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Abstract Number: 2820

Sustained Clinical Remission after Discontinuation of Infliximab with a Raising Dose Strategy in Patients with Rheumatoid Arthritis (RRRR study): A Randomized Controlled Trial

Yoshiya Tanaka1, Koji Oba2,3, Takao Koike4,5, Nobuyuki Miyasaka6, Tsuneyo Mimori7, Tsutomu Takeuchi8, Shintaro Hirata9, Eiichi Tanaka10, Hidekata Yasuoka11, Yuko Kaneko8, Kosaku Murakami7, Tomohiro Koga12, Kazuhisa Nakano13, Koichi Amano14, Kazuyasu Ushio15, Tatsuya Atsumi16, Masayuki Inoo17, Kazuhiro Hatta18, Shinichi Mizuki19, Shohei Nagaoka20, Shinichiro Tsunoda21, Hiroaki Dobashi22, Nao Horie3 and Norihiro Sato3, 1University of Occupational and Environmental Health, Kitakyushu, Japan, 2Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan, 3Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Japan, 4Hokkaido Medical Center for Rheumatic Diseases, Sapporo, Japan, 5NTT Sapporo Medical Center, Sapporo, Japan, 6Department of Medicine and Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan, 7Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan, 8Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, 9Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan, 10Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 11Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, tokyo, Japan, 12Center for Bioinformatics and Molecular Medicine, Nagasaki University, Graduate School of Biomedical Sciences, Nagasaki, Japan, 13The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 14Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan, 15Ushio Clinic, Osaka, Japan, 16Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, 17Utazu hospital, Utatsu-cho, Japan, 18Department of General Medicine, Tenri Hospital, Tenri, Japan, 19Center for Rheumatic Diseases, Matsuyama Red Cross Hospital, Matsuyama, Japan, 20Department of Rheumatology, Yokohama Minami Kyosai Hospital, Yokohama, Japan, 21Division of Rheumatology Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan, 22Division of Endocrinology and Metabolism, Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Kagawa University, Miki-cho, Japan

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: infliximab, randomized trials, remission, rheumatoid arthritis (RA) and tumor necrosis factor (TNF)

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Session Information

Date: Tuesday, October 23, 2018

Title: 5T089 ACR Abstract: RA–Treatments IV: Strategy (2820–2825)

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Infliximab (IFX), a TNF inhibitor, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline levels of serum TNF-α could be considered as a key indicator for optimal dosing of IFX for treatment of rheumatoid arthritis (RA) to achieve the clinical response and its sustained remission. The Remission induction by Raising the dose of Remicade in RA (RRRR) study (trial registry no;UMIN000005113) was designed to evaluate the clinical remission after 54 weeks of “programmed” treatment, whose dose of IFX for each patient was determined by the baseline serum TNF-α. The sustained remission rate after 1-year discontinuation of IFX was compared to standard treatment of IFX at week 106.

Methods: RRRR study was a randomized, active controlled, multicenter phase 4 study. IFX-naïve RA patients who showed an inadequate response to MTX were randomized 1:1 to the programmed treatment strategy (programmed group) and the standard treatment strategy (standard group).

Patients in programmed group received 3 mg/kg IFX at week 0, 2, and 6. After 14 weeks, a dose of IFX was kept or raised based on baseline levels of serum TNF-α (3 mg/kg for TNF-α < 0.55 pg/mL; 6 mg/kg for 0.55 pg/mL- <1.65 pg/mL; 10mg/kg for 1.65 pg/mL or greater) every 8 weeks until week 54 after enrollment. Patients in standard group received 3mg/kg of IFX from week 0 to 54. If patients showed a simplified disease activity index (SDAI) ≤ 3.3 at week 54, they discontinued IFX. The primary endpoint was the proportion of patients who kept discontinuation of IFX at week 106 (1-year sustained discontinuation rate).

Results: From April 2011 to September 2013, 405 patients were enrolled and 337 patients who completed IFX treatment at week 0, 2, and 6 were randomized to the programmed group (n = 170) and the standard group (n = 167). The patient characteristics in intention-to treat population were similar between groups (Table 1). One hundred and seventeen patients (68.8%) in the programmed group and 112 patients (67.1%) in the standard group completed the 54 weeks IFX treatment after enrollment. At week 54, 39.4% (67/170) in the programmed group and 32.3% (54/167) in the standard group could attain the remission defined by SDAI (p = 0.176) and withdrew IFX treatment.

