PMID- 23268367
OWN - NLM
STAT- MEDLINE
DCOM- 20131017
LR  - 20191210
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Linking)
VI  - 72
IP  - 9
DP  - 2013 Sep 1
TI  - Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid 
      arthritis with an inadequate response to TNF inhibitors.
PG  - 1461-8
LID - 10.1136/annrheumdis-2012-202775 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of tabalumab, a monoclonal 
      antibody that neutralises membrane-bound and soluble B-cell activating factor 
      (BAFF), in patients with active rheumatoid arthritis (RA) who showed inadequate 
      response to tumour necrosis factor (TNF) inhibitors. METHODS: Patients on stable 
      methotrexate and with inadequate response to one or more TNF inhibitors were 
      randomised to placebo (n=35), 30 mg tabalumab (n=35) or 80 mg tabalumab (n=30) 
      given intravenously at 0, 3 and 6 weeks. The primary outcome was the proportion 
      of patients achieving an American College of Rheumatology 50% response (ACR50) at 
      week 16 (all tabalumab-treated patients vs placebo). RESULTS: At week 16, no 
      significant differences were observed in the combined tabalumab group versus 
      placebo in ACR50 (12.7% vs 2.9%, p=0.101) or ACR20 response rates (27.0% vs 
      17.1%, p=0.198). However, significant differences between the combined tabalumab 
      group and placebo were observed at earlier time points for ACR20, ACR50 and 
      Disease Activity Score in 28 joints (DAS28)-C-reactive protein (CRP) reduction. 
      Treatment-emergent adverse events (AEs) were similar with 30 mg tabalumab 
      (65.7%), 80 mg tabalumab (76.7%) and placebo (71.4%), although certain events 
      occurred more often with tabalumab than placebo (eg, infection, anaemia and 
      gastrointestinal events). Serious AEs occurred in two (6.7%) patients receiving 
      80 mg tabalumab and three (8.6%) receiving placebo, with one serious infection in 
      the placebo group. Initial increases in total and mature B cells were followed by 
      progressive decreases, despite declines in serum tabalumab. CONCLUSIONS: At week 
      16, the primary end point was not achieved, but an indication of efficacy was 
      observed at earlier time points. Safety findings for tabalumab were consistent 
      with other biological RA therapies. CLINICAL TRIAL REGISTRATION NUMBER: 
      NCT00689728.
FAU - Genovese, Mark C
AU  - Genovese MC
AD  - Division of Immunology and Rheumatology, Stanford University, , Palo Alto, CA 
      94304, USA. Genovese@Stanford.edu
FAU - Fleischmann, Roy M
AU  - Fleischmann RM
FAU - Greenwald, Maria
AU  - Greenwald M
FAU - Satterwhite, Julie
AU  - Satterwhite J
FAU - Veenhuizen, Melissa
AU  - Veenhuizen M
FAU - Xie, Li
AU  - Xie L
FAU - Berclaz, Pierre-Yves
AU  - Berclaz PY
FAU - Myers, Stephen
AU  - Myers S
FAU - Benichou, Olivier
AU  - Benichou O
LA  - eng
SI  - ClinicalTrials.gov/NCT00689728
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121225
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (B-Cell Activating Factor)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - PQP8VH3MJW (tabalumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adolescent
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/physiopathology
MH  - B-Cell Activating Factor/*antagonists & inhibitors
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Resistance
MH  - Drug Therapy, Combination
MH  - Female
MH  - Health Status
MH  - Humans
MH  - Injections, Intravenous
MH  - Joints/drug effects/physiopathology
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor-alpha/*antagonists & inhibitors
MH  - Young Adult
OTO - NOTNLM
OT  - Autoimmune Diseases
OT  - Methotrexate
OT  - Rheumatoid Arthritis
OT  - TNF-alpha
OT  - Treatment
EDAT- 2012/12/27 06:00
MHDA- 2013/10/18 06:00
CRDT- 2012/12/27 06:00
PHST- 2012/12/27 06:00 [entrez]
PHST- 2012/12/27 06:00 [pubmed]
PHST- 2013/10/18 06:00 [medline]
AID - annrheumdis-2012-202775 [pii]
AID - 10.1136/annrheumdis-2012-202775 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2013 Sep 1;72(9):1461-8. doi: 10.1136/annrheumdis-2012-202775. 
      Epub 2012 Dec 25.