Keywords
Spondyloarthritis
Infliximab
Biosimilar pharmaceuticals
Drug switching
Treatment outcome
Categories
How to Cite
Abstract
Background: Biosimilar infliximab agents are increasingly used in the management of axial spondyloarthritis (axSpA), primarily driven by cost considerations. While clinical outcomes after switching from originator infliximab (INF) to several biosimilars have been reported, real-world data regarding switching to Ixifi remain limited. Objectives: To evaluate clinical outcomes, treatment retention and safety following non-medical switching from originator INF to the biosimilar Ixifi in patients with axSpA. Methods: This single-center observational cohort study included adult patients with axSpA who were transitioned from originator INF to Ixifi for non-medical reasons. Clinical assessments and laboratory parameters were recorded at baseline and at 3 and 6 months after switching. Disease activity was evaluated using ASDAS, BASDAI and BASFI. Safety outcomes and treatment discontinuation were systematically recorded. Results: 72 patients were included. Inflammatory markers, including C-reactive protein and erythrocyte sedimentation rate, remained stable over 6 months (p>0.05 for all), as did ASDAS scores (p>0.05). In contrast, BASDAI and BASFI showed modest but statistically significant improvements at month 6 (p=0.008 and p=0.002, respectively). 2 serious infections (2.8%) and 2 infusion reactions (2.8%) were observed. Treatment discontinuation occurred in 13.9% of patients, exclusively due to loss of efficacy. The estimated 6-month treatment retention rate was 86.1%. Conclusion: In this real-world cohort, non-medical switching from originator infliximab to Ixifi in axSpA was associated with maintained short-term clinical stability, acceptable treatment retention and a favorable safety profile. However, the absence of a control group limits causal interpretation of these findings. Larger studies with longer follow-up are warranted to confirm long-term outcomes.
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Copyright (c) 2026 Dilara Bulut Gökten, Rıdvan Mercan (Author)