A Randomized Controlled Trial of Dose Reduction of Biologic Therapy in Axial Spondyloarthritis: Rationale and Protocol of an Open-Label Non-inferiority Study and a Review of Literature

Abstract

Axial spondyloarthritis (SpA) is a spectrum of inflammatory conditions predominantly involving the spine and sacroiliac (SI) joints. The development of biological therapies has revolutionized the treatment paradigm in SpA. This has led to a great improvement in clinical outcomes, including inflammation suppression, symptom alleviation, and functional improvement. Despite its usefulness, the question regarding the optimal duration of therapy remains unanswered. This is particularly important given the cost associated with biological therapies, and the potential side effects related to immune suppression. Currently, guideline and data regarding dose reduction of biologics treatment in axial SpA has not been well established. This randomized controlled trial aims to study the possibility of biologic dose reduction in patients with axial SpA. The primary measure will be the occurrence of disease flare up in participants undergoing biologics tapering compared with participants on standard dose of treatment. The study also aims to evaluate the role of anti-drug antibodies in disease flare, the effect of biologics dose reduction on structural changes, and the cost effectiveness of biologics dose reduction. The results of this study will be crucial for clinical decisions and establishing future guidelines regarding dose reduction of biologics in SpA.

Keywords

• Spondyloarthritis
• Biologics
• Immunogenecity
• MRI