Abstract
Objective. The study aimed at observing drug survival and determining potential predictors of anti-TNFα switch among ankylosing spondylitis (AS) patients. Methods. The study retrospectively recorded clinical data of patients fulfilling modified New York criteria in a single university clinic. The data were analyzed using appropriate statistical test, which were considered significant if p < 0.05. Results. A total of 120 patients met the inclusion criteria. Switchers had a median BASFI score of 2.7, a median ASDASCRP of 1.59 and a 41.7% prevalence of uveitis, compared to non-switchers which had a median BASFI score of 2.0, a median ASDASCRP of 1.20 and a uveitis prevalence of 22.9% respectively (p = 0.009; p = 0.025; p = 0.043). After a median of 7.0 years of observation, 96 patients (80.0%) were still being treated with their first anti-TNFα agent, with a Kaplan-Meier survival time estimate of 11.5 (10.1-12.9) years. The Kaplan-Meier study of the time of treatment until switch of the first biologic agent according to ASDASCRP categories revealed 9.3 (8.8-9.8) years for inactive disease, 10.6 (8.8-12.5) years for moderately active disease and 7.1 (5.7-8.5) years for highly active disease. The switch hazard ratio for CRP was 1.019 (1.007-1.031; p = 0.002), for BASDAI 1.226 (1.017-1.477; p = 0.032), for BASFI 1.264 (1.057-1.513; p = 0.010) and for ASDASCRP 1.592 (1.173-2.159; p = 0.003). Conclusion. Romanian AS patients on anti-TNFα agents exhibit high retention rate and drug survival of anti-TNFα agents. Switchers have significantly higher baseline disease activity indices which, along baseline acute phase reactants, can significantly predict switching of the first anti-TNFα agent. Patients with AS treated with anti-TNFα agents had a higher prevalence of uveitis than those who did not therapeutic switch.
Highlights
Ankylosing spondylitis (AS) is a chronic inflammatory disease which mainly involves the axial skeleton predominantly in male carriers of the HLA-B27 gene
ankylosing spondylitis (AS) disease activity was evaluated by dosing acute phase reactants (ESR - normal < 20 mm/h, Westergren method; CRP - normal < 5 mg/L, nephelometry; fibrinogen – normal < 490 mg/dL, enzyme-linked immunoabsorbant assay) and by calculation composite indices, such as BASDAI [8], Bath Ankylosing Spondylitis Functional Index (BASFI) [11, 12], ASDASCRP [9, 13]
Almost all the patients took prescribed NSAIDs and 49.2% of the patients took sulfasalazine knowing that 47.5% of the patients had peripheral manifestations which warranted this treatment
Summary
Ankylosing spondylitis (AS) is a chronic inflammatory disease which mainly involves the axial skeleton (spine, sacroiliac joints) predominantly in male carriers of the HLA-B27 gene. Romanian AS patients need to fulfill the following criteria in order to be started on biologic agents: a) diagnosis of AS according to the modified New York criteria [7]; b) active disease, defined by all of the following three criteria: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI [8]) > 6 on two occasions at least 4 weeks apart; Ankylosing Spondylitis Disease Activity Score (ASDAS [9]) ≥ 2.5; erythrocyte sedimentation rate (ESR) > 28 mm/h and/or C-reactive protein (CRP) more than 3 times the upper limit of normal; c) failure of traditional therapies, defined by the following two criteria: at least two NSAIDs administered continuously for 6 weeks each, in maximum recommended or tolerated doses; in case of peripheral manifestations, at least 4 months of sulfasalazine 2-3 g/day and at least one local (joints, entheses) injection with glucocorticoids for peripheral manifestations if indicated; d) no known contraindications according to summaries of product characteristics. Drug survival and response rates were lower among switchers, half of switchers achieved treatment response [32]
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