Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: The STRASS trial was a 18-month randomized controlled trial, conducted in established RA patients in DAS28 remission with etanercept (ETA) or adalimumab (ADA), comparing the impact of a DAS28-driven step-down strategy based on TNF-blocker injection spacing (S arm) to a maintenance strategy (M arm). We aimed to identify baseline characteristics predicting relapse (DAS28 > 2.6 and ΔDAS28 > 0.6) or persistent stable remission (DAS28 constantly £ 2.6) during the 18-month follow-up.
Methods: Inclusion criteria were: ETA or ADA > 1 year, DAS28 remission > 6 months, stable damage on X-rays. Patients were randomized and followed every 3 months for 18 months. In the S arm, the inter-injection interval was increased every 3 months up to complete interruption at 4th step. Relapse was defined by DAS28 >2.6 and ΔDAS28 >0.6 (Cox model). Predictive factors for relapse or persistent remission were identified by univariate then multivariate analysis using logistic regression. Optimal cut-off was determined with ROC curves analysis.
Results: 137 patients were included, 64 and 73 in the S and M arm (mean/%: age 55 yrs, female 78%, RA duration 9.5 yrs, ACPA+ 78%, erosive 88%, DAS28 1.8, ETA 54 %, ADA 46 %).
In the S arm, 46 (71.9%) patients were able to space out their injections, among which 17 (14.1%) completely stopped the TNF-blocker. Although mean DAS28 was not statistically different between the 2 strategy arms, RA relapse occurred in both arms more frequently in the S arm (81% vs. 56% in the M arm)1 (see Table). By univariate analyses, predictors of relapse were HAQ score (p=0.05), treatment strategy arm (p=0.001), morning stiffness duration (p=0.04) and patient global assessment (PGA) (p=0.02). Baseline DAS score, Sharp score and smoking status were not associated with later relapse. Baseline factors predicting persistent remission were DAS28 score (p=0.003), HAQ score (p=0.01), treatment strategy arm (p=0.001), morning stiffness duration (p=0.008) and patient global assessment (PGA) (p=0.03). By multivariate analysis, predictors of relapse were spacing strategy – S arm – (OR=3.45; CI95%: 1.51-7.92, p=0.003) and HAQ score (OR=2.84; CI95%: 1.07-7.54, p=0.03). Predictors of persistent remission were strategy treatment arm (OR=0.30; CI95%: 0.13-0.70, p=0.005) and DAS28 score (OR=0.41; CI95%: 0.20-0.83, p=0,01). Receiver-operator characteristics of HAQ and DAS scores plotted as predictors of relapse and remission, respectively, resulted in no meaningful thresholds identified.
Conclusion: TNF-blocker injection spacing and HAQ / DAS28 were the main predictors of relapse / persistent stable remission in these established RA patients.
Table: Percentage of relapse according to assessment schedule and strategy treatment group.
|
N (%) |
Visit (months) |
Total (N=137) |
M arm (N=73) |
S arm (N=64) |
Predictors OR (95% CI) |
|
Time of 1st relapse |
M0 |
0 (0.0%) |
0 (0.0%) |
0 (0.0%) |
Spacing 3.45 (1.51, 7.92) HAQ 2.84 (1.07, 7.54) |
|
M3 |
25 (27.2%) |
11 (27.5%) |
14 (26.9%) |
||
|
M6 |
19 (20.6%) |
8 (20.0%) |
11 (21.1%) |
||
|
M9 |
10 (10.9%) |
2 (5.0%) |
8 (15.3%) |
||
|
M12 |
15 (16.3%) |
5 (12.5%) |
10 (19.2%) |
||
|
M15 |
8 (8.7%) |
5 (12.5%) |
3 (5.7%) |
||
|
M18 |
15 (16.3%) |
9 (22.5%) |
6 (11.5%) |
||
|
Stable remission i.e., DAS28£2.6 |
M0 thru M18 |
39 (28.5 %) |
28 (38.3%) |
11 (17.2%) |
Spacing 0.30 (0.13, 0.70) DAS28 0.41 (0.20, 0.83)
|
1Fautrel B et al. EULAR 2013. OP0066.
Disclosure:
T. Pham,
Abbott Laboratories,
2;
J. Morel,
Abbott Laboratories,
2;
T. Alfaiate,
None;
E. Dernis,
None;
P. Gaudin,
None;
O. Brocq,
None;
E. Solau-Gervais,
None;
J. M. Berthelot,
None;
J. C. Balblanc,
None;
X. Mariette,
None;
F. Tubach,
None;
B. Fautrel,
None.
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