PMID- 27471815
OWN - NLM
STAT- MEDLINE
DCOM- 20170509
LR  - 20191210
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 27
IP  - 2
DP  - 2017 Mar
TI  - Efficacy and safety of tabalumab plus standard of care in Japanese patients with 
      active systemic lupus erythematosus: Subgroup analyses of the ILLUMINATE-1 study.
PG  - 284-291
LID - 10.1080/14397595.2016.1206260 [doi]
AB  - OBJECTIVE: To assess the efficacy and safety of tabalumab, an anti-B cell 
      activating factor (BAFF) antibody, in combination with standard of care (SoC) 
      therapy in Japanese patients with active systemic lupus erythematosus (SLE). 
      METHODS: A subgroup analysis was conducted in Japanese patients (n = 45) enrolled 
      in ILLUMINATE-1, a phase III global trial in SLE patients (N = 1164). Patients 
      received SoC plus tabalumab or placebo, starting with a loading dose (240 mg) at 
      week 0, followed by 120 mg every 4 weeks (120 Q4W, n = 15), 120 mg every 2 weeks 
      (120 Q2W, n = 15), or placebo Q2W (n = 15). The primary endpoint was proportion 
      achieving SLE Responder Index-5 (SRI-5) improvement at week 52. RESULTS: A 
      numerically greater SRI-5 response rate was achieved with 120 Q2W (46.7%; 
      p = 0.059 vs. placebo) compared with 120 Q4W (20.0%) and placebo Q2W (13.3%). The 
      proportion of patients with severe SLE flare was lower for 120 Q2W (0%) and 120 
      Q4W (6.7%) than for placebo (26.7%). The rates of serious adverse events (AEs) 
      and treatment-emergent AEs were similar across treatments. CONCLUSION: In 
      Japanese SLE patients, tabalumab 120 Q2W improved SRI-5 response rate and reduced 
      the frequency of severe flares compared with placebo. Safety profiles were 
      similar with tabalumab and placebo.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AD  - a The First Department of Internal Medicine , School of Medicine, University of 
      Occupational and Environmental Health , Kitakyushu , Japan.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - b Division of Rheumatology, Department of Internal Medicine , Keio University 
      School of Medicine , Tokyo , Japan.
FAU - Akashi, Naotsugu
AU  - Akashi N
AD  - c Eli Lilly Japan K.K. , Kobe , Japan , and.
FAU - Takita, Yasushi
AU  - Takita Y
AD  - c Eli Lilly Japan K.K. , Kobe , Japan , and.
FAU - Kovacs, Birgit
AU  - Kovacs B
AD  - d Eli Lilly and Company , Indianapolis , IN , USA.
FAU - Kariyasu, Sawako
AU  - Kariyasu S
AD  - c Eli Lilly Japan K.K. , Kobe , Japan , and.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160729
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - PQP8VH3MJW (tabalumab)
SB  - IM
EIN - Mod Rheumatol. 2016 Nov;26(6):i. PMID: 27782755
MH  - Adult
MH  - Antibodies, Monoclonal/administration & dosage/*adverse effects/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Female
MH  - Humans
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Standard of Care
OTO - NOTNLM
OT  - BAFF
OT  - Japanese
OT  - SRI
OT  - Safety
OT  - Systemic lupus erythematosus
EDAT- 2016/07/30 06:00
MHDA- 2017/05/10 06:00
CRDT- 2016/07/30 06:00
PHST- 2016/07/30 06:00 [pubmed]
PHST- 2017/05/10 06:00 [medline]
PHST- 2016/07/30 06:00 [entrez]
AID - 10.1080/14397595.2016.1206260 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2017 Mar;27(2):284-291. doi: 10.1080/14397595.2016.1206260. Epub 
      2016 Jul 29.