Bert Vander Cruyssen (Bert.VanderCruyssen@Ugent.be) Patrick Durez (Patrick.Durez@ruma.ucl.ac.be) Rene Westhovens (Rene.firstname.lastname@example.org) Marie-Joelle Kaiser (Mjkaiser@chu.ulg.ac.be) Ilse Hoffman (Ilse.Hoffman@skynet.be) Filip De Keyser (Filip.Dekeyser@Ugent.be) The MIRA Study Group (email@example.com)
Introduction: This study describes the results of the Belgian “MabThera In Rheumatoid Arthritis (MIRA)” registry: effectiveness, safety and evaluation of the current retreatment practice on the background of the Belgian reimbursement criteria for rituximab.
Methods: All Belgian rheumatologists had the possibility to participate in the study. Patients entered the registry as from November 2006 and the entry is still open.
Results: By mid September 2009, 401 patients had entered the registry with a mean followup time of 70 weeks. Overall, DAS28-ESR decreased from 6.0 at baseline to 4.2 at week16. Further decrease of disease activity was observed at the end of year 1 and year 2 with mean DAS28-ESR of 4.0 and 3.7 at these respective time points. More than 80% of patients showed a EULAR response at week 16. Patients could be retreated if they had DAS scores of > 3.2 at least 6 months after the previous course. A second and third course were given in 224 and 104 patients respectively. At month 6 after the second course, significantly lower DAS28-ESR values were observed compared to the first course. This was especially the case for patients who were retreated before they showed an obvious flare (DAS increase > 1.2).
Conclusions: This study describes the follow-up of a daily clinical practice cohort of 401 RA patients with long-standing refractory disease treated with rituximab. Relatively high DAS28 values at the start of each retreatment, compared to values 6 months after each treatment course, were noted. Moreover, further decrease of DAS28 scores after the second course were more pronounced, especially, in those who didn’t show an obvious flare.