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Abstract Number: 1385

Discontinuation of Oral Glucocorticoid After Initiation of Biological DMARDs Due to a Higher Dose of Methotrexate; A Retrospective Observational Study Based on Data from a Japanese Multicenter Registry Study

Mochihito Suzuki1, Toshihisa Kojima 2, Nobunori Takahashi 2, Shuji Asai 2 and Naoki Ishiguro 2, 1Nagoya University Graduate School of Medicine, Nagoya, Japan, 2Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Biologic drugs, prednisolone, prednisone and methotrexate (MTX), rheumatoid arthritis, treatment

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Session Information

Date: Monday, November 11, 2019

Session Title: RA – Treatments Poster II: Established Treatments

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose:  

In the treatment of rheumatoid arthritis (RA), glucocorticoid that provide anti-inflammatory effects is an important drug. We recommend discontinuing of glucocorticoid as soon as possible, but many patients have taken oral glucocorticoid for the long term in daily clinical practice. On the other hand, there are several reports on discontinuation of glucocorticoid due to the initiation of biological disease-modifying antirheumatic drugs (bDMARD). The aim of this study is to examine association of methotrexate (MTX) dose with discontinuation of glucocorticoid after 52 weeks since initiation of 1st bDMARDs.

Methods: This study was based on data from a Japanese multicenter registry, Tsurumai Biologics Communication Registry (TBCR), and enrolled 3119 patients who used bDMARDs from 2008 Oct to 2015 Oct. We examined the status of oral glucocorticoid use after 52 weeks since initiation of bDMARDs as 1st bDMARDs. In predictive analyses, discontinuation of glucocorticoid after 52 weeks since initiation of bDMARDs was used as outcome variable. Factor associated with baseline characteristics at the time of initiation of bDMARDs was assessed with univariate and stepwise forward multivariate logistic regression. Propensity score matching (PS) matching was used to align the patients background with selection bias in observational studies. The adjustment variables were age, disease duration, sex, disease activity, seropositivity, and glucocorticoid dose.

Results: 564 patients who used glucocorticoid and MTX when bDMARDs was initiated as 1st bDMARDs were included (Table 1). 164 cases (29.1%) were discontinued glucocorticoid up to 52 weeks after initiation of bDMARDs. In the multivariate analysis, age (odds ratio (OR) 0.98), MTX dose (OR1.11) and glucocorticoid dose (OR0.87) were independently predictive factors of discontinuation of glucocorticoid at the time of initiation of bDMARDs (Table 2). When we adjusted factors of baseline characteristic by using propensity score matching of the patients group taking MTX≤8mg and MTX >8mg, 105 pairs were extracted (Table 3). In the patients group taking MTX >8 mg, discontinuous rate of glucocorticoid (41.0%) was significantly higher. Regarding the clinical course, DAS28-CRP at baseline was 4.53 in the group of patients taking MTX >8 mg, and 4.51 in the group of patients taking MTX≤8 mg, and there was no obvious significant difference. At 52 weeks, 2.87 in the group of patients taking MTX >8 mg, and 2.59 in the group of patients taking MTX≤8 mg, and there was also no obvious significant difference. Further, there was no obvious significant difference in the rate of change in disease activity.

Conclusion: This cohort study investigated the association with discontinuation of oral glucocorticoid and MTX dose in the patients treated with bDMARDs. In the clinical practice, MTX dose at the time of initiation of bDMARDs was predictive factor of discontinuation of glucocorticoid. A higher dose of MTX associated with discontinuation of glucocorticoid in the patients treated with bDMARDs. Glucocorticoid use suggested that it could be decreased or discontinued in the patients treated with bDMARDs.

Data are presented as mean±standard deviation.
bDMARDs, biological disease-modifying antirheumatic drugs; DAS28, disease activity score in 28 joints; CRP, serum c-reactive protein; MTX, methotrexate; TNF, tumor necrosis factor.

Data are presented as mean±standard deviation.
95% CI, 95% confidence interval; bDMARDs, biological disease-modifying antirheumatic drugs; DAS28, disease activity score in 28 joints; CRP, serum c-reactive protein; MTX, methotrexate; TNF, tumor necrosis factor. *P < 0.05

Data are presented as mean±standard deviation.
bDMARDs, biological disease-modifying antirheumatic drugs; MTX, methotrexate; DAS28, disease activity score in 28 joints; CRP, serum c-reactive protein. *Student’s t test, **chi-squared test.


Disclosure: M. Suzuki, Bristol-Myers Squibb, 8; T. Kojima, AbbVie, 2, 8, Abbvie, 8, Astellas, 2, 8, Bristol-Myers Squibb, 2, 8, Chugai, 2, 8, Chugai Pahrmaceutical, 2, 8, Chugai Pharmaceutical CO., LTD., 2, 8, Daiichi-Sankyo, 2, 8, Eli Lilly, 2, 8, Janssen, 2, 8, Janssen Pharmaceutical, 8, Lilly, 2, 8, Mitsubishi Tanabe, 2, 8, Novartis, 2, 8, Pfizer, 2, 8, Takeda, 2, 8, Tanabe Mitsubishi Pharma, 8; N. Takahashi, AbbVie, 8, Asahi Kasei, 8, Astellas, 8, Bristol-Myers Squibb, 8, Chugai, 8, Chugai Pharmaceutical CO.,LTD., 8, Daiichi-Sankyo, 8, Eisai, 8, Eli Lilly, 8, Janssen, 8, Mitsubishi Tanabe, 8, Ono, 8, Pfizer, 8, Takeda, 8, UCB Japan, 8; S. Asai, AbbVie, 8, Abbvie, 8, Astellas, 8, Bristol-Myers Squibb, 8, Chugai, 8, Chugai Pahrmaceutical, 8, Chugai Pharmaceutical CO.,LTD., 8, Daiichi-Sankyo, 8, Eisai, 8, Janssen, 8, Janssen Pharmaceutical, 8, Pfizer, 8, Takeda, 8, Tanabe Mitsubishi Pharma, 8, UCB Japan, 8; N. Ishiguro, AbbVie, 2, 8, Abbvie, 2, 8, Asahi Kasei, 2, 8, Astellas, 2, 8, Astellas Pharma, 2, 8, Bristol-Myers Squibb, 2, 8, Chugai, 2, 8, Chugai Pahrmaceutical, 2, 8, Chugai Pharmaceutical CO.,LTD., 2, 8, Daiichi-Sankyo, 2, 8, Eisai, 2, 8, Eli Lilly, 2, 8, Janssen Pharmaceutical, 8, Kaken, 2, 8, Lilly, 8, Medical Corporation Sanjinkai, 2, 5, 8, Medical Corporation Toukoukai, 2, 5, 8, Mitsubishi Tanabe, 2, 8, Ono, 2, 8, Otsuka, 2, 8, Pfizer, 2, 8, Taisho Toyama, 2, 8, Takeda, 2, 8, Tanabe Mitsubishi Pharma, 2, 8, UCB, 8, Zimmer Biomet, 2, 8.

To cite this abstract in AMA style:

Suzuki M, Kojima T, Takahashi N, Asai S, Ishiguro N. Discontinuation of Oral Glucocorticoid After Initiation of Biological DMARDs Due to a Higher Dose of Methotrexate; A Retrospective Observational Study Based on Data from a Japanese Multicenter Registry Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/discontinuation-of-oral-glucocorticoid-after-initiation-of-biological-dmards-due-to-a-higher-dose-of-methotrexate-a-retrospective-observational-study-based-on-data-from-a-japanese-multicenter-registr/. Accessed March 7, 2021.
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