Original articleMaintained clinical response of infliximab treatment in ankylosing spondylitis: A 6-year long-term study
Introduction
Ankylosing spondylitis (AS) is a chronic progressive inflammatory disease with a prevalence of about 0.1–1.1% of the Caucasian adult population worldwide [1], [2]. It affects mostly young patients in the second and third decade of life [3]. The areas predominantly involved in AS are the spine, the sacroiliac joints and the entheses [4], [5] but patients suffering from AS may also have associated peripheral arthritis or extraarticular involvement, mainly uveitis and inflammatory bowel disease [6]. Therapeutic options for patients suffering from the more severe forms of SpA have been limited during the last decades. Non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy have been the basis for AS therapy in order to ameliorate spinal pain. None of the disease-modifying antirheumatic drugs (DMARDs) has shown efficacy in axial disease [7], [8], with the exception of sulfasalazine that has demonstrated some limited effect in patients with AS who had peripheral involvement [9]. Inflammation at the interphase of cartilage and bone has been demonstrated by magnetic resonance imaging (MRI) [10], [11], [12] and by immunohistological investigations of sacroiliac joint biopsies [13], [14], [15]. Moreover, it has been shown that tumor necrosis factor (TNF) α messenger RNA and protein were present in the inflamed sacroiliac joints of patients with early AS [13], [16]. Therefore, therapeutic agents that target the pro-inflammatory cytokine TNFα arose as new alternative AS treatment options. Infliximab, a chimeric monoclonal IgG1 antibody is one of the three main biological agents targeting TNFα. The short-term efficacy of infliximab has been demonstrated in several studies on patients with AS but long-term treatment data are scarce [17], [18], [19], [20], [21]. Recently we reported on the beneficial effects of infliximab treatment, with an infliximab survival of 77.9% [22]. Here, we investigate infliximab efficacy, toxicity and reasons for drug discontinuation during long-term disease course in an open label observational study of patients with active AS.
Section snippets
Methods
Forty patients with AS according to the New York revised criteria [23] were enrolled between January 2003 and July 2003. All patients had active axial spondyloarthropathy and they were given infliximab (5 mg/kg/body weight) intravenously at weeks 0, 2, 6 and every 8 weeks thereafter. If the clinical response was insufficient, the interval between the infusions was shortened to 6 weeks. All patients were followed up according to a standardized protocol which has been approved by the Institutional
Results
All 40 patients who took part in this observational study were eligible for anti-TNF therapy. They all had negative pure protein derivative skin test and normal chest radiographs. They were all presented with axial spondyloarthropathy, while nine of them had simultaneously peripheral joint disease and seven out of the 40 patients had a history of uveitis. Table 1 shows the clinical and demographic data of our patients at baseline. They were all 40 of them men with mean age 41.3 (±10.5) and a
Discussion
This study was conducted to investigate primarily the efficacy and safety of infliximab, but moreover to evaluate the durability of response to infliximab therapy. In the study reported herein, efficacy endpoints were confirmed. The BASDAI 50% improvement was found to be similar throughout the entire observation period with high proportions of patients fulfilling this response criterion at the end of the sixth year (65%). Furthermore, the mean BASDAI scores showed ongoing improvements over this
Conflict of interest statement
The authors have no conflict of interest to declare.
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