PMID- 30647190
OWN - NLM
STAT- Publisher
LR  - 20190418
IS  - 0315-162X (Print)
IS  - 0315-162X (Linking)
DP  - 2019 Jan 15
TI  - Use of Magnetic Resonance Imaging to Support Dose Selection in a Phase II Trial
      of Baricitinib Combined with Conventional Synthetic Disease-modifying
      Antirheumatic Drugs in Rheumatoid Arthritis.
LID - jrheum.171469 [pii]
LID - 10.3899/jrheum.171469 [doi]
AB  - OBJECTIVE: Magnetic resonance imaging (MRI) was used in a Phase IIb study
      (NCT01185353) of baricitinib in patients with RA to support dose selection for
      the Phase III program. METHODS: 301 patients with active RA on stable
      methotrexate were randomized 2:1:1:1:1 to placebo or once-daily baricitinib (1-, 
      2-, 4-, or 8-mg) for up to 24 weeks. 154 patients with definitive radiographic
      erosion had MRI of the hand/wrist at baseline and weeks 12 and 24. Two expert
      radiologists, blinded to treatment and visit order, scored images for synovitis, 
      osteitis, bone erosion, and cartilage loss. Combined inflammation (osteitis + 3x 
      synovitis score) and total joint damage (erosion + 2.5x cartilage loss score)
      scores were calculated. Treatment groups were compared using analysis of
      covariance adjusting for baseline scores. RESULTS: Mean changes from baseline to 
      week 12 for synovitis were -0.10, -1.50, and -1.60 for patients treated with
      placebo, baricitinib 4-mg, and baricitinib 8-mg, respectively (P=0.003 vs placebo
      for baricitinib 4- and 8-mg); mean changes for osteitis were 0.00, -3.20, and
      -2.10 (P=0.001 vs placebo for baricitinib 4-mg and P=0.037 for 8-mg) and mean
      changes for bone erosion were 0.90, 0.10, and 0.40 (P=0.089 for 4-mg and P=0.275 
      for 8 mg), respectively in these treatment groups. CONCLUSION: Using MRI findings
      in this subgroup of patients suggest suppression of synovitis, osteitis, and
      combined inflammation by baricitinib 4- and 8-mg, which corroborate previously
      demonstrated clinical efficacy of baricitinib and increase confidence that
      baricitinib 4-mg could positively effect reduction of the radiographic
      progression in Phase III studies.
FAU - Peterfy, Charles
AU  - Peterfy C
AD  - Spire Sciences, Inc. Boca Raton, FL, USA
FAU - DiCarlo, Julie
AU  - DiCarlo J
AD  - Spire Sciences, Inc. Boca Raton, FL, USA
FAU - Emery, Paul
AU  - Emery P
AD  - The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of
      Leeds, Leeds, UK
FAU - Genovese, Mark C
AU  - Genovese MC
AD  - Division of Immunology and Rheumatology, Stanford University, Stanford, CA, USA
FAU - Keystone, Edward C
AU  - Keystone EC
AD  - Department of Rheumatology, University of Toronto, Toronto, ON, Canada
FAU - Taylor, Peter C
AU  - Taylor PC
AD  - Botnar Research Centre, University of Oxford, Oxford, UK
FAU - Schlichting, Doug E
AU  - Schlichting DE
AD  - Eli Lilly and Company, Indianapolis, IN, USA
FAU - Beattie, Scott D
AU  - Beattie SD
AD  - Eli Lilly and Company, Indianapolis, IN, USA
FAU - Luchi, Monica
AU  - Luchi M
AD  - Incyte Corporation, Wilmington, DE, USA
FAU - Macias, William
AU  - Macias W
AD  - Eli Lilly and Company, Indianapolis, IN, USA
LA  - eng
PT  - Journal Article
DEP - 20190115
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
EDAT- 2019/01/17 06:00
MHDA- 2019/01/17 06:00
CRDT- 2019/01/17 06:00
PHST- 2019/01/17 06:00 [entrez]
PHST- 2019/01/17 06:00 [pubmed]
PHST- 2019/01/17 06:00 [medline]
AID - jrheum.171469 [pii]
AID - 10.3899/jrheum.171469 [doi]
PST - aheadofprint
SO  - J Rheumatol. 2019 Jan 15. pii: jrheum.171469. doi: 10.3899/jrheum.171469.