Methods: We analyzed the efficacy of TCZ treatment in 80 RA patients at 24 weeks after initial treatment with TCZ by using “DAS28 remission” defined to be DAS28-ESR < 2.6 and “Boolean remission” defined to be all criteria in the Boolean definition ≤ 1. We stratified the 80 RA patients by previous use of biologics, by concomitant use of methotrexate (MTX), by age over or under 65 years, by disease duration and by physical dysfunction as measured by the Japanese version of the Health Assessment Questionnaire (J-HAQ). We compared the achievement of “DAS28 remission” by chi-square test and “Boolean remission” by Fisher’s exact test. We further analyzed the predictive factors that influenced the achievement of “Boolean remission” at 24 weeks after initial treatment of TCZ by using stepwise multiple logistic regression analysis.
Results: Among the 80 RA patients, 88.8% were women. The median [25%, 75%] age was 60.0 [48.2, 65.0] years and disease duration was 100 [49, 176] months. MTX was used in 70% of patients and corticosteroid was in 77.5%. The number (percentage) achieving “DAS28 remission” and “Boolean remission” at week 24 were 40 (50.0%) and 10 (12.5%), respectively. There was no difference in reaching remission either defined by “DAS28 remission” or “Boolean remission” when patients were stratified by previous biologics use, concomitant MTX use, or age over or under 65 years. There were significant differences in achieving “Boolean remission”, but not “DAS28 remission”, when patients were stratified by disease duration (p = 0.0368) or by J-HAQ (p = 0.0444) in tertile. The predictive factor for not achieving “Boolean remission” at 24 weeks was a worse baseline J-HAQ score (odds ratio: 3.66, 95% confidence interval: 1.17–14.48).
Table. Risk factors at baseline for not satisfying “Boolean remission” at 24 weeks
|
odds ratio |
95% confidence interval |
P value |
Disease duration (month) |
1.007 |
0.099–1.021 |
0.235 |
J-HAQ |
3.655 |
1.174–14.475 |
0.039 |
ESR (mm/h) |
0.98 |
0.954–1.005 |
0.121 |
Corticosteroid use (%) |
2.952 |
0.617–14.085 |
0.163 |
Conclusions: This study showed that the achievement of “Boolean remission” was 12.5% and “DAS28 remission” was 50% in patients treated with TCZ. Greater physical dysfunction is a negative predictor for achieving “Boolean remission”.
Disclosure: D. Hoshi, None; K. Shidara, None; Y. Seto, None; E. Tanaka, None; A. Nakajima, None; S. Momohara, None; A. Taniguchi, None; H. Yamanaka, Chugai Pharmaceutical Co.,Ltd., Astellas Pharma Inc., Wyeth K.K., Daiichi Sankyo Co.,Ltd., Banyu Pharmaceutical Co.,Ltd., Mitsubishi Tanabe Pharma Corporation, Abbott Japan Co.,Ltd., Eisai Co.,Ltd., Santen Pharmaceutical Co.,Ltd., Taishotoyama Pharmaceuti, 2, Abbott, Eisai Co.,Ltd., Takeda Pharmaceutical Company Limited, Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceutical K.K., Hoffmann-La Roche, Chugai Pharmaceutical Co.,Ltd, Pfeizer Inc., 5 .