Background: Switching from reference infliximab (RI) to biosimilar infliximab (BI) had no\ndetrimental effects on efficacy and safety. However, long-term follow-up data is missing. Objective:\nTo evaluate patients with Ankylosing Spondylitis (AS) in clinical remission who were switching from\nRI to BI, in terms of the safety and efficacy of this, in a long-term fashion. Methods: One hundred\nand nine consecutive unselected AS patients were investigated. All were naïve to other biologics and\nwere followed-up at predefined times receiving RI. Patients in clinical remission were asked to switch\nfrom RI to BI. Those who switched to BI were compared with a matched control-group receiving\ncontinuous RI. During follow-up, several parameters were recorded for at least 18 months. Disease\nactivity wasmeasured using the Bath Ankylosing Spondylitis disease activity index (BASDAI), and the\nAnkylosing Spondylitis disease activity score (ASDAS), using the C-reactive protein. Remission was\ndefined as BASDAI < 4 and ASDAS < 1.3. Results: Eighty-eight patients were evaluated (21 excluded\nfor different reasons). From those, 45 switched to BI, while 43 continued receiving RI. No differences\nbetween groups regarding demographic, clinical and laboratory parameterswere observed.All patients\nwere in clinical remission. During follow-up, five patients from the BI-group and three from the\nmaintenance-group discontinued the study (4 patients nocebo effect, 1 loss of efficacy). After 18months\nof treatment, all patients in both groups remained in clinical remission. No significant adverse events\nwere noted between groups. Conclusion: BI is equivalent to RI in maintaining AS in clinical remission\nfor at least 18 months.
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