At week 106, the 1-year sustained discontinuation rate of the programmed group and standard group was 23.5% (40/170) and 21.6% (36/167), respectively (2.2% difference, 95% confidence interval = -6.6 to 11.0%; p = 0.631). No difference was observed in severe infections and other severe adverse events between groups.

Conclusion: Programmed treatment strategy using different dose of IFX based on the baseline levels of serum TNF-α tended to increase the remission rate at week 54, but did not increase the sustained remission rate after 1-year discontinuation of IFX treatment at week 106.

Table1. Patients characteristics

Standard group

(N = 167)

Programmed group

(N = 170)

Age, years, median (range)

59 (20 to 83)

58 (20 to 81)

Female, n (%)

136 (81.4)

129 (75.9)

Duration of disease, > 3 years, n (%)

69 (41.3)

71 (41.8)

Baseline SDAI, mean (SD)

27.0 (13.1)

28.2 (14.1)

Tender/painful joint count, mean (SD)

7.7 (6.4)

8.7 (6.4)

Swollen joint count, mean (SD)

7.4 (5.2)

7.4 (4.9)

Patients’ global assessment VAS, mean (SD)

49.8 (19.1)

50.7 (25.1)

Physicians’ global assessment VAS, mean (SD)

49.0 (19.1)

48.6 (22.4)

CRP, mg/dL, median (range)

0.91 (0.0 to 15.1)

1.0 (0.0 to 20.7)

Baseline DAS28 CRP, mean (SD)

4.1 (1.0)

4.2 (1.0)

Baseline TNF-α, < 0.55 pg/dL, n (%)

55 (32.9)

51 (30.0)

Baseline TNF-α, 0.55 to < 1.65 pg/dL, n (%)

61 (36.5)

68 (40.0)

Baseline TNF-α, > 1.65 pg/dL, n (%)

51 (30.5)

51 (30.0)

HAQ-DI score, mean (SD)

1.0 (0.8)

1.0 (0.8)

mTSS, median (range)

8.25 (0 to 318)

8 (0 to 403)

RF, IU/ml, median (range)

45.2 (0 to 2301)

59 (0 to 2050)

Dose of MTX, mg/w, mean (SD)

10.8 (3.2)

11.5 (3.3)

SD, standard deviation;SDAI, simplified disease activity index; VAS, visual analog scale; CRP, C-reactive protein; DAS28, disease activity score 28; HAQ-DI, health assessment questionnaire disability index; mTSS, modified total sharp score; RF, rheumatoid factor;


