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RMD Open. 2019 May 10;5(1):e000898. doi: 10.1136/rmdopen-2019-000898. eCollection 2019.

Low rates of radiographic progression of structural joint damage over 2 years of baricitinib treatment in patients with rheumatoid arthritis.

Author information

Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Rheumatology, University of Colorado, Englewood, Colorado, USA.
First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Eli Lilly and Company, Indianapolis, Indiana, USA.
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.
Leeds Teaching Hospitals NHS Trust, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.



To evaluate radiographic progression of structural joint damage over 2 years in patients with rheumatoid arthritis from baricitinib clinical trials who were disease-modifying antirheumatic drug (DMARD)-naïve or had an inadequate response to conventional synthetic DMARDs (csDMARD-IR).


Patients had completed one of three phase III studies and entered a long-term extension (LTE) study, continuing on the same baricitinib dose as at originating study completion. At 52 weeks, DMARD-naïve patients receiving methotrexate (MTX) or combination therapy (baricitinib 4 mg+MTX) were switched to baricitinib 4 mg monotherapy (±MTX per investigator opinion); MTX-IR patients receiving adalimumab were switched to baricitinib 4 mg on background MTX. At 24 weeks, csDMARD-IR patients receiving placebo were switched to baricitinib 4 mg on background csDMARD. Radiographs at baseline, year 1 and year 2 were scored using the van der Heijde modified Total Sharp Score. Linear extrapolation was used for missing data.


Of 2573 randomised patients, 2125 (82.6%) entered the LTE, of whom 1893 (89.1%) entered this analysis. At year 2, progression was significantly lower with initial baricitinib (monotherapy or combination therapy) versus initial MTX in DMARD-naïve patients (proportion with non-progression defined by ≤smallest detectable change (SDC): 87.3% baricitinib 4 mg+MTX; 70.6% MTX; p≤ 0.001). In MTX-IR patients, progression with initial baricitinib was significantly lower than with initial placebo and similar to initial adalimumab (≤SDC: 82.7% baricitinib 4 mg; 83.5% adalimumab; 70.6% placebo; p≤0.001). In csDMARD-IR patients, significant benefit was seen with baricitinib 4 mg (≤SDC: 87.2% vs 73.2% placebo; p≤0.01).


Treatment with once-daily baricitinib resulted in low rates of radiographic progression for up to 2 years.


autoimmune diseases; dmards (synthetic); rheumatoid arthritis

Conflict of interest statement

Competing interests: DvdH: received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB and is director of Imaging Rheumatology bv. MS: received consulting and/or speaking fees from AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Johnson & Johnson, UCB. YT: received speaking fees and/or honoraria from Daiichi-Sankyo, Astellas, Eli Lilly and Company, Chugai, Sanofi, Abbvie, Pfizer, YL Biologics, Bristol-Myers, Glaxo-SmithKline, UCB, Mitsubishi-Tanabe, Novartis, Eisai, Takeda, Janssen, Asahi-kasei and has received research grants from Mitsubishi-Tanabe, Bristol-Myers, Eisai, Chugai, Takeda, Abbvie, Astellas, Daiichi-Sankyo, Ono, MSD, Taisho-Toyama. LX, GM, TI, MC, RAO: employees and stock owners of Eli Lilly and Company. PE: received grant/research support or consulting support from Abbott, AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Gilead, MSD, Novartis, Pfizer, Roche, Samsung, Takeda, UCB.

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