Exploring a new ultrasound score as a clinical predictive tool in patients with rheumatoid arthritis starting abatacept: results from the APPRAISE study

Maria-Antonietta D'Agostino, Maarten Boers, Richard J Wakefield, Hilde Berner Hammer, Olivier Vittecoq, Georgios Filippou, Peter Balint, Ingrid Möller, Annamaria Iagnocco, Esperanza Naredo, Mikkel Østergaard, Corine Gaillez, Manuela Le Bars, Maria-Antonietta D'Agostino, Maarten Boers, Richard J Wakefield, Hilde Berner Hammer, Olivier Vittecoq, Georgios Filippou, Peter Balint, Ingrid Möller, Annamaria Iagnocco, Esperanza Naredo, Mikkel Østergaard, Corine Gaillez, Manuela Le Bars

Abstract

Objectives: To explore whether changes in a composite (power Doppler/greyscale ultrasound (PDUS)) synovitis score, developed by the OMERACT-EULAR-Ultrasound Task Force, predict disease activity outcomes in rheumatoid arthritis (RA).

Methods: Patients with RA who were methotrexate inadequate responders starting abatacept were evaluated. Individual joint PDUS scores were combined in the Global OMERACT-EULAR Synovitis Score (GLOESS) for metacarpophalangeal joints (MCPs) 2-5, all joints (22 paired) and a reduced (9 paired) joint set. The predictive value of changes in GLOESS at week 1-16 evaluations for clinical status and response (Disease Activity Score (DAS)28 (C reactive protein, CRP) <2.6; DAS28(CRP) ≤3.2; DAS28(CRP) ≥1.2 improvement) up to week 24, and correlations between DAS28 and GLOESS were assessed.

Results: Eighty-nine patients completed the 24-week treatment period. Changes in GLOESS (MCPs 2-5) from weeks 1 to 16 were unable to predict DAS28 outcomes up to week 24. However, significant improvements in GLOESS (MCPs 2-5) were observed at week 12 in patients with DAS28 ≥1.2 improvement at week 24 versus those who did not achieve that clinical response. In patients achieving DAS28 ≥1.2 improvement or DAS28 ≤3.2 at week 24, changes in GLOESS (22 and 9 paired joint sets) were greater in patients who already achieved DAS28 ≥1.2 at week 12 than in those who did not. No significant correlations were found between changes in DAS28 and GLOESS definitions at any time point.

Conclusions: PDUS was not correlated with clinical status or response as measured by DAS28-derived criteria, and PDUS changes were not predictive of clinical outcome. The discrepancies require further exploration.

Trial registration number: NCT00767325; Results.

Keywords: DMARDs (biologic); Disease Activity; Rheumatoid Arthritis; Ultrasonography.

Figures

Figure 1
Figure 1
Mean change from baseline in GLOESS and components at week 12 in patients who did, or did not, achieve (A) DAS28 ≥1.2 improvement, (B) DAS28 ≤3.2 or (C) DAS28

Figure 2

Mean change from baseline in…

Figure 2

Mean change from baseline in GLOESS at week 12 in patients who did,…

Figure 2
Mean change from baseline in GLOESS at week 12 in patients who did, or did not, also achieve DAS28 ≥1.2 improvement, in (A) patients who achieved DAS28 ≤3.2 at week 24 or (B) patients who achieved DAS28 ≥1.2 improvement at week 24. Patients who discontinued due to lack of efficacy, adverse event or withdrawal of consent are considered as non-responders. Error bars represent SEM. DAS28, Disease Activity Score 28; GLOESS, Global OMERACT-EULAR Synovitis Score; MCPs, metacarpophalangeal joints. GLOESS was calculated for each joint set using both hands, giving a potential score of 0–24 for MCPs 2–5, 0–132 for the 22 paired joint set, and 0–54 for the reduced (9 paired) joint set.
Figure 2
Figure 2
Mean change from baseline in GLOESS at week 12 in patients who did, or did not, also achieve DAS28 ≥1.2 improvement, in (A) patients who achieved DAS28 ≤3.2 at week 24 or (B) patients who achieved DAS28 ≥1.2 improvement at week 24. Patients who discontinued due to lack of efficacy, adverse event or withdrawal of consent are considered as non-responders. Error bars represent SEM. DAS28, Disease Activity Score 28; GLOESS, Global OMERACT-EULAR Synovitis Score; MCPs, metacarpophalangeal joints. GLOESS was calculated for each joint set using both hands, giving a potential score of 0–24 for MCPs 2–5, 0–132 for the 22 paired joint set, and 0–54 for the reduced (9 paired) joint set.

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