Lack of Additive Benefits of Concomitant Methotrexate Use to Tocilizumab Monotherapy for Rheumatoid Arthritis in Daily Clinical Practice

Keisuke Izumi¹, Yuko Kaneko², Hidekata Yasuoka³, Noriyuki Seta⁴, Hideto Kameda⁵, Masataka Kuwana⁵ and Tsutomu Takeuchi⁶, ¹Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, ²Dept of Internal Medicine, Keio Univ School of Medicine, Shinjuku-ku, Japan, ³Division of Rheumatology, Department of Internal Medicine, Keio Univ School of Medicine, Tokyo, Japan, ⁴Department of Internal Medicine, Keio university, Tokyo, Japan, ⁵Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ⁶Keio University School of Medicine, Tokyo, Japan

Meeting: ACR/ARHP Annual Meeting 2012

Keywords: methotrexate (MTX), radiography, Rheumatoid arthritis (RA), tocilizumab and treatment

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose:

To explore the benefit of concomitant use of methotrexate (MTX) for the effectiveness of TCZ in rheumatoid arthritis (RA) patients in daily clinical practice.

Methods:

A total of consecutive 115 RA patients initiating TCZ treatment in KEIO university hospital from July 2008 to March 2011 were enrolled. They received 8 mg/kg of TCZ every 4 weeks, and were observed for 52 weeks to evaluate the clinical and structural outcomes as well as safety.

Results:

Baseline patient characteristics were as follows: mean age of 55.6 years; mean disease duration of RA of 8.54 years; prior treatment with TNF inhibitors in 46.6%; concomitant use of methotrexate (MTX) in 57.3% and use of concomitant glucocorticoid was in 43.7%. Baseline patients’ characteristics were comparable between the combination group of TCZ and MTX and the TCZ monotherapy group. TCZ improved disease activity measured by DAS28-ESR from 5.02 at baseline to 1.97 at week 52; 68.9% of patients achieved DAS28 remission (DAS28-ESR < 2.6 LOCF method), and 50.0% of patients achieved CDAI remission. Structural remission (DTSS≤0.5) was achieved in 60.9 % of the patients. The percentages of DAS28 remission, CDAI remission and structural remission in patients who received TCZ as monotherapy were comparable to those in the patients who received TCZ in combination with MTX. The retention rate of TCZ at week 52 was 81.4% in TCZ monotherapy and 86.4% in TCZ plus MTX group. Safety data was comparable between the 2 groups and was as reported in previous study reports.

	TCZ combination with MTX (n=59)	TCZ monotherapy (n=44)	Total (n=103)	p
⊿DAS28-ESR (mean±SD, at week 52)	2.07±1.18	1.99±0.73	1.97±0.93	0.937*
DAS28-ESR remission (%, at week 52)	62.7	77.3	68.9	0.114**
CDAI remission (%, at week 52)	43.2	57.9	50.0	0.184**
⊿TSS (mean±SD, at week 52)	0.73±1.52	1.05±3.15	0.87±2.34	0.726*
No progression of joint damage (%, at week 52)	60.9	70.7	60.9	0.266**
Wilcoxon test between TCZ+MTX and TCZ monotherapy *Pearson’s χ2 test between TCZ+MTX and TCZ monotherapy

Conclusion:

The efficacy of TCZ was observed in RA patients regardless of the concomitant use of methotrexate in real-world clinical practice.

Disclosure:

K. Izumi,
None;

Y. Kaneko,
None;

H. Yasuoka,
None;

N. Seta,
None;

H. Kameda,
None;

M. Kuwana,
None;

T. Takeuchi,

Abbott, Astellas Pharma, Brystol-Meyers, Chugai Pharma, Eisai Pharma, Mitsubishi-Tanabe Pharma, Pﬁzer, Takeda Pharmaceutical,

ACR Meeting Abstracts - https://acrabstracts.org/abstract/lack-of-additive-benefits-of-concomitant-methotrexate-use-to-tocilizumab-monotherapy-for-rheumatoid-arthritis-in-daily-clinical-practice/