PMID- 36680420
OWN - NLM
STAT- MEDLINE
DCOM- 20231225
LR  - 20240102
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 34
IP  - 1
DP  - 2023 Dec 22
TI  - Long-term evaluation of E6011, an anti-fractalkine monoclonal antibody, in 
      patients with rheumatoid arthritis inadequately responding to biological 
      disease-modifying antirheumatic drugs.
PG  - 45-49
LID - 10.1093/mr/road005 [doi]
AB  - OBJECTIVES: The objective of the study is to evaluate the long-term safety and 
      efficacy of E6011, a humanized anti-fractalkine monoclonal antibody, in patients 
      with rheumatoid arthritis with an inadequate response to biological 
      disease-modifying antirheumatic drugs. METHODS: In the double-blind treatment 
      phase (24 weeks), placebo or E6011 400 mg was administered until Week 10. 
      Thereafter, E6011 200 mg or 400 mg was administered to Week 22. Subjects who 
      completed the evaluation at Week 24 of the treatment phase were rolled over into 
      the extension phase. The extension phase lasted until Week 104, and all subjects 
      received E6011 400 mg or 200 mg every 2 weeks in an open-label manner until Week 
      102. RESULTS: A total of 47 subjects completed the double-blind treatment phase 
      and were rolled over into the extension phase. In total, 46 (97.9%) subjects 
      experienced any adverse events, and the incidence of treatment-related adverse 
      events was 57.4%. No clear efficacy trend in the American College of Rheumatology 
      20% response rates was observed. CONCLUSIONS: E6011 was well tolerated in active 
      rheumatoid arthritis patients who had shown an inadequate response to biologic 
      disease-modifying antirheumatic drugs, but no clear benefit in the American 
      College of Rheumatology 20% response rates was observed. Further studies are 
      needed to clarify the clinical benefit of E6011.
CI  - (c) Japan College of Rheumatology 2023. Published by Oxford University Press. All 
      rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AD  - University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Division of Rheumatology, Department of Internal Medicine, Keio University School 
      of Medicine, Tokyo, Japan.
AD  - Saitama Medical University, Saitama, Japan.
FAU - Yamanaka, Hisashi
AU  - Yamanaka H
AD  - Rheumatology, Sanno Medical Center, Tokyo, Japan.
FAU - Nanki, Toshihiro
AU  - Nanki T
AD  - Division of Rheumatology, Department of Internal Medicine, Toho University School 
      of Medicine, Tokyo, Japan.
FAU - Umehara, Hisanori
AU  - Umehara H
AD  - Division of Rheumatology and Immunology, Nagahama City Hospital, Shiga, Japan.
FAU - Yasuda, Nobuyuki
AU  - Yasuda N
AD  - KAN Research Institute Inc., Kobe, Japan.
AD  - Eisai Co. Ltd., Tokyo, Japan.
FAU - Tago, Fumitoshi
AU  - Tago F
AD  - Eisai Co. Ltd., Tokyo, Japan.
FAU - Kitahara, Yasumi
AU  - Kitahara Y
AD  - Eisai Co. Ltd., Tokyo, Japan.
AD  - Eisai Inc., Nutley, NJ, USA.
FAU - Kawakubo, Makoto
AU  - Kawakubo M
AD  - Eisai Co. Ltd., Tokyo, Japan.
FAU - Torii, Kentaro
AU  - Torii K
AD  - Eisai Co. Ltd., Tokyo, Japan.
FAU - Hojo, Seiichiro
AU  - Hojo S
AD  - Eisai Co. Ltd., Tokyo, Japan.
FAU - Kawano, Tetsu
AU  - Kawano T
AD  - KAN Research Institute Inc., Kobe, Japan.
AD  - Gastroenterology, Nichinan-City Chubu Hospital, Miyazaki, Japan.
FAU - Imai, Toshio
AU  - Imai T
AD  - KAN Research Institute Inc., Kobe, Japan.
AD  - Advanced Therapeutic Target Discovery, Department of Gastroenterology, Kobe 
      University Graduate School of Medicine, Hyogo, Japan.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - G8NT4Q571B (quetmolimab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - *Antirheumatic Agents/adverse effects
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - Drug Therapy, Combination
MH  - Double-Blind Method
MH  - Treatment Outcome
OTO - NOTNLM
OT  - E6011
OT  - fractalkine
OT  - long-term
OT  - monoclonal antibody
OT  - rheumatoid arthritis
EDAT- 2023/01/22 06:00
MHDA- 2023/12/25 06:42
CRDT- 2023/01/21 03:22
PHST- 2022/11/18 00:00 [received]
PHST- 2022/12/19 00:00 [revised]
PHST- 2023/01/04 00:00 [accepted]
PHST- 2023/12/25 06:42 [medline]
PHST- 2023/01/22 06:00 [pubmed]
PHST- 2023/01/21 03:22 [entrez]
AID - 6995205 [pii]
AID - 10.1093/mr/road005 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2023 Dec 22;34(1):45-49. doi: 10.1093/mr/road005.