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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

1
Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
2
Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
3
Rheumatology, University of Colorado, Englewood, Colorado, USA.
4
First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
5
Eli Lilly and Company, Indianapolis, Indiana, USA.
6
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.
7
Leeds Teaching Hospitals NHS Trust, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.

Abstract

Objectives:

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).

Methods:

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.

Results:

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).

Conclusions:

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

KEYWORDS:

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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