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 (ΔTSS ≤ 0.5) remission rates in the TCZ group and 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

Acknowledgements

We thank clinical research nurses, Ms. Harumi Kondo, Ms. Mayumi Ota, and Ms. Tsuneko Nakamura, for their generous assistance with collecting data.

The publication fees were partly supported by Chugai Pharmaceutical Co., Ltd.

Conflict of interest

Kameda H has received lecture fees from Mitsubishi-Tanabe Pharma, Centocor, Pfizer Japan, Takeda Pharmaceutical Co Ltd, Abbott, Eisai Pharma, and Chugai Pharma. Takeuchi T has received lecture fees from Abbott Japan Co, Abbvie GK, Asahi Kasei Pharma Corp, Astellas Pharma Inc, Astra-Zeneca KK, Bristol-Myers KK, Chugai Pharmaceutical Co, Ltd., Daiichi-Sankyo Co, Eisai Co, Eli-Lilly Japan KK, Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma Co, Novartis Pharma KK, Pfizer Japan Inc, Sanofi-aventis KK, Santen Pharmaceutical Co, Ltd., Taisho Toyama Pharmaceutical Co, Ltd., Takeda Pharmaceutical Co, Ltd., and Teijin Pharma Ltd. The other authors declare no conflict of interest.