Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety: long-term extension over 7 years with focus on clinical efficacy and safety

Frank Heldmann; Xenofon Baraliakos; Uta Kiltz; Jan Brandt; Irene E. van der Horst-Bruinsma; Robert Landewé; Joachim Sieper; Gerd Rüdiger Burmester; Filip van den Bosch; Kurt de Vlam; Hill Gaston; Mathias Gruenke; Matthias Witt; Thierry Appelboom; Paul Emery; Maxime Dougados; Marjatta Leirisalo-Repo; Maxime Breban; Juergen Braun

Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety: long-term extension over 7 years with focus on clinical efficacy and safety

Frank Heldmann, Xenofon Baraliakos, Uta Kiltz, Jan Brandt, Irene E. van der Horst-Bruinsma, Robert Landewé, Joachim Sieper, Gerd Rüdiger Burmester, Filip van den Bosch, Kurt de Vlam, Hill Gaston, Mathias Gruenke, Matthias Witt, Thierry Appelboom, Paul Emery, Maxime Dougados, Marjatta Leirisalo-Repo, Maxime Breban, Juergen Braun

Research output: Contribution to journal › Article › Academic › peer-review

6 Citations (Scopus)

Abstract

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. 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. 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. 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

Original language	English
Pages (from-to)	184-190
Number of pages	7
Journal	Clinical and experimental rheumatology
Volume	34
Issue number	2
Publication status	Published - 7 Apr 2016

Keywords

Adult
Antirheumatic Agents
C-Reactive Protein
Cohort Studies
Female
Humans
Infliximab
Journal Article
Male
Middle Aged
Research Support, Non-U.S. Gov't
Spondylitis, Ankylosing
Tumor Necrosis Factor-alpha

Cite this

Heldmann, F., Baraliakos, X., Kiltz, U., Brandt, J., van der Horst-Bruinsma, I. E., Landewé, R., Sieper, J., Burmester, G. R., van den Bosch, F., de Vlam, K., Gaston, H., Gruenke, M., Witt, M., Appelboom, T., Emery, P., Dougados, M., Leirisalo-Repo, M., Breban, M., & Braun, J. (2016). Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety: long-term extension over 7 years with focus on clinical efficacy and safety. Clinical and experimental rheumatology, 34(2), 184-190.

Heldmann, Frank ; Baraliakos, Xenofon ; Kiltz, Uta et al. / Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety : long-term extension over 7 years with focus on clinical efficacy and safety. In: Clinical and experimental rheumatology. 2016 ; Vol. 34, No. 2. pp. 184-190.

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title = "Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety: long-term extension over 7 years with focus on clinical efficacy and safety",

abstract = "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. 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. 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. 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",

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author = "Frank Heldmann and Xenofon Baraliakos and Uta Kiltz and Jan Brandt and {van der Horst-Bruinsma}, {Irene E.} and Robert Landew{\'e} and Joachim Sieper and Burmester, {Gerd R{\"u}diger} and {van den Bosch}, Filip and {de Vlam}, Kurt and Hill Gaston and Mathias Gruenke and Matthias Witt and Thierry Appelboom and Paul Emery and Maxime Dougados and Marjatta Leirisalo-Repo and Maxime Breban and Juergen Braun",

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Heldmann, F, Baraliakos, X, Kiltz, U, Brandt, J, van der Horst-Bruinsma, IE , Landewé, R, Sieper, J, Burmester, GR, van den Bosch, F, de Vlam, K, Gaston, H, Gruenke, M, Witt, M, Appelboom, T, Emery, P, Dougados, M, Leirisalo-Repo, M, Breban, M & Braun, J 2016, 'Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety: long-term extension over 7 years with focus on clinical efficacy and safety', Clinical and experimental rheumatology, vol. 34, no. 2, pp. 184-190.

Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety: long-term extension over 7 years with focus on clinical efficacy and safety. / Heldmann, Frank; Baraliakos, Xenofon; Kiltz, Uta et al.
In: Clinical and experimental rheumatology, Vol. 34, No. 2, 07.04.2016, p. 184-190.

Research output: Contribution to journal › Article › Academic › peer-review

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AU - Baraliakos, Xenofon

AU - Kiltz, Uta

AU - Brandt, Jan

AU - van der Horst-Bruinsma, Irene E.

AU - Landewé, Robert

AU - Sieper, Joachim

AU - Burmester, Gerd Rüdiger

AU - van den Bosch, Filip

AU - de Vlam, Kurt

AU - Gaston, Hill

AU - Gruenke, Mathias

AU - Witt, Matthias

AU - Appelboom, Thierry

AU - Emery, Paul

AU - Dougados, Maxime

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AU - Breban, Maxime

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AB - 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. 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. 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. 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

KW - Adult

KW - Antirheumatic Agents

KW - C-Reactive Protein

KW - Cohort Studies

KW - Female

KW - Humans

KW - Infliximab

KW - Journal Article

KW - Male

KW - Middle Aged

KW - Research Support, Non-U.S. Gov't

KW - Spondylitis, Ankylosing

KW - Tumor Necrosis Factor-alpha

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Heldmann F, Baraliakos X, Kiltz U, Brandt J, van der Horst-Bruinsma IE , Landewé R et al. Clinical experience with the European Ankylosing Spondylitis Infliximab Cohort (EASIC): long-term extension over 7 years with focus on clinical efficacy and safety: long-term extension over 7 years with focus on clinical efficacy and safety. Clinical and experimental rheumatology. 2016 Apr 7;34(2):184-190.