Tocilizumab is clinically, functionally, and radiographically effective and safe either with or without low-dose methotrexate in active rheumatoid arthritis patients with inadequate responses to DMARDs and/or TNF inhibitors: A single-center retrospective cohort study (KEIO-TCZ study) at week 52

Keisuke Izumi, Yuko Kaneko, Hidekata Yasuoka, Noriyuki Seta, Hideto Kameda, Masataka Kuwana, Tsutomu Takeuchi

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Abstract

Objectives. To explore the effectiveness and safety of tocilizumab (TCZ) with or without methotrexate (MTX) in active rheumatoid arthritis (RA) patients showing inadequate responses to DMARDs and/or TNF inhibitors in clinical practice. Methods. We observed consecutive 115 RA patients initiating TCZ treatment in Keio University Hospital, dividing them into two groups with (TCZ + MTX group) or without MTX (TCZ group), and evaluated clinical, functional and structural outcomes besides safety at week 52. Results. Overall mean age, RA duration, and DAS28-ESR were 55.4, 8.4 years, and 5.0, respectively. Proportions of the prior use of TNF inhibitors and concomitant MTX were 45.5% and 57.4%, respectively. Mean dose of concomitant MTX was 8.4 mg/week. Baseline characteristics were comparable between the groups. TCZ improved disease activity measured by DAS28-ESR to 2.1 at week 52 overall, without significant difference between the groups. Clinical (DAS28-ESR < 2.6),functional (HAQ-DI =£0.5), and structural (ATSS<0.5) remission ratesintheTCZgroupand the TCZ + MTX group were 79.1%/63.8% (P = 0.10), 62.8%/54.4% (P = 0.40), and 70.0%/53.8% (P = 0.61), respectively. Retention rates were 81.0% in the TCZ + MTX group and 88.5% in the TCZ group (P = 0.47. The rate of serious adverse events was comparable between the groups. Conclusions. TCZ was clinically, functionally, and radiographically effective and safe either with or without low-dose MTX.

Original languageEnglish
JournalModern Rheumatology
Volume25
Issue number1
DOIs
Publication statusPublished - 2015

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Antirheumatic Agents
Methotrexate
Rheumatoid Arthritis
Cohort Studies
Retrospective Studies
ametantrone
Safety
tocilizumab

Keywords

  • Joint destruction
  • Methotrexate
  • Remission
  • Rheumatoid arthritis
  • Tocilizumab

ASJC Scopus subject areas

  • Rheumatology

Cite this

@article{697d039ddbce46ba98815a10754a9268,
title = "Tocilizumab is clinically, functionally, and radiographically effective and safe either with or without low-dose methotrexate in active rheumatoid arthritis patients with inadequate responses to DMARDs and/or TNF inhibitors: A single-center retrospective cohort study (KEIO-TCZ study) at week 52",
abstract = "Objectives. To explore the effectiveness and safety of tocilizumab (TCZ) with or without methotrexate (MTX) in active rheumatoid arthritis (RA) patients showing inadequate responses to DMARDs and/or TNF inhibitors in clinical practice. Methods. We observed consecutive 115 RA patients initiating TCZ treatment in Keio University Hospital, dividing them into two groups with (TCZ + MTX group) or without MTX (TCZ group), and evaluated clinical, functional and structural outcomes besides safety at week 52. Results. Overall mean age, RA duration, and DAS28-ESR were 55.4, 8.4 years, and 5.0, respectively. Proportions of the prior use of TNF inhibitors and concomitant MTX were 45.5{\%} and 57.4{\%}, respectively. Mean dose of concomitant MTX was 8.4 mg/week. Baseline characteristics were comparable between the groups. TCZ improved disease activity measured by DAS28-ESR to 2.1 at week 52 overall, without significant difference between the groups. Clinical (DAS28-ESR < 2.6),functional (HAQ-DI =£0.5), and structural (ATSS<0.5) remission ratesintheTCZgroupand the TCZ + MTX group were 79.1{\%}/63.8{\%} (P = 0.10), 62.8{\%}/54.4{\%} (P = 0.40), and 70.0{\%}/53.8{\%} (P = 0.61), respectively. Retention rates were 81.0{\%} in the TCZ + MTX group and 88.5{\%} in the TCZ group (P = 0.47. The rate of serious adverse events was comparable between the groups. Conclusions. TCZ was clinically, functionally, and radiographically effective and safe either with or without low-dose MTX.",
keywords = "Joint destruction, Methotrexate, Remission, Rheumatoid arthritis, Tocilizumab",
author = "Keisuke Izumi and Yuko Kaneko and Hidekata Yasuoka and Noriyuki Seta and Hideto Kameda and Masataka Kuwana and Tsutomu Takeuchi",
year = "2015",
doi = "10.3109/14397595.2014.897793",
language = "English",
volume = "25",
journal = "Modern Rheumatology",
issn = "1439-7595",
publisher = "Springer Japan",
number = "1",

