Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: The MIRA registry was set up to collect safety, efficacy and (re)treatment practice data for Belgian RA patients treated with rituximab.
Methods: All rheumatologists from Belgium and Luxemburg were invited to participate in the study. Patient demographics were collected at baseline. Follow-up data included disease activity measures, attrition and reasons for discontinuation. Evolution of disease activity is reported here for the subpopulation followed for at least 3 years. Data are presented as mean±standard error (SE) or as percentages. Data analysis was performed with SPSS 20.0 software.
Results: The MIRA registry includes 649 patients (treated by 80 rheumatologists in 52 centers), who started rituximab therapy between November 2006 and October 2011. The study population consisted for 75% of females; 55.3% were RF positive and 33.9% anti-CCP positive. Patients starting rituximab were on average 57.4±0.5 years old with a mean disease duration of 12.8±0.4 years. Patients received on average 2.82±0.07 (range 1-9) rituximab treatments, over a median follow up time of 82 weeks (range 0-254 weeks). At database lock, 433 patients (66.72%) were still on rituximab treatment, 182 (28.04%) had stopped, and 34 patients (5.24%) were lost to follow up.
Over the study period, a clear evolution was observed in the baseline characteristics of patients starting rituximab treatment. The number of previously failed anti-TNF drugs used before starting rituximab significantly decreased over time (chi-square p<0.001). In 2006, 50.0 % of patients had previously been treated with more than one anti-TNF, whereas in 2011 only 33.4% of patients had received more than one anti-TNF before switching to rituximab. In parallel, the DAS28 values at baseline significantly decreased, from 6.31±0.59 in 2006 to 5.65±0.17 in 2011 (ANOVA, p<0.001).
Evolution of disease activity was analysed in a subset of 139 patients who were followed for at least 3 years. DAS28 showed significant changes over the study period (ANOVA, p<0.001), declining in the first 8 weeks after rituximab treatment, and stabilising afterwards. DAS28 in this subgroup with 3-year follow-up at weeks 0, 8, 52, 104 and 156 respectively were 6,16±0.09, 4.47±0.45, 3.79±0.18, 3.85±0.29 and 3.58±0.42.
Conclusion: Data from the MIRA registry shows that over the last 5 years, less alternative anti-TNF treatments were used in Belgium before switching RA patients to rituximab. Additionally, rituximab treatment tended to be started in patients with lower disease activity. Furthermore, this clinical practice study demonstrates that rituximab treatment results in adequate long-term disease control.
Disclosure:
F. De Keyser,
Roche Pharmaceuticals, UCB, MSD, AstraZeneca, Pfizer,
5;
P. Durez,
BMS – Less than US$2000 ,
8;
R. Westhovens,
Janssen Research and Development, LLC,
;
M. J. Kaiser,
None;
I. Hoffman,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/three-year-follow-up-of-rituximab-in-rheumatoid-arthritis-results-from-the-belgian-mira-mabthera-in-rheumatoid-arthritis-registry/