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Research ArticleArticle
Open Access

Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 Pivotal Studies

Uta Kiltz, James Cheng-Chung Wei, Désirée van der Heijde, Filip van den Bosch, Jessica A. Walsh, Annelies Boonen, Lianne S. Gensler, Theresa Hunter, Hilde Carlier, Yan Dong, Xiaoqi Li, Rebecca Bolce, Vibeke Strand and Juergen Braun
The Journal of Rheumatology July 2020, jrheum.200093; DOI: https://doi.org/10.3899/jrheum.200093
Uta Kiltz
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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James Cheng-Chung Wei
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Désirée van der Heijde
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Filip van den Bosch
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Jessica A. Walsh
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Annelies Boonen
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Lianne S. Gensler
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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  • ORCID record for Lianne S. Gensler
Theresa Hunter
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Hilde Carlier
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Yan Dong
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Xiaoqi Li
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Rebecca Bolce
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Vibeke Strand
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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  • ORCID record for Vibeke Strand
Juergen Braun
Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and Ruhr-Universität Bochum, Bochum, Germany; J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical University, Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the Netherlands; F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium; J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah, USA; A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands; L.S. Gensler, MD, University of California San Francisco, San Francisco, California, USA; T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli Lilly and Company, Indianapolis, Indiana, USA; V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, USA. UK has received grant/research support and consultancy fees from AbbVie, Chugai, Eli Lilly and Company, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JCW has received consultant and/or speaking fees from Johnson & Johnson, AbbVie, UCB, and Novartis. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. FvdB has received research grant support, consultancy honoraria, or speaker fees from AbbVie, Eli Lilly and Company, Janssen, Merck, and UCB Pharma, and received consultancy honoraria or speaker fees from Bristol Myers-Squibb, Celgene, Novartis, Pfizer, and Sanofi. JAW has received grants and/or consultant fees from AbbVie, Celgene, Novartis, Pfizer, UCB, and Eli Lilly and Company. AB has received consulting fees from Eli Lilly and Company, Novartis, and UBC, has received grant support from AbbVie and Celgene. LSG has received grant and research support from AbbVie, Amgen, Novartis, and UCB, and has received consulting fees from Eli Lilly and Company, Galapagos, Janssen, Novartis, and Pfizer. TH, HC, YD, XL, and RB are current employees and shareholders of Eli Lilly and Company. VS reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi, and UCB. JB is a consultant for AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCB. Address correspondence to Dr. U. Kiltz, Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, 44649 Herne, Germany. Email: uta.kiltz@elisabethgruppe.de. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication July 6, 2020.
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Abstract

Objective This study evaluated the effect of ixekizumab (IXE) on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biological disease-modifying antirheumatic drug (bDMARD)–naïve or failed at least 1 tumor necrosis factor inhibitor (TNFi).

Methods In 2 multicenter, randomized, double-blind, placebo-controlled, and active‑controlled (bDMARD-naïve only) trials, patients with r-axSpA were randomly assigned to receive 80 mg of IXE [every 2 weeks (Q2W) or every 4 weeks (Q4W)], placebo (PBO), or adalimumab (ADA; bDMARD-naïve only). After 16 weeks, patients who received PBO or ADA were rerandomized to receive IXE (Q2W or Q4W) up to Week 52. Functioning and health were measured by the generic 36-item Short Form Health Survey (SF‑36) and the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI). Societal health utility was assessed by the 5-level EuroQol-5 Dimension (EQ-5D-5L).

Results At Week 16, both doses of IXE in bDMARD-naïve and TNFi-experienced patients resulted in larger improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical. A larger proportion of patients reaching improvement in ASAS HI ≥ 3 as well as an achievement of ASAS HI good health status was reported in patients treated with IXE. Improvements were maintained through Week 52.

Conclusion IXE significantly improved functioning and health as assessed by both generic and disease-specific measures, as well as societal health utility values in patients with r-axSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16, and improvements were sustained through 52 weeks.

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The Journal of Rheumatology
Vol. 48, Issue 1
1 Jan 2021
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Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 Pivotal Studies
Uta Kiltz, James Cheng-Chung Wei, Désirée van der Heijde, Filip van den Bosch, Jessica A. Walsh, Annelies Boonen, Lianne S. Gensler, Theresa Hunter, Hilde Carlier, Yan Dong, Xiaoqi Li, Rebecca Bolce, Vibeke Strand, Juergen Braun
The Journal of Rheumatology Jul 2020, jrheum.200093; DOI: 10.3899/jrheum.200093

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Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 Pivotal Studies
Uta Kiltz, James Cheng-Chung Wei, Désirée van der Heijde, Filip van den Bosch, Jessica A. Walsh, Annelies Boonen, Lianne S. Gensler, Theresa Hunter, Hilde Carlier, Yan Dong, Xiaoqi Li, Rebecca Bolce, Vibeke Strand, Juergen Braun
The Journal of Rheumatology Jul 2020, jrheum.200093; DOI: 10.3899/jrheum.200093
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The Journal of Rheumatology
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Print ISSN: 0315-162X; Online ISSN: 1499-2752
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