Disclosure: Y. Tanaka, Mitsubishi-Tanabe, Bristol-Myers Squibb, Eisai, Chugai, Takeda, AbbVie, Astellas, Daiichi-Sankyo, Ono, MSD, Taisho-Toyama, 2,Daiichi-Sankyo, Astellas, Eli Lilly, Chugai, Sanofi, AbbVie, YL Biologics, Bristol-Myers Squibb, GSK, UCB, Mitsubishi-Tanabe, Novartis, Eisai, Takeda, Janssen, Asahi Kasei, 8; K. Oba, Asahi Kasei Pharma Co.; Eisai Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Tsumura & Co., 4,Chugai Pharmaceutical Co, Ltd.; Daiichi Sankyo Co., Ltd.; Merck Serono Co., Ltd., 7; T. Koike, AbbVie,Ayumi Pharma ,Astellas Pharma,Bristol-Myers,Chugai Pharmaceutical,Daiichi Sankyo,Eisai ,Mitsubishi Tanabe Pharma,Pfizer Japan,Takeda Pharm,Teijin Pharma,UCB Pharma., 8,Bristol-Myers,Eli Lilly Japan,Pfizer Japan,Daiichi Sankyo,Sanofi, 5; N. Miyasaka, None; T. Mimori, Acterion, Astellas, Asahi Kasei Pharma, Ayumi, Chugai, Daiichi Sankyo, Eisai, JB, Mitsubishi Tanabe, MSD, Nippon Shinyaku, Pfizer, Sanofi and Takeda, and speakers’ fee from Bristol-Myers Squibb, Chugai and Mitsubishi-Tanabe, 2; T. Takeuchi, Astellas Pharma Inc, Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Asahikasei Pharma Corp., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc.,Eisai Co., Ltd., AYUMI Pharmaceutical Corporation, Nipponka, 2,AbbVie GK., Bristol–Myers K.K., Chugai Pharmaceutical Co,. Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., and Astellas Pharma Inc, and Diaichi Sankyo Co.,Ltd., Eisai Co., Ltd., Sanofi K.K., Teijin Pharma Ltd., Takeda Pharmaceutical Co., Ltd., Nova, 8,Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Abbivie GK, Nipponkayaku Co.Ltd, Janssen Pharmaceutical K.K., Astellas Pharma Inc,. Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co, Ltd., Taisho Toyama, 5; S. Hirata, AbbVie, Ayumi, Eli Lilly, UCB, 2,Bristol-Myers Squibb, UCB, 9,AbbVie, Eisai, Tanabe-Mitsubishi, 9,AbbVie, Astellas, Ayumi, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, Jansen, Kissei, Pfizer, Sanofi, Takeda, Tanabe-Mitsubishi, UCB, 8; E. Tanaka, Abbvie, Ayumi Pharmaceutical, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, and UCB Pharma, 9; H. Yasuoka, None; Y. Kaneko, Eisai, Abbvie, 2,AbbVie, Astellas, Ayumi, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, Hisamitsu, Jansen, Kissei, Pfizer, Sanofi, Takeda, Tanabe-Mitsubishi, and UCB, 8; K. Murakami, Mitsubishi-Tanabe, 2,Mitsubishi-Tanabe, 8; T. Koga, None; K. Nakano, Mitsubishi-Tanabe, Astellas, Eisai, 2,Abbvie, Chugai, Daiichi-Sankyo, Bristol-Myers, Mitsubishi-Tanabe, Astellas, Pfizer, Asahi-kasei, Sanofi, Janssen, 8; K. Amano, Mitsubishi Tanabe Pharma Co., 5; K. Ushio, None; T. Atsumi, Bayer Yakuhin Co.Ltd.,Otsuka Pharmaceutical Co.,Lt d. Chugai Pharmaceutical Co., Ltd ., Takeda Pharmaceutical Co., Ltd ., Eisai Co. ,Ltd., Bristol- Myers Squibb Co., Daiichi Sankyo Co., Ltd., Mitsubishi Tanabe Pharma Co., Asahi asei Pharma Co., 2,Mitsubishi Tanabe Pharma Co., Chugai Pharmaceutical Co., Ltd., Astellas Pharma Inc., Takeda Pharmaceutical Co., Ltd., Pfier lnc., Daiichi Sankyo Co., Ltd., Bristol-Myers Squibb Co., Eli Lilly Japan, 8; M. Inoo, None; K. Hatta, None; S. Mizuki, AbbVie,Chugai Pharmaceutical., 2,Mitsuibishi-Tanabe, Takeda, Janssen,AbbVie,Pfizer., 8; S. Nagaoka, None; S. Tsunoda, None; H. Dobashi, None; N. Horie, None; N. Sato, None.

To cite this abstract in AMA style:

Tanaka Y, Oba K, Koike T, Miyasaka N, Mimori T, Takeuchi T, Hirata S, Tanaka E, Yasuoka H, Kaneko Y, Murakami K, Koga T, Nakano K, Amano K, Ushio K, Atsumi T, Inoo M, Hatta K, Mizuki S, Nagaoka S, Tsunoda S, Dobashi H, Horie N, Sato N. Sustained Clinical Remission after Discontinuation of Infliximab with a Raising Dose Strategy in Patients with Rheumatoid Arthritis (RRRR study): A Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/sustained-clinical-remission-after-discontinuation-of-infliximab-with-a-raising-dose-strategy-in-patients-with-rheumatoid-arthritis-rrrr-study-a-randomized-controlled-trial/. Accessed .
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