Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: The anti-IL6-R tocilizumab (TCZ), indicated for the treatment of moderate to severe rheumatoid arthritis (RA), has demonstrated its clinical and structural efficacy in phase III, but little information is available on concomitant ultrasound and clinical evolution.
Methods: 103 patients with moderate to severe RA were treated with TCZ 8 mg/kg+ methotrexate (MTX) in the Torpedo study every 4 weeks during 12 months. 40-joint ultrasound (US) examinations (B and Doppler (D) modes scores 0 to 120) were performed at baseline, 12, 24 and 48 weeks of treatment in parallel with usual clinical parameters assessments (DAS28, SJC, TJC). Doppler score was semi-quantitative, graded as 0(normal), 1, 2 or 3 (worst) for each joint and for each US mode following a pre-established coding guideline. Analysis was performed on the intent-to-treat population (patients with at least one TCZ infusion). Non-responder imputation was performed for DAS 28 and CDAI remissions.
Results: 103 patients main characteristics at baseline were: mean age 52±12, disease duration 4±3 years, 75% women, 66% DMARD IR*, 74% with concomitant steroid treatment, mean DAS 28 = 5.5±1.0. Efficacy: under TCZ + MTX, percentage of patients in DAS28 and CDAI remission increased in parallel with decrease in B and D modes ultrasound scores (table 1). Among the patients on DAS 28 remission at W48, 28 were on DAS28 remission for at least 6 months, and 15% of them had no synovitis in B mode and 56 % had no Doppler signal (D mode). At week 48, 17% /39% of patients under steroids at baseline could discontinue/decrease steroid dose below 5mg equivalent prednisone/day at W 48. Safety: reported AE’s** (97% of patients with at least one AE) and SAE’s** (23% of patients with at least one SAE) were in accordance with the known safety profile of TCZ.
|
|
Baseline |
W12 |
W24 |
W48 |
|
Number of patients in the analysis |
103 |
103 |
103 |
103 |
|
% patients in remission DAS 28 |
0 |
36 |
42 |
46 |
|
% patients in remission CDAI |
0 |
8 |
16 |
22 |
|
Number of patients in the analysis |
103 |
94 |
87 |
77 |
|
40-joint US D mode mean score±Sd Median [Q1; Q3] |
10.4±12.4 7 [2; 14] |
5.2±6.9 3 [1; 7] |
4.0±5.1 2 [0; 6] |
3.2±5.2 1 [0; 5] |
|
40-joint US B mode mean score±Sd Median [Q1; Q3] |
26.2±17.5 21 [12; 37] |
18.2±14.3 14 [8; 25] |
14.3±11.0 11 [6; 21] |
11.4±10.9 9 [3; 18] |
Table 1 : Clinical and ultrasound evolution of patients
*IR = inadequate responder **AE = adverse event, SAE = serious adverse event
Conclusion: In this study, parallel efficacy was shown in RA patients treated with TCZ on clinical, ultrasound scores together with steroid sparing effect. However, long term clinical remission could be associated with persistence of Doppler signals and synovitis on ultrasound. Safety profile was consistent with the previously published data.
Disclosure:
T. Schaeverbeke,
Roche Pharmaceuticals, Pfizer, UCB, Abbott, BMS,
5,
Roche Chugai,
2;
P. Gaudin,
Abbott, BMS,
5,
Abbott, MSD, Pfizer, Chugai, Roche,
2;
A. Perdriger,
Roche-Chugai,
2;
C. Roux,
Roche-Chugai, Servier, Amgen, Lilly, Abbott, Novartis,
2;
M. Vray,
Roche-Chugai,
2,
GSK,
5;
S. Rouanet,
Roche Pharmaceuticals,
3;
G. Steinberg,
Roche Pharmaceuticals,
3;
F. Etchepare,
Roche-Chugai, Abbott, Esaote, Pfizer,
5.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/concomitant-assessment-of-clinical-and-ultrasound-efficacy-and-safety-of-tocilizumab-in-patients-with-moderate-to-severe-rheumatoid-arthritis-the-torpedo-study/