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Doerner, T.; Schulze-Koops, H.; Burmester, G. -R.; Iking-Konert, C.; Schmalzing, M.; Engel, A.; Kaestner, P.; Kellner, H.; Kurthen, R.; Krüger, K.; Rubbert-Roth, A.; Schwenke, H.; Peters, M. A. and Tony, H. -P. (2019): Early and late responses in patients with rheumatoid arthritis who were conventional synthetic disease-modifying anti-rheumatic drug inadequate responders and were treated with tocilizumab or switched to rituximab: an open-label phase 3 trial (MIRAI). In: Clinical and Experimental Rheumatology, Vol. 37, No. 6: pp. 937-945

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Objective To evaluate early and late responses in biological-naive patients with rheumatoid arthritis (RA) initiating tocilizumab and early tocilizumab non-responders who switched to rituximab. Methods In this open-label, non-randomised phase 3 study, RA patients with inadequate response to conventional synthetic DMARDs received tocilizumab 8 mg/kg intravenously at study begin and weeks 4, 8 and 12. After evaluation at week 16, early responders (Disease Activity Score based on 28 joints-erythrocyte sedimentation rate [DAS28-ESR] <2.6) completed the study;partial responders (DAS28-ESR decrease >1.2 or DAS28-ESR >= 2.6-<= 3.2) were to continue tocilizumab through week 28;non-responders (DAS28-ESR decrease <= 1.2) switched to rituximab (1000 mg, weeks 16 and 18) with safety follow-up through week 66. Results Of 519 patients, 222 (42.8%) achieved early DAS28-ESR remission at week 16;240 patients continued treatment, 213 (41.0%) received tocilizumab, and 27 ( 5.2%) switched to rituximab. At week 32 DAS28-ESR remission was achieved by 117/213 patients (54.9%) who continued tocilizumab and 4/27 patients (14.8%) who switched to rituximab;good EULAR response was achieved by 66.7% and 25.9% and CDAI remission by 19.2% and 14.8% of patients, respectively. Serious adverse events occurred through week 32 in 45/490 patients (9.2%) who received tocilizumab (serious infections, 2.7%) and through week 66 in 8/27 patients (29.6%) who switched to rituximab. Conclusion Early response to tocilizumab was observed in 42.8% of patients. Half of early partial responders benefitted from continuing tocilizumab. Switching non-responders to rituximab seems feasible. No new safety signals were observed in patients treated with tocilizumab or switched to rituximab.

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