Article
Long-term efficacy of infliximab in patients with ankylosing spondylitis – real life data confirm the potential for dose reduction by stretching infusion intervals
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Authors
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Xenofon Baraliakos
- Rheumazentrum Ruhrgebiet, Herne
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Frank Heldmann
- Rheumazentrum Ruhrgebiet, Herne
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Filip van den Bosch
- Universitair Ziekenhuis, Gent, Belgium
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Gerd-Rüdiger Burmester
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
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Hill Gaston
- University of Cambridge, Cambridge, United Kingdom
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Irene van der Horst-Bruinsma
- VU Medical Center, Amsterdam
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Andreas Krause
- Immanuel Krankenhaus Berlin, Klinik für Innere Medizin, Abteilung Rheumatologie und Klinische Immunologie, Berlin
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Reinhold E. Schmidt
- Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie, Hannover
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Matthias Schneider
- Poliklinik, Funktionsbereich & Hiller Forschungszentrum für Rheumatologie, UKD, Heinrich-Heine-Universität Düsseldorf, Düsseldorf
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Andermann Bianka
- Praxis für Rheumatologie, Berlin
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Astrid van Tubergen
- Maastricht University Medical Center, Maastricht, Netherlands
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Matthias Witt
- Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Rheumaeinheit, München
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Jürgen Braun
- Rheumazentrum Ruhrgebiet, Herne
| Published: | September 1, 2015 |
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Outline
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Introduction: Long-term data on anti-TNF treatment in patients with ankylosing spondylitis (AS) are still scarce. Here we studied 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.
Conclusion: 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.
