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Research ArticleArticle
Open Access

Disease Activity Cutoff Values in Initiating Tumor Necrosis Factor Inhibitor Therapy in Ankylosing Spondylitis: A German GO-NICE Study Subanalysis

Jürgen Braun, Xenofon Baraliakos, Uta Kiltz, Klaus Krüger, Gerd R. Burmester, Siegfried Wassenberg and Matthias H. Thomas
The Journal of Rheumatology March 2019, jrheum.181040; DOI: https://doi.org/10.3899/jrheum.181040
Jürgen Braun
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany. The work was supported by MSD Haar. MSD had a role in the study design and in the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer. J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; U. Kiltz, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; K. Krüger, MD, Rheumatologisches Praxiszentrum München; G.R. Burmester, MD, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin; S. Wassenberg, MD, Rheumazentrum Ratingen; M.H. Thomas, PhD, Medical Affairs, MSD Sharp & Dohme GmbH. Address correspondence to Prof. Dr. med. J. Braun, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, D-44649 Herne, Germany. E-mail: sekretariat@rheumazentrum-ruhrgebiet.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication February 13, 2019.
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Xenofon Baraliakos
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany. The work was supported by MSD Haar. MSD had a role in the study design and in the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer. J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; U. Kiltz, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; K. Krüger, MD, Rheumatologisches Praxiszentrum München; G.R. Burmester, MD, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin; S. Wassenberg, MD, Rheumazentrum Ratingen; M.H. Thomas, PhD, Medical Affairs, MSD Sharp & Dohme GmbH. Address correspondence to Prof. Dr. med. J. Braun, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, D-44649 Herne, Germany. E-mail: sekretariat@rheumazentrum-ruhrgebiet.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication February 13, 2019.
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Uta Kiltz
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany. The work was supported by MSD Haar. MSD had a role in the study design and in the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer. J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; U. Kiltz, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; K. Krüger, MD, Rheumatologisches Praxiszentrum München; G.R. Burmester, MD, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin; S. Wassenberg, MD, Rheumazentrum Ratingen; M.H. Thomas, PhD, Medical Affairs, MSD Sharp & Dohme GmbH. Address correspondence to Prof. Dr. med. J. Braun, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, D-44649 Herne, Germany. E-mail: sekretariat@rheumazentrum-ruhrgebiet.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication February 13, 2019.
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Klaus Krüger
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany. The work was supported by MSD Haar. MSD had a role in the study design and in the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer. J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; U. Kiltz, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; K. Krüger, MD, Rheumatologisches Praxiszentrum München; G.R. Burmester, MD, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin; S. Wassenberg, MD, Rheumazentrum Ratingen; M.H. Thomas, PhD, Medical Affairs, MSD Sharp & Dohme GmbH. Address correspondence to Prof. Dr. med. J. Braun, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, D-44649 Herne, Germany. E-mail: sekretariat@rheumazentrum-ruhrgebiet.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication February 13, 2019.
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Gerd R. Burmester
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany. The work was supported by MSD Haar. MSD had a role in the study design and in the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer. J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; U. Kiltz, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; K. Krüger, MD, Rheumatologisches Praxiszentrum München; G.R. Burmester, MD, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin; S. Wassenberg, MD, Rheumazentrum Ratingen; M.H. Thomas, PhD, Medical Affairs, MSD Sharp & Dohme GmbH. Address correspondence to Prof. Dr. med. J. Braun, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, D-44649 Herne, Germany. E-mail: sekretariat@rheumazentrum-ruhrgebiet.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication February 13, 2019.
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Siegfried Wassenberg
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany. The work was supported by MSD Haar. MSD had a role in the study design and in the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer. J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; U. Kiltz, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; K. Krüger, MD, Rheumatologisches Praxiszentrum München; G.R. Burmester, MD, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin; S. Wassenberg, MD, Rheumazentrum Ratingen; M.H. Thomas, PhD, Medical Affairs, MSD Sharp & Dohme GmbH. Address correspondence to Prof. Dr. med. J. Braun, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, D-44649 Herne, Germany. E-mail: sekretariat@rheumazentrum-ruhrgebiet.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication February 13, 2019.
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Matthias H. Thomas
From the Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum, Herne; Rheumatologisches Praxiszentrum München; Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin; Rheumazentrum Ratingen, Ratingen; Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany. The work was supported by MSD Haar. MSD had a role in the study design and in the collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. M. Thomas is a full-time employee of MSD Sharp & Dohme GmbH, Haar. U. Kiltz received an unrestricted grant from AbbVie. G.R. Burmester received lecture and/or consulting fees from MSD. K. Krüger received speaker fees and research grants from AbbVie, MSD, and Pfizer. J. Braun, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; X. Baraliakos, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; U. Kiltz, MD, Rheumazentrum Ruhrgebiet, Herne and Ruhr University Bochum; K. Krüger, MD, Rheumatologisches Praxiszentrum München; G.R. Burmester, MD, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin; S. Wassenberg, MD, Rheumazentrum Ratingen; M.H. Thomas, PhD, Medical Affairs, MSD Sharp & Dohme GmbH. Address correspondence to Prof. Dr. med. J. Braun, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, D-44649 Herne, Germany. E-mail: sekretariat@rheumazentrum-ruhrgebiet.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication February 13, 2019.
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Abstract

