TY - JOUR
T1 - Abatacept reduces disease activity and ultrasound power Doppler in ACPA-negative undifferentiated arthritis
T2 - a proof-of-concept clinical and imaging study
AU - Buch, Maya H
AU - Hensor, Elizabeth M A
AU - Rakieh, Chadi
AU - Freeston, Jane E
AU - Middleton, Edward
AU - Horton, Sarah
AU - Das, Sudipto
AU - Peterfy, Charles
AU - Tan, Ai Lyn
AU - Wakefield, Richard J
AU - Emery, Paul
N1 - © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: [email protected].
PY - 2016/10/11
Y1 - 2016/10/11
N2 - OBJECTIVES: No proven treatment exists for ACPA-negative undifferentiated arthritis (UA). The aim of this study was to evaluate whether abatacept is effective in treating poor prognosis, ACPA-negative UA, including its effect on power Doppler on US (PDUS).METHODS: A proof-of-concept, open-label, prospective study of 20 patients with DMARD-naïve, ACPA-negative UA (⩾2 joint synovitis) and PDUS ⩾ 1 with clinical and 20-joint US (grey scale/PDUS) assessments at baseline, 6, 12, 18 and 24 months. All patients received 12 months of abatacept (monotherapy for minimum first 6 months). The primary end point was a composite of the proportion of patients that at 6 months achieved DAS44 remission, a maximum of one swollen joint for at least 3 consecutive months and no radiographic progression (over 0-12 months).RESULTS: Twenty of the 23 patients screened were enrolled [14 female; mean (sd) age 53.4 (11.2) years, symptom duration 7.5 (0.9) months]. Two (10%) achieved the composite primary end point. A reduction in the mean (sd) DAS44 was observed from a baseline value of 2.66 (0.77) to 2.01 (0.81) at 6 months and to 1.78 (0.95) at 12 months. The DAS44 remission rates were 6/20 (30%; 95% CI: 15, 51%) at 6 months and 8/20 (40%; 95% CI: 22, 62%) at 12 months. A striking decrease in the median (interquartile range; IQR) total PDUS score was noted from 10 (4-23) at baseline to 3 (2-12) and 3 (0-5) at 6 and 12 months, respectively.CONCLUSION: This report is a first in potentially identifying an effective therapy, abatacept monotherapy, for poor-prognosis, ACPA-negative UA, supported by a clear reduction in PDUS. These data justify evaluation in a controlled study.
AB - OBJECTIVES: No proven treatment exists for ACPA-negative undifferentiated arthritis (UA). The aim of this study was to evaluate whether abatacept is effective in treating poor prognosis, ACPA-negative UA, including its effect on power Doppler on US (PDUS).METHODS: A proof-of-concept, open-label, prospective study of 20 patients with DMARD-naïve, ACPA-negative UA (⩾2 joint synovitis) and PDUS ⩾ 1 with clinical and 20-joint US (grey scale/PDUS) assessments at baseline, 6, 12, 18 and 24 months. All patients received 12 months of abatacept (monotherapy for minimum first 6 months). The primary end point was a composite of the proportion of patients that at 6 months achieved DAS44 remission, a maximum of one swollen joint for at least 3 consecutive months and no radiographic progression (over 0-12 months).RESULTS: Twenty of the 23 patients screened were enrolled [14 female; mean (sd) age 53.4 (11.2) years, symptom duration 7.5 (0.9) months]. Two (10%) achieved the composite primary end point. A reduction in the mean (sd) DAS44 was observed from a baseline value of 2.66 (0.77) to 2.01 (0.81) at 6 months and to 1.78 (0.95) at 12 months. The DAS44 remission rates were 6/20 (30%; 95% CI: 15, 51%) at 6 months and 8/20 (40%; 95% CI: 22, 62%) at 12 months. A striking decrease in the median (interquartile range; IQR) total PDUS score was noted from 10 (4-23) at baseline to 3 (2-12) and 3 (0-5) at 6 and 12 months, respectively.CONCLUSION: This report is a first in potentially identifying an effective therapy, abatacept monotherapy, for poor-prognosis, ACPA-negative UA, supported by a clear reduction in PDUS. These data justify evaluation in a controlled study.
KW - Abatacept/therapeutic use
KW - Adult
KW - Antirheumatic Agents/therapeutic use
KW - Arthritis/diagnostic imaging
KW - Arthritis, Rheumatoid/diagnostic imaging
KW - Female
KW - Hand Joints/diagnostic imaging
KW - Humans
KW - Knee Joint/diagnostic imaging
KW - Male
KW - Middle Aged
KW - Patient Reported Outcome Measures
KW - Peptides, Cyclic/immunology
KW - Prospective Studies
KW - Radiography
KW - Remission Induction
KW - Rheumatoid Factor/immunology
KW - Severity of Illness Index
KW - Synovitis/diagnostic imaging
KW - Ultrasonography, Doppler
U2 - 10.1093/rheumatology/kew357
DO - 10.1093/rheumatology/kew357
M3 - Article
C2 - 28028155
SN - 1462-0324
VL - 56
SP - 58
EP - 67
JO - Rheumatology (Oxford, England)
JF - Rheumatology (Oxford, England)
IS - 1
ER -