Doerner, T., Schulze-Koops, H., Burmester, G. -R., Iking-Konert, C., Schmalzing, M., Engel, A., Kaestner, P., Kellner, H., Kurthen, R., Krueger, 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). Clin. Exp. Rheumatol., 37 (6). S. 937 - 946. PISA: CLINICAL & EXPER RHEUMATOLOGY. ISSN 1593-098X

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Abstract

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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Doerner, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulze-Koops, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burmester, G. -R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Iking-Konert, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmalzing, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engel, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaestner, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kellner, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kurthen, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krueger, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rubbert-Roth, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schwenke, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peters, M. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tony, H. -P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-128301
Journal or Publication Title: Clin. Exp. Rheumatol.
Volume: 37
Number: 6
Page Range: S. 937 - 946
Date: 2019
Publisher: CLINICAL & EXPER RHEUMATOLOGY
Place of Publication: PISA
ISSN: 1593-098X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INTERLEUKIN-6 RECEPTOR INHIBITION; DOUBLE-BLIND; EULAR RECOMMENDATIONS; MULTICENTER; PATHOGENESIS; COMBINATION; MANAGEMENT; REMISSION; EFFICACY; CRITERIAMultiple languages
RheumatologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/12830

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