Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Radiographic progression is a key outcome in early RA. We previously developed a radiographic progression prediction method based on the patient’s report of symptom duration and the radiological damage at first examination1. We previously included data on predicted radiological progression for a subset of patients in the SWEFOT trial. Here, we applied the analysis of predicting radiological progression (prediction of progression in early RA, or POPERA) to the full data set from this randomized trial with the aim to compare predicted versus observed radiological progression in early RA patients treated with MTX or combination therapies.
Methods:
In the SWEFOT trial2, 3, 487 patients with early RA were given MTX, and non-responders after 3-4 months (DAS28>3.2) were randomized to MTX+SSZ+HCQ (“Triple therapy”) vs. MTX+infliximab (“anti-TNF”). The others continued on MTX (“MTX-responders”). Hand and foot X-rays (baseline, 1, and 2 years) were analyzed with the Sharp-van der Heijde Score (SHS). Predicted progression at 1 and 2 years was calculated as the baseline SHS divided by symptom duration in months multiplied by 12 or 24, respectively. The analysis involved intention-to-treat (ITT) patients, and, in order to allow inclusion of patients with SHS 0 at baseline in the mathematical model, all SHS values in the entire data set were increased by 1. Comparisons between observed progressions were done by non-parametric, Mann-Whitney U testing.
Results:
In all three groups of patients, observed radiographic progression was reduced from predicted by 50-96%. In patients who had failed both MTX monotherapy and subsequent triple therapy, the reduction of radiographic progression was numerically the least at 12 months (40.7%). After 12 months, there were no significant between-group differences. After 24 months, progression was reduced more in the anti-TNF arm than in both the MTX and triple therapy arms.
Conclusion:
The progression observed in patients who failed their first 2 antirheumatic therapies was 59.3% of predicted at 12 months. The overall results demonstrated significant reductions from predicted radiological progression in patient groups who were successfully treated with MTX and in those who were included in either group of the randomization. Over 24 months, anti-TNF therapy was superior to triple therapy. The POPERA method may provide valuable information on the relative radiographic efficacy of treatments for early RA.
Table I – Mean Observed Radiographic Reduction from Predicted
|
|
MTX responders |
Triple therapy ITT |
Anti-TNF ITT |
Triple therapy completers |
Anti-TNF completers |
|
Percent reduction at 12 months |
73.9 (±5.5) |
50.1 (±10.1)
|
72.3 (±5.6) |
56.7 (±14.2)
|
76.5 (±4.8) |
|
Percent reduction at 24 months |
87.8* (±2.8) |
87.2† (±3.1) |
89.8†* (±3.1) |
91.0 (±3.4)
|
96.0 (±1.8)
|
* Anti-TNF (ITT) vs. MTX: p=0.013
† Anti-TNF (ITT) vs. Triple therapy: p=0.021
1Wick et al. Ann Rheum Dis 64:134-137, 2005
2Van Vollenhoven et al. Lancet 374:459-466, 2009
3Van Vollenhoven et al. Lancet 379:1712–1720, 2012
Disclosure:
A. Levitsky,
None;
K. Forslind,
None;
R. F. van Vollenhoven,
AbbVie, BMS, GSK, Merck, Pfizer, Roche, UCB,
2,
AbbVie, AstraZeneca, Biotest, BMS, GSK, Lilly, Merck, Pfizer, Roche, UCB, Vertex,
5.
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