Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Tocilizumab (TCZ), as monotherapy and in combination with methotrexate (MTX), has been shown to be efficacious for rheumatoid arthritis patients with insufficient response to MTX or other disease-modifying antirheumatic drugs. These observations were extended to patients with early rheumatoid arthritis (ERA) or refractory to tumor necrosis factor inhibitors. This study was designed to compare the rate of remission induction and the cardiorespiratory endurance (CRE) in early RA patients treated with TCZ or MTX.
Methods:
Eligible patients had disease duration ≤2 years, were MTX-naive, and had active RA (DAS28 ≥3.2). Thirty (23 women and 7 men) RA patients were randomized to received either TCZ 8 mg/kg every month or MTX 20 mg weekly for 6 months. After this first period, all patients were treated with MTX for an additional 6 months period. Baseline demographics did not differ between groups : mean age +/- SD (56.9 +/- 10.4) vs (49.4 +/- 14.0), mean disease duration (0.49 +/- 1.3) vs (0.99 +/- 2.3), mean DAS 28-CRP (4.7 +/- 1.3) vs (4.4 +/- 1.0), mean HAQ (1.4 +/- 0.7) vs (0.9 +/- 0.6) . ACR and EULAR core set values were evaluated monthly by an independent joint assessor. Differences were statistically tested using Mann-Whitney or Wilcoxon rank tests.
Results:
13 and 17 ERA patients were included in the MTX and TCZ arm, DAS 28CRP promptly improved with a between group statistically significant difference observed at month 3 and 6. At week 24, respectively 76.5 % (13/17), 75 % (12/16) of patients in the TCZ group achieved DAS28CRP remission (<2.6) and SDAI remission (<3.3) vs 41.7% (5/12), 50 % (6/12) in the MTX group. Interestingly, a SJC of 0 was achieved at 6, 9 and 12 month in a significantly greater proportion of patients in the TCZ group (88%) compared to the MTX group (36%) (p<0.012). According to the new ACR/EULAR Boolean definition, remission was achieved in 31.3% (5/16) of TCZ patients and 0% (0/13) of MTX patients (p<0.048). The proportion of patients achieving HAQ scores within the norm (£0.5) was not significantly greater in the TCZ group (70.5% [12/17]) than in the MTX group (33.3% [4/12]). For the submaximal CRE test, 13 patients were excluded from the analysis because they were unable to perform the 3rd stage. The work capacity during the active treatment was not statistically improved at 6 months (W65%/kg : 1.86 +/-0.85 vs 1.57 +/-0.60 watts/kg for the MTX group and 1.55 +/-0.60 vs 1.57 +/- 0.49 for the TCZ group). Serious AEs were reported by only one patient in the TCZ group who developed an episode of diverticulitis at 24 weeks.
Conclusion:
These results demonstrate that remission is a realistic therapeutic goal when TCZ monotherapy is administered early in the RA disease process. In this population of naive DMARDs ERA patients, TCZ was superior to MTX alone in producing prolonged clinical remission. We failed to demonstrate that early RA patients intensively treated with TCZ or MTX could restore their CRE despite a large clinical response.
Disclosure:
P. Durez,
None;
G. Depresseux,
None;
M. Avaux,
None;
A. Nzeusseu Toukap,
None;
B. Lauwerys,
None;
L. Meric de Bellefon,
None;
M. S. Stoenoiu,
None;
F. A. Houssiau,
None.
« Back to 2012 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/remission-induction-in-early-active-rheumatoid-arthritis-comparison-of-tocilizumab-versus-methotrexate-monotherapy/