TY - JOUR
T1 - Efficacy of VX-509 (decernotinib) in combination with a disease-modifying antirheumatic drug in patients with rheumatoid arthritis
T2 - Clinical and MRI findings
AU - Genovese, Mark C.
AU - Yang, Fang
AU - Østergaard, Mikkel
AU - Kinnman, Nils
PY - 2016
Y1 - 2016
N2 - Objective To assess early effects on joint structures of VX-509 in combination with stable disease-modifying antirheumatic drug (DMARD) therapy using MRI in adults with rheumatoid arthritis (RA). Methods This phase II, placebo-controlled, double-blind, dose-ranging study randomised patients with RA and inadequate DMARD response to VX-509 100â €..mg (n=11), 200â €..mg (n=10) or 300â €..mg (n=10) or placebo (n=12) once daily for 12â €..weeks. Outcome measures included American College of Rheumatology score (ACR20; improvement of ≥20%) and disease activity score (DAS28) using C reactive protein (CRP), and the RA MRI scoring (RAMRIS) system. Results ACR20 response at week 12 was 63.6%, 60.0% and 60.0% in the VX-509 100-mg, 200-mg and 300-mg groups, respectively, compared with 25.0% in the placebo group. DAS28-CRP scores decreased in a dose-dependent manner with increasing VX-509 doses. Decreases in RAMRIS synovitis scores were significantly different from placebo for all VX-509 doses (p<0.01) and for RAMRIS osteitis scores (p<0.01) for VX-509 300â €..mg. Treatment was generally well tolerated. Conclusions VX-509 plus a DMARD reduced the signs and symptoms of RA in patients with an inadequate response to a DMARD alone. MRI responses were detected at week 12. Treatment was generally well tolerated. Trial registration number NCT01754935; results.
AB - Objective To assess early effects on joint structures of VX-509 in combination with stable disease-modifying antirheumatic drug (DMARD) therapy using MRI in adults with rheumatoid arthritis (RA). Methods This phase II, placebo-controlled, double-blind, dose-ranging study randomised patients with RA and inadequate DMARD response to VX-509 100â €..mg (n=11), 200â €..mg (n=10) or 300â €..mg (n=10) or placebo (n=12) once daily for 12â €..weeks. Outcome measures included American College of Rheumatology score (ACR20; improvement of ≥20%) and disease activity score (DAS28) using C reactive protein (CRP), and the RA MRI scoring (RAMRIS) system. Results ACR20 response at week 12 was 63.6%, 60.0% and 60.0% in the VX-509 100-mg, 200-mg and 300-mg groups, respectively, compared with 25.0% in the placebo group. DAS28-CRP scores decreased in a dose-dependent manner with increasing VX-509 doses. Decreases in RAMRIS synovitis scores were significantly different from placebo for all VX-509 doses (p<0.01) and for RAMRIS osteitis scores (p<0.01) for VX-509 300â €..mg. Treatment was generally well tolerated. Conclusions VX-509 plus a DMARD reduced the signs and symptoms of RA in patients with an inadequate response to a DMARD alone. MRI responses were detected at week 12. Treatment was generally well tolerated. Trial registration number NCT01754935; results.
KW - DMARDs (biologic)
KW - Magnetic Resonance Imaging
KW - Rheumatoid Arthritis
U2 - 10.1136/annrheumdis-2015-208901
DO - 10.1136/annrheumdis-2015-208901
M3 - Journal article
C2 - 27084959
AN - SCOPUS:84964765486
VL - 75
SP - 1979
EP - 1983
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
SN - 0003-4967
IS - 11
ER -