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TY - JOUR

T1 - Tocilizumab is clinically, functionally, and radiographically effective and safe either with or without low-dose methotrexate in active rheumatoid arthritis patients with inadequate responses to DMARDs and/or TNF inhibitors

T2 - A single-center retrospective cohort study (KEIO-TCZ study) at week 52

AU - Izumi, Keisuke

AU - Kaneko, Yuko

AU - Yasuoka, Hidekata

AU - Seta, Noriyuki

AU - Kameda, Hideto

AU - Kuwana, Masataka

AU - Takeuchi, Tsutomu

PY - 2015

Y1 - 2015

N2 - Objectives. To explore the effectiveness and safety of tocilizumab (TCZ) with or without methotrexate (MTX) in active rheumatoid arthritis (RA) patients showing inadequate responses to DMARDs and/or TNF inhibitors in clinical practice. Methods. We observed consecutive 115 RA patients initiating TCZ treatment in Keio University Hospital, dividing them into two groups with (TCZ + MTX group) or without MTX (TCZ group), and evaluated clinical, functional and structural outcomes besides safety at week 52. Results. Overall mean age, RA duration, and DAS28-ESR were 55.4, 8.4 years, and 5.0, respectively. Proportions of the prior use of TNF inhibitors and concomitant MTX were 45.5% and 57.4%, respectively. Mean dose of concomitant MTX was 8.4 mg/week. Baseline characteristics were comparable between the groups. TCZ improved disease activity measured by DAS28-ESR to 2.1 at week 52 overall, without significant difference between the groups. Clinical (DAS28-ESR < 2.6),functional (HAQ-DI =£0.5), and structural (ATSS<0.5) remission ratesintheTCZgroupand the TCZ + MTX group were 79.1%/63.8% (P = 0.10), 62.8%/54.4% (P = 0.40), and 70.0%/53.8% (P = 0.61), respectively. Retention rates were 81.0% in the TCZ + MTX group and 88.5% in the TCZ group (P = 0.47. The rate of serious adverse events was comparable between the groups. Conclusions. TCZ was clinically, functionally, and radiographically effective and safe either with or without low-dose MTX.

AB - Objectives. To explore the effectiveness and safety of tocilizumab (TCZ) with or without methotrexate (MTX) in active rheumatoid arthritis (RA) patients showing inadequate responses to DMARDs and/or TNF inhibitors in clinical practice. Methods. We observed consecutive 115 RA patients initiating TCZ treatment in Keio University Hospital, dividing them into two groups with (TCZ + MTX group) or without MTX (TCZ group), and evaluated clinical, functional and structural outcomes besides safety at week 52. Results. Overall mean age, RA duration, and DAS28-ESR were 55.4, 8.4 years, and 5.0, respectively. Proportions of the prior use of TNF inhibitors and concomitant MTX were 45.5% and 57.4%, respectively. Mean dose of concomitant MTX was 8.4 mg/week. Baseline characteristics were comparable between the groups. TCZ improved disease activity measured by DAS28-ESR to 2.1 at week 52 overall, without significant difference between the groups. Clinical (DAS28-ESR < 2.6),functional (HAQ-DI =£0.5), and structural (ATSS<0.5) remission ratesintheTCZgroupand the TCZ + MTX group were 79.1%/63.8% (P = 0.10), 62.8%/54.4% (P = 0.40), and 70.0%/53.8% (P = 0.61), respectively. Retention rates were 81.0% in the TCZ + MTX group and 88.5% in the TCZ group (P = 0.47. The rate of serious adverse events was comparable between the groups. Conclusions. TCZ was clinically, functionally, and radiographically effective and safe either with or without low-dose MTX.

KW - Joint destruction

KW - Methotrexate

KW - Remission

KW - Rheumatoid arthritis

KW - Tocilizumab

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DO - 10.3109/14397595.2014.897793

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