Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
Halting joint damage is a central goal in the treatment of rheumatoid arthritis. Much research has been conducted to identify factors associated with progressive radiographic damage typically measured by the Sharp/van der Heijde score (SHS). Trials have also suggested that treatment choices impact disease course including the development of rapid radiographic progression, defined as a threshold change in SHS ≥ 5U/year. In the 48-week, double-blind, noninferiority RACAT trial, 353 patients with suboptimal methotrexate response were randomized to two treatment strategies, either first adding sulfasalazine and hydroxychloroquine (triple therapy or T) or first adding etanercept (E). After 24 weeks of treatment patients not achieving a DAS28 improvement of 1.2 were switched in a blinded fashion to the other therapy. We explored the associations of strategy and baseline factors with SHS progression.
Two expert readers provided SHS for patients at baseline and 48 weeks. Using the mean value of the two readers, SHS change was categorized as a an increase ≤ 0.5 U or > 0.5U. Possible baseline predictors of change evaluated included swollen and tender joint count, ESR, Global Health Assessment, DAS28, gender, smoking, RF status, disease duration and baseline SHS. From logistic regression models we obtained odds ratios (OR) for each predictor alone and in multivariable models with all factors. We analyzed all participants, the two strategy subgroups (T and E) and the four treatment subgroups (T-only, E-only, T switch to E, and E switch to T).
Results
Of 304 participants with week-48 Sharp scores, only 4.3% (13 of 304) had increases in SHS ≥5U evenly spread over the four treatment groups, while 23% demonstrated increases >0.5 units again evenly spread over treatments. Approximately 60% demonstrated changes of -0.5, 0, or 0.5U, and 17% showed improvement (<-0.5 change).
Baseline SHS values were significantly different for increases ≤ 0.5U compared to increases >0.5U (15.3 vs. 26.4, p=0.006). In multivariable analyses, only baseline SHS consistently predicted disease progression (see Table). Other measures, including treatment strategy, were not predictive of radiographic progression. No evidence suggested that any of the four treatments was associated with change defined either as >0.5U or as ≥5U. Only 4% had changes ≥5U.
|
|
Univariate |
Multivariable* |
||
|
Baseline Characteristic |
OR (95% CI) |
p value |
OR (95% CI) |
p value |
|
Sharp Score at Baseline |
1.02 (1.01,1.03) |
0.002 |
1.02 (1.01,1.03) |
0.007 |
|
Male Gender |
1.04 (0.61,1.78) |
0.881 |
1.18 (0.66,2.11) |
0.584 |
|
Ever Smoked |
0.58 (0.34,1.01) |
0.052 |
0.60 (0.33,1.08) |
0.090 |
|
DAS28 |
1.22 (0.91,1.65) |
0.185 |
1.23 (0.49,3.10) |
0.660 |
|
Swollen Joint Count |
1.02 (0.97,1.07) |
0.487 |
1.00 (0.93,1.07) |
0.950 |
|
Tender Joint Count |
1.00 (0.96,1.04) |
0.986 |
0.99 (0.91,1.08) |
0.861 |
|
Erythrocyte Sedimentation Rate |
1.01 (1.00,1.02) |
0.042 |
1.00 (0.98,1.03) |
0.862 |
|
Patient Global Health Assessment |
1.00 (0.99,1.01) |
0.779 |
1.00 (0.98,1.02) |
0.771 |
|
Disease Duration |
1.01 (0.98,1.04) |
0.524 |
0.98 (0.94,1.02) |
0.304 |
|
RF Status |
1.59 (0.87,2.89) |
0.131 |
1.46 (0.78,2.74) |
0.240 |
|
Table: Univariate and multivariable associations of patient factors with SHS progression (increase >0.5U) over 48 weeks (same results obtained using stepwise up or down selection to detect intercorrelation); *model includes all variables shown |
||||
Conclusion
Similar to other trials, we found that radiologic progression is most strongly associated with baseline SHS. A weak and non-significant association with positive RF status was observed. We found no significant radiographic advantage with either of the two treatment strategies or among the 4 treatment groups. Rapid radiographic progression, an increase in SHS≥5U, was uncommon (less than 4.3%) regardless of strategy.
Disclosure:
A. Erickson,
None;
D. Rybin,
None;
M. Brophy,
None;
R. Lew,
None;
T. R. Mikuls,
Genentech/Roche,
2;
T. Moore,
None;
K. Hannagan,
None;
E. Keystone,
Abbott, Amgen, AstraZeneca, BMS, F. Hoffmann-La Roche, Janssen, Lilly, Novartis, Pfizer Sanofi-Aventis, UCB,
2,
Abbott Laboratories, AstraZeneca, Biotest, BMS, F. Hoffmann-La Roche, Genentech, Janssen, Lilly, Merck, Pfizer, UCB,
5,
Abbott, AstraZeneca, BMS Canada, F. Hoffmann-La Roche, Janssen, Pfizer, UCB, Amgen,
8;
J. O’ Dell,
Abbvie, Lilly, Antares, Medac,
5.
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