Background The efficacy of anti-TNF therapy in patients with active ankylosing spondylitis (AS) has been established for short and longer-term periods.
Objectives 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.
Methods 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.
Results 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<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 <2 in 3/4 remission parameters and a score >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.
Conclusions 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 (<10% of patients). There was no new safety signal in this small prospective study over 10y.
Disclosure of Interest 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
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