Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation: An Early Remission Induction Study

Abstract

Objective: To evaluate the efficacy of tight-control, rapid escalation to tumor necrosis factor inhibition in early axial spondyloarthritis (axSpA) in relation to gut inflammation.

Methods: GO-GUT (NCT03270501) was a prospective, open-label, 52-week trial in treatment-naïve patients with axSpA with less than one year of symptom duration and high disease activity. At baseline, patients underwent ileocolonoscopy with histopathological evaluation of the gut mucosa. Next, all patients received two different nonsteroidal anti-inflammatory drugs in optimal dose for a period of four weeks. If inactive disease, defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) with CRP <1.3, or clinically important improvement (ΔASDAS-CRP ≥ 1.1) resulting in low disease activity (ASDAS-CRP <2.1) was not achieved, monotherapy with 50 mg golimumab every four weeks was initiated. Patients were observed until they achieved sustained clinical remission (ASDAS-CRP <1.3 at two consecutive visits with 12 weeks interval) or end of trial. Upon achievement of sustained clinical remission, all medication was discontinued, and the possibility of drug-free remission was evaluated.

Results: Fifty-eight patients were included in the trial. Microscopic gut inflammation was present in 28.6% of patients, which was predominantly acute inflammation. An escalation of therapy to golimumab was required for 72.7% of patients. The primary study endpoint of sustained clinical remission was reached by 61.8% of patients, irrespective of gut inflammation. Treatment discontinuation resulted in disease relapse within one year in 78.1% of patients.

Conclusion: Applying a treat-to-target approach in treatment-naïve early axSpA allows to induce high rates of sustained clinical remission, regardless of the presence of microscopic gut inflammation.