THU0286 Clinical efficacy and safety of infliximab – first results after a decade of continuous treatment in ankylosing spondylitis:
Authors: X. Baraliakos, J. Listing, C. Fritz, H. Haibel, R. Alten, G. Burmester, A. Krause, S. Schewe, M. Schneider, H. Sörensen, R. Schmidt, J. Sieper, J. Braun
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> The efficacy of anti-TNF therapy in patients with active ankylosing spondylitis (AS) has been established for short and longer-term periods. <h3>Objectives</h3> This is the final report of the first clinical trial with anti-TNF in patients with initially active AS, providing efficacy and safety data over 10 years of treatment with infliximab. <h3>Methods</h3> At the start of the PCP of the study (baseline, BL), n=69 fulfilled the 1984 NY criteria and had active disease (BASDAI and spinal pain ≥4). After 3 months, all patients continued to receive infliximab 5mg/kg i.v./6 weeks in an OLE phase of the study and were assessed systematically at regular intervals. All results are described on the basis of a completer analysis. <h3>Results</h3> While 42 patients were still in the study at 5y (60.9%), 29 (42.2%) reached the end of 10y. At 10y, the mean ASDAS was 1.7±1.0 (BL: 4.3±0.8, p&lt;0.001). Similarly, all other assessed parameters remained in low levels throughout the study (Table 1). ASDAS inactive disease status was reached by 12/29 (41.4%) patients but only 5 patients fulfilled ASAS partial remission (PR) criteria (17.2%). This difference was due to 6/24 patients not in ASAS-PR (25%) who had scores &lt;2 in 3/4 remission parameters and a score &gt;2 in only 1 parameter: BASFI (n=4) and patient’s global assessment (n=2). There were no differences in BL status scores between completers and patients who had dropped out. At the last available assessment time point, the mean BASDAI was 3.9±2.1 for drop outs vs. 2.7±2.0 for completers. Overall, 40 patients dropped out of the study due to AEs (n=23), treatment prescribed by the local rheumatologist (n=6), wish for pregnancy (n=5), non-compliance (n=2), while a minority discontinued due to lack of response (n=3), all of the latter within the first year. There was one death due to a myocardial infarction. The most frequent AEs that lead to discontinuation of the study were laboratory results: increase of liver enzymes and/or anti-nuclear antibodies (n=8); infusion reactions gave reason to discontinue in 3 patients. One patient had developed tuberculosis during the first 3 months of the study, before systematic screening procedures had been installed. <h3>Conclusions</h3> The efficacy of infliximab lasted over 10 years – in those 29 patients who had remained in the study. There was no indication of a loss of efficacy. The most frequent reason for treatment discontinuation were AEs and pragmatic reasons. Lack of efficacy and infusion reactions contributed to only 15% of all drop outs (&lt;10% of patients). There was no new safety signal in this small prospective study over 10y. <h3>Disclosure of Interest</h3> X. Baraliakos Grant/Research support from: MSD Germany, J. Listing: None Declared, C. Fritz: None Declared, H. Haibel Grant/Research support from: MSD Germany, R. Alten Grant/Research support from: MSD Germany, G. Burmester Grant/Research support from: MSD Germany, A. Krause Grant/Research support from: MSD Germany, S. Schewe Grant/Research support from: MSD Germany, M. Schneider Grant/Research support from: MSD Germany, H. Sörensen Grant/Research support from: MSD Germany, R. Schmidt Grant/Research support from: MSD Germany, J. Sieper Grant/Research support from: MSD Germany, J. Braun Grant/Research support from: MSD Germany