Objective International recommendations for the management of axial spondyloarthritis including ankylosing spondylitis (AS) recommend a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) level of disease activity of ≥ 4 to initiate treatment with biologics. We aimed to evaluate the level of disease activity used to initiate tumor necrosis factor inhibitor (TNFi) treatment and the level of responses to treatment based on different BASDAI cutoffs.

Methods This is a posthoc analysis of the noninterventional, prospective, GO-NICE study in the subgroup of biologic-naive AS treated with golimumab (GOL) 50 mg subcutaneously once monthly.

Results Of the 244 biologic-naive AS patients at baseline, 70.5% had a BASDAI ≥ 4 (Group 1), 14.3% had 2.8 to < 4 (Group 2), and 15.2% had even < 2.8 (Group 3). A total of 134 patients (54.9%) completed the 24-month observational period. The mean BASDAI in Groups 1, 2, and 3 was initially 5.9 ± 1.3, 3.4 ± 0.4, and 2.0 ± 0.8, decreased to 2.2 ± 2.0, 1.9 ± 1.2, and 1.0 ± 1.2 within 3 months (all p < 0.0001 vs baseline), and decreased significantly to 2.2 ± 1.7, 1.9 ± 1.7, and 1.4 ± 1.0 at Month 24 (all p < 0.005), respectively. BASDAI 50% improvement was noted in 68.8%, 44.8%, and 45.2% of patients at Month 3, and in 84.9%, 61.9%, and 55.0% at Month 24.

Conclusion TNFi treatment was initiated in almost a third of AS patients with lower disease activity states as assessed by BASDAI cutoff of ≥ 4. Patients with a BASDAI between 2.8 and < 4 appeared to benefit significantly from GOL treatment, while patients with BASDAI < 2.8 did not. This finding should lead to a reevaluation of the established BASDAI cutoff of ≥ 4.

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Disease Activity Cutoff Values in Initiating Tumor Necrosis Factor Inhibitor Therapy in Ankylosing Spondylitis: A German GO-NICE Study Subanalysis
Jürgen Braun, Xenofon Baraliakos, Uta Kiltz, Klaus Krüger, Gerd R. Burmester, Siegfried Wassenberg, Matthias H. Thomas
The Journal of Rheumatology Mar 2019, jrheum.181040; DOI: 10.3899/jrheum.181040

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Disease Activity Cutoff Values in Initiating Tumor Necrosis Factor Inhibitor Therapy in Ankylosing Spondylitis: A German GO-NICE Study Subanalysis
Jürgen Braun, Xenofon Baraliakos, Uta Kiltz, Klaus Krüger, Gerd R. Burmester, Siegfried Wassenberg, Matthias H. Thomas
The Journal of Rheumatology Mar 2019, jrheum.181040; DOI: 10.3899/jrheum.181040
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