Method: The 229 patients were treated with TCZ 8 mg/kg every 4 weeks. The clinical remission (the disease activity score using the 28 joint count (DAS)28-ESR<2.6 and clinical disease activity index (CDAI)≤2.8), structural remission (the estimated yearly progression of modified total Sharp score (ΔmTSS) ≤0.5), and functional remission (health assessment questionnaire (HAQ)≤0.5) were evaluated. Sustained remission was defined as the remission sustainment rate at week 104 in patients who achieved remission at 52 weeks.
Result: Treatment with TCZ was continued for 2 years in 127 patients (55%). The patient characteristics who continued 2 years TCZ treatment were as follows. Mean age: 57.9 years; mean disease duration: 11.3 years; prior treatment with TNF inhibitor: 80 patients (63.0%); concomitant methotrexate (MTX): 80 patients (63.0%). The remission rates represented by DAS28<2.6 and CDAI≤2.8 (measures of clinical remission) and HAQ≤0.5 (measure of functional remission) tended to increase over time. At Week 104, 71.2% had achieved DAS28<2.6, 37.4% had achieved CDAI≤2.8, and 38.2% had achieved HAQ≤0.5. The main reason for discontinuation of TCZ was adverse drug reactions (47/229, 20.5%). In adverse drug reactions, pneumonia was 9 cases. Analysis of mTSS in 112 patients out of the 127 patients revealed ΔmTSS to be 20.1 at baseline, 1.1 at Week 52, and 0.6 at Week 104, indicating 97% inhibition compared to baseline. ΔmTSS≤0.5 was about the same at Weeks 52 and 104, with ΔmTSS≤0.5 at Week 104 in 52.9% (Table). Sustained remission: DAS28<2.6 in 85.5%, CDAI≤2.8 in 70.0%, ΔmTSS≤0.5 in 64.9%, and HAQ≤0.5 in 83.3%. Multivariate analysis revealed predictive factors affecting total remission of DAS28, CDAI, TSS and HAQ at week 104 were disease duration (P=0.03) and CDAI (P=0.04) at baseline.
|DAS28-ESR<2.6||0 (0%)||67 (54%)||69 (59%)||89 (71%)|
|CDAI≤2.8||0 (0%)||18 (15%)||30 (22%)||46 (37%)|
|HAQ≤0.5||16 (13%)||36 (29%)||38 (31%)||47 (38%)|
Conclusion: Patients who could continue treatment with tocilizumab for 2 years were achieved significant remission of CDAI, which includes no measures for assessing inflammatory markers such as CRP. Moreover, structural remission and functional remission were both maintained over the long term in a high percentage of patients.
Disclosure: Y. Tanaka, Abbott, Astellas Pharma, Chugai Pharma, Mitsubishi-Tanabe Pharma, MSD, Pfizer, Takeda Pharma, 2, Abbott, Astellas Pharma, Chugai Pharma, Eisai Pharma, Mitsubishi-Tanabe Pharma, 8 ; T. Takeuchi, Abbott, Bristol-Myers Squibb, Chugai Pharma, Eisai Pharma, Mitsubishi-Tanabe Pharma, Takeda Pharma, Janssen Pharma, Pfizer, 2 ; K. Amano, Abbott, Astellas Pharma, Chugai Pharma, Eisai Pharma, Mitsubishi-Tanabe Pharma, 2 ; E. Sato, None; M. Nawata, None; H. Nagasawa, None; D. Hoshi, None; K. Saito, None; S. Fukuyo, None; K. Hanami, None; H. Kameda, Mitsubishi-Tanabe Pharma, Centocor, Pfizer, Takeda Pharma, Abbott, Eisai Pharma, Chugai Pharma, 2 ; T. Kurasawa, None; Y. Kaneko, None; H. Yamanaka, Abbott, Bristol-Myers Squibb, Chugai Pharma, Eisai Pharma, Hoffmann-La Roche, Mitsubishi-Tanabe Pharma, Takeda Pharma, Pfizer, 2 .