PMID- 26443622
OWN - NLM
STAT- MEDLINE
DCOM- 20160605
LR  - 20240416
IS  - 1528-0020 (Electronic)
IS  - 0006-4971 (Print)
IS  - 0006-4971 (Linking)
VI  - 127
IP  - 2
DP  - 2016 Jan 14
TI  - Intravenous immune globulin and thromboembolic adverse events in patients with 
      hematologic malignancy.
PG  - 200-7
LID - 10.1182/blood-2015-05-647552 [doi]
AB  - In patients with hypogammaglobulinemia secondary to chronic lymphocytic leukemia 
      (CLL) or multiple myeloma (MM), intravenous immune globulin (IVIg) may be 
      administered to reduce the risk of infection. Since 2013, IVIg products have 
      carried a boxed safety warning about the risk of thromboembolic events (TEEs), 
      with TEEs reported in 0.5% to 15% of patients treated with IVIg. In this 
      retrospective cohort study of older patients with CLL or MM identified from the 
      Surveillance, Epidemiology, and End Results-Medicare Linked Database, we assessed 
      rates of clinically serious TEEs in 2724 new users of IVIg and a 
      propensity-matched comparison group of 8035 nonusers. For the primary end point, 
      arterial TEE, we observed a transient increased risk of TEE during the day of an 
      IVIg infusion and the day afterward (hazard ration = 3.40; 95% confidence 
      interval [CI]: 1.25, 9.25); this risk declined over the remainder of the 30-day 
      treatment cycle. When considered in terms of absolute risk averaged over a 1-year 
      treatment period, the increase in risk attributable to IVIg was estimated to be 
      0.7% (95% CI: -0.2%, 2.0%) compared with a baseline risk of 1.8% for the arterial 
      TEE end point. A statistically nonsignificant risk increase of 0.3% (95% CI: 
      -0.4%, 1.5%) compared with a baseline risk of 1.1% was observed for the venous 
      TEE end point. Further research is needed to establish the generalizability of 
      these results to patients receiving higher doses of IVIg for other indications.
FAU - Ammann, Eric M
AU  - Ammann EM
AUID- ORCID: 0000-0001-5882-5388
AD  - Department of Epidemiology and.
FAU - Jones, Michael P
AU  - Jones MP
AD  - Department of Biostatistics, College of Public Health, University of Iowa, Iowa 
      City, IA;
FAU - Link, Brian K
AU  - Link BK
AD  - Division of Hematology, Oncology and Blood & Marrow Transplantation, Department 
      of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, 
      IA;
FAU - Carnahan, Ryan M
AU  - Carnahan RM
AD  - Department of Epidemiology and.
FAU - Winiecki, Scott K
AU  - Winiecki SK
AUID- ORCID: 0000-0003-4912-4621
AD  - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation & 
      Research, US Food and Drug Administration, Silver Spring, MD;
FAU - Torner, James C
AU  - Torner JC
AD  - Department of Epidemiology and.
FAU - McDowell, Bradley D
AU  - McDowell BD
AD  - Population Research Core, Holden Comprehensive Cancer Center, University of Iowa 
      Hospitals and Clinics, Iowa City, IA; and.
FAU - Fireman, Bruce H
AU  - Fireman BH
AD  - Division of Research, Kaiser Permanente Northern California, Oakland, CA.
FAU - Chrischilles, Elizabeth A
AU  - Chrischilles EA
AD  - Department of Epidemiology and Population Research Core, Holden Comprehensive 
      Cancer Center, University of Iowa Hospitals and Clinics, Iowa City, IA; and.
LA  - eng
GR  - U58DP003862-01/DP/NCCDPHP CDC HHS/United States
GR  - HHSN261201000140C/CA/NCI NIH HHS/United States
GR  - HHSF223200910006I/FD/FDA HHS/United States
GR  - R01 NS048597/NS/NINDS NIH HHS/United States
GR  - P30 CA086862/CA/NCI NIH HHS/United States
GR  - HHSN261201000035I/CA/NCI NIH HHS/United States
GR  - U58 DP003862/DP/NCCDPHP CDC HHS/United States
GR  - HHSN261201000035C/PC/NCI NIH HHS/United States
GR  - HHSN261201000034C/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20151006
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
CIN - Blood. 2016 Jan 14;127(2):171-2. PMID: 26769768
MH  - Aged
MH  - Aged, 80 and over
MH  - Case-Control Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Hematologic Neoplasms/epidemiology/*therapy
MH  - Humans
MH  - Immunoglobulins, Intravenous/adverse effects/*therapeutic use
MH  - Immunotherapy/adverse effects/methods
MH  - Male
MH  - Retrospective Studies
MH  - SEER Program
MH  - Thromboembolism/*chemically induced/epidemiology
MH  - United States/epidemiology
PMC - PMC4713161
EDAT- 2015/10/08 06:00
MHDA- 2016/06/06 06:00
PMCR- 2017/01/14
CRDT- 2015/10/08 06:00
PHST- 2015/05/28 00:00 [received]
PHST- 2015/10/02 00:00 [accepted]
PHST- 2015/10/08 06:00 [entrez]
PHST- 2015/10/08 06:00 [pubmed]
PHST- 2016/06/06 06:00 [medline]
PHST- 2017/01/14 00:00 [pmc-release]
AID - S0006-4971(20)30558-9 [pii]
AID - 2015/647552 [pii]
AID - 10.1182/blood-2015-05-647552 [doi]
PST - ppublish
SO  - Blood. 2016 Jan 14;127(2):200-7. doi: 10.1182/blood-2015-05-647552. Epub 2015 Oct 
      6.