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)

Thomas Dörner; Hendrik Schulze-Koops; Gerd-Rüdiger Burmester; Christof Iking-Konert; Marc Schmalzing; Andreas Engel; Peter Kästner; Herbert Kellner; Reiner Kurthen; Klaus Krüger; Andrea Rubbert-Roth; Holger Schwenke; Marvin A Peters; Hans-Peter Tony

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

Standard

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). / Dörner, Thomas; Schulze-Koops, Hendrik; Burmester, Gerd-Rüdiger; Iking-Konert, Christof; Schmalzing, Marc; Engel, Andreas; Kästner, Peter; Kellner, Herbert; Kurthen, Reiner; Krüger, Klaus; Rubbert-Roth, Andrea; Schwenke, Holger; Peters, Marvin A; Tony, Hans-Peter.

in: CLIN EXP RHEUMATOL, Jahrgang 37, Nr. 6, 27.04.2019, S. 937-945.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Dörner, T, Schulze-Koops, H, Burmester, G-R, Iking-Konert, C, Schmalzing, M, Engel, A, Kästner, P, Kellner, H, Kurthen, R, Krüger, K, Rubbert-Roth, A, Schwenke, H, Peters, MA & 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, Jg. 37, Nr. 6, S. 937-945.

APA

Dörner, T., Schulze-Koops, H., Burmester, G-R., Iking-Konert, C., Schmalzing, M., Engel, A., Kästner, P., Kellner, H., Kurthen, R., Krüger, K., Rubbert-Roth, A., Schwenke, H., Peters, M. A., & 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), 937-945.

Vancouver

Dörner T, Schulze-Koops H, Burmester G-R, Iking-Konert C, Schmalzing M, Engel A et al. 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. 2019 Apr 27;37(6):937-945.

Bibtex

@article{7ddcbdf3d25d45dfafd8d636f43c61af,

title = "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)",

abstract = "OBJECTIVES: To evaluate early and late responses in biological-na{\"i}ve 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.CONCLUSIONS: 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.",

keywords = "Antibodies, Monoclonal, Humanized/therapeutic use, Antirheumatic Agents/therapeutic use, Arthritis, Rheumatoid/drug therapy, Double-Blind Method, Humans, Remission Induction, Rituximab/therapeutic use, Treatment Outcome",

author = "Thomas D{\"o}rner and Hendrik Schulze-Koops and Gerd-R{\"u}diger Burmester and Christof Iking-Konert and Marc Schmalzing and Andreas Engel and Peter K{\"a}stner and Herbert Kellner and Reiner Kurthen and Klaus Kr{\"u}ger and Andrea Rubbert-Roth and Holger Schwenke and Peters, {Marvin A} and Hans-Peter Tony",

year = "2019",

month = apr,

day = "27",

language = "English",

volume = "37",

pages = "937--945",

journal = "CLIN EXP RHEUMATOL",

issn = "0392-856X",

publisher = "Clinical and Experimental Rheumatology S.A.S.",

number = "6",

}

RIS

TY - JOUR

T1 - 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

T2 - an open-label phase 3 trial (MIRAI)

AU - Dörner, Thomas

AU - Schulze-Koops, Hendrik

AU - Burmester, Gerd-Rüdiger

AU - Iking-Konert, Christof

AU - Schmalzing, Marc

AU - Engel, Andreas

AU - Kästner, Peter

AU - Kellner, Herbert

AU - Kurthen, Reiner

AU - Krüger, Klaus

AU - Rubbert-Roth, Andrea

AU - Schwenke, Holger

AU - Peters, Marvin A

AU - Tony, Hans-Peter

PY - 2019/4/27

Y1 - 2019/4/27

N2 - OBJECTIVES: To evaluate early and late responses in biological-naïve 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.CONCLUSIONS: 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.

AB - OBJECTIVES: To evaluate early and late responses in biological-naïve 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.CONCLUSIONS: 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.

KW - Antibodies, Monoclonal, Humanized/therapeutic use

KW - Antirheumatic Agents/therapeutic use

KW - Arthritis, Rheumatoid/drug therapy

KW - Double-Blind Method

KW - Humans

KW - Remission Induction

KW - Rituximab/therapeutic use

KW - Treatment Outcome

M3 - SCORING: Journal article

C2 - 31025930

VL - 37

SP - 937

EP - 945

JO - CLIN EXP RHEUMATOL

JF - CLIN EXP RHEUMATOL

SN - 0392-856X

IS - 6

ER -