PMID- 23213069
OWN - NLM
STAT- MEDLINE
DCOM- 20130606
LR  - 20220317
IS  - 1477-0962 (Electronic)
IS  - 0961-2033 (Linking)
VI  - 22
IP  - 2
DP  - 2013 Feb
TI  - Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 
      studies in patients with systemic lupus erythematosus.
PG  - 144-54
LID - 10.1177/0961203312469259 [doi]
AB  - Safety data were pooled and analyzed from one phase 2 and two phase 3 
      double-blind, placebo-controlled, repeat-dose systemic lupus erythematosus (SLE) 
      trials of belimumab 1, 4 (phase 2 only), and 10 mg/kg. Types and rates of adverse 
      events (AEs) were similar across treatment groups. Rates of patients experiencing 
      any serious AE were 16.6%, 19.5%, 13.5%, and 18.0% with placebo, and belimumab 1, 
      4, and 10 mg/kg, respectively; rates of serious infusion reactions (including 
      hypersensitivity reactions) occurring on the same days as infusions were 0.4%, 
      0.9%, 0%, and 0.9%, and rates of serious infections were 5.5%, 7.1%, 6.3%, and 
      5.3%. Malignancy rates/100 patient-years (excluding non-melanoma skin cancer) 
      were 0.29 with placebo vs. 0.20 with all belimumab doses combined; mortality 
      rates/100 patient-years were 0.43 vs. 0.73. These data support the conclusion 
      that belimumab in combination with standard SLE therapy was generally well 
      tolerated in a predominantly autoantibody-positive population with active SLE.
FAU - Wallace, D J
AU  - Wallace DJ
AD  - Cedars-Sinai Medical Center/David Geffen School of Medicine at UCLA, 8737 Beverly 
      Blvd, W Hollywood, CA 90048, USA. dwallace@ucla.edu
FAU - Navarra, S
AU  - Navarra S
FAU - Petri, M A
AU  - Petri MA
FAU - Gallacher, A
AU  - Gallacher A
FAU - Thomas, M
AU  - Thomas M
FAU - Furie, R
AU  - Furie R
FAU - Levy, R A
AU  - Levy RA
FAU - van Vollenhoven, R F
AU  - van Vollenhoven RF
FAU - Cooper, S
AU  - Cooper S
FAU - Zhong, Z J
AU  - Zhong ZJ
FAU - Freimuth, W
AU  - Freimuth W
FAU - Cervera, R
AU  - Cervera R
CN  - BLISS-52 and -76, and LBSL02 Study Groups
LA  - eng
SI  - ClinicalTrials.gov/NCT00071487
SI  - ClinicalTrials.gov/NCT00410384
SI  - ClinicalTrials.gov/NCT00424476
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20121204
PL  - England
TA  - Lupus
JT  - Lupus
JID - 9204265
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
EDAT- 2012/12/06 06:00
MHDA- 2013/06/07 06:00
CRDT- 2012/12/06 06:00
PHST- 2012/12/06 06:00 [entrez]
PHST- 2012/12/06 06:00 [pubmed]
PHST- 2013/06/07 06:00 [medline]
AID - 0961203312469259 [pii]
AID - 10.1177/0961203312469259 [doi]
PST - ppublish
SO  - Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.