THU0234 Long-Term Efficacy of Infliximab in Patients with Ankylosing Spondylitis – Real Life Data Confirm the Potential for Dose Reduction by Stretching Infusion Intervals. (9th June 2015) - Baraliakos, X.
Abstract : Background: Long-term data on anti-TNF treatment in patients with ankylosing spondylitis (AS) are still scarce. Objectives: To study the long term efficacy and safety of anti-TNF agents in AS in a pan-European setting using data from daily practice. Methods: Patients from the EASIC and the DIKAS trial had been included in this 8-year observational study. Clinical data were collected every 2 years. All patients were initially treated with infliximab at the usual dosage (5mg/kg). Standard assessments were regularly performed, and adverse events (AEs) and serious AEs (SAEs) were documented. The data are presented as completer analysis. Results: Of initially 71 patients, 55 (77.5%) were included in this long-term extension study (46 male, 83.6%). Of these 55 patients, 7 (12.7%) switched from infliximab to another biologic for different reasons. At the end of the study, 31 patients (56.4%) received NSAIDs in addition to TNF-blockers. The mean doses of infliximab remained stable over time (4.7±0.6 mg/kg, min: 3.6, max: 6.4) but the infusion intervals increased (7.1±1.5 weeks, range 6-12 weeks). There was no correlation between the duration of infusion interval and the disease status achieved by the patients. Overall, the mean BASDAI (baseline (BL): 6.4, 2y: 2.4, 8y: 2.5), BASFI (BL: 5.9, 2y: 2.9, 8y: 3.5), BASMI (BL: 4.0, 2y: 2.7, 8y: 3.9), patient's global (BL: 7.0, 2y: 2.9, 8y: 2.9), and CRP (mg/dl) values (BL: 2.9, 2y: 0.6, 8y: 0.4) remained low throughout the entire observation period. The majority of adverse events were mild, most of them were respiratory tract infections. Two malignancies occurred: one basal cell carcinoma and one malignant melanoma, all during the first 7 years of treatment. These two were the only SAE judged to be possibly related to the study drug. Conclusions: This study confirms the favourable outcome of AS patients who complete anti-TNF therapy over many years. The persistently decreased BASDAI, BASFI and BASMI values suggest a good control of disease activity, in combination with preserved function and spinal mobility over 8 years. The observation that infusion intervals could be prolonged confirms that dose reduction of anti-TNF therapy is feasible. Disclosure of Interest: None declared