Session Information
Date: Sunday, November 8, 2015
Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster I
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose:
Seronegative RA patients have inferior clinical response to rituximab [1]. However, there is significant heterogeneity in this group of patients for baseline clinical features (e.g. radiographic erosion, or alternative markers of B cell dysfunction such as ANA or hypergammaglobulinaemia), as well as for clinical response to rituximab. These features may help to predict response [2]. Objective: To identify clinical predictors of response to rituximab in seronegative RA as a means to select patients suitable for B cell targeted biologics
Methods:
Baseline demographic and clinical characteristics will be extracted from RF and CCP2 negative patients in the following clinical trials: REFLEX, DANCER, IMAGE, SERENE and SUNRISE (which recruited 376 RF-CCP- patients). This preliminary analysis includes data on 88 patients from rituximab-treated arms of SERENE and IMAGE with complete data, but does not include analysis of erosions or ANA. We used 6 month DAS28, adjusted for baseline DAS28 as our primary response outcome, and tested each variable using univariate linear regression.
Results:
Table 1 shows the result of univariate analysis of each potential predictor. Positive coefficients indicate increase in adjusted 6-month DAS28 for presence (categorical variables) or unit increase (continuous variables) in the characteristic. Negative coefficients indicate characteristics associated with a reduction in in 6-month adjusted DAS28.
|
Characteristic |
Coefficient (95% CI) |
P value |
|
Age, per year |
0.01 (-0.01, 0.04) |
0.233 |
|
Female |
0.47 (-0.27, 1.21) |
0.208 |
|
BMI, per unit |
0.04 (0.00, 0.08) |
0.046 |
|
Total IG (ln-trans)*, per unit |
-0.67 (-1.65, 0.31) |
0.176 |
|
IGA (ln-trans)*, per unit |
-0.34 (-0.91, 0.23) |
0.237 |
|
IGG (ln-trans)*, per unit |
-0.62 (-1.55, 0.30) |
0.185 |
|
IGM (ln-trans)*, per unit |
-0.03 (-0.64, 0.58) |
0.922 |
|
Smoker Ex Current |
0.67 (-0.09, 1.41) 0.11 (-0.72, 0.94) |
0.082 0.795 |
|
Disease duration (ln-trans) |
-0.01 (-0.29, 0.28) |
0.959 |
|
N previous DMARDs 1-2 >2 |
0.13 (-0.49, 0.76) 0.26 (-1.23, 1.75) |
0.671 0.729 |
|
Oral glucocorticoid at baseline |
-0.68 (-1.28, -0.08) |
0.028 |
|
DAS28, per unit |
0.49 (0.20, 0.77) |
0.001 |
|
HAQ-DI, per unit |
0.19 (-0.32, 0.71) |
0.459 |
Conclusion: Response to rituximab in seronegative RA is associated with lower BMI and use of oral glucocorticoids, with a trend to association with never smoking in univariate analyses. Our data were consistent with a previously-reported association of response with hypergammaglobulinaemia but we cannot confirm clinical utility of IgG as predictor in this analysis. Final analysis will include data from 376 patients using comprehensive multivariable modelling, including erosion and ANA data.
To cite this abstract in AMA style:
Hensor EMA, Vital EM, Emery P. Which Seronegative RA Patients Respond to Rituximab? – Preliminary Analysis of a Merged Clinical Trials Dataset [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/which-seronegative-ra-patients-respond-to-rituximab-preliminary-analysis-of-a-merged-clinical-trials-dataset/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/which-seronegative-ra-patients-respond-to-rituximab-preliminary-analysis-of-a-merged-clinical-trials-dataset/