A treat-to-target strategy incorporating early biologic escalation achieves high rates of sustained remission in treatment-naïve axial spondyloarthritis, according to new findings published in Arthritis & Rheumatology. The prospective GO-GUT trial (NCT03270501) shows that rapid escalation to golimumab induces sustained clinical remission in a substantial proportion of patients with early axial spondyloarthritis (axSpA), regardless of the presence of microscopic gut inflammation at baseline. Axial spondyloarthritis, including ankylosing spondylitis, is characterized by chronic inflammatory back pain resulting from sacroiliac joint and spinal inflammation and may progress to structural damage with syndesmophyte formation and spinal ankylosis. Tumor necrosis factor alpha inhibitors have become a cornerstone of therapy by targeting key inflammatory pathways and providing effective symptom control, although their influence on long-term structural progression remains an area of active investigation.
Golimumab, a fully human IgG1 monoclonal antibody directed against tumor necrosis factor alpha, downregulates pro-inflammatory signaling and has previously demonstrated efficacy in reducing disease activity, improving physical function, and enhancing patient-reported outcomes in axSpA. In the GO-GUT study, 58 treatment-naïve patients with symptom duration of less than one year and high disease activity were enrolled in a 52-week, prospective, open-label design. All participants underwent baseline ileocolonoscopy with histopathological evaluation to assess subclinical gut inflammation.
Patients initially received two different nonsteroidal anti-inflammatory drugs at optimal doses for four weeks. Those who did not achieve inactive disease, defined as an Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) below 1.3, or a clinically important improvement leading to low disease activity, were escalated to subcutaneous golimumab 50 mg every four weeks. Microscopic gut inflammation was identified in 28.6 percent of patients at baseline, predominantly acute in nature. Escalation to golimumab was required in 72.7 percent of the cohort.
The primary endpoint of sustained clinical remission, defined as ASDAS-CRP below 1.3 at two consecutive visits 12 weeks apart, was achieved in 61.8 percent of patients. Notably, remission rates did not differ significantly according to gut inflammation status, suggesting that microscopic intestinal involvement did not adversely influence treatment response in early disease. However, among patients who discontinued therapy after achieving sustained remission, 78.1 percent experienced disease relapse within one year, highlighting the limited durability of drug-free remission in this population.
These findings support the clinical utility of a treat-to-target strategy with early biologic escalation in axial spondyloarthritis, demonstrating that high rates of sustained remission are achievable irrespective of baseline gut mucosal inflammation. At the same time, the substantial relapse rate following treatment withdrawal underscores the need for further studies to identify predictors of durable remission off therapy, optimize discontinuation strategies, and clarify the long-term implications of gut inflammation in the disease trajectory of axSpA.
References
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- Gelfer G, Perry L, Deodhar A. Golimumab for the treatment of axial spondyloarthritis. Expert Rev Clin Immunol. 2016;12(1):9-18.