Research ArticleAccepted Article
Open Access
Radiographic progression of structural joint damage over 5 years of baricitinib treatment in patients with rheumatoid arthritis: Results from RA-BEYOND
Désirée van der Heijde, Cynthia E. Kartman, Li Xie, Scott Beattie, Douglas Schlichting, Daojun Mo, Patrick Durez, Yoshiya Tanaka and Roy Fleischmann
The Journal of Rheumatology September 2021, jrheum.210346; DOI: https://doi.org/10.3899/jrheum.210346
Désirée van der Heijde
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Cynthia E. Kartman
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Li Xie
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Scott Beattie
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Douglas Schlichting
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Daojun Mo
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Patrick Durez
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Yoshiya Tanaka
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Roy Fleischmann
From Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands; Eli Lilly and Company, Indianapolis United States; UCL-Saint Luc, Brussels, Belgium; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan; Metroplex Clinical Research Center/University of Texas Southwestern Medical Center, Dallas, United States Financial support for the studies was provided by Eli Lilly and Company, which developed baricitinib, under license from Incyte Corporation. All costs associated with the development of this manuscript, including article processing charges, were funded by Eli Lilly and Company. Medical writing services, provided by Lydia Morris, PhD, and editing provided by Angela Lorio, ELS of Syneos Health (Morrisville, NC), were also funded by Eli Lilly and Company. Conflicts of interest: DvdH has received consulting fees from AbbVie, Astellas, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma and is the Director of Imaging at Rheumatology BV. PD has received speaker's fees from BMS, Celltrion, Eli Lilly and Company, and Sanofi. YT has received speaker's fees from AbbVie, Asahi-kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GSK, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, and grant/research support from Abbvie, Asahi-Kasei, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, and Takeda. RF has received consultancy fees and research/grant support from AbbVie, Amgen, Eli Lilly and Company, GSK, Gilead, Novartis, Pfizer, Regeneron, Samumed, Sanofi, Selecta, TEVA, UCB, and Viela. CEK, SB, and DM are employees and shareholders of Eli Lilly and Company. LX and DS are previous employees of Eli Lilly and Company and hold stocks in the company. Address correspondence to Cynthia E. Kartman, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN USA 46225, email: kartman_cynthia@lilly.com
Abstract
Objective To evaluate the effect of baricitinib on inhibiting radiographic progression of structural joint damage over 5 years in patients with active rheumatoid arthritis (RA).
Methods Patients completed 1 of 3 phase 3 baricitinib trials (NCT01711359, NCT01710358, NCT01721057) and entered the long-term extension RA-BEYOND (NCT01885078), in which patients received once-daily 4 mg or 2 mg baricitinib. Across these trials, patients initially receiving methotrexate (MTX) or adalimumab switched to baricitinib 4 mg at week 52. Patients initially receiving placebo switched to baricitinib 4 mg at week 24. Radiographs were scored at baseline and years 2, 3, 4, and 5. Change from baseline in van der Heijde modified Total Sharp Score (ΔmTSS) was computed.
Results Overall, 2125/2573 (82.6%) randomized patients entered RA-BEYOND; 1837/2125 (86.4%) entered this analysis. From years 3 to 5, higher proportions of DMARD-naïve patients on initial baricitinib (monotherapy; +MTX) had no progression versus initial MTX (ΔmTSS≤0, year 5: 59.6% baricitinib 4 mg; 66.2% baricitinib 4 mg+MTX; 40.7% MTX). Higher proportions of patients with inadequate response (IR) to MTX on initial baricitinib or adalimumab versus placebo had no progression (ΔmTSS≤0, year 5: 54.8% baricitinib 4 mg; 55.0% adalimumab; 50.3% placebo). Higher proportions of patients with conventional synthetic (cs)DMARD-IR on initial baricitinib 4 mg had less progression versus initial placebo or baricitinib 2 mg (ΔmTSS≤0, year 5: 66.7% baricitinib 4 mg; 58.2% baricitinib 2 mg; 60.0% placebo).
Conclusion Oral baricitinib maintained lower levels of radiographic progression than initial csDMARD or placebo through 5 years in patients with active RA.
In this issue
The Journal of Rheumatology
Vol. 52, Issue 1
1 Jan 2025
Accepted manuscript
Radiographic progression of structural joint damage over 5 years of baricitinib treatment in patients with rheumatoid arthritis: Results from RA-BEYOND
Désirée van der Heijde, Cynthia E. Kartman, Li Xie, Scott Beattie, Douglas Schlichting, Daojun Mo, Patrick Durez, Yoshiya Tanaka, Roy Fleischmann
The Journal of Rheumatology Sep 2021, jrheum.210346; DOI: 10.3899/jrheum.210346
Accepted manuscript
Radiographic progression of structural joint damage over 5 years of baricitinib treatment in patients with rheumatoid arthritis: Results from RA-BEYOND
Désirée van der Heijde, Cynthia E. Kartman, Li Xie, Scott Beattie, Douglas Schlichting, Daojun Mo, Patrick Durez, Yoshiya Tanaka, Roy Fleischmann
The Journal of Rheumatology Sep 2021, jrheum.210346; DOI: 10.3899/jrheum.210346
