PMID- 24720551
OWN - NLM
STAT- MEDLINE
DCOM- 20150821
LR  - 20191210
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 25
IP  - 1
DP  - 2015 Jan
TI  - Efficacy and safety of mavrilimumab in Japanese subjects with rheumatoid 
      arthritis: findings from a Phase IIa study.
PG  - 21-30
LID - 10.3109/14397595.2014.896448 [doi]
AB  - OBJECTIVE: A phase IIa study investigated efficacy and safety/tolerability of 
      ascending doses of mavrilimumab (anti-granulocyte-macrophage colony-stimulating 
      factor receptor [GM-CSFR]alpha monoclonal antibody) in adult subjects with moderate 
      to severe rheumatoid arthritis from Japan and Europe. Findings from the Japanese 
      population are presented. METHODS: Fifty-one subjects received mavrilimumab 
      (10-100 mg) or placebo subcutaneously every other week for 12 weeks, followed by 
      a 12-week follow-up period. The primary endpoint was the proportion of subjects 
      achieving a Disease Activity Score using 28 joints (DAS28)-C-reactive protein 
      (CRP) response (decrease > 1.2 from baseline). Secondary endpoints included 
      DAS28-CRP remission, Health Assessment Questionnaire Disability Index (HAQ-DI) 
      and American College of Rheumatology (ACR) response. RESULTS: By Week 12, more 
      mavrilimumab- versus placebo-treated subjects achieved a DAS28-CRP response 
      (50.0% vs. 23.5%, p = 0.081); a significant response was seen in the 30 mg and 
      100 mg dose groups (both 75.0% vs. 23.5%, p = 0.028). The 100 mg group also 
      demonstrated statistically significant HAQ-DI and ACR20 responses at Week 12. 
      Results were generally consistent between Japanese and European populations. 
      Overall, adverse events (AEs) were mild to moderate in intensity with one serious 
      AE of pneumonia, considered possibly treatment-related. CONCLUSIONS: A rapid and 
      clinically meaningful response was seen in subjects treated with GM-CSFRalpha 
      blockade with mavrilimumab, supporting further investigation of mavrilimumab for 
      the treatment of RA in Japanese subjects.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Keio University School of Medicine , Tokyo , Japan.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
FAU - Close, David
AU  - Close D
FAU - Godwood, Alex
AU  - Godwood A
FAU - Wu, Chi-Yuan
AU  - Wu CY
FAU - Saurigny, Didier
AU  - Saurigny D
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140411
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 1158JD1P9A (mavrilimumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/administration & dosage/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Methotrexate/administration & dosage/*therapeutic use
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Granulocyte-macrophage colony-stimulating factor
OT  - Mavrilimumab
OT  - Phase II
OT  - Rheumatoid arthritis
EDAT- 2014/04/12 06:00
MHDA- 2015/08/22 06:00
CRDT- 2014/04/12 06:00
PHST- 2014/04/12 06:00 [entrez]
PHST- 2014/04/12 06:00 [pubmed]
PHST- 2015/08/22 06:00 [medline]
AID - 10.3109/14397595.2014.896448 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2015 Jan;25(1):21-30. doi: 10.3109/14397595.2014.896448. Epub 2014 
      Apr 11.