Frank Heldmann1, Xenofon Baraliakos2, Uta Kiltz2, Jan Brandt3, Irene E van der Horst-Bruinsma4, Robert Landewé5, Joachim Sieper6, Gerd Rüdiger Burmester7, Filip van den Bosch8, Kurt de Vlam9, Hill Gaston10, Mathias Gruenke11, Matthias Witt11, Thierry Appelboom12, Paul Emery13, Maxime Dougados14, Marjatta Leirisalo-Repo15, Maxime Breban16, Juergen Braun2. 1. Rheumazentrum Ruhrgebiet, Herne, Germany. frank.heldmann@ediacon.de. 2. Rheumazentrum Ruhrgebiet, Herne, Germany. 3. Rheumapraxis-Steglitz/Charité, Berlin, Germany. 4. VU Medical Center, Amsterdam, the Netherlands. 5. Department of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, the Netherlands. 6. Charité Campus Benjamin Franklin, Berlin, Germany. 7. Charité University Medicine Berlin, Germany. 8. Universitair Ziekenhuis Ghent, Belgium. 9. University Hospital Leuven, Belgium. 10. Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK. 11. Klinikum der Universität München, Germany. 12. Hopital Erasme Brussels, Belgium. 13. University of Leeds, UK. 14. Hopital Cochin Paris, France. 15. Helsinki University Central Hospital, Helsinki, Finland. 16. Hopital Ambroise Paré, Boulogne, France.
Abstract
OBJECTIVES: Knowledge on the long-term effects of anti-TNF therapy in patients with ankylosing spondylitis (AS) is still limited. Our objective was to study the long-term efficacy and safety of anti-TNF therapy in AS. METHODS: After having completed the first part of the EASIC trial a total of 71 patients were enrolled into this 96-week extension study. Patients were treated with the same dosages and dosing intervals of infliximab as in the EASIC core study. Efficacy was assessed by using standardised assessment tools such as BASDAI, BASFI, BASMI, patient global assessment, CRP levels and the proportion of patients without any sign of enthesitis or arthritis. Long-term safety was assessed by documenting adverse events (AE), serious adverse events (SAE) and reasons for dropping out. RESULTS: Of the 71 patients included, 64 (90.1%) completed the trial , and 7 discontinued: one was lost to follow-up, 3 withdrew informed consent and in 3 patients therapy was stopped for different reasons: secondary loss of response, recurrent infections and basal cell carcinoma of the skin. The completers showed rather stable low scores of BASDAI (mean 2.4, median 2.52), BASFI (mean 3.1, median 2.76) and BASMI (mean 3.2, median 3) as well as patients global assessment and CRP. The vast majority of patients did not have enthesitis or arthritis. A total of 476 AE were observed, 13 of which were SAE. The majority of these were infections and most of them affected the respiratory tract. Two malignancies occurred: one basal cell carcinoma and one malignant melanoma. These were the only SAE judged to be possibly related to the study drug. CONCLUSIONS: Anti-TNF treatment with infliximab is efficacious over long periods of time in patients with AS. The observation of two skin related malignancies, including one melanoma, during the whole study period of 7 years is in line with reports from previous large AS data sets.
OBJECTIVES: Knowledge on the long-term effects of anti-TNF therapy in patients with ankylosing spondylitis (AS) is still limited. Our objective was to study the long-term efficacy and safety of anti-TNF therapy in AS. METHODS: After having completed the first part of the EASIC trial a total of 71 patients were enrolled into this 96-week extension study. Patients were treated with the same dosages and dosing intervals of infliximab as in the EASIC core study. Efficacy was assessed by using standardised assessment tools such as BASDAI, BASFI, BASMI, patient global assessment, CRP levels and the proportion of patients without any sign of enthesitis or arthritis. Long-term safety was assessed by documenting adverse events (AE), serious adverse events (SAE) and reasons for dropping out. RESULTS: Of the 71 patients included, 64 (90.1%) completed the trial , and 7 discontinued: one was lost to follow-up, 3 withdrew informed consent and in 3 patients therapy was stopped for different reasons: secondary loss of response, recurrent infections and basal cell carcinoma of the skin. The completers showed rather stable low scores of BASDAI (mean 2.4, median 2.52), BASFI (mean 3.1, median 2.76) and BASMI (mean 3.2, median 3) as well as patients global assessment and CRP. The vast majority of patients did not have enthesitis or arthritis. A total of 476 AE were observed, 13 of which were SAE. The majority of these were infections and most of them affected the respiratory tract. Two malignancies occurred: one basal cell carcinoma and one malignant melanoma. These were the only SAE judged to be possibly related to the study drug. CONCLUSIONS: Anti-TNF treatment with infliximab is efficacious over long periods of time in patients with AS. The observation of two skin related malignancies, including one melanoma, during the whole study period of 7 years is in line with reports from previous large AS data sets.
Authors: X Baraliakos; F Heldmann; F van den Bosch; G Burmester; H Gaston; I E van der Horst-Bruinsma; A Krause; R Schmidt; M Schneider; J Sieper; B Andermann; A van Tubergen; M Witt; J Braun Journal: RMD Open Date: 2016-07-19