an insufficient response to or intolerance of NSAIDs the next line of treatment is tumor necrosis factor (TNF)–targeted therapies, which have demonstrated efficacy in recent trials in patients with nonradiographic axial SpA 14, 15, 16, 17, 18, 19. TNF‐blocking agents have already been approved for this indication in the European Union (EU) and other countries but not yet in the US. In this randomized, double‐blind, placebo‐controlled clinical trial (GO‐AHEAD), we investigated the effect of treatment with golimumab, a fully human anti‐TNF antibody, administered subcutaneously every 4 weeks at a dose of 50 mg over 16 weeks, in patients with active nonradiographic axial SpA. The primary end point was 20% improvement in disease activity according to the ASAS criteria (ASAS20) 20 at week 16.