Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Tocilizumab (TCZ), an anti-IL-6-receptor antibody, is used for the treatment of moderate to severe rheumatoid arthritis (RA) in adults with inadequate response or intolerance to previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or anti-tumor necrosis factor (anti-TNF). The approved dose in EU is 8 mg/kg every four weeks. The reduction of these dose is recommended in selected cases for security reasons. There are studies that assess dose reduction with other biologic therapies in patients with clinical remission. However, no studies evaluate the effectiveness of reducing the dose, either for safety or low disease activity, in patients treated with TCZ. Our objective was to evaluate the effectiveness of reducing the dose of TCZ in a serie of patients with RA.
Methods:
A retrospective longitudinal observational study that included RA patients receiving reduced doses of tocilizumab. The demographics and disease characteristics were recorded in all patients. The dose reduction was based clinical practice. For qualitative variables percentages were obtained and for quantitative variables means were calculated with confidence intervals. Comparison between disease activity before and after dose reduction was performed with a t- student test.
Results:
A total of 67 RA patients treated with an initial dose of TCZ of 8 mg/kg were included in this study. A dose reduction was started in 25 of them – 22 patients reduced the dose due to clinical remission of the disease ( DAS 28 <
2,6) and 3 aditional patients due to leukopenia. Initial dose reduction was 6 mg/kg of TCZ and afterwards in 8 patients the dose was reduced to 4mg/kg. All the patients with reductions due leukopenia received 4mg/kg. The mean follow-up before the dose reduction was 25 months (SD 22.4). At the end of the follow-up, 24 patients remained in dose reduction and 1patients had to discontinue because of severe leukopenia. The DAS28 mean at the begining of the dose reduction was 2.20 (SD 1.45) and at the end 1.59 (0.78) with a median follow-up of 14 months. There was no statistically significant difference regarding disease activity before and after dose reduction (p = 0.36).
Conclusion:
In RA patients treated with Tocilizumab who achieve clinical remission this condition can be mantained with a lower dose of the drug. The economic consequences may be relevant. Further studies are needed to verify these results.
|
Women n(%) |
26 ( 92,9) |
|
Age mean(SD) |
57,9 (12,1) |
|
RF positive n(%) |
25 (89.3) |
|
ACPA positive n(%) |
17 (60.7) |
|
RA duration mean(SD) |
13,7 (9.8) |
|
Erosive disease n(%) |
19 (67,9) |
|
Rheumatoid nodules n(%) |
4 (14,3) |
|
Previous treatment n(%) Methotrexate Leflunomide Hidroxicloroquine Anti TNF |
28(100) 9 (32,1) 7 (25,0) 7 (25) |
|
RA duration until Tocilizumab, mean (SD) |
6,5 (6,68) |
Disclosure:
C. Prieto- Candau,
None;
V. Moreira- Navarrete,
None;
C. Vargas-Lebrón,
None;
J. M. Prieto-Martinez,
None;
D. Ruiz-Montesinos,
None;
J. Toyos-Saenz de Miera,
None;
F. Navarro-Sarabia,
None.
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