Session Information
Session Type: ACR Late-breaking Abstract Session
Session Time: 9:00AM-11:00AM
Background/Purpose: The application of ultrasonography
(US) in rheumatology clinical practice is growing. The ARCTIC trial
(NCT01205854) was designed to examine if the use of a treatment strategy including
information from a structured US assessment would lead to better clinical and
radiographic outcomes for patients with rheumatoid arthritis (RA), compared to
a conventional strategy based on clinical and laboratory assessments alone.
Methods: The study population consisted
of disease-modifying antirheumatic drug (DMARD) naïve early RA patients with
<2 years symptom duration, fulfilling the 2010 ACR/EULAR classification
criteria and with indication for DMARD therapy. Patients were followed in a
tight control regimen with 13 visits over the 2-year follow-up period and randomized
1:1 to A) an US tight control (UTC) strategy targeting DAS < 1.6, no swollen
joints and no power-Doppler (PD) signal in any joint or B) a conventional tight
control (CTC) strategy targeting DAS<1.6 and no swollen joints. US was
performed by experienced sonographers at every visit in the UTC arm, using a
validated semi-quantitative scoring system with scores 0-3 for grey scale (GS)
and PD in 32 joints (1). Patients in both arms were treated according to the
same treat-to-target strategy with a step-up DMARD escalation approach starting
with MTX, then triple combination therapy MTX/SSZ/HCQ, then biologic DMARD
if target was not reached.
The primary endpoint was the proportion of patients meeting all the
3 following criteria: 1) Sustained clinical remission, defined as DAS<1.6 at
16, 20 and 24 months 2) No swollen joints at 16, 20 and 24 months (44 SJC) and
3) No progression (<0.5 units) in van der Heijde-modified total Sharp Score
(vdHSS) between 16 and 24 months. Secondary efficacy endpoints included various
measures of disease activity/remission and vdHSS.
Results: A total of 238 patients
were randomized, and all patients with at least one follow-up visit were
included in the full analysis set (UTC n=118, CTC n=112). 105 patients
in the UTC arm and 99 patients in the CTC arm completed the study. The primary endpoint was
reached by 26 patients (22.0%) in the UTC and 21 patients (18.8%) in the CTC
(p=0.54, mean difference 3.3%; 95%CI -7.1% to 13.7%). Secondary efficacy outcomes
are shown in Table 1.
Conclusion:
There was
no difference in the probability of achieving sustained clinical remission and
halt of radiographic progression between the two strategies. Both the strategy adding
ultrasonography and the conventional strategy led to early and sustained
improvements in clinical outcomes, providing excellent disease control and
minimal radiographic progression. The implementation and systematic use of US in
the follow-up of early RA patients treated with an aggressive treat-to-target
strategy is not justified based on the results of the ARCTIC trial.
References: 1
Hammer HB, et al, Ann Rheum Dis 2011
Table 1. Clinical and radiographic outcomes
|
Variable |
Ultrasonography tight control (n=118) |
Conventional tight control (n=112) |
Difference (95% CI) |
p-value |
|
Primary endpoint, n (%) |
||||
|
DAS<1.6, SJC44<1, ΔvdHSS<0.5 between 16 and 24 months1,2 |
26 (22.0) |
21 (18.8) |
3.3 (-7.1 to 13.7) |
0.54 |
|
Components of primary endpoint, n (%) |
||||
|
No swollen joints (SJC44<1) at 16, 20 and 24 months1,2 |
62 (52.5) |
61 (54.5) |
1.9 (-14.8 to 11.1) |
0.77 |
|
DAS remission (DAS<1.6) at 16, 20 and 24 months1,2 |
64 (54.2) |
58 (51.8) |
2.45 (-10.4 to 15.4) |
0.71 |
|
No radiographic progression (ΔvdHSS<0.5) 16-24 months1,2 |
49 (41.5) |
39 (34.8) |
6.7 (-19.2 to 5.8) |
0.30 |
|
Secondary outcomes at 24 months (end of study), n (%) |
||||
|
DAS remission (DAS<1.6) 1 |
80 (67.8) |
75 (67.0) |
0.8 (-11.3 to 13.0) |
0.89 |
|
CDAI remission (CDAI≤2.8) 1 |
70 (59.3) |
59 (52.7) |
6.6 (-6.2 to 19.5) |
0.31 |
|
SDAI remission (SDAI≤3.3) 1 |
71 (60.2) |
56 (50.0) |
10.2 (-2.6 to 23.0) |
0.12 |
|
EULAR good/moderate response1 |
98 (83.1) |
90 (80.4) |
2.7 (-7.3 to 12.7) |
0.60 |
|
Radiographic outcomes, median (25th; 75th percentile) |
||||
|
Change in vdHSS total score 0-24 months3 |
1 (0; 2.5) |
1.5 (0.5; 3) |
-0.43 (-0.93 to 0.07) |
0.09 |
|
Change in vdHSS erosion score 0-24 months3 |
0.5 (0; 1.5) |
1 (0.5; 2) |
-0.39 (-0.77 to -0.02) |
0.04 |
|
Change in vdHSS JSN score 0-24 months3 |
0 (0; 0.5) |
0 (0; 0.5) |
0 (-0.06 to 0.06) |
1 |
|
Treatment at end of study, n (%) |
||||
|
MTX monotherapy |
63 (53.4) |
80 (71.4) |
-18.0 (-30.3 to -5.8) |
0.03 |
|
MTX/SSZ/HCQ |
21 (17.8) |
13 (11.6) |
6.2 (-2.9 to 15.3) |
0.18 |
|
Biologic treatment |
34 (28.8) |
19 (17.0) |
11.8 (1.1 to 22.6) |
0.03 |
|
1Missing observations at 24 months imputed with worst outcome 2Missing observations before 24 months imputed with last observation carried forward 3 Missing observations imputed using linear intra- and extrapolation |
||||
To cite this abstract in AMA style:
Haavardsholm EA, Aga AB, Olsen IC, Hammer HB, Uhlig T, Fremstad H, Madland TM, Lexberg S, Haukeland H, Rødevand E, Høili C, Stray H, Bendvold AN, Hansen IJW, Bakland G, Nordberg LB, Lillegraven S, van der Heijde D, Kvien TK. Aiming for Remission in Rheumatoid Arthritis: Clinical and Radiographic Outcomes from a Randomized Controlled Strategy Trial Investigating the Added Value of Ultrasonography in a Treat-to-Target Regimen [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/aiming-for-remission-in-rheumatoid-arthritis-clinical-and-radiographic-outcomes-from-a-randomized-controlled-strategy-trial-investigating-the-added-value-of-ultrasonography-in-a-treat-to-target-regim